HVTN 702 and the Quest for Vaccine

One of the most anticipated HIV vaccine efficacy trials in the field—HVTN 702, or Uhambo—stopped vaccinations early after a scheduled review showed the vaccine did not offer protection.

The trial team will continue to follow participants over the next year to monitor safety and answer urgent questions raised by the trial results. In this episode of Px Pulse, HVTN 702 Protocol Co-chair and AVAC Board Member Linda-Gail Bekker explores what the trial team hopes to learn during the follow-up period and how these answers might impact the ongoing pursuit for an HIV vaccine. AVAC’s Regional Stakeholder Engagement Advisor Nandisile Luthuli also joins the conversation to shed light on the trial team’s plans for continuing community engagement, and AVAC’s Director of Research Engagement, Stacey Hannah, talks about the successes of the trial.

Webinar: HVTN 702 updates and next steps

Leaders of HVTN 702 HIV vaccine efficacy trial in South Africa (also known as Uhambo), announced that vaccinations would be stopped early because the vaccine candidate did not prevent HIV. Importantly, there were no safety concerns. Since then, conversations have ensued—from local and global levels—to understand the result and its implications for the future of HIV vaccine development.

AVAC and Advocacy for the Prevention of HIV and AIDS (APHA) held a global webinar on Wednesday, February 19 to reflect on this news and how that may impact HIV prevention globally.

Listen to the recording of the webinar here.

The call provided civil society perspectives from APHA and the Vaccine Resource Advocacy Group (VARG), updates from HVTN 702 researchers, and broader context of HIV vaccine development from the United States NIH’s Division of AIDS (DAIDS).

HVTN 702 is one of several Phase III vaccine trials ongoing at this time. HVTN 705/ HPX2008 (Imbokodo), HVTN 706/HPX3002 (Mosaico) and the PrEPVacc Study are all exploring novel HIV vaccine candidates. Broadly neutralizing antibodies and additional ARV-based prevention options are also in large-scale trials. Though the failure to find efficacy with HVTN 702 represents a disappointment, unflagging momentum in research must continue. It’s crucial to understand these results and the scientific contribution they will make to a future, urgently needed vaccine.

See AVAC’s updated infographics for a visual picture of the pipeline of research on biomedical HIV prevention:

For additional background on the HVTN 702 trial, check out the HVTN’s fact sheet.

As always, please be in touch with any questions!

Vaccine Efficacy Trials Pipeline

This infographic shows a timeline for each of the three major vaccine efficacy trials proposed or underway now.

Vaccines Research Pipeline

This graphic shows the many types of Vaccines undergoing research, categorized by the immune response they are designed to elicit—broadly neutralizing antibodies, non-neutralizing antibodies, T-cell responses or a combination of these.

HVTN 702 Stopped Early for Non-Efficacy

Today the US National Institute of Allergy and Infectious Diseases (NIAID) announced that HVTN 702, a large-scale HIV vaccine efficacy trial of a canary pox-based vaccine candidate, has stopped vaccinations because the vaccine does not prevent HIV.

HVTN 702 (also known as Uhambo) was stopped following a scheduled review by an independent data and safety monitoring board. The review showed no significant difference between the two arms of the trial and importantly, no safety concerns. Trial participants are being informed of the stop and will remain in the study for follow-up.

AVAC applauds the 5,407 trial participants in South Africa for their time and dedication, and the trial team for their hard work in conducting this trial and getting an answer quickly, even if it’s not the one we’d hoped for. The 252 new infections diagnosed across the study is yet another important reminder of the need for access to and uptake of current treatment and prevention options, like oral PrEP, and for continued investments in the development of additional vaccine and non-vaccine options.

HVTN 702 is a Phase 2b/3 study testing a regimen adapted from the vaccine strategy tested in the RV144 Thai vaccine trial, which showed roughly 30 percent lower infection rate among volunteers who received the vaccine versus those who received the placebo.

The vaccine approach in HVTN 702 is different from that being tested in other large-scale vaccine efficacy studies HVTN 705/HPX2008 (the Imbokodo Study) and HVTN 706/HPX3002 (the Mosaico study). It is also different from the planned PrEPVacc Study, which will test yet another vaccine strategy along with oral PrEP. The stop of HVTN 702 does not affect these trials or any other HIV prevention efficacy trials taking place globally.

AVAC and Advocacy for the Prevention of HIV and AIDS (APHA) held a global webinar on Wednesday, February 19 to discuss the latest updates and reflect on how they may impact HIV prevention globally. A recording of the webinar can be found here.

As always, please contact us with any questions.

Press Release

HIV Vaccine Trial HVTN 702 Stopped Early for Non-Efficacy

Contact

Mitchell Warren, +1 (914) 661-1536, [email protected]
Kay Marshall, +1 (347) 249-6375, [email protected]

Other Vaccine Trials Not Affected; AVAC Calls for Ongoing Support to Vaccine Research

New York City – Today the US National Institute of Allergy and Infectious Diseases (NIAID) announced that HVTN 702, a large-scale HIV vaccine efficacy trial of a canary pox-based vaccine candidate, has been stopped because the vaccine does not prevent HIV.

