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, mitchell@avac.org
Kay Marshall, +1 (347) 249-6375, kay@avac.org

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!

Follow the Money: HIV R&D Resource Tracking Reports 2018

Two new reports tracking resources for investment in HIV research and development are hot off the presses. The Resource Tracking for HIV Prevention R&D Working Group, a collaboration among AVAC, IAVI and UNAIDS, has launched its 15th annual report, HIV Prevention Research & Development Investments: Investing to end the epidemic, detailing overall 2018 investment and analysis of funding trends. And the Cure Resource Tracking Group, a collaboration between AVAC and the International AIDS Society, has also released its annual report, Global Investment in HIV Cure Research and Development in 2018.

These two reports represent powerful tools for advocacy. Both reports can be used to advance advocacy for a host of issues directly impacted by financial investments: the prevention crisis in the global HIV response is insurmountable without cutting-edge research and development and the scale-up of existing interventions, while cure research spearheads crucial innovation, and offers hope and inspiration to the millions affected by the epidemic.

Read on for links to downloads and key findings from each report:

Key Findings in Prevention R&D Funding

The report indicates an uptick after five consecutive years of declining investment. In 2018, funding for HIV prevention R&D increased by a modest 1.2 percent or US$13 million from the previous year, growing to US$1.14 billion. While the increase is encouraging, it’s the smallest net increase since 2003. This incremental growth impacted the various prevention categories differently. Investment increased for pre-exposure prophylaxis (PrEP), female condoms and prevention of vertical transmission (PMTCT) but decreased for voluntary medical male circumcision (VMMC), preventive vaccines, microbicides and treatment as prevention (TasP).

Despite the significant variation among these categories, donor trends remained more or less the same. Public sector (79 percent of overall or US$900 million) and philanthropic sector (14.4 percent of overall or US$164 million) investments remained mostly unchanged from 2017, while the private sector saw a 30 percent surge in investment, rising to at least 6.6 percent of overall funding or US$74.7 million in 2018. Actual commercial investment levels are higher as not all private companies responded to the Working Group’s request for data.

While US and European investment remained steady in 2018 compared to 2017, these figures are still the lowest in over a decade at US$829 million and EU$57.5 million, respectively. Outside the US, increases came from Australia, Canada, the European Commission, Germany and the UK, while declines were observed from Brazil, France and Japan. Global philanthropic levels also saw no change in 2018 and the Bill & Melinda Gates Foundation (BMGF) remained the preeminent funder in that category at US$149.7 million or 91 percent of all philanthropic sector investment.

In 2018, the US public sector and BMGF accounted for 86 percent of all funding. Citing the promise of the current R&D pipeline, the report cautions against this funding imbalance and the resulting impact on the longevity and sustainability of the field. Much hope can be drawn from the latest scientific strides: the ongoing efficacy trials for long-acting injectable PrEP and antibody mediated-prevention; the planned Phase III trial of a novel HIV vaccine regimen; and the dapivirine vaginal ring – another potential option for women. All of the above is contingent on sustainable financing and a diverse donor base that cushions against priority shifts from large donors.

Key Findings in Cure R&D Funding

The report estimates global investments in HIV cure research, which includes therapeutic HIV vaccines (for treatment) shows US$323.9 million in 2018, representing a 12 percent increase over the US$288.8 million invested in 2017. Compared to the US$88.1 million invested since tracking began in 2012, this is a 268 percent increase. The public sector accounted for the majority of funding, with the remaining US$19.7 million invested by philanthropies such as Aidsfonds, amfAR, the Bill & Melinda Gates Foundation, CANFAR, Institut Pasteur, Sidaction and Wellcome Trust.

We hope these reports will serve as tools for advocacy and inform public policy that accelerates scientific progress. We thank all of the individuals who contributed data to the report and who gave time and effort as trial participants.

If your organization is a funder or recipient of HIV prevention grants and we don’t know you already please contact us at avac@avac.org!

Don’t Miss This Week’s Webinars

[UPDATE: Slides and recordings from both webinars are now available. Links are provided below.]

This week, AVAC is hosting two webinars, each bringing focus to different challenges facing HIV prevention right now.

First up is Tuesday’s webinar, May 21, 9-10:30 EDT, Breaking the Cycle of Transmission: Increasing uptake and effective use of HIV prevention among high-risk adolescent girls and young women in South Africa—quantitative findings & segmentation. Recording available.

Presented by the HIV Prevention Market Manager, this webinar is the second in a series presenting findings from research on what encourages or discourages the effective use of HIV prevention among adolescent girls and young women. Check out the first webinar in the multi-part series, which covered the qualitative results.

