What’s Next for HIV Vaccines? Mosaico Study Webinar on Jan 25

On the heels of Wednesday’s announcement from Janssen Pharmaceutical Company that the Mosaico HIV vaccine trial is ending for lack of efficacy, there’s much to learn and discuss.

Please join AVAC and the HIV Vaccine Trials Network (HVTN) for a webinar on January 25th at 9am PST/12pm EST/6pm CET. The webinar will include study investigators and community representatives as we all discuss the outcome of the Mosaico study, what these results mean and next steps. Register here.

The Mosaico study, also known as HVTN 706/HPX3002, was the third large-scale vaccine efficacy study to conclude early for non-efficacy since 2020. Uhambo/HVTN 702 and Imbokodo/HVTN 705 were stopped in 2020 and 2021 respectively. One large-scale, Phase 2b trial known as PrEPVacc is continuing, studying two vaccine regimens and two daily oral PrEP regimens (F/TAF and TDF/FTC) in men and women; expected completion in late 2024. In addition, several early phase trials using mRNA technology have launched. It’s a field in transition.

This latest announcement raises critical questions about the direction of the essential work to develop an HIV vaccine. Understanding the results of the Mosaico study is central to this task. A vaccine strategy is vital for a durable end to the epidemic but a clear path is not in sight, and new longer-acting PrEP options, which hold promise to bring the world closer to controlling the epidemic, add to the complexity, the opportunities and challenges for HIV vaccine development.

To help navigate all of this, see our updated resources on the issue:

● AVAC’s statement on the Mosaico trial

● Years Ahead in Biomedical HIV Prevention Research (Detailed)

● Years Ahead in HIV Prevention Research (Simple)

● A Review of Pipeline of New HIV Prevention Options

● A Vaccine Factsheet

We look forward to hearing from you on the 25th and working with you going forward.

Mosaico HIV Vaccine Study Stopped Early for Non-Efficacy

Today, the Mosaico study, a large-scale HIV vaccine efficacy study also known as HVTN 706/HPX3002, was stopped early for non-efficacy. The study took place in several countries in North and South America and Europe to test the safety and efficacy of the adenovirus26-based vaccine regimen among 3,900 cis-gender men and transgender individuals who have sex with cis-gender men and/or transgender individuals. An independent data and safety monitoring board, at a scheduled review of the trial data, found the regimen to be safe, but that it did not meet the pre-defined criteria for efficacy and recommended that the study be stopped and trial participants informed.

The Mosaico study used a similar version of the vaccine regimen in its companion study, the Imbokodo trial, which was stopped in August 2021 as it also did not significantly reduce the overall risk of HIV acquisition among over 2,600 cis-gender women in five sub-Saharan African countries.

● Read the Janssen Pharmaceutical Company press release.

● Read the HVTN press release.

● Read the AVAC press release.

● The HVTN and AVAC will host a global webinar on Wednesday, January 25 to reflect on this news and how it may impact HIV vaccine R&D and prevention globally. Stay tuned for registration details soon.

“The hard truth is the science of HIV vaccine development is extremely challenging,” AVAC said in its statement. “HIV remains a global threat, and a safe, efficacious and accessible HIV vaccine is still needed to provide a durable end to the pandemic. At the same time, we now have more proven HIV prevention options than ever before, but they are not reaching everyone who needs and wants them. Even as researchers continue the necessary work of accelerating HIV vaccine research, the broader HIV response must act as if we may never have a vaccine and prioritize the roll out of existing prevention options and research for additional ones. Ending this pandemic requires simultaneous action on multiple fronts of research, development and delivery.”

We hope you join us on January 25 with your questions and comments to discuss the ways forward.

Press Release

HIV Vaccine Research Must Continue Following Disappointing Result from Mosaico Trial

Renewed Commitment to Expanding Access to All Existing
HIV Prevention Options Must be a Global Priority

Contact

Kay Marshall, +1 (347) 249-6375, [email protected]

January 18, 2023 — Today, Janssen Pharmaceutical Companies of Johnson & Johnson and partners announced that the Mosaico study, a large-scale HIV vaccine efficacy study also known as HVTN 706/HPX3002, was stopped early for non-efficacy. The study took place in several countries in North and South America and Europe to test the safety and efficacy of the adenovirus26-based vaccine regimen among 3,900 cis-gender men and transgender individuals who have sex with cis-gender men and/or transgender individuals. An independent data and safety monitoring board, at a scheduled review of the trial data, found the regimen to be safe, but that it did not meet the pre-defined criteria for efficacy and recommended that the study be stopped and trial participants informed.

