Platforms and Pipelines, Processes and Progress: The 4 P’s to Watch in HIV Vaccine R&D in 2022

On this World AIDS Vaccine Day, the field of global health faces a much-changed world. The extraordinary successes in COVID-19 vaccine development, which stemmed from the scientific knowledge and networks created by the HIV response, have advanced vaccine development by leaps, with innovation, commitment and coordination that accelerated the research and development process at unimaginable speed. The pandemic also exposed the entrenched barriers to vaccine access at a scale never seen before. Misinformation, stigma, greed, and the humbler problems of coordination and planning have hampered delivery of COVID vaccines, just as they have HIV prevention.

The response to COVID-19 makes clear, the world must do better. Scientific advances and equity must go further to deliver HIV prevention and a future HIV vaccine. However, in the past two years, results from major HIV vaccine trials have both upended what we know and reframed the questions we must ask. We need to act with urgency to develop new and faster models for advancing HIV vaccine science that can adapt quickly to what is learned. And we need to continue to push new models for equitably delivering the fruits of that science.

This HVAD, AVAC is kicking off a series of conversations to reframe and reenergize the search for an HIV vaccine.

In 2020, AVAC saw the connections between COVID-19 and HIV, and outlined their implications in Five “P”s to Watch.

In 2022, those insights remain central to what lay ahead, and we’ve built on them as we consider the state of the HIV vaccine field today. We’re bringing together some of the most creative minds in the field—advocates, researchers, policy makers and vaccine funders – to explore four angles we’re watching as we make progress towards an HIV vaccine.

Webinars and New Resources

Platforms & pipelines for developing new approaches to HIV vaccine research.

COVID-19 ushered in a new “Golden Age” in research on vaccines using a previously unproven delivery platform – messenger RNA (mRNA). mRNA vaccines hit the target in COVID, but will they work in HIV? What antigen or combination of antigens should it deliver to be effective? Join this webinar or use this fact sheet to learn more about what researchers have learned, what remains to be discovered about mRNA and HIV vaccines, and about the HIV mRNA HIV vaccine studies now underway.

Webinar
Wednesday, May 18 with Bart Haynes (Duke), Nina Russel (Bill & Melinda Gates Foundation) and Ntando Yola (DTHF).

Recording and Slides: YouTube / Nina Russell’s Slides / Bart Haynes Slides

Processes that offer innovation on the traditional phase I/II/III approach to research.

Biomedical research has evolved more rapidly in recent years than in any time in human history. New bioengineered platforms and products are changing the ways diseases are treated and prevented. And new global commitments to sharing information and data are finally moving the needle toward making research a truly global enterprise. In many ways, though, HIV vaccine trial design remains stuck in the 20th century.

New approaches to research such as experimental medicine vaccine trials (EMVTs) offer the prospect of answering crucial questions safely and quickly. But the commercial, legal and regulatory frameworks are not designed to move HIV vaccine research through the pipeline with greater certainty, ease and speed. And community engagement models for these next-gen research approaches are still in development. Join us to discuss the opportunities and challenges of new approaches to vaccine research, and how advocates can help maximize the potential of a 21st century HIV vaccine research agenda.

Webinar
Tuesday May 24, 2022 with Gail Broder (HVTN), Pontiano Kaleebu (MRC/UVRI & LSHTM Uganda Research Unit) and Robin Shattock (Imperial College).

Recording and Slides: YouTube / Robin Shattock’s Slides / Gail Broder’s Slides / Pontiano Kaleebu’s Slides

Prospects for HIV vaccine products in development, and for new approaches that may need more support.

Thanks to the efforts to tens of thousands of volunteers, researchers and advocates, the world has learned infinitely more about the human immune system, vaccine science and HIV than was known when HIV Vaccine Awareness Day was first commemorated twenty-five years ago, in 1997. Given the current state of HIV vaccine science, the broader HIV prevention landscape, and what’s been learned through COVID, how should HIV vaccine research move into the future? How can we best use that hard-earned knowledge to make choices about HIV vaccines in development now, and chart a course for which products on the horizon have the best chances of achieving their ultimate goal?

Webinar
Tuesday May 31, 2022 with Galit Alter (Harvard), William Kilembe (ZEHRP), Ethel Makila (IAVI) and Dale Hu (NIH).

