Discussion with Jon Cohen on HIV and COVID-19 Vaccine Research

[UPDATE: Webinar recording now available; click here.]

Six months? A year? Longer? Never? How long until there’s a vaccine against COVID-19? How is COVID vaccine research moving so quickly? How do HIV vaccine and COVID-19 vaccine research relate and inform each other? How do we ensure COVID research happens quickly and ethically?

As we approach HIV Vaccine Awareness Day (HVAD) on May 18, these questions are driving how we think about the ever-evolving global advocacy agenda.

Please join us for a webinar on Wednesday, May 13 at 10am ET to discuss all of this with Jon Cohen, one of the leading journalists covering both HIV and COVID.

Jon is a Science staff writer, award-winning journalist and author of Shots in the Dark: The Wayward Search for an AIDS Vaccine. Jon will discuss the rapidly growing pipeline of COVID vaccine candidates and share insights on how the HIV vaccine field has laid the groundwork for this — along with how COVID research can contribute to the ongoing search for an HIV vaccine.

We’ll also discuss some of the thornier issues emerging in COVID research: just yesterday, the WHO issued a report stating that well-designed “human challenge” studies could accelerate COVID-19 vaccine development. The report articulates important criteria for assessing a challenge study, but they left out the most important one: Until there is an approved treatment, a challenge trial with a potentially fatal and as-yet untreatable pathogen is unacceptable. See AVAC and TAG’s statement on the report here.

And stay tuned for details an upcoming webinar in June featuring representatives from the NIH’s Vaccine Research Center who will discuss some of their leading COVID vaccine candidates, including mRNA candidates, an approach also used in HIV vaccine research.

For the latest on COVID-19 and HIV, visit our special page—www.avac.org/covid—which includes pipeline updates, how COVID-19 is affecting HIV vaccine and prevention research, previous call recordings and more.

Advocates Call for Ethical Research for COVID-19 Solutions

More than 260 organizations and individuals have joined an Advocates Call for Ethical Research for COVID-19 Solutions. Read the letter reiterating the essential role of ethical research, and the need to move forward based on facts and evidence, and help us carry this message forward!

New Resources on AVAC.org and PrEPWatch.org

On the heels of our spotlight last week looking at the intersection of COVID-19 and HIV, this edition of the Advocates Network features new resources for HIV prevention research and advocacy, work that’s as important today as ever before. Both HIV and COVID-19 are urgent matters of public health, demanding a sustained commitment. Use these tools to stay informed and connected, and scroll down for COVID-19 materials.

PrEP Use Today

  • Our infographic, PrEP Initiations By Country World Wide, updates the global number of people initiating PrEP to date. We are monitoring this data particularly closely to see the impact of COVID-19 on PrEP use, so stay tuned for next quarter’s update and all things PrEP at PrEPWatch.org.

Three Weeks of Activism in Action: PEPFAR COPs 2020

Every year, country teams from more than 50 countries work with the US Government’s President’s Emergency Plan for AIDS Relief (PEPFAR) to make plans and set targets for the year ahead. Over three weeks, civil society and advocates are in meeting rooms fighting for better policies and winning important gains. Check out this year’s wins:

Px Pulse: Understanding HVTN 702

The latest installment of AVAC’s podcast, Px Pulse, talks about what’s next for HVTN 702 (also known as Uhambo). Data show the vaccine tested is safe, but offers no protection against HIV.

COVID-19 & HIV

AVAC.org’s dedicated page to COVID-19 and HIV provides essential resources to support an advocacy agenda on the combined impact of COVID-19 and HIV.

Spotlight on HVTN 702: AVAC’s Latest Podcast Episode

The latest installment of AVAC’s podcast, , is up. In this episode, AVAC puts a spotlight on HVTN 702, or Uhambo, one of the most anticipated HIV vaccine efficacy trials in the field. Data show the vaccine tested is safe, but vaccinations were stopped early after a scheduled review showed it did not offer protection.

The news delivered disappointment to local communities, to the thousands of South Africans who participated in the study, and to the field worldwide. Meanwhile, the trial team will continue to follow participants over the next year to monitor safety and gather data to help answer urgent questions raised by the trial results. While the vaccine in the trial did not work, the trial was extremely well-conducted and got an answer quickly.

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.

For more resources on the issue go to AVAC.org’s HVTN 702 Updates and Next Steps.


For the full podcast episode, highlights and more resources, visit avac.org/px-pulse. And subscribe on Apple Podcasts, Spotify or wherever you get your podcasts!

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.

###

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.