Press Release

The Search for an HIV Vaccine Must Continue

Field Will Learn for Halted PrEPVacc Arm

New York, 6 December 2023 – Today the PrEPVacc trial team announced at a special session at the International Conference on AIDS and STIs in Africa (ICASA) in Harare, Zimbabwe, that they were stopping vaccinations in the study following a review by an independent data safety committee that determined there was little chance the vaccines being tested could stop HIV acquisition. The oral PrEP arms of the study will continue. 

PrEPVacc was testing two different vaccine strategies against a placebo: one regimen combining a DNA vaccine with a protein-based vaccine (AIDSVAX), and another regimen combining DNA, MVA and a protein-based vaccine (CN54gp140). 

“We always hope for a positive outcome in HIV prevention trials, and this news is disappointing,” said Mitchell Warren, AVAC executive director. “We look forward to seeing the full PrEPVacc data in 2024 and hope it will add to the body of evidence that is helping scientists understand how to develop better vaccine candidates that will one day protect against HIV.”  

“The PrEPVacc outcome underscores yet again that the science of HIV vaccine development is extremely challenging,” he added. “Now is not the time to step back from vaccine research. There are several promising strategies in early-stage research that must continue, along with research for other HIV prevention options. We will not end HIV without ensuring that everyone who is vulnerable to HIV infection has a choice of effective and desirable prevention options.”  

Importantly, PrEPVacc’s PrEP arms will continue. The study is testing two different formulations of daily oral PrEP, looking to see if a new formulation – F/TAF (also known as Descovy) – is at least as good in the trial population at protecting against HIV acquisition as F/TDF (also known as Truvada and the most widely used version of PrEP). The trial will provide the first data for F/TAF among cisgender women (who make up 87% of the just over 1,500 PrEPVacc trial participants). F/TAF is approved for use in the US and UK, but not for those individuals who have receptive vaginal sex, since previous trials regrettably did not enroll cisgender women. 

The PrEPVacc study is scheduled to conclude in 2024 and data from all arms of the study are expected to be reported in the last half of 2024. 

“The PrEP arms of PrEPVacc will provide important insights into the potential of expanding access of F/TAF for PrEP to women in East and Southern Africa who need additional options to protect themselves from HIV. Equitable access to new interventions should be a goal of every research program,” said Stacey Hannah, AVAC’s director of Research Engagement. 

“PrEPVacc is a complex, innovative trial design, and, while the vaccine result today is disappointing, the trial team has worked from the outset to implement the Good Participatory Practice (GPP) Guidelines. The team’s hard work on the front-end to apply GPP to this trial is paying off especially now in the ability to deliver complex, disappointing results to trial participants, advocates, policymakers and other key supporters of PrEPVacc and of HIV prevention broadly.” 

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About AVAC  

AVAC is an international non-profit organization that provides an independent voice and leverages global partnerships to accelerate ethical development and equitable delivery of effective HIV prevention options, as part of a comprehensive and integrated pathway to global health equity. Follow AVAC on Twitter @HIVpxresearch; find more at www.avac.org and www.prepwatch.org.

HIV Vaccine Research

HIV vaccine research is a multifaceted endeavor that requires collaboration across many disciplines to develop a vaccine that protects people from HIV infection. The graphic outlines the different areas of research that are being pursued, including vaccine platforms, immune system research, clinical research capacity, and community engagement.

Excerpted From Lab to Jab.

Introducing From the Lab to the Jab: A new series of advocates’ guides

AVAC is excited to launch From the Lab to the Jab, a new series of advocates’ guides that highlight key advocacy issues to ensure equitable access to safe, effective, and affordable vaccines.

Co-created as part of our USAID-supported Coalition to Accelerate and Support Prevention Research (CASPR), with additional support from the New Venture Fund, From the Lab to the Jab issue briefs provide a roadmap for advocacy to advance the development and delivery of essential vaccines for HIV, COVID-19, tuberculosis, and other global public health threats, and approaches to ensure equitable access to these life-saving vaccines.

Go to avac.org/FromLabToJab to learn about next generation vaccine research and development; the basics of mRNA technology; initiatives that support local manufacturing; and understanding and overcoming barriers that undermine equitable access to vaccines. Each brief also highlights the advocacy needed to keep these efforts on track and in line with what communities need and want. 

Stay tuned for an invitation to join the From the Lab to the Jab Webinar in January 2024, and be part of the conversation that will use these briefs to strengthen advocacy and create a roadmap to achieve key transformational priorities in global health. 

