VARG HVAD 2018 Report

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Creating and Sustaining Partnerships for Strengthened HIV Vaccine Advocacy HIV Vaccine Awareness Day 2018 Report

thevarg.org #HVAD2018

INDEX

Objectives of the VARG

2

VARG Members

6

Emissaries

10

South Africa

12

Malawi

17

Zimbabwe

18

Thailand

19

Uganda

21

Nigeria

24

United States of America

26

Kenya

27

Creating and Sustaining Partnerships for Strengthened HIV Vaccine Advocacy #HVAD2018

Vaccines are among the most efficient tools for promoting individual and public health.

The Vaccine Advocacy Resource Group (VARG), is an independent, advocate led, global team of AIDS prevention research advocates that play a critical liaison role in the highly complex field of HIV vaccine research. Since 2013, the VARG convenes virtually to receive research updates, discuss advocates’ perspectives for planned HIV vaccine research, and set out priority actions for ongoing and future HIV vaccine research. VARG has served as a critical platform for bringing together vaccine-specific advocates to build their skills and understanding to effectively engage, navigate and influence traditionally scientific spaces, strengthen our engagement with communities, and continue to hold networks, civil society and trial sites accountable to each other.

The VARG promotes a human rights perspective to HIV vaccine research and amplifies the voices of communities across the globe where research happens.

HIV Vaccine Awareness Day (HVAD) on 18 May commemorates U.S. President Bill Clinton’s 1997 declaration that, “only a truly effective, preventive HIV vaccine can limit and eventually eliminate the threat of AIDS”.

In 2014 alone, AIDS killed more than 1.2 million people globally and HIV newly infected 2 million people, with two-thirds of them in Sub-Saharan Africa. Recent modeling data shows us that even with substantially increased use of existing treatment and prevention options there will be hundreds of thousands of new HIV infections per year in low- and middle-income countries for decades to come. The world needs an AIDS vaccine, and science can get us there. Promising new vaccine candidates are progressing toward clinical evaluation, with late-stage studies about to begin for some.

Each year, the VARG commemorates the month of HVAD by implementing a variety of activities around the globe influenced by the local context. This report highlights some of that work and celebrates the partnerships that make the work of the VARG a possibility.

The HVAD activities undertaken this year were possible through funding from the VARG’s founding partner, AVAC. To learn more about AVAC’s HVAD 2018 activities visit: https://www.avac.org/blog/hiv-vaccine-awareness-day-2018-tools-more

Creating and Sustaining Partnerships for Strengthened HIV Vaccine Advocacy #HVAD2018 1

OBJECTIVES OF THE VARG The VARG has three main objectives and it is under objective three that HVAD activities are carried out.

Objective 1 Build the capacity of stakeholders involved in HIV vaccine research Sub Objective 1: Capacity building for the VARG to effectively engage researchers, scientists and trial networks Sub Objective 2: Capacity building for researchers, scientists and trial networks to improve partnerships with HIV Vaccine advocates Sub Objective 3: Capacity building for journalists to understand and engage with HIV vaccine research education

Objective 2 Strengthening accountability of the HIV vaccine trial sector

Objective 3 Strengthen and sustain global and national HIV vaccine advocacy mainstreamed in the HIV prevention agenda

Strategic Context As the global and national HIV prevention discourse evolves rapidly, it is essential for advocates to keep HIV vaccine advocacy on the agenda.

Strategic Approach Globally the HIV prevention discourse is shaped through a range of key allies and research institutions all with complimentary and, at times, competing agendas. The VARG aims to advocate for ongoing visibility for HIV vaccine research.

Deliverable Success •

Number of National HIV Plans that mention HIV vaccine research

•

Number of national budgets that allocate dedicated funding to advancing HIV vaccine research

•

Number of key global and national meetings that the VARG actively participates

•

Annual HIV vaccine research resource tracking advocacy alerts published

Level of Engagement One on one, virtual, National AIDS Councils, National Regulatory agencies

Creating and Sustaining Partnerships for Strengthened HIV Vaccine Advocacy #HVAD2018 2

HIV VACCINE AWARENESS DAY MAY 18

2018

The Story Is …

“The story is the science.” That’s how Larry Corey, veteran scientist and head of the HVTN, described it when AVAC spoke with him about where the vaccine field is today. (He said a lot more, too, so be sure to check out the Px Pulse podcast at www.avac.org/px-pulse in late May). There’s enormous truth in this, to be sure. In the past year, three major efficacy trials have launched to test vaccine and antibody candidates that represent years of research, innovation and insight.

Today’s vaccine vials and antibody infusion drip bags hold more effort, experimentation, careful analysis and scientific hypotheses than any products the field has ever evaluated. One story is the science—and the center spread graphics highlight the momentum in the field, and the scientific advances and the magnitude of investments, both financial and human.

But AVAC and our many partners, including those at the HVTN, know that there are other stories that are just as important.

We’re thinking of activists’ stories, advocates’ stories, women’s stories; the stories of transgender women and men, and the stories of adolescents.

There are also stories that have yet to be written. Many of these involve bridging human rights and biomedical strategies— something that’s easy to say but still quite hard to do. Many countries are expanding index testing (finding and testing the sexual and needle-sharing partners and children of people living with HIV) and self-testing (particularly for men and key populations) as part of an urgent effort to find and diagnose 95 percent of people living with HIV. These are powerful strategies. They also need to be implemented in the context of programs attentive to issues of stigma, confidentiality, community acceptance and partnership. This work is new; the story is still unfolding.

For this HIV Vaccine Awareness Day, we highlight some of the stories that we’ve gathered alongside our advocate partners over the past year. We’ll be adding new chapters in the year to come.

The Story Is…Primary prevention can’t be overlooked or oversimplified In the context of HIV, primary prevention is the term public health experts use for strategies that focus on HIV-negative people. Today’s strategies include: male and female condoms and lube; daily oral PrEP; harm reduction programs for people who inject drugs; voluntary medical male circumcision; and structural interventions. These structural interventions reduce stigma and violence against people at high risk of HIV and promote their social and economic capital. People at high risk of HIV include adolescent girls and young women, men who have sex with men, transgender individuals and other key populations.

This definition is probably familiar. Why are we writing it again? Because this existing package of strategies—

which has the potential to dramatically reduce rates of new HIV diagnoses—isn’t being taken to scale everywhere it should be. “Scale” means reaching high levels of coverage of all these tools in all of the populations that need them.

We have to keep on naming the things that need to be done, and at the same time we have to keep on reminding our allies that these tools are not enough.

Failure to incorporate research and development, funding, political commitment and timelines into the global HIV response is a failure to plan for the end of epidemic levels of HIV. It’s that simple.

The Global Prevention Coalition (GPC) and its “Prevention Roadmap” initiative at country level has, since late 2017, sought to raise the profile of primary prevention and, in doing so, it’s highlighting the Continues on back >

Creating and Sustaining Partnerships for Strengthened HIV Vaccine Advocacy #HVAD2018 3

The Story Is …

HIV Vaccine Awareness Day • May 2018

> Continued from front

challenges that exist at the country level. Budgets are tight. There is an urgent imperative to scale up testing to find people living with HIV, link them to ART and support them in achieving virologic suppression. Efforts to reach these targets in each country are taking up the bulk of national funds dedicated to HIV and affecting messaging and programmatic focus. PEPFAR is urging partners to evaluate their testing programs largely in terms of the “yield” of HIV-positive individuals identified. Programs that reach out to HIV-negative individuals at high risk of potential infection and provide them with prevention do exist, but they are supported inconsistently. They are not prioritized and they should be.

The GPC and its country-level efforts are shining a light on these gaps. But that won’t be enough.

Resources, political will and strong demands from civil society are essential.

And that still won’t be enough.