HVTN 702 (also known as Uhambo) was stopped following a scheduled review by an independent data and safety monitoring board that showed no significant difference between the vaccine and placebo arms of the trial. The review identified no safety concerns. Trial participants are being informed of the stop and will remain in the study for follow-up.

“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 very disappointing that this vaccine candidate does not work, but the trial was well-conducted and got an answer as quickly as possible. Over the last decade, the HIV vaccine field has made unprecedented progress in working together to tackle the tough questions that need to be answered to move research forward intelligently, share important findings, and avoid duplicative endeavors. The HIV vaccine field is more coordinated than ever before, which means it can take the answers this trial has provided and move the research agenda forward in new directions.”

“South Africa and South Africans have made enormous contributions to HIV vaccine and prevention research, as researchers, clinicians and trial participants,” Warren said. “AVAC recognizes the significant contribution of the 5,400 volunteers in this trial. Their involvement makes HIV prevention research possible. AVAC commends the trial staff and the global research team for their hard work in conducting this trial, getting an answer fast, and prioritizing participants throughout the process. We are glad the funders for this and other research recognize the imperative to work together to sustain investment.”

HVTN 702 evaluated whether an investigational HIV vaccine regimen is safe, tolerable, and effective at preventing HIV infection among 5,400 South African adult women and men. The Phase 2b/3 study, the largest and most advanced HIV vaccine trial to take place in South Africa, and was adapted from the vaccine strategy tested in the RV144 Thai vaccine trial, which showed roughly 30 percent lower infection rate among volunteers who received the vaccine versus those who received the placebo.

The vaccine approach in HVTN 702 is different from that being tested in other large-scale vaccine efficacy studies HVTN 705/HPX2008 (the Imbokodo Study) and HVTN 706/HPX3002 (the Mosaico study). It is also different from the planned PrEPVacc Study, which will test yet another vaccine strategy along with oral PrEP. The stop of HVTN 702 does not affect these trials or any other HIV prevention efficacy trials taking place globally.

“A vaccine is absolutely essential to achieving a durable end to the HIV epidemic,” said Warren. “It will be important for the HVTN 702 partners to share data from the study as quickly as possible, and for the field to come together as it did after RV144 to ensure that what can be learned from this trial is fed back into the research pipeline expeditiously. Other ongoing HIV prevention efficacy studies, including three vaccine efficacy trials, two antibody-mediated prevention trials and two long-acting injectable ARV studies will yield results in the coming years; and the earlier stage research pipeline is diverse and promising. It is critical that funding for HIV vaccine and other prevention research – as well as industry involvement – continue as part of a comprehensive agenda to end the epidemic.”

For more information, learn about the HIV vaccine research pipeline and about HVTN 702.

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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 AIDS vaccines, male circumcision, microbicides, PrEP and other emerging HIV prevention options as part of a comprehensive response to the pandemic. For more information, visit www.avac.org.

The latest on AVAC.org

Check out the resources below for the latest AVAC material, including our just-released AVAC Report 2019: Now What?, our opinion piece on Devex highlighting priorities for 2020 and beyond, and several new resources and publications!!

AVAC Report 2019: Now What?

Our November publication of our annual report asks Now What? as we look ahead to 2020 and the certainty of missing HIV prevention targets set by UNAIDS. In answer, we issue a call to action: enact bold, activist, visible leadership on HIV; sustain investment; use today’s evidence to guide tomorrow’s prevention targets; and double down on multilayered prevention approaches.

Check out these additional resources in the report:

The Global Development Community is Listening

On December 3rd, Devex published AVAC’s opinion piece exploring the critical challenges and opportunities we laid out in Now What? Read on for the actions we think will make the difference from leaders and communities at every level.

Youth Leadership Will Turn the Tide Against HIV

We commemorated World AIDS Day 2019 with the launch of a series of blogs from the new generation of leaders who must carry the torch to end the epidemic. Learn why we call these leaders Generation Now and have pledged our support to their remarkable efforts. And read the blogs to see their responses, framing the challenges ahead.

Abuja Commitments for Spending on Health Put in Context

To coincide with the recent ICASA conference Accountability International published, with support from the AVAC-led Coalition to Accelerate & Support Prevention Research (CASPR), Mind the Gap: African HIV Financing Scorecard. This report tracks current African domestic investments in HIV treatment and prevention. The report also makes the case for the importance of considering other indicators, beyond the 2001 Abuja pledge of 15 percent of annual budget investments into the health sectors, when evaluating political will and opportunities to increase investment and access to health.

Learning from “Like” Products to Accelerate the Introduction of New Prevention Options

As part of the OPTIONS Consortium, which AVAC co-leads, we published The Dapivirine Ring: Key learnings from like-product introductions, which examines historical experiences introducing products that share characteristics with the dapivirine vaginal ring, specifically, products that were vaginally inserted or partially efficacious.