“We always hope that efficacy trials will show positive results that lead to new prevention options,” said Mitchell Warren, Executive Director of AVAC. “It is disappointing that this particular vaccine candidate did not work, but Mosaico was an important, well-designed and well-conducted trial, especially in the midst of the COVID-19 pandemic and the roll-out of oral PrEP. The trial demonstrated that it is not only possible to design and conduct an HIV vaccine trial in the current environment, but that it is essential to do it.”

“The hard truth is the science of HIV vaccine development is extremely challenging,” Warren added, “but this is not the time to dial back support for ongoing research. Far from it – HIV remains a global threat, and a safe, efficacious and accessible HIV vaccine is still needed to provide a durable end to the pandemic. At the same time, we now have more proven HIV prevention options than ever before, but they are not reaching everyone who needs and wants them. Even as researchers continue the necessary work of accelerating HIV vaccine research, the broader HIV response must act as if we may never have a vaccine and prioritize the roll out of existing prevention options and research for additional ones. Ending this pandemic requires simultaneous action on multiple fronts of research, development and delivery.”

HIV vaccine research is complex and difficult. It is imperative that researchers work together and glean as much information as possible from the research process and from each study. Mosaico and the ongoing PrEPVacc efficacy study will both provide important information to help refine future vaccine research; various antibody studies are providing key information to inform both antibody-based prevention and vaccine development; and basic science research and early phase human studies are providing still more clues to what is needed to develop a safe and effective HIV vaccine.

“While this outcome is a disappointment, it must be seen as a result of the necessary effort to find, and keep the hope alive for, an HIV vaccine. This is, therefore, not an end, but one more addition to the knowledge it will take to find an HIV vaccine. We salute the nearly 4,000 Mosaico trial participants and the communities that were part of this important study. They join hundreds of thousands of previous HIV vaccine trial participants who have selflessly helped in this important global health endeavor,” said Ntando Yola, from the Desmond Tutu Health Foundation and Advocacy for Prevention of HIV in Africa (APHA) in South Africa. “As advocates we stand with communities across the globe who want to see an end to HIV. Working through the Coalition to Accelerate and Support Prevention Research (CASPR), we will continue to work with researchers, funders and policy makers to ensure that community voices, concerns and needs are at the forefront of ethically conducted, participatory HIV prevention research.”

“AVAC congratulates the trial teams at sites across the globe for their work on a superbly run study,” said Stacey Hannah, AVAC’s Director of Research Engagement and CASPR Project Director. “We applaud Janssen for working in collaboration with the HIV prevention community, for their leadership in HIV vaccine research and for their longstanding commitment to robust stakeholder engagement through the Good Participatory Practices (GPP) Guidelines that must be continued to maintain trust in vaccines and in research, irrespective of trial results. In fact, this commitment to GPP helps ensure all of us navigate disappointing results.”

“We’re proud to have worked with the Mosaico trial team to ensure advocate and community voices were heard in the design of the trial, especially around integrating oral PrEP into the design,” added Hannah. “While it is very disappointing that this vaccine will not move forward, this trial was a success in its innovative design and conduct, and provides important lessons for HIV prevention efficacy trials in the years to come.”

The Mosaico study evaluated whether an adenovirus26-based vaccine with a Clade C and mosaic gp140 vaccine regimen could safely and effectively reduce the rate of new HIV infections among cis-gender men and transgender individuals having sex with cis-gender men and/or transgender individuals in Argentina, Brazil, Italy, Mexico, Peru, Poland, Spain, and the United States. Participants received a total of four vaccines over twelve months of either a prime-boost vaccine regimen of a mosaic viral-vectored vaccine, Adeno26.Mos4.HIV (Ad26 prime) together with an aluminum phosphate-adjuvanted Clade C and Mosaic gp140 HIV bivalent vaccine (boost) or a placebo.