There is nothing about HIV vaccines or other prevention research in the Global Prevention Coalition framework.

This is a grievous omission. It sends the wrong message to countries and makes advocacy harder. But we are up to the challenge.

In the coming year, prevention advocates will call on the keepers of prevention roadmaps at the country and global levels, urging them to add research milestones and commitments as part of a comprehensive push to make primary prevention work, for real and for the long-term.

The Story Is…Stakeholder engagement Stakeholder engagement in research has provided crucial insights to inform trial design and build trust between researchers and trial-site communities.

Commitment to a process that brings in stakeholders early and often, and affords them an opportunity for rich collaboration with researchers is instrumental to a successful research agenda.

These are also familiar words. HIV vaccine research groups have a long and solid history of commitment to their communities. The International AIDS Vaccine Initiative (IAVI), from its early years, invested in a range of programs in the countries where it conducted research. This work continues in Kenya, India, Uganda,

Zambia and other places. Likewise, the HVTN thought extensively about community engagement—among people of color in the US and overseas—and was one of the first groups to write Good Participatory Practice (GPP) Guidelines into procedural documents. Most recently, the pharmaceutical company Janssen, a partner in the ongoing HPX2008/HVTN 705 trial, is actively developing a company-wide GPP program.

Community Advisory Boards (CABs) are one of the most familiar forms of stakeholder engagement. They have many functions but often involve leaders and community representatives who serve as partners to trial sites and may hold the trial accountable in turn.

CAB members and the research staff responsible for implementing CAB work deserve huge credit for successful trial launch, conduct and closure. With multiple efficacy trials underway within the same communities and cohorts engaged in treatment and prevention scale-up, expanded stakeholder engagement is more important than ever.

Working together, long-time vaccine advocates and researchers need to expand the conversation. It may mean they look for people who aren’t quite satisfied with the status quo, illustrated by the age-old adage that “the world needs an HIV vaccine”. It may mean engaging the PrEP advocate who has never been to a vaccine trial site, or the woman advocating for HIV prevention for her community who may have questions about how vaccine trials are conducted. As prevention research proceeds in the context of more biomedical options, all new trials must search out the skeptics and engage with concerns, and some of this is already happening.

This type of engagement can get hard and messy.

And by definition, it almost has to. If the vaccine field plans to declare success from these trials, it has to be because of a push and pull where external stakeholders have had input and trials have been responsive to community interests.

AVAC will continue to watch this story unfold. If nothing else, we look forward to telling a success story of trials that set a new standard for responsive models of stakeholder engagement and lay a foundation for what’s sure to be a future with more trials and more complexities and, hopefully, fewer new infections.

Creating and Sustaining Partnerships for Strengthened HIV Vaccine Advocacy #HVAD2018 4

Creating and Sustaining Partnerships for Strengthened HIV Vaccine Advocacy

5

#HVAD2018

Neber, Imperial College, MRC-ure, iAVI

PrEPvacc

Janssen

Ad26

P5, GSK, Sanofi Pasteur

Pox-Protein

ALVAC/AIDSVAX Clade B, A/E Thailand

2003-2009

31% efficacy

RV144

2015

KEY: IV Intravenous SC Subcutaneous

Phase I/II HIVAd26.Mos.HIV + Ad26, MVA V-A004/ or gp140 boost APPROACH Rwanda, South Africa, Thailand, Uganda, USA

Phase I gp140 + adjuvant HIV-V-A003 USA

2016

HPX1002

HPX2004/ HVTN117/ TRAVERSE

Clade C

HPX2003/ HVTN118/ ASCENT

2018 2019

HVTN 120

Phase IIb DNA+Protein or DNA+MVA with PrEP

EST. 2018-2022

PrEPvacc

Phase IIb Ad26.Mos4.HIV + gp140 South Africa, Zambia, Zimbabwe, Malawi, Mozambique

Estimated completion: 2022

HVTN 111

HPX2008/ HVTN 705

HVTN 108

South Africa Designed to lead to a product submitted for regulatory approval and eventual public health introduction.

Development Track

HVTN 107

Phase IIb/III ALVAC/gp120 Clade C

Estimated completion: July 2021

HVTN702

2017

Phase I and I/IIa prime-boost candidates with varying vectors, primes, boosts and adjuvants

Phase I and I/ II Ad26 mosaic, cladec or mosaic gp140 Kenya, Rwanda, USA

Research Track

Southern Africa and US Designed to identify components of an effective vaccine strategy.

Phase I/II ALVAC/gp120 Clade C

HVTN 100

Phase I HIVMVA Mosaic boost V-A002/ USA MENSCH

Phase Ib ALVAC/AIDSVAX Clade B/E

HVTN 097

2014

VACCINE EFFICACY TRIALS PIPELINE

The story is the science. The graphic below shows a snapshot of the status of vaccine efficacy trials. May 2018 marks continued progress in an unprecedented level of vaccine development activity.

The Story Is …

1,612

US

1.5%

1%

= Transgender men and women

= Men

= Women

= 100 participants

Basic

Preclinical

Clinical

Cohort & site development

Advocacy & policy

45%

Other

South Africa DST/SAMRC

UK MRC

ANRS

Ragon Institute Swedish Res. Council

3.9M

5M

5.3M

6M

10M

114M

70.8M

29M 12M

USAID EC

33M

MHRP

BMGF

NIH

Peru

644

4,005

88

Zambia

180

Rwanda

79

Uganda

PARTICIPANTS

9,788 TOTAL TRIAL

South Africa

629

Brazil

860

UK

21 Switzerland

2%

45%

222

222

Zimbabwe Botswana 307

306

Mozambique

267

Malawi

Tanzania Kenya 267

53%

79

Thailand

TOTAL FUNDING

US$894M

605M

TOP AIDS VACCINE FUNDERS, 2016 (US Million)

VACCINE AND ANTIBODY TRIAL PARTICIPANT RECRUITMENT, 2018

17%

36%

TOTAL VACCINE SPENDING BY AREA, 2016

The story is support and stakeholders. The top graphics depict who funds HIV vaccine research and development and how the money is spent. The bottom graphic shows numbers of vaccine trial participants throughout the world by country and by target population.

HIV Vaccine Awareness Day • May 2018

THE VARG MEMBERS Morenike Folayan Morenike has worked for many years in Nigeria, regionally, and internationally, to build capacity to enable communities engage effectively in HIV prevention research. As a co-founder of the New HIV Vaccine and Microbicide Advocacy Society in Nigeria, she has been a leader in the effort to facilitate a supportive environment for future HIV vaccine implementation research and future HIV vaccine uptakes. She contributed to Nigeria’s national HIV vaccine strategic plan development. Her particular expertise is in the development of curricula and implementation of capacity-building training and workshops for lay persons and community members to enable them to engage actively in dialogues and discussions on HIV prevention research design and implementation.

Maureen Luba Maureen Luba, a board Member of the International Partnership for Microbicides and a passionate advocate for HIV prevention tools for young women and girls. Maureen is a 2015 AVAC fellow who and a tireless advocate for HIV prevention programming in PEPFAR and the Global Fund funded projects. She currently coordinates an advocacy project that aims at improving the participation of people living with HIV and key populations in the Global Fund and PEPFAR processes in Malawi, Tanzania and Zimbabwe

Rosemary Mburu As the head of WACI Health, Rosemary is a longstanding advocate for HIV vaccines with expertise in policy analysis, budget advocacy, influencing decision making processes, mobilizing civil society and community voices for action. She has extensively worked on building and strengthening civil society organizing for health advocacy in Africa. She oversees the Civil Society Platform on Health in Africa (CISPHA) and Africa Free of New HIV Infections (AfNHI), an African-led Network on HIV Prevention Research. In Kenya, Rosemary, through WACI Health, partners with IAVI and KAVI Institute of Clinical Research in advancing vaccine research advocacy.

