Avac Event

PrEPVacc: An in-depth look at the trial, and what’s next

During this webinar, the PrEPVacc team and AVAC reviewed the status of the PrEPVacc trial. PrEPVacc, a 3-in-1 trial testing two different vaccine candidates (plus placebo arm) and two daily oral PrEP regimens, recently discontinued vaccinations in the trial due to an independent data review board’s conclusion that the vaccines were having no effect in preventing HIV infection. On this call, we will review key aspects of PrEPVacc, including its innovative study design, implementation, integrated social science, and data analysis plans. Speakers engaged in conversation about what we’ve learned from PrEPVacc, what we can still learn, and what this may mean for the HIV prevention field.

  • PrEPVacc Trial Design: Sheena McCormack, PrEPVacc Project Lead, MRC Clinical Trials Unit, University College London, UK
  • Trial Implementation and Baseline Data: Eugene Ruzagira, PrEPVacc Trial Director, MRC/UVRI & LSHTM Uganda Research Unit
  • Integrated Social Science: Rachel Kawuma, PrEPVacc Social Scientist, MRC/UVRI & LSHTM Uganda Research Unit
  • Analysis Plan: Sheila Kansiime, PrEPVacc Statistician, MRC/UVRI & LSHTM Uganda Research Unit

Recording / Sheena McCormack Slides / Eugene Ruzagira Slides / Rachel Kawuma Slides / Sheila Kansiime Slides

Px Pulse: A season of listening

As we look ahead to 2024 and the vital work AVAC and partners will be carrying forward, the conversations from 2023 offer guidance and insights. Px Pulse, AVAC’s podcast on critical issues facing HIV prevention research, hosted several not-be-missed conversations in 2023 that will reverberate into the year ahead.  

From a stalled PEPFAR reauthorization to LGBTQIA+ voices fighting persecution in Uganda; from efforts to bring equity to a new global architecture for pandemic readiness to advances in HIV vaccine science and advocacy to include pregnant people in research—we hope that all of these conversations can inform our advocacy in 2024. Click on the episode for both recordings and resources.

PEPFAR at 20: Keeping the promise (23:16)

Considered one of the greatest US foreign policy and global development achievements of the century, the program has saved upwards of 25 million lives since it launched in 2003. But PEPFAR is marking its 20th anniversary while fighting for its future. LISTEN HERE.

LGBTQIA+ Advocacy in Uganda: Facing down fear and fighting for justice (24:19)

In March 2023, the Ugandan Parliament moved forward broad-reaching legislation to further criminalize LGBTQIA+ people. This podcast features Ugandan advocates and AVAC partners discussing the specifics of how these attacks have gained momentum and their ties to US-based religious extremists. The advocates discuss what needs to happen next. LISTEN HERE.

The Shape of Pandemic Preparedness is Being Decided. Now is the Time for Collective Action (15:14)

Health leaders around the world are in the midst of creating a new architecture to deal with pandemics. Chris Collins, the CEO and President at Friends of the Global Fight Against AIDS, Tuberculosis and Malaria, talks about what’s at stake, which policymakers get it already, why this year matters so much, and what advocates can do about it. LISTEN HERE.

PPPR Advocacy 101: Find out what it means to you (19:05)

Over the coming months, global leaders will make key decisions about several initiatives to prepare for the next pandemic. This podcast explores what they commit to, how much they will spend and how well these plans safeguard equity. LISTEN HERE.

Inclusion of Pregnant and Lactating People in HIV Research: What you need to know (34:28)

AVAC’s Manju Chatani-Gada takes us through conversations with a trial participant who became pregnant, researchers, policymakers and donors to understand why this population gets excluded, the impact it has and what to do about it. LISTEN HERE.

Evolving Strategies for an HIV Vaccine: One researcher explains where the field is going and why? (21:23)

Evolving Strategies for an HIV Vaccine: One researcher explains where the field is going and why? Dr. Katy Stephenson explores the implications of recent trial results, the big questions driving next generation vaccine development, and new strategies underway in early phase research. LISTEN HERE.

Happy listening—and let us know what topics you want to hear more about in 2024! 

The Search for an HIV Vaccine Must Continue

Field Will Learn for Halted PrEPVacc Arm

By Jeanne Baron

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.” 

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.