“As the HIV prevention field – researchers, funders, policymakers, advocates and communities – has done for decades, we will take the lessons learned from Mosaico and move forward in the quest for an end to HIV and improved health equity in communities across the globe,” said Warren.

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About AVAC: Founded in 1995, AVAC is a non-profit organization that uses education, policy analysis, advocacy and a network of global collaborations to accelerate the ethical development and global delivery of HIV prevention options as part of a comprehensive response to the pandemic. Follow AVAC on Twitter @HIVpxresearch and find more at www.avac.org and www.prepwatch.org.

HIV Vaccines: An introductory factsheet

This is an updated introductory two-page document that describes HIV vaccines research and reviews key developments in the field.

Webinar Roundup — Including An Upcoming Webinar With Tony Fauci!

In October AVAC’s calendar of webinars took on a range of topics, each crucial for the field, and November’s webinars will be just as rich and diverse. Read on for highlights from October’s discussions and related resources, and be sure to register for webinars and events that are coming up this month, including a Fireside Chat with Tony Fauci!

Upcoming Webinars and Meetings

PEP Needs Some Pep! Addressing PEP Neglect in HIV Prevention Research, Programming and Uptake
Thursday, November 3 at 9:00am ET; 16h00 EAT
Register here
PEP, post-exposure-prophylaxis, is an HIV prevention intervention marked by both great promise and profound neglect. PEP works, but far too few people know about, or when and how to obtain this valuable intervention. Join The Choice Agenda for a discussion with James Ayieko, Julie Fox, Ken Mayer, Catherine Koss, Njambi Njuguna and Ace Robinson.

Africa Health R&D Week 2022
November 8 – 11, 2022, virtual
Register here
Join AVAC, IAVI, CASPR and others for a continental forum on domestic resource mobilization (DRM) for health research and development (R&D) in Africa. This week-long program for advocates, media, policymakers, program implementers, researchers, and funders will bring clarity to key issues and trends of DRM for health R&D in Africa.
Agenda / Concept Note / Flyers

Reintroducing PrEPWatch
Thursday, November 10 at 9:00am EDT; 17h00 EAT
Register here
Join us as we introduce AVAC’s updated PrEPWatch.org, a one-stop clearinghouse for the latest PrEP data on implementation and uptake, resources, and information on PrEP policies, programs and products, approved and in development. During this webinar, we’ll share:

New data on PrEP rollout worldwide and by country.
New ways to access global and country-specific PrEP resources for PrEP planning and advocacy.
Stories of innovation from the field.
Toolkits for each phase of planning, from policies & budgets to monitoring & evaluation, and everything in between.

Much Accomplished, Much to Do: A Conversation Looking Back & Looking Ahead with Tony Fauci
Monday, November 28 at 11:30am EDT; 18h30 EAT
Register here
Join AVAC for a conversation with NIAID Director, Anthony Fauci as we discuss all that’s been accomplished in the HIV and COVID-19 responses over the years, what’s ahead, and what the future looks like for NIAID, for Dr. Fauci and for pandemic preparedness.

Recordings and Resources

Doxycycline for STI prevention: Evidence and Current Research
Featuring Dr. Connie Celum, Jennifer Mahn, Dr. Victor Omollo, Rodney Perkins and Dr. Jenell Stewart
Recording / Slides / Resources

Private Sector Delivery Opportunities for the Dual Prevention Pill (DPP): Lessons from family planning (FP) for the introduction of multi-purpose prevention technologies (MPTs)
Co-hosted by AVAC and FP2030, this webinar highlighted findings from a report on private sector opportunities for the DPP and explored lessons from the family planning field
Recording / Slides / Resources

RINGing the Bell for Choice: Actions and Solutions on Dapivirine Ring (DVR) Access
The Choice Agenda hosted a conversation around the latest in DVR advocacy last month. Watch the webinar, explore up-to-date resources on DVR, and sign-up for The Choice Agenda listserv—a growing community of over 800 prevention advocates and counting.

The Way Forward for HIV Vaccine Development

HIV vaccine science is at a crossroads. New science, new findings from recent phase III trials that ended without efficacy, innovations learned from COVID-19 vaccines, and new approaches to trial design are all contributing to a period of innovation and transition in HIV vaccine development. AVAC’s latest blog, An HIV Vaccine: The challenges ahead, frames these issues and draws highlights from a webinar series AVAC convened earlier this year.