Creating and Sustaining Partnerships for Strengthened HIV Vaccine Advocacy #HVAD2018 6

THE VARG MEMBERS Tian Johnson Lead consultant to the South African National AIDS Council on the development of Human Rights, Stigma and Discrimination content for the country’s National Strategic Plan on HIV, STI’s and TB 2017 – 2022, Tian has over the last two decades worked on a vast range of development areas. He brings to the VARG the ability to navigate and influence policy and community spaces within the epidemic response nationally and regionally.

Historically, Tian’s work centred around access to education for girls, the prevention of gender based violence, creating and sustaining networks of people with HIV and documenting South Africa’s integrated strategy for the prevention of, response to and support for survivors of sexual assault billed by former U.N. Secretary General Ban Ki Moon as a best practice model. While directing a national programme that sought to end rape in all forms of detention, Tian has also focused on female condom programming and contraceptive access, vaginal microbicide programming models, the intersections of faith and sexual rights and reviewing comprehensive sexuality education models in 12 African countries. Tian has consulted on work that looks at monitoring and mitigating the impact of gender violence and HIV amongst sex workers as well as an analysis of women’s access to paralegal services in the context of HIV and gender based violence in Sub Saharan Africa. As an independent consultant, Tian currently sits on the Strategic Advisory group for the Coalition to Accelerate and Support Prevention Research (CASPR) a five year USAID supported project that seeks to build and sustain an Africa-centred network for advancing advocacy, policy, regulatory, community engagement and communications efforts to accelerate biomedical HIV prevention research. Tian represents the VARG on the African AIDS Vaccine Virtual Network Steering Committee.

Ntando Yola Ntando Yola is a co-lead of the newly formed South Africa civil society resource group on prevention research named the Advocacy for `Prevention of HIV and AIDS (APHA). A 2013 AVAC Fellow with a track record in advocacy for stakeholder engagement in HIV prevention trials he was a keynote speaker at the 2013 AIDS Vaccine conference at which he contributed to setting the standard for civil society engagement in vaccine research meetings. He has invested over a decade working with the Desmond Tutu HIV Centre and is well known in the South Africa vaccine development community. His community engagement work has included working in trials across various research networks as a member of the HIV Vaccine Trials Network’ (HVTN) Social Behavioral Working Group and the current Community Working Group (CWG) Co-Chair of the HIV Prevention Trials Network (HPTN). Ntando is committed to facilitating VARG support to civil society groups and other role players in South Africa through dissemination of appropriate messaging and mobilization of all role players for HIV vaccine research and development.

Creating and Sustaining Partnerships for Strengthened HIV Vaccine Advocacy #HVAD2018 7

THE VARG MEMBERS Chamunorwa (Chamu) Mashoko Chamunorwa was a 2012 AVAC fellow. His decade of HIV prevention research experience began when he joined University of Zimbabwe–University of California San Francisco (UZ-UCSF) Research collaboration as a community outreach worker. In the following years, he has become a vocal prevention research advocate concerned with women’s prevention needs. Chamunorwa leads Advocacy Core Team (ACT), a collective of 20 civil society organizations championing access to quality health services for all. ACT plays a critical role through its membership in assisting the Ministry of Health. He is also involved in updating communities on HIV clinical studies and is currently sensitizing communities in Zimbabwe on the AMP, HOPE and DREAM studies.

Udom Likhitwonnawut Udom has worked on HIV prevention advocacy and programming for nearly 20 years. A Community Advisory Board member of a research institute affiliated with Chiang Mai University he is regularly called upon to participate in global and regional scientific and think-tanks meetings. He is currently associated with the Thai NGO Coalition on AIDS (TNCA). Udom leads Good Participatory Practice efforts in Thailand both with research centers and with national bodies, most notably the Thai Ministry of Public Health. Through TNCA, Udom has also co-organized Thailand’s first National Community Advisor Board.

Matthew Rose Matthew Rose is an HIV, AIDS, and social justice advocate working in federal health policy. He currently serves as the Policy and Advocacy Manager for NMAC formerly known as the National Minority AIDS Council. He is responsible for NMAC’s policy and advocacy portfolio. He supports and works to develop and implement NMAC’s policy positions on federal appropriations and authorization legislation related to HIV/AIDS and health disparities. Matthew was a volunteer in the HVTN 505 trial and spoke out publicly about his experience and motivations for enrolling in the trial. Matthew is currently the community co-chair of the Microbicide Trial Network.

Creating and Sustaining Partnerships for Strengthened HIV Vaccine Advocacy #HVAD2018 8

THE VARG MEMBERS Veronica Noseda Veronica is the National Coordinator of Le Planning Familial – the sexual and reproductive health and rights leader organization in France. Previously, she worked for more than a decade in the AIDS field, where she was a Project Manager at Sidaction, a collective of researchers, healthcare professionals and NGOs in France and developing countries, dedicated to the development of scientific and medical research programs and the support of prevention and assistance programs for those living with HIV/AIDS. During that period, she was very active in the field of prevention research addressing social science issues related to pre-exposure prophylaxis and HIV vaccine research. She continues to engage with HIV vaccine research development efforts in France including recent efforts by the National Agency for Research on AIDS (ANRS) and the University of Paris-Est Crétéil to conduct a VRI01 phase I/II, multicenter, national, open-label, randomized HIV vaccine trial.

Hilary Bainemigisha Hilary is an editor/columnist with The New Vision, Uganda’s major daily newspaper with a significant online presence. He has been a very vocal and strategic advocate for HIV prevention research and has covered vaccine research extensively.

Creating and Sustaining Partnerships for Strengthened HIV Vaccine Advocacy #HVAD2018 9

THE VARG EMISSARIES Dr. Kundai Chinyeze Kundai is a medical doctor currently working as the Medical Director at the International AIDS Vaccine Initiative (IAVI). Her focus is on the design and implementation of Phase 1-3 clinical trials, combination prevention studies and observational studies. She also leads the IAVI International Training and Investigator Initiated Programs to build scientific and research capacity in 5 African Countries. She was awarded a Canon Collins Trust scholarship to study for a Masters in Public Health at Leeds University and received the Leeds University John Griffith Prize for distinctive work in public health in 2010. Dr Chinyenze has over 12 years of experience working in East and Southern Africa, including 10 years in clinical HIV/AIDS care, programme management and HIV prevention research.

Professor Quarraisha Abdool Karim Prof. Quarraisha Abdool Karim is one of the world’s leading HIV and AIDS researchers making pioneering contributions to understanding the evolving global and South Africa HIV epidemic, while also fighting for the rights of those affected by HIV and AIDS. Professor Abdool Karim holds a professorship in Clinical Epidemiology from the Mailman School of Public Health, Columbia University, USA, and is also an honorary professor in Public Health at the Nelson R Mandela School of Medicine, University of KwaZulu-Natal. She is also a visiting scientist at Massachusetts General Hospital and visiting lecturer at Harvard University. Since 1998 Professor Abdool Karim has trained over 600 scientists in the region. She was the principal investigator of the landmark CAPRISA 004 Tenofovir Gel trial, which provided proof of concept for Microbicides, highlighted by Science as one of the Top 10 scientific breakthroughs in 2010. Her 2016 L’Oréal-UNESCO for Women in Science Award was a recognition of her contributions to HIV prevention and treatment. She was also named one of five “exceptional laureates” for her remarkable activities and contributions related to HIV in South Africa and the African continent. Professor Abdool Karim is a NRF A-rated researcher and UNAIDS Special Ambassador for Adolescents and HIV.