Vaccine Research and Development: Key Lessons and Ways Forward

From Lab to Jab

This issue brief on the vaccine research and development (R&D) process is one of a series of four briefs, which provide a roadmap for advocacy to advance the development of essential vaccines for HIV, COVID-19, tuberculosis, and other global public health threats, and approaches to ensure equitable access to these life-saving vaccines. Additional topics cover the role of mRNA technology, the need for local vaccine production, and issues around global access.

Vaccine Access: What’s Working and What’s Next

From Lab to Jab

This issue brief covers the web of issues that influence access to vaccines. It is one of a series of four issue briefs, which provide a roadmap for advocacy to advance the development of essential vaccines for HIV, COVID-19, tuberculosis, and other global public health threats, and approaches to ensure equitable access to these life-saving vaccines. Additional topics cover the research and development (R&D) process, the role of mRNA technology; and the need for local vaccine production.

Vaccine Development History

A graphic showing the duration between discovery of the microbiologic cause of selected infectious diseases and the development of a vaccine.

Excerpted From the Lab to Jab.

Local Vaccine Production: Harnessing Its Potential for Equity

From the Lab to the Jab

This issue brief on local vaccine production covers the current state of local production, what is needed to facilitate it, and ideas for advocacy to harness its potential. It is one of four briefs in a series providing a roadmap for advocacy to advance the development of essential vaccines for HIV, COVID-19, TB and
other global public health threats, including approaches to ensure equitable access to these life-saving vaccines once developed. Additional topics cover the research and development (R & D) process, issues around global access; and the advent of the mRNA platform for vaccines.

From the Lab to the Jab

A series of advocate guides to the latest in vaccine R&D

From the Lab to Jab are a series of briefs to learn the latest in vaccine R&D for HIV, COVID-19, TB and other global public health threats. Access them all here and stay tuned for a related webinar in early 2024. Watch this space or sign up for our email newsletter.

Phase 1 mRNA HIV Vaccine Trials

A breakdown of current HIV mRNA trials and a primer on the basics of mRNA technology.

Advancing Choice in HIV Prevention

In recent weeks, important new resources for advancing choice in HIV prevention have been announced. Don’t miss these highlights from the field. They point to an HIV response in transition, and help to define the role advocacy must play. As policy, practice and budgets strive to keep up with advances in research, advocacy around choice becomes a cross-cutting priority—so that the promise of new options in HIV prevention won’t be squandered in siloed programs, or by poorly-planned supply chains, or because of disconnected policy decisions. People have diverse needs and face complex challenges; ending HIV depends on finding the option that works best for each individual.  

The Choice Manifesto 

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The African Women’s HIV Prevention Community Accounability Board (AWPCAB) launched the HIV Prevention Choice Manifesto, calling for increased political and financial support to ensure every proven method of HIV prevention is integrated into the HIV response, so that all women who need prevention will have access to the options that will make prevention possible for them. At the launch event in Kampala, UNAIDS Executive Director Winnie Byanyima gave a keynote address in support of the Manifesto’s call for all stakeholders to commit to the budgets and strategies that will make choice possible.  

“I congratulate you for the HIV Prevention Choice Manifesto. It’s about pushing everyone towards people-centered, women-centered and women-led approaches to HIV prevention. You have fought with your lives to get here. You are fearless feminists. Women must lead for themselves.” – Winnie Byanyima, UNAIDS Executive Director

Learn more about the HIV Prevention Choice Manifesto and other advocacy resources for choice in our latest AVAC blog, Reclaiming Choice: The launch of the HIV Prevention Choice Manifesto and what that means.  

The Dual Prevention Pill (DPP) 

The DPP Consortium created a multiyear strategy to frame priorities and next steps in the development and delivery of the dual prevention pill (DPP), which is being developed to prevent HIV and unintended pregnancy. This multipurpose prevention technology (MPT) combines oral PrEP with an oral contraceptive. The updated strategy consolidates two years of progress toward preparing the field for new MPTs. The strategy addresses additions to the MPT pipeline, the potential role of the private sector in delivering a future DPP, recommendations for provider counseling on the use of the DPP, market research on potential DPP users, the latest analysis on cost, and more.

Stay tuned for more resources and updates to come on the DPP, the Choice Manifesto, and tools for connecting choice to HIV prevention, ending the epidemic and the role of choice in global health equity in HIV, and beyond.