In July, the Treatment Action Group (TAG) released its 2022 annual overview of research and development in HIV, Hepatitis and TB; it included a specific report on HIV vaccines and passive immunization, or bNAbs. This pipeline report provides added context to our blog.

And for more on HIV vaccines, read the May JIAS Viewpoint, HIV vaccines in 2022: where to from here?; AVAC’s backgrounder on experimental medicine vaccine trials (EMVTs), and AVAC’s fact sheet of early phase trials testing mRNA-based HIV vaccines—a one-stop sheet including a expanded snapshot of up-to-date mRNA trials and additional resources to explore and learn more.

A few highlights from these resources include:

Research using mRNA technology for an HIV vaccine is in very early stages. This innovation could speed the research process, but cannot alone answer some of the most crucial questions bedeviling the advance of HIV vaccine research.
The development of quick, iterative trial designs has become crucial, as the field continues to try and answer a fundamental question: what immune response needs to be triggered for effective protection against HIV. The use of innovative trial designs, including experimental medicine vaccine trials (EMVTs) hold promise and potential, and should be prioritized.
Re-invigorated collaboration, recognizing the quest for an HIV vaccine as one of the greatest scientific challenges of the modern era, is essential to analyse closely what the field has learned to date, develop clarity on the critical scientific challenges and agree on a coordinated strategy to pursue answers.

Stay tuned for more updates on HIV vaccine R&D after next month’s bi-annual HIV Vaccine Trials Network meeting.

HIV Vaccines: The challenges ahead

Just two years ago, AVAC highlighted the connections between COVID-19 and HIV, and outlined their implication. Two years later, those insights on Platforms, Process, Partnerships, Payers and Participatory Practices that Drive Vaccine Development remain critical. The field has continued to build on those insights as it considers priorities for the HIV vaccine field today—and tomorrow.

Because recent results from major HIV vaccine trials have had disappointments and reframed the questions the field must ask, AVAC hosted a 2022 webinar series on the progress in HIV vaccines in light of a rapidly changing research landscape. This document provides highlights from the presentations and discussions as part of this series to help advocates understand and mobilize around an agenda for HIV vaccine research and access.

New Issue of PxWire!

PxWire is AVAC’s quarterly update covering the latest in the field of biomedical HIV prevention research and development, implementation and advocacy. Each issue includes news, emerging issues and features upcoming events.

The HIV field gathers for its first hybrid International AIDS Conference (IAC) since the start of COVID-19 pandemic at a pivotal moment in HIV prevention. Across research to rollout – accelerated product access, new products reaching the market, new trials starting (and pausing) and recent research results – the ability to deliver two new proven PrEP methods will be determined by conversations and decisions happening now.

After initial approval ten years ago, oral PrEP initiations have surpassed 2M globally, reaching 2,797,304 – with significant progress over the past year, but still well below UN targets.

Check out the full issue of PxWire here and scroll down for important updates.

Research Fundamentals: An HIV Vaccine — What’s the challenge and what’s the science?

Some vaccines are easier to develop than others. COVID-19 vaccines were developed with unprecedented speed, taking a matter of months to become available. A measles vaccine took about 10 years to develop. But the field’s been working on an HIV vaccine for 40 years.

In this episode, AVAC’s Jeanne Baron and co-host immunologist Katharine Kripke of AVENIR Health explore why HIV is different with two experts on vaccine research: Caltech’s Pamela Bjorkman and IAVI’s Vincent Kioi.

Learn how HIV has evolved like no other virus today to escape detection by the immune system. Learn why the right target on HIV is so hard to reach and how scientists are tackling it all.

Previous Research Fundamentals

More Vaccine Resources

Time to Develop a Vaccine

We know that an AIDS vaccine is possible and that a vaccine will be an important part of a long-term strategy to end the AIDS epidemic. The road ahead is long, but clinical trials—even those with disappointing results—and early-stage research provide critical clues to the way forward. This graphic is excerpted from Vaccines by the Numbers: Trials, discoveries, money and more.

Contact

Upcoming Webinars and Meetings

Recordings and Resources

Previous Research Fundamentals

More Vaccine Resources

Stay up-to-date!