Professor Linda Gail Bekker Linda-Gail Bekker, is Professor of Medicine and Deputy Director of the Desmond Tutu HIV Centre at the Institute of Infectious Disease and Molecular Medicine, University of Cape Town. She is also chief operating officer of the Desmond Tutu HIV Foundation, a not for profit organization that works to improve the wellbeing of people from some of the poorest communities in South Africa. She is a physician scientist with a keen interest in HIV, tuberculosis and related diseases. Her doctoral work focused on the host response to tuberculosis both with and in the absence of HIV co-infection. Subsequently her research interests have expanded to include programmatic and action research around antiretroviral roll out and TB integration, prevention of HIV in women, youth and men who have sex with men.

Creating and Sustaining Partnerships for Strengthened HIV Vaccine Advocacy #HVAD2018 10

THE VARG EMISSARIES Professor Glenda Gray An NRF A-rated scientist, CEO and President of the South African Medical Research Council (SAMRC), Prior to her appointment at the SAMRC, she was the Executive Director of the Perinatal HIV Research Unit, an affiliate of Wits University which she co-founded. Glenda’s global profile includes a role as Co-PI of the HIV Vaccine Trials Network (HVTN), a transnational collaboration for the development of HIV/AIDS prevention vaccines. She is also Director of International Programmes for HVTN, Chairperson of the Board of the Global Alliance for Chronic Diseases, and a member of the Institute of Medicine of the National Academies, USA. She received South Africa’s highest honour – the Order of Mapungubwe – for her pioneering research in PMTCT. Other prestigious accolades include the Nelson Mandela Health and Human Rights Award for her significant contributions in the field of mother-to-child transmission of HIV. Selected as one of Time’s 100 Most Influential People in the World, Glenda is a recognised leader in her field.h.

William Snow The former Director of the Global Vaccine Enterprise Secretariat, William has a long and distinguished history in the HIV vaccine field. Having been engaged with efforts to make preventive HIV vaccines since 1990, advocating for due speed, the role of traditional vaccinology, industry engagement and the still-urgent need for long-lasting ways to control HIV infection worldwide, Wlliam is a co-founder and a long-time board member of AVAC and was instrumental in establishing national, local and global community advisory boards at the National Institutes for Health clinical trial networks AVEG, HIVNET and HVTN. He has served on the NIAID AIDS Vaccine Research Subcommittee, the NIH Vaccine Research Center Scientific Advisory Working Group and, over the past 20 years, on advisory committees and boards for almost every HIV vaccine group. William is serving his third term on the NIAID AIDS Vaccine Research Subcommittee (AVRS), and has for more then a decade served on the Scientific Advisory Working Group at the NIH Vaccine Research Center and the Scientific Advisory Board at The Duke Center for HIV/AIDS Vaccine Immunology and Immunogen Discovery (CHAVI-ID). He is also part of the IAVI Clinical Trials Advisory Committee (CTC).

Stacey Hannah Stacey Hannah was instrumental in conceptualization, nurturing and supporting the VARG. Stacey is currently the Director of Research Engagement at AVAC from where she manages AVAC's Good Participatory Practices program, and oversees training related activities of AVAC and its partners. She has over twelve years of experience in HIV prevention research, which began in South Africa helping prepare the first HIV vaccine trial site in the country. She has worked in long-term posts in Kenya, South Africa, and Uganda. Before joining AVAC, she took a short break from the HIV world to develop and implement a research literacy program for the TB Alliance, a product-development-partnership for new TB drug regimens. Stacey has degrees in microbiology, nutrition and chemistry from the University of Florida and an MHS in international health from the Johns Hopkins University School of Hygiene and Public Health.

Creating and Sustaining Partnerships for Strengthened HIV Vaccine Advocacy #HVAD2018 11

SOUTH AFRICA N t a n d o Yo l a

Ntando.Yola@hiv-research.org.za Commemorating 2018 HIV Vaccine Awareness Day (HVAD), the VARG partnered with Ubuntu Research Foundation (URF), a community initiative led by a group of young women who work in HIV research and have an interest to mobilize multiple key stakeholders and advance health research in the Eastern Cape (EC) province of South Africa. The event was held on 26 May, in Mthatha, a town where HVTN 702 is conducted.

The EC province lies along the Indian ocean coastline and prides itself with a rich heritage, culture, natural and diverse landscapes rich in aqua-culture as well. It is also home to a number of South Africa’s liberation leaders, like Winnie-Madikizela Mandela, Nelson Mandela, Oliver Tambo, Steve Biko and many others.

On the flipside, the province is also one of the poorest, with health rating high on the list of its major challenges. It is home to a population of over 6 million people with a general life expectancy of about 63 years. It has one of the lowest employment rates in the country, experiences a number of health-related challenges with HIV rates estimated at 12.1% and women being the hardest hit, as it is in the rest of South Africa.

This is what motivated Ubuntu Research foundation to facilitate a critical conversation that will challenge various role players who can play a key role in advancing research as part of a response to address health and HIV challenges. In addition to being a host to HVTN 702, the ECHO study is also conducted in the province.

Creating and Sustaining Partnerships for Strengthened HIV Vaccine Advocacy #HVAD2018 12

...CONTINUED

The event brought together multiple critical stakeholders who are influencers at multiple levels in the area, who include the following: •

Researchers

•

Walter Sisulu University Faculty of Health Sciences (the dean’s office and post-graduate students)

•

The Mayor or representative from OR Tambo municipality

•

Eastern Cape AIDS Council, its Civil Society partners and Women’s Sector representatives

•

Community Advisory Board members

•

Representatives from the Chieftaincy

•

Media

•

Department of Health

Topics of discussion: •

The role of clinical research in HIV, health and communities

•

Building broad systematic infrastructure for Research and Development

•

HIV Vaccine research and development landscape

•

Support for and involvement of communities in HIV vaccine research

•

Next steps in supporting current research and sustainability

Key issues that emerged from the panel discussion and group discussions, highlighted: •

what it would take to have the community realize research as one of the critical paths to advancing good health and address its structural drivers.

•

there were strong questions from the audience that sought to understand how communities are part of decisions to conduct research as well as

•

how to ensure they are not used as a data collection vehicle for other

purposes either than benefiting the communities.

There were questions on balancing risk from benefit as part of clinical trial conduct as communities are vulnerable. The question of oversight of CAB members came in to the spotlight as well, highlighting that they are not as empowered to play their role effectively thereby protecting communities, whilst advancing research. The discussions largely focused on community ownership of research, including trial participants who do not receive feedback on research findings. The conversations highlighted the progress on the vaccine research site and an update that the site has been recently initiated to begin the study. Further reference was made to a study that “never came back to share outcomes with the community” and how this can be prevented with HVTN702. The trial in question was identified as ISS T-003, an Italian funded phase Il, randomized, double-blind, placebo-controlled trial to evaluate the immunogenicity and safety of a therapeutic, recombinant, biologically active HIV-1 Tat Protein Vaccine in HIV-Infected, Anti-Tat Negative, ARV-Treated Adult Volunteers . The study took place in South Africa and involved the recruitment of 200 participants between 18 and 45 years of age. The total amount of time required for participation in this study was a maximum of 51 weeks (approximately one year). Participants were asked to visit the research clinic at least 12 times during the study including administration of the Tat vaccine, or placebo on 3 occasions, at 4-weekly intervals.

Creating and Sustaining Partnerships for Strengthened HIV Vaccine Advocacy #HVAD2018 13

A B S T R A C T: I S S T- 0 0 3 T H E R A P E U T I C H I V VA C C I N E C L I N I C A L T R I A L HIV-Tat immunization induces cross-clade neutralizing antibodies and CD4(+) T cell increases in antiretroviral-treated South African volunteers: a randomized phase II clinical trial.