Recording: YouTube

Dual Prevention Pill: Integrating services and expanding choices

Advocates are coming together from several fields to plan for the introduction of the Dual Prevention Pill (DPP). Currently in development, this daily pill would prevent both HIV and pregnancy. Once approved, the DPP would be an important new option in a menu of choices for contraception and HIV prevention, paving the way for additional multi-purpose prevention technologies (MPTs) in the pipeline. Advocacy to ensure these options become real choices will be essential.

In April, AVAC and FP2030 convened a consultation with family planning (FP) and sexual and reproductive health (SRH) stakeholders to understand their unique perspectives on the DPP. The consultation put a spotlight on key questions and issues that will inform planning for DPP introduction, the development and delivery of future MPTs and, hopefully, accelerate the integration of SRH and HIV prevention programs.

The consultation identified key issues including the need to:

Understand the market for the DPP. Demand is expected from a segment of the market of women looking for contraception and HIV prevention.
Program health services to allow for method switching. Individual women may change what contraception they prefer at different times in their lives.
Educate providers, partners and communities about the DPP in the context of HIV prevention and contraception. Overcoming stigma and community acceptance are fundamental to supporting women to use the DPP and other prevention methods.
Expand, integrate and demedicalize health services now, and include access to oral PrEP in particular, which will create a model for increasing access to the DPP and other MPTs.

Learn more with the resources below!

April 12th DPP Consultation materials, including recording and slides. See the FP2030 landing page here.
Meeting summary featuring key takeaways and top questions. French version here.
Updated FAQs on the DPP.

AVAC Applauds Confirmation of Dr. John Nkengasong as US Global AIDS Coordinator

AVAC applauds the US Senate in officially confirming Dr. John Nkengasong as the new US Global AIDS Coordinator leading the President’s Emergency Plan for AIDS Relief (PEPFAR), the largest funder of HIV/AIDS programming in the world. President Biden nominated and the Senate voted to confirm Nkengasong.

“This confirmation is long overdue. COVID-19 has had a devastating impact on the HIV pandemic,” said Mitchell Warren, executive director of AVAC. “We are very hopeful that with John’s leadership, vision and experience, we can maintain the urgency and impact in ending the AIDS pandemic, continue responding to COVID, and build the sustainable health infrastructure that we so desperately need.”

With consistent bipartisan support and a dynamic, data-driven approach, PEPFAR has transformed foreign aid programs, strengthened global health security, and saved more than 20 million lives since it was created by President George W. Bush in 2003. Its impact is so great, and leadership so important to US efforts to advance global health and security, that its program director holds the title of ambassador—unique among US global health employees, and its activities are coordinated by the US Department of State.

“It’s a real win for the global AIDS response that the US government chose someone to lead PEPFAR who is from the region where much of its work actually is. It shows a commitment to truly listening to and learning from the people PEPFAR is meant to serve,” said Warren.

Nkengasong is the first person of African origin nominated and confirmed for this position. He directs the Africa Centers for Disease Control and Prevention (CDC), part of the African Union and before that, served as the chief of the international laboratory branch in HIV/AIDS and TB at the US CDC, and as acting deputy director at its Center for Global Health.

“John is exceptionally well qualified to confront the enormous challenges ahead, including increasing PEPFAR’s impact in the face of COVID-19 and building a foundation for pandemic preparedness and global health equity,” Warren added. “He is a highly accomplished scientist and administrator, known and respected in both the global North and South, with a strong commitment to global health equity. AVAC fully supports John’s leadership in this critical post and looks forward to working with him toward our shared goals of ending the AIDS epidemic and ensuring global health equity.”

Join Us for Our HVAD 2022 Webinar Series

[UPDATED]: This blog post has been updated with webinar recordings where available.

The 25th anniversary of HIV Vaccine Awareness Day on May 18 is nearly upon us. Nothing about HIV vaccine research has ever been easy, and this past year has shown us how difficult this research is—and how essential it continues to be.

So, join us for our HVAD webinar series this month to mark important milestones in HIV vaccine development and discuss the path forward. The series will be chaired by Bill Snow and Stacey Hannah and will offer expert perspective on four angles that are critical to vaccine development: Platforms & Pipelines, Processes and Prospects.

