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.

HVAD 2022: 25 years of advocacy and progress

Today is HIV Vaccine Awareness Day (HVAD), and AVAC has a full line-up of resources, presentations, perspectives pieces, webinars and partners to feature. This year, we’re focused on advocacy to generate new hypotheses, fresh ideas and novel strategies to what is tested, and how. It’s time to come together, consolidate what we’ve learned and coordinate a strategy for HIV vaccine research into the future.

Read

HIV vaccines in 2022: where to from here? A new Viewpoint in the Journal of the IAS, authored by AVAC’s Mitchell Warren and Stacey Hannah with IAVI’s Kundai Chinyenze, Imperial College’s Robin Shattock, Desmond Tutu Health Foundation and APHA’s Ntando Yola discusses the way forward for HIV vaccine development, in the context of recent trials and new initiatives.

Today, IAVI shared news of another Phase I trial using mRNA-based technology to test a new HIV vaccine candidate. Check out our updated snapshot of Phase 1 mRNA HIV Vaccine Trials that are underway.

The lack of efficacy in recent vaccine efficacy trials has prompted researchers to look for trial designs that can more quickly ask and answer key questions, inform decisions about which vaccine candidates to advance into larger trials and, hopefully, accelerate the discovery of viable vaccine candidates. Check out AVAC’s backgrounder on experimental medicine vaccine trials (EMVTs).

Listen

AVAC’s Jeanne Baron is joined by Avenir Health’s Katharine Kripke, Caltech’s Pamela Bjorkman and IAVI’s Vincent Muturi-Kioi to explore some of the key scientific challenges an HIV vaccine will have to overcome in another installment of the Px Pulse podcast series Research Fundamentals.

Participate

Don’t forget to join AVAC for its three-part webinar series kicking off today chaired by long-time HIV vaccine advocate and AVAC co-founder Bill Snow and moderated by AVAC’s Director of Research Engagement Stacey