Ensoli B¹, Nchabeleng M2, Ensoli F3, Tripiciano A4,3, Bellino S4,5, Picconi O4, Sgadari C4, Longo O4,6, Tavoschi L7,8, Joffe D7, Cafaro A4, Francavilla V4,3, Moretti S4, Pavone Cossut MR4, Collacchi B4, Arancio A4,3, Paniccia G4,3, Casabianca A9, Magnani M9, Buttò S4, Levendal E10,11, Ndimande JV12, Asia B13, Pillay Y13, Garaci E14,15, Monini P7; SMU-MeCRU study group.

Author information 1.

National AIDS Center, Istituto Superiore di Sanità, Rome, Italy. barbara.ensoli@iss.it.

2.

MeCRU, Sefako Makgatho Health Sciences University (SMU), Ga-Rankuwa, South Africa.

3.

Laboratory of Clinical Pathology and Microbiology, San Gallicano Institute, Istituti Fisioterapici Ospitalieri, Rome, Italy.

4.

National AIDS Center, Istituto Superiore di Sanità, Rome, Italy.

5.

National Center for Epidemiology, Surveillance and Health Promotion, Istituto Superiore di Sanità, Rome, Italy.

6.

Italian Medicines Agency, Rome, Italy.

7.

Head Office, National AIDS Center, Istituto Superiore di Sanità, Cape Town, South Africa.

8.

European Center for Disease Prevention and Control, Stockholm, Sweden.

9.

Department of Biomolecular Science, University of Urbino, Urbino, Italy.

10. South African Medical Research Council, Cape Town, South Africa.

11. Health Systems Trust, Cape Town, South Africa.

12. Department of Health, Marshall Town, Gauteng Province, South Africa.

13. National Department of Health, Pretoria, South Africa.

14. Istituto Superiore di Sanità, Rome, Italy.

15. University of Tor Vergata, Rome, Italy.

BACKGROUND: Although combined antiretroviral therapy (cART) has saved millions of lives, it is incapable of full immune reconstitution and virus eradication. The transactivator of transcription (Tat) protein is a key human immunodeficiency virus (HIV) virulence factor required for virus replication and transmission. Tat is expressed and released extracellularly by infected cells also under cART and in this form induces immune dysregulation, and promotes virus reactivation, entry and spreading. Of note, anti-Tat antibodies are rare in natural infection and, when present, correlate with asymptomatic state and reduced disease progression. This suggested that induction of anti-Tat antibodies represents a pathogenesis-driven intervention to block progression and to intensify cART. Indeed Tat-based vaccination was safe, immunogenic and capable of immune restoration in an open-label, randomized phase II clinical trial conducted in 168 cART-treated volunteers in Italy. To assess whether B-clade Tat immunization would be effective also in patients with different genetic background and infecting virus, a phase II trial was conducted in South Africa.

METHODS: The ISS T-003 was a 48-week randomised, double-blinded, placebo-controlled trial to evaluate immunogenicity (primary endpoint) and safety (secondary endpoint) of B-clade Tat (30 µg) given intradermally, three times at 4-week intervals, in 200 HIV-infected adults on effective cART (randomised 1:1) with CD4(+) T-cell counts ≥200 cells/µL. Study outcomes also included cross-clade anti-Tat antibodies, neutralization, CD4(+) T-cell counts and therapy compliance.

RESULTS: Immunization was safe and well-tolerated and induced durable, high titers anti-Tat B-clade antibodies in 97 % vaccinees. Anti-Tat antibodies were cross-clade (all vaccinees tested) and neutralized Tat-mediated entry of oligomeric B-clade and C-clade envelope in dendritic cells (24 participants tested). Anti-Tat antibody titers correlated positively with neutralization. Tat vaccination increased CD4(+) T-cell numbers (all participants tested), particularly when baseline levels were still low after years of therapy, and this had a positive correlation with HIV neutralization. Finally, in cART non-compliant patients (24 participants), vaccination contained viral load rebound and maintained CD4(+) T-cell numbers over study entry levels as compared to placebo.

CONCLUSIONS: The data indicate that Tat vaccination can restore the immune system and induces cross-clade neutralizing anti-Tat antibodies in patients with different genetic backgrounds and infecting viruses, supporting the conduct of phase III studies in South Africa. Trial registration ClinicalTrials.gov NCT01513135, 01/23/2012.

Creating and Sustaining Partnerships for Strengthened HIV Vaccine Advocacy #HVAD2018 14

Bulelwa Nogidela-Makhutha, Ubuntu Research Foundation

Creating and Sustaining Partnerships for Strengthened HIV Vaccine Advocacy #HVAD2018 15

...CONTINUED The meeting recommended that communities should influence the research agenda and this advocacy position should be championed by URF. The meeting also discussed the value of and support for research that is aimed at improving health systems and that research should be made popular in communities for them to understand and support it. Within this discussion, an example of successful research that emerged from and informed by the community in this region was shared Prof. E Blanco-Blanco about a study that effectively addressed diabetes in the Mthatha community, even though due to funding it was not sustained.

Action Points: •

There should be capacity building drive to ensure communities are at the centre of driving research from an informed premise.

•

The current HVTN study ought to be supported so as to be a good example of involving communities and have the understand research better.

•

All the discussions and next steps mapped out the role URF has to play in its role and was assured of the support from the various stakeholders present.

•

The ECAC chair invited and tasked URF to be a facilitator with the support of the council in reviving the research sector in the province’s AIDS council and there will be follow up to this regard from the secretariat.

•

The VARG will continue to be a partner in all the URF, especially as they relate to advancing HIV vaccine research.

•

Advocacy for Prevention of HIV and AIDS (APHA), was also proposed as a key partner in all HIV prevention and health research

•

For all of the proposed work to take place, resources and fundraising was agreed upon as critical and that partnerships between the universities, and other partners will ensure the work is taken forward.

•

As an important highlight, the fact that May 18 is HIV Vaccine Awareness Day, it was agreed upon that URF will commemorate this day annually.

Left to Right: Dr. T. Apalata, Walter Sisulu University Ethics Committee; Professor E. Blanco-Blanco, Walter Sisulu Health Sciences Faculty and Professor S.D. Vasaikar, National Health Laboratory Services.

Creating and Sustaining Partnerships for Strengthened HIV Vaccine Advocacy #HVAD2018 16

MALAWI Maureen Luba maureenluba@gmail.com In addition to a statement in a national newspaper commemorating International HIV Vaccine Awareness Day, issued by the VARG in partnership with AfNHi and AVAC, VARG Member Maureen Luba and fellow advocate Ulanda Mtamba granted an interview with Malawi’s national broadcaster , MBC, that spoke about about the ongoing search for an HIV Vaccine, the role of trial participants and the importance of keeping HIV Vaccine research on the national agenda.

Part One: https://youtu.be/9DwUtwp9h8Q Part Two: https://youtu.be/P5YBkzUFbjM

Creating and Sustaining Partnerships for Strengthened HIV Vaccine Advocacy #HVAD2018 17

ZIMBABWE Chamunorwa Mashoko korarain@gmail.com VARG member Chamunorwa Mashoko partnered with the award-winning radio station, Capitalk 100.4FM. Capitalk 100.4 FM is Zimbabwe’s first and only Harare based commercial talk radio station. The following fact sheet, created by the VARG’s founding partner, AVAC, was read out and broadcast throughout the week on Capitalk 100.4 FM highlighting the work that is underway to find a vaccine for HIV. You can listen to the announcement here : https://youtu.be/sM9N-jQQqQA

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Creating and Sustaining Partnerships for Strengthened HIV Vaccine Advocacy #HVAD2018 18

THAILAND Udom Likhitonnawut udomli@gmail.com

The half-day event commemorated not only HVAD but also the 25th anniversary of AFRIMS. About 120 people attended the meeting. They were CAB members from 5 CABs, research teams from 6 institutes and officers from MoPH and HIV vaccine development sub-committee. The event was opened by the USA Ambassador to Thailand, Glyn Davies, the Deputy Minister of the MoPH, and the Surgeon General of the Thai Army Medical Department. This was followed by Dr. Suwat Chariyalertsak, one of the co-PIs of HPTN 052, iPrEX, and the cabotegravir long-acting PrEP. He talked about the history of HIV prevention since the first reported case in 1981 up to the present which included HIV prevention methods such as PEP, PMTC, RV144, iPrEX, TasP, and the on-going HIV prevention trials. He concluded that there is still a need for HIV vaccine.