Platforms & Pipelines
Wednesday May 18, 2022 @ 10:00am EDT
The miracle of mRNA: What’s possible beyond SARS-CoV-2—understanding mRNA, its history and potential challenges for HIV vaccines. With Bart Haynes (Duke), Nina Russel (Bill & Melinda Gates Foundation) and Ntando Yola (DTHF).
Recording and Slides: YouTube / Nina Russell’s Slides / Bart Haynes’ Slides

Processes
Tuesday May 24, 2022
The changed landscape of clinical research: the potential for experimental medicine vaccine trials in the current research environment. With Gail Broder (HVTN), Pontiano Kaleebu (MRC/UVRI & LSHTM Uganda Research Unit) and Robin Shattock (Imperial College London).
Recording and Slides: YouTube / Robin Shattock’s Slides / Gail Broder’s Slides / Pontiano Kaleebu’s Slides

Prospects
Tuesday May 31, 2022 @ 10:00am EDT
What have we learned, why it matters and what it means? Understanding recent results in HIV vaccine research and implications for the future. Unpacking results from Uhambo and Imbokodo trials and understanding the implications for the current pipeline of products. With Galit Alter (Harvard), William Kilembe (ZEHRP), Ethel Makila (IAVI) and Mary Marovich (NIAID).
Recording: YouTube

And watch this space for more HVAD resources!

CROI 2022: Global Advocates Offer Insights and Directions on the Science and Next Steps Needed

On Wednesday, April 27, 9:30-11:00am ET, join the CROI Community Liaison Subcommittee, AVAC, and European AIDS Treatment Group (EATG) for a webinar to debrief this year’s Conference on Retroviruses and Opportunistic Infections. Following a brief overview of some of the most notable science presented at CROI 2022, a panel of community discussants from around the world will unpack findings from the conference, share perspectives, and offer advocacy suggestions. Topics will span science presented on HIV prevention and treatment, HIV and aging, HIV cure, and COVID-19 — among other topics.

Recorded CROI 2022 sessions are now available to all on demand. Recordings from the series of research updates held during CROI — Margarita Breakfast Clubs — are available here.

The webinar discussants are:

Harry Tembo, Zambia Community Advisory Platform, Zambia
Katie Willingham, The Well Project, United States
Richard Jefferys, Treatment Action Group, United States
Shobha Shukla, Citizen News Service, India
Simon Collins, i-Base and EATG, United Kingdom

CureROAR: Supporting advocacy in HIV cure research

AVAC is excited to announce its CureROAR program, a new initiative to support partners in HIV cure research and advocacy. CureROAR offers mentorship, peer support, networking opportunities and technical assistance. Ten veteran health advocates are the inaugural group to join the program, and together they bring a range of expertise on global health and HIV prevention, including PrEP implementation, sexual and reproductive health, advocacy for key populations, LGBTQ and TG rights, women’s empowerment and more. They are health care providers, educators, advocates and leaders. Meet AVAC’s CureROAR members.

Research for an HIV cure is in a robust period of scientific investigation. Several cure strategies are being explored, while understanding of the HIV reservoir and other key scientific concepts is also advancing. This progress in HIV cure research, as part of a pipeline of biomedical tools to help end the epidemic, must be supported and guided by an advocacy agenda that puts communities first. CureROAR members will dive into the science of cure strategies. The direction of research, the interventions that come from those efforts, and policies and programs to deliver them, must reflect the needs and priorities of the diverse populations that will benefit from a cure. Bringing the lens of seasoned advocates to HIV cure research is fundamental to ethically advancing the field today. And when a cure strategy proves itself, it is knowledgeable, ready advocacy that will ensure the fruits of science reach those who need them most.

CureROAR is part of AVAC’s larger program of HIV cure initiatives, including managing the community engagement activities of the REACH, PAVE and I4C Collaboratories, which are among the ten NIH-funded Martin Delaney Collaboratories for HIV Cure Research (MDC). Interested in learning more? Check out the recording from the April webinar: Breaking Down The Latest in HIV Cure Research: What do new data mean for people with HIV.

For getting more involved, contact [email protected].

New Resources on the Science from CROI, the Ring, DPP and More!

In this week’s roundup, you’ll find details on an upcoming webinar covering the stand-out science from CROI 2022; an important read on vaccine equity; new resources to support advocacy for the dapivirine vaginal ring; resources for learning about and advocating for the Dual Prevention Pill; and a special tribute to Zena Stein.