The Complex Challenges of HIV Vaccine Development Require Renewed and Expanded Global Commitment

Several AVAC staff and partners contributed to a new viewpoint in The Lancet journal describing what it will take to develop and deliver an HIV vaccine. In The Complex Challenges of HIV Vaccine Development Require Renewed and Expanded Global Commitment, the authors highlight the need to plan now for regulatory review, procurement, and implementation of a potential HIV vaccine to speed its availability. Additionally, drawing on our Resource Tracking Working Group data, the authors call for increased funding for HIV prevention research and the need for strengthening the pipeline of early stage HIV vaccine candidates.

Support AVAC

As the end of the year approaches, we hope you’ll remember AVAC in your charitable giving. Help us sustain this essential work with your support in one or more of the following ways:

AVAC’s “3D” View of the World: 2019 and beyond

This infographic lays out AVAC’s top-line recommendations from AVAC Report 2019: Now What? The recommendations fall into three categories: deliver — prevention programs whose impact is well-measured and -defined; demonstrate — next-generation engagement for next-generation trials; develop — new targets for the post-2020 world.

AVAC Report 2019: With 2020 targets sure to be missed, we ask Now What?

Report cover

Today, AVAC released Now What?, our 2019 annual report on the state of the HIV prevention field. Each year, the AVAC Report frames the most pressing advocacy issues facing the HIV response. At the threshold of 2020, it’s clear that global goals for HIV prevention will miss the mark by a long shot.

Though important progress has been made, the crisis UNAIDS called out in 2016 persists today with new infections around 1.7 million annually, a far cry from the 2020 target of fewer than 500,000.

So, we asked ourselves, Now What?, and answered with cross-cutting analysis and an advocacy agenda to match.

FIRST, we call for leadership that is bold, visible and activist, from the new head of UNAIDS, to houses of parliament to civil society coalitions: take uncompromising stances, demand accountability, speak out for intersectional issues of race, gender, class and climate. This work needs to be funded, full-throttle and fearless.

SECOND, we call for the use of today’s most recent evidence to guide new prevention targets that will pave the way for epidemic control. Clear milestones for the prevention research pipeline must be set. Investments over the past decades have provided us with the prevention options we have today, and much-needed new strategies are under now investigation. The field needs targets for prevention research that people can understand and influence.

THIRD, we call for multilayered prevention approaches that are centered around the person, not the virus. Since last World AIDS Day, we’ve learned again, perhaps most strikingly from the ECHO trial, about the dynamic needs of women for HIV and pregnancy prevention. The complexity of translating results into policy, bring renewed urgency to the need for comprehensive HIV prevention and reproductive health approaches. Multilayered prevention incorporates multipurpose strategies (i.e., products that prevent both pregnancy and HIV) within programs designed to address structural barriers (i.e., policy reform, transforming community norms, facilitating educational empowerment).

2020 will be a pivotal year—join us in calling on leaders, from the grassroots to global capitals, to make 2020 a turning point, when siloes come down, crises are transformed by innovation, and prevention is center stage in the fight against HIV.

Happy reading, and we’d love to hear how you answer Now What?

What’s New on AVAC.org and PrEPWatch.org

We don’t want you to miss a host of resources posted in recent weeks on AVAC.org and PrEPWatch. In case you missed them, these tools and resources will sharpen your take on the field.

Reporting on Global HIV Prevention

Check out these reports—recently published by AVAC and partners—for updates on funding trends in prevention and cure R&D, as well as a fresh look at places that have beaten back HIV with existing interventions:

Smarter Rollout

These articles and tools support advocates, implementers and decision-makers working on PrEP rollout today with an eye on future interventions tomorrow:

  • Reaching and Targeting More Effectivley: The application of market segmentation to improve HIV prevention programmes, by AVAC’s Anabel Gomez and others, and published in the Journal of the International AIDS Society, explores how to leverage the power of market segmentation for the promotion and uptake of primary prevention.
  • Just updated in July, AVAC’s Global PrEP Tracker on PrEPWatch.org provides the latest data on programs, number of enrollments by country, regulatory status and more.
  • A User’s Guide to PrEP Tools offers a handy table to navigate the many tools produced by different organizations to support policy makers, implementers, providers and others on PrEP access, uptake and continuation. Use this table to learn more about these tools, who they’re designed for, and when to use them.
  • The PrEP4Youth video series of public service announcements encourages adolescent girls and young women in South Africa to consider PrEP as an HIV prevention method. Created by the OPTIONS Consortium in collaboration with the South African National Department of Health, these videos feature popular actresses and put young women at the center with short empowering messages.

Apply to be an AVAC Fellow in 2020

AVAC would like to remind you that our call for applications for the 2020 class of AVAC Fellows is open until September 20. We encourage you to learn more about the program and share this information with your network!