VARG member Udom Likhitwonnawut spoke next and used the AVAC/IAVI model demonstrating the impact of an HIV vaccine. Using a slide from Professor Glenda Gray that shows the UNAIDS Investment Framework Enhanced Model and projections of the potential impact of an HIV vaccine. Udom also talked about Dr. Anthony Fauciâ&#x20AC;&#x2122;s presentation at the 2017 IAS Conference in Paris that showed that the eradication of AIDS is unlikely without vaccine. Ending with action items and advocacy points for the Thai government to consider which centred on work needed to better understand who the target populations for a potential vaccine are, how to integrate an HIV vaccine with other prevention options and model options that analyse an HIV vaccine as an anchor instead of condom as anchor as it is now. A historical account of RV144 was also shared that provided context and grounding for Dr Vasanâ&#x20AC;&#x2122;s presentation.

Dr. Sandya Vasan from AFRIMS provided background information on HIV vaccine trials after RV144: RV 305 (late booster), RV 306 (early booster) and RV 328 (AIDSVAX alone). The presentation was an update on the status of the trials. What was interesting is that the retention of these trials were very high - more than 90% on all three even with the late booster which enrolled participants from RV 144 which had a lag time about 6-8 years. Dr. Eugene Kroon from SEARCH program of the AIDS Research Centre of the Thai Red Cross talked about the optional clinical procedures of the after RV 144 trials and why they do them. The procedures included mucosal samples and procedures to collect them such as cervical biopsy, rectal swap and sigmoid biopsy, leukapheresis, bone marrow aspiration. He talked about the rates that people consented to these (bone marrow aspiration about 55% and leukapheresis is more than 90%). Dr. Kroon also talked about the safety of these procedures which are quite safe and carried out by specialists at one of the best hospitals in Thailand (and the Thai Red Cross is a part of the hospital/medical school complex).

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...CONTINUED Dr. Punnee Pitisuttithum from the Vaccine Trial Centre, Mahidol University who is the co-PI of RV 144 and VAX 003, and Janssen’s Ad26 trial (the phase 1/2 trial) presented next. She explained the main component of the immune system - the immunoglobulin and its component (IgG, IgA, IgM….) and the structure of gp120 protein on the HIV envelop and different regions of the protein that are targets of the immunoglobulin. This was followed by the results of the RV 144 follow-on studies - which looked at vaccine induced immune response (AIDSVAX does this while Alvac didn’t and the immune responses of both vaccines used together are similar to AIDSVAX alone - hence it is AIDSVAX that makes RV 144 effective). She also showed that AIDSVAX induced more response with AE subtype and not so well with B subtype which might explain why the VAX 003 and another trial that used AIDSVAX in USA didn’t work. She also showed that late booster (of RV 144 regiment) activated more CD4 and CD8 responses and makes the cells more susceptible to HIV infection while the early booster doesn’t do that.

The last two presentations were updates on the MSM cohort for the upcoming HIV prevention for MSM and the HVTN 702 and 705 by the chief of Retrovirology Department, Dr. Robert O’ Connell..

The last presentation was on a therapeutic HIV vaccine by Dr. Donn Colby from SEARCH, the AIDS Research Centre of the Thai Red Cross. His presentation was focused on using the Ad26 vaccine for therapeutic purposes and showed that there will be analytical treatment interruptions after the participants receive the vaccine. There are no results from this study (RV 405) yet.

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UGANDA Hilary Bainemigisha HBainemigisha@newvision.co.ug Scientists engagement with media owners and managers as part of World Vaccine Awareness Day Objectives of the meeting/engagement • To update media owners and managers on ongoing HIV vaccine research with the aim of increasing their knowledge and interest in the subject.

• To mobilize media bosses and interest them in the HIV vaccine story so that they can start giving it consideration, if not priority in their platforms.

• To explain the media bosses how the HIV vaccine story is not a vain subject, should not need to ne news before it can run and needs to be kept alive.

• To lay the groundwork for continuous dialogue and collaboration between the media owners and managers and scientists working in the area of HIV vaccine research.

• To build a cohort of media bosses who are interested in HIV vaccine research and will therefore demand it from the reporters or enforce coverage for stories on the subject.

Participation The media breakfast was attended by media owners and managers (editors) from key media houses in Uganda, including print, radio Television and social media.

Speakers • Prof. Pontiano Kaleebu: Director, Uganda Virus Research Institute (UVRI).

• Dr Francis Kiweewa, Head of Research and Scientific Affairs, Makerere University Walter Reed Project (MUWRP).

Prof. Pontiano Kaleebu, Director, Uganda Virus Research Institute (UVRI) kicked off the media engagement by giving an overview of some of the ongoing and planned HIV vaccine trials globally.

Highlights • Prof. Kaleebu said that while advances in treatment had helped improve the lives of people living with HIV, the disease will not be eliminated without a vaccine. According to Prof. Kaleebu, viruses such as smallpox have been successfully eliminated because of vaccines.

• In the case of HIV, the complexity of the virus has been a big hurdle in finding an effective vaccine, three decades after the disease was first developed.

• Prof. Kaleebu noted that several approaches are being used to develop the different vaccine concepts that are currently under trial.

• These approaches include the use of active immunization, broadly neutralizing antibodies (passive immunization), non-neutralizing anti-bodies, DNA, T-cells, and among others.

•

He explained in detail the hope in passive immunization, Mosaic studies and the time lines that increase our hopes for success

•

He noted that Uganda will soon be part of another large efficacy trial called PrepVacc, which will use a combination of a DNA and the Thai

vaccine. The study will be conducted among HIV negative high-risk individuals in Uganda, Tanzania, Mozambique and South Africa involving 2500 volunteers. In Uganda it will be conducted among fishing communities in Masaka.

Creating and Sustaining Partnerships for Strengthened HIV Vaccine Advocacy #HVAD2018 21

...CONTINUED •

Dr Francis Kiweewa on his part started his presentation by explaining that vaccine development is often a long process, conducted in different phases.

“Most start with a lot of promise in animals and create a lot of excitement. Then we go into phase I and II and realize they are inducing an immune response but which is not strong enough to prevent HIV infection.” - Dr Kiweewa.

•

He added that to date there have been five vaccine candidates that have reached phase III trials, and all except the Thailand study were a failure.

•

As a result, the vaccine concept that is driving much of the research happening globally today is based on the Thai study.

•

Currently four phase III vaccine trials are on-going. Dr Kiweewa said these trials are being studied with a lot of hope and optimism that one of them could be effective.

•

The results from these trials, which are taking place in South Africa, the Americas and Europe are expected to be out between 2020-2021.

Challenges in HIV Vaccine Research •

The scientists noted that despite the hope and optimism that finding a vaccine is possible in the near future, HIV vaccine research still faces several challenges;

•

For example, the diverse nature of the virus continues to affect development of an effective vaccine. In Uganda for instance, Prof. Kaleebu noted that 50 per cent of the viruses are recombinants. On top of diversity, the virus also mutates very fast, creating an even bigger challenge for researchers.