Webinar: The most notable science at CROI

Wednesday, April 27, 2022 at 9:30am ET/15:00 SAST
Join us, the CROI Community Liaison Subcommittee, and European AIDS Treatment Group for a webinar to debrief on this year’s CROI. A fabulous panel will unpack findings from the conference, share perspectives, and offer advocacy suggestions. Topics will span science presented on HIV prevention and treatment, HIV and aging, HIV cure, and COVID-19. Register here. Recorded sessions from CROI 2022 are now available on demand. For context on the sessions, the recordings from the Margarita Breakfast Clubs explore findings from the research of the day at CROI.

Read Vaccine equity: The rollout that needs a booster shot

An opinion piece in The Hill newspaper by AVAC Executive Director Mitchell Warren points out connections in global health that cut across disease and must be addressed for biomedical products to reach those who need them most. “COVID-19 has shown us the fragility of our efforts to end diseases in places where poverty is entrenched…. We invest hundreds of millions in large trials but nothing similar on how to disseminate the results…. This is not unique to any one disease: We have seen it in the lack of global vaccine equity in the COVID-19 response and we’ve seen it in TB and HIV…. We are achieving breakthroughs in developing new medicines and vaccines, but we are failing to deliver them with equity and with impact. It is well past time to do better.”

Important Voices: Ring user speak out

A video series, developed by the USAID-funded MOSAIC Project, features the voices of women from trials in Kenya, South Africa, Zambia and Zimbabwe that tested the dapivirine vaginal ring. Trial participants explain why the ring works for them and their need for future access to this HIV prevention method.

Watch This Space: HIV and unintended pregnancy prevention

Last week, AVAC and FP2030 held a consultation on the Dual Prevention Pill (DPP), a daily pill that is currently being developed for the simultaneous prevention of unintended pregnancy and HIV acquisition. The webinar brought in dynamic perspectives from the family planning and sexual & reproductive health communities. Be sure to keep this on your radar, as there will be more opportunities at AIDS2022 to learn more, get your questions answered and develop advocacy priorities for this promising multipurpose technology. Currently, the DPP is moving through the R&D process and could be available as early as 2024. It would be the first MPT available. Get more details on the DPP on PrEPWatch.org.

Listen: Life and legacy of Zena Stein

To reflect on the legacy of Zena Stein, a public health, human rights and HIV prevention champion who influenced so many working in HIV prevention, the editor of the American Journal of Public Health produced a video-podcast conversation with CAPRISA’s Quarraisha Abdool Karim and AVAC’s Mitchell Warren.

New COVID-19 Vaccines Trials in Sub-Saharan Africa

Join us on April 6, 2022 10am ET for a special webinar on the Ubuntu trial, hosted by the COVID Advocates Advisory Board (CAAB) and our Coalition to Accelerate and Support Prevention Research (CASPR). Led by the COVID-19 Prevention Network (CoVPN), Ubuntu is a new, landmark COVID-19 vaccine trial in sub-Saharan Africa investigating the efficacy of mRNA vaccines in people living with HIV against the omicron variant.

COVID-19 GPP Resources: A deep dive for advocates

While there are a number of resources that address stakeholder engagement in COVID-19 research, some may not adequately reflect the needs of advocates. Join a conversation reviewing resources for advocates’ needs and shaping future resources!

This discussion will be moderated by AVAC’s Jessica Salzwedel.

Role of Advocates in Prevention Trials — Chilufya Kasanada, TALC
Essential Principals and Practices for GPP Compliance — Cathy Slack, HAVEG
GPP Resources & Implementation in Solidarity — Nina Gobat, WHO

Register here.

Breaking Down the Latest in HIV Cure Research: What do new data mean for people living with HIV

Join a conversation with researchers as they break down the recent case of HIV cure, the first among women. Speakers will also provide updates from an ongoing trial studying pediatric remission. Join to learn what these advances mean for science and for people living with HIV.

8am PT / 11am ET / 5pm SAT / 6pm EAT

Featuring:

Dr. Yvonne Bryson, University of California at Los Angeles
Dr. Deborah Persaud, Johns Hopkins University
Bridgette Picou, The Well Project CAB Co-Chair and Columnist “Being Bridgette” Positively Aware Magazine