Next up, on Thursday, May 23, 9-10am EDT is The Growing Epidemic of Vaccine Hesitancy and the Implications for Global Health. Recording available.

Join us to hear Heidi Larson, the Director of The Vaccine Confidence Project at the London School of Tropical Medicine and Hygiene discuss what is called vaccine hesitancy and its implications across global health. We’ll also be joined by Laura Lopez Gonzalez, deputy editor at Bhekisisa, a health journalism center of the Mail & Guardian newspaper in South Africa. They’ll share perspectives on broader vaccine issues that impact the AIDS response as they play out in the media.

Bring your questions and join the conversation!

And if you missed it, check out last week’s HVAD webinar on HIV vaccine science and advocacy priorities. Download the slides and recording here.

Will a Vaccine Crisis of Confidence Impact the Global Response to HIV?

This HIV Vaccine Awareness Day, AVAC has an updated toolkit of resources for translating HIV vaccine research with a renewed sense of urgency, and two dedicated hashtags to rally the call on social media: #HIVvaccineAware and #HVAD2019. We hope you’ll join the conversation — with the updated HVAD 2019 toolkit and our upcoming webinars!

Mitchell Warren is Executive Director of AVAC. This post first appeared in Science Speaks.

This year’s annual HIV Vaccine Awareness Day arrives Saturday at a promising and also perilous time for vaccines.

On one hand, multiple vaccine candidates that might protect against HIV are advancing in large clinical trials. Thanks to an extraordinary global commitment and US government investment, two large-scale studies testing different HIV vaccines are underway in Africa, and a third trial is slated to start soon in the Americas and Europe. Simultaneously, researchers are advancing other promising approaches in the lab, such as those that harness powerful anti-HIV antibodies to protect against the virus.

This golden age of vaccines is not limited to HIV. Infants in three African countries will soon receive a vaccine designed to reduce malaria — a disease that kills one child every 30 seconds, according to UNICEF. A vaccine to prevent pulmonary tuberculosis in adults may soon advance to a large-scale trial and could become a central component of strategies to contain this life-threatening disease that, when left untreated, kills half the patients it affects. And an experimental Ebola vaccine is being deployed with urgency to stop a growing outbreak in the Democratic Republic of the Congo.

Vaccines have changed our lives in fundamental ways. In many parts of the world, vaccine-preventable diseases that terrified our parents and grandparents are dim memories today. But vaccines are not simple products. Many have challenges. Some are hard to manufacture; some only provide temporary or partial protection. Improving vaccines, using them effectively, educating potential users and ensuring that vaccines reach those in need all require public support and engagement.

Today, however, a rising global tide of anti-vaccine misinformation and sentiment is challenging that informed engagement — with potentially deadly results. Anti-vaccine fervor, based on discredited pseudo-science and too often endorsed by religious, government or community leaders, has led to the resurgence of diseases, such as the current — and completely preventable — measles outbreak, that were once considered conquered.

The implications of the anti-vaccination movement are enormous. Just as vaccines against some of the greatest global killers finally come within reach, fear and misinformation could diminish vital commitments to continued vaccine research, and important investments in vaccine education and delivery. Effective vaccines might not get developed, manufactured, distributed or used due to misguided, anti-vaccine sentiment — potentially putting millions of people at risk for entirely preventable deaths and diseases.

In the case of HIV, a faltering commitment to a vaccine would be devastating. Even with highly effective treatment and a daily prevention pill (known as PrEP) that can reduce HIV infections by more than 95%, nearly 2 million people still become infected with HIV each year. In the United States, a government pledge to end the domestic epidemic must confront the reality of an HIV infection rate that has barely changed since 2013. And in many parts of the world, new HIV infection rates, especially among vulnerable and marginalized populations, are actually rising rather than falling. All of these statistics point to one undeniable truth: we have made important progress against HIV, but this epidemic will not end without a vaccine.

In labs around the world, vaccine researchers are doing what we’ve asked them to do…making unprecedented progress against some of the most complex pathogens ever targeted.

Now, we must all leverage that scientific progress to rebuild a vital component of public health – faith in and support for vaccines. New vaccines in development present the greatest opportunity to save lives in human history. We cannot allow that opportunity slip away due to indifference, neglect or misinformation.

This HIV Vaccine Awareness Day, it’s time for a renewed global commitment to vaccine research, development and delivery. Vaccines save lives today, and a new generation of vaccines can save even more lives tomorrow.

HIV Vaccine Research and Development Pipeline: 2019 Supplement

A slide deck overview of what’s happening in HIV vaccine research now.