•

The declining HIV incidence also makes it difficult to enroll to enroll large groups of volunteers for trials.

•

Part of the work researchers are currently working on in the lab is to see how to address the issue of recombinants and mutation.

•

Another challenge, according to Prof. Kaleebu is the fact that most of the research on HIV vaccine development is concentrated on the HIV sub type C, which is prevalent mostly in South Africa. Part of this is because on top of having a high HIV prevalence, South Africa is also investing heavily in terms of financial resources to undertake HIV research.

•

Countries, for instance those in Eastern Africa which have a different strain of the virus therefore need to invest more in vaccine trials that address their sub types of the virus.

•

Dr Kiweewa noted that despite commitments made by African governments to invest at least 2% of their GDP on research, many have not lived to these commitments. Except for South Africa which has invested heavily in HIV research, much of the work on HIV going on in high burden countries is being funded through external donations.

Media, Advocacy and Challenges •

One of the key areas for advocacy that the scientists hope the media can focus on is to advocate to governments to invest more in medical research generally.

•

It was noted that South Africa had attracted many of the clinical trials because they have heavily invested financial resources in HIV research.

•

Hilary Bainemigisha, the convener of the meeting, highlighted the importance of mobilizing media owners and managers because they are the planners, policy makers, gateway controllers and can set the agenda of their media houses.

• He said that these press bosses need to be aware of the HIV vaccine development updates in order to plan publicity, manage the science, identify the mistakes and help reporters to break down the science to the audience.

• Mr Bainemigisha says once the media owners get interested in HIV vaccine updates, the managers will fall in line and so will the reporters and that will increase the coverage of HIV vaccine stories.

• While several journalists have been trained on reporting on HIV, editors have not had the same training. When editors don’t understand the stories or have no interest in them, they don’t give them priority in the story competition for space.

Creating and Sustaining Partnerships for Strengthened HIV Vaccine Advocacy #HVAD2018 22

...CONTINUED

Discussion of the issues “There are unfair demands placed on us by activists. The HIV industry is well funded but when they want the media as partners, they don’t want to share the resources. Yet communication is one of the vital deliverables donors give HIV advocates.” – Participant and media house owner • Media owners asked scientists to budget for publicity. They said it was acceptable for them to be partners in the fight against HIV but it was unfair for scientists to expect the media to do it free of charge while researchers cannot carry out their work free of charge. Let everybody do their bit and be paid for it.

• Media owners referred to the upcoming HIV Vaccine Awareness Day saying donors must have funded awareness activities. But many said the media did not get any money for adverts/airtime to do awareness yet the scientists still expect media to do it for free.

• Media managers and owners appreciated a partnership that was not selfish and based on the knowledge that the media industry needs money /income/profits to survive • Media owners and managers said while scientists are privileged in their role of research, the media is also privileged in its skills of communication and available audiences. In the fight against HIV, the two important roles need to be respected, equally funded and supported • Another issue raised was the fact that most stories on HIV/AIDS are often not well written or too complicated to be released to the audience. The editors and managers sometimes stop these stories because goofing affects the reputation of the media house. So a story rather not runs.

They appreciated and called for protracted training of journalists in HIV reporting.

• Media managers also raised the issue of ethics. For instance, when dealing with stories of children or people living with HIV, who have not disclosed, they are required to block their identities and often this makes their stories unbelievable.

• Competition has also made it difficult for HIV stories to get space in the media. Because media houses are dealing with balancing how to make revenue and informing the public, often times, they are most likely to publish a story that gets more revenue than an important story on HIV vaccine.

• Journalists, editors and media owners need to be trained to see that HIV is a community problem that requires partnerships. In reporting on HIV, journalists therefore need to take on an advocacy role as part of their social corporate responsibility.

VARG at the High-Level Dialogue on Domestic Health Funding On June 12, a high-level dialogue was held with Parliamentarians and other stakeholders in research, academia, and advocates on how to improve domestic funding to health research. Convened by the Ugandan National Health Research Organization (UNHRO) and supported by IAVI, different presenters gave their arguments justifying the need for improved funding. Health research in Uganda is financed from a variety of sources but mostly from external funders.

The total health research investment in Uganda for 2014/2015 was USD 116.84 million out of which the share of domestic financing was USD 11.08 million. Therefore, 90.51% of the financing for health research was generated from external sources and only 9.49% was from the domestic sources. The ratio of total health research financing to the total GDP of Uganda stands at 0.41%. However, the ratio of domestic financing for health research to the total GDP is as low as 0.04%. (EAHRC, 2018) It was decided that instead of the different research organisations lobbying individually, an umbrella body is formed and costed. Members of Parliament gave advice on the strategies that could be used for potential advocacy initiatives and UNHRO was nominated to lead the main process. The VARG also participated in the Vaccine Interest Group (VIG), a high-level dialogue on HIV vaccine research with Parliamentarians organized through the Parliamentary Forum on Quality Health Care Service Delivery. This platform served as a networking mechanism between advocates, researchers, funding agencies and other stakeholders.

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NIGERIA Morenike Ukpong toyinukpong@yahoo.co.uk FESTIVAL OF BLOGS! Blogs have proven to be a great way of getting out important information to a critical mass of readers without navigating a cumbersome media or editorial process. This is something that NHVMAS capitalized

FESTIVAL OF BLOGS

on this HVAD by organizing a festival of blogs sourced from the public,

THE 2018 HIV VACCINE AWARENESS DAY Everyone has the right to live a life free of the risk of HIV infection.

Over the last several decades, access to a safe and effective vaccine has made this possible for people around the world. A HIV vaccine will similarly reduce that risk, and with time eradicate HIV infection.

researchers and advocates in commemoration of HVAD 2018. The

18th 2018 May

There are some efforts in the field to develop a HIV vaccine. The New HIV Vaccine and Microbicide Advocacy Society (NHVMAS)will like to celebrate the efforts of a large collective of people – researchers, bioethicists, community advocates, donors – all over the world that have continued to invest in the process of developing a HIV vaccine.

Join us this year by contributing a blog post acknowledging the need for a HIV vaccine, celebrating efforts at developing a HIV vaccine till date, and imagining the difference a HIV vaccine will make for global health, wellness and development.

What is a festival of blogs?

A festival of blogs is a collection of blogs posted by different authors about the same theme celebrating successes and achievements. NHVMASis hosting a festival of blogs to celebrate the HIV Vaccine Awareness Day scheduled for the 18th of May 2018. We are therefore calling on all persons to share blogs on the NHVMAS website celebrating HIV vaccine research efforts till date, and sharing visions of what impact a HIV vaccine could have on global health, peace and development. Stories related to HIV vaccine development, historical perspective, drawing and all forms of arts are also welcome.

blog posts were published through online media publications and shared via the NHVMAS websites, shared through the listserv and also through facebook and twitter accounts. Top global scientists, advocates, government officials, research institutions and organizations contributed content that profiled an impressive range of insight and perspective on HIV vaccine research locally, regionally and globally. You can read some of the blogs here: http://nhvmas-ng.org/site/blog/ Many of these blogs and thought pieces were identified and published by a range of media houses including, the Guardian, Crawler, PM News

The blogs will be posted throughout the week of the 18th of May 2018 on the NHVMAS listser v. we plan to compile the blogs and archive them on the NHVMASwebsite.

Nigeria and Doctors Quarters.

The objective of this festival of blogs is to amplify all voices about their interest in HIV vaccine development, their expectations about the vaccine, and promote continued investment in HIV Vaccine research.

Working with journalists on the community thoughts and expectations

Join us as we the voices of all persons, especially those worst affected by HIV about the need for a HIV vaccine now more than ever!

How to participate: 1. Send your blogs along with a headshot to Tosin Alaka tosinba2000@gmail. com. Your blogs along with your headshot shall be posted on NHVMAS facebook, and shared on twitter and instagram. Your blogs shall also be shared on the NHVMASlistser v.

2. Please encourage your friends and peers to send in blogs for the festival.

on the HIV vaccine development: NHVMAS worked with a team of journalists to interview community members and experts on their views of vaccine research. Some of the questions asked in the field were: 1. A vaccine is a substance that teaches the body to recognise and fight against germs in the body. An effective HIV vaccine

3. Please promote and share your blog as well as the blogs of others with your network and contacts.

can be used to prevent HIV infection by teaching the body to fight against HIV. ·

What are your thought about the kind of HIV vaccine that should be developed?

·

What will you like about a HIV vaccine?

·

Will you be willing to volunteer for a HIV Vaccine experimentation?

2. An effective HIV vaccine can also be used as Therapeutic HIV vaccines designed to treat people who are infected with HIV and prevent HIV from advancing to AIDS, replace daily use of antiretroviral drugs, and help rid the body of HIV. ·

What are your thoughts about having therapeutic HIV vaccine that PLWHIV can use?

·

How should the Nigeria government support the HIV vaccine research?

·

What will you like to say to scientists and other researchers working hard to develop a HIV Vaccine?

Extracts from the various interviews were aired on African Independent Televisions, Radio Nigeria and several newspapers Watch the television broadcast here : www.instvblog.com/hiv-aids-world-vaccine-day-experts-hope-for-vaccine-to-tackle-scourge/

Creating and Sustaining Partnerships for Strengthened HIV Vaccine Advocacy #HVAD2018 24

...CONTINUED HVAD - Community outreach: The LeNNiB Champions conducted a community outreach programme in Ogba and Agege areas of Lagos State, providing the community with information on HIV, AIDS and vaccine research updates; information, education and communication materials on vaccines; and basic facts about HIV/AIDS that are community friendly and cultural sensitive,.

The LeNNiB (Leave No Nigerian Behind) Champions Mentorship Programme is a community centered advocacy programme that is focused on empowering young people through trainings and mentorship, to make significant changes in their various communities and environment while addressing the HIV prevention needs of community members. The LeNNiB Champion project is a NHVMAS bridging project that helps individual advocates and organizations to learn how to include HIV prevention advocacy into planned and ongoing programs that are important but not exclusively focused on HIV control. The objective is to empower community organizations to facilitate HIV prevention through structural interventions.

The champions shall therefore be envisioning making HIV prevention advocacy an integral component of all development work in Nigeria.

Key community messages: NHVMAS worked with the community members including students, community advocates and educators to share their interest and expectations on the HIV vaccine research and development efforts. Over 600 messages were generated .These key messages were presented on the placard and uploaded on the NHVMAS and Morenike Ukpongâ&#x20AC;&#x2122;s facebook pages and twitter handles.

To get real time updates on the work of NHVMAS to advance the national discussion on HIV vaccine research like their facebook page at: https://www.facebook.com/nhvmas With 20 top rated blogs, four top Nigeria newspaper publications, two highly rated television and radio broadcasts, over 600 messages, and a community education campaign on HIV vaccine, the work of NHVMAS to commemorate and mobilise around HVAD2018 was a resounding success!

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USA Matthew Rose mkingrose@gmail.com Matthew Rose, took part in the May episode of AVAC’s Px Pulse podcast along with VARG Emissaries Kundai Chinyeze and Bill Snow who is also the founder of AVAC and friend of the VARG, HVTN’s Larry Corey. In the podcast, they help set expectations for where the field is now and where it is going.

“We have to think about promise, design and collaboration but not only in terms of science not only in terms of how do we engage with community but in terms of how we build support for a vaccine candidate and how we go forward. So with promise I like to think about: “what are we telling people, what is the community hearing?.” - Matthew Rose, VARG Member

To listen to the full podcast go to: https://www.avac.org/podcast/hiv-vaccine-science

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KENYA Rosemary Mburu rosemary@wacihealth.org Celebrating Africa Day: HIV Vaccine Development - A four-point agenda https://posteritymediang.com/celebrating-africa-day-a-four-point-agenda/ Each year on May 18, advocates all over the world commemorate the day to mark progress in the search for an AIDS vaccine. Also, the Africa Day is the annual commemoration of the foundation of the Organisation of African Unity OAU, on 25 May, 1963. The OAU is now the African Union (AU). As we recognize and celebrate the Africa Day, we also recognize the need to develop an Africa Agenda for HIV Vaccine Research and Development While vaccine development is always a long-term process, there have been unprecedented advances in recent years and several promising concepts are being tested in large-scale trials.

For Africa, where a high burden of disease still persists, it is important that we find a safe, effective and affordable vaccine. It will be one of the most critically important tools to control the HIV epidemic in our region.

Beyond controlling the epidemic, development of an effective HIV vaccine will likely be necessary to achieve a durable end to the HIV/AIDS pandemic. It is critical, therefore, to continue and accelerate a robust research effort to develop an HIV vaccine that is at least moderately effective, while also aggressively scaling up the implementation of current treatment and prevention tools.

I would like highlight four critical elements towards an AIDS Vaccine for Africa, with Africa in commemorating the day:

1. Increasing involvement of African researchers in the product development pathway We have seen gold-standard HIV vaccine trials conducted in Africa, yet the leadership of the research is rarely African. In my view, this is less an issue of capability but more about perception regarding quality of research in Africa which then determines leadership in research projects.

Without a doubt, African researchers have been performing cutting-edge research to contribute to finding an AIDS Vaccine and can play active and equal roles as their western counterparts. This dynamic can be shifted by encouraging research that reflects African realities and considers key regional priorities. HIV vaccine research in Africa should purposely consider developing research capacity by African researchers as that will ensure sustainability of research programs. This would also contribute significantly to developing and introducing an HIV vaccine where the greatest disease burden persists.

2. Ensuring good participatory practice in clinical trials Ethical guidance documents generally stress community engagement as essential to the ethical conduct of trials. This involves various considerations including proper stakeholder identification through a broad, inclusive and multifaceted understanding of the context in which the trial is taking place. The process should not only help to empower and equip African community stakeholders to meaningfully engage in the research process but also to harness the expertise that community stakeholders can contribute to the design and conduct of research.

3. Strengthening African-led advocacy African leadership in civil society is essential to sustaining support for HIV prevention research. Building advocacy for research across Africa both at national and regional levels will significantly contribute enhancing demand and backing of prevention research from civil society, communities, policymakers, and other key stakeholders. African led advocacy agenda and local ownership is critical for the realisation of regional research priorities such as calling for increasing domestic resources for research in Africa.

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...CONTINUED However, civil society must be sufficiently capacitated to rise to the task. This includes the ability of both holding government accountable and to take on new responsibilities in the implementation and the monitoring of greatly expanded HIV R&D activities. The recently formed network, Africa Free of New HIV Infections (AfNHi), an Africa regional network for HIV prevention research advocacy is well positioned to provide the needed leadership.

4. Scaling up Domestic resources for research in Africa Recent trends indicate a decline in key aspects of biomedical new HIV prevention funding. Changing funding dynamics and priorities in donor countries have shaped these trends and will continue to do so in years to come. Currently, neither national budgets nor regional commitments to health demonstrate adequate investment in new HIV prevention R&D. There is, therefore, a need for African governments to raise political will towards increased investments in HIV prevention R&D. This will serve, among other positive outcomes, to accelerate research and rollout of New Prevention Technologies (NPTs) and ensure that African nations can prioritise Africaâ&#x20AC;&#x2122;s research agenda. It is also imperative to raise the level of awareness on new HIV prevention R&D and the funding landscape among civil society leaders to scale up momentum for advocacy in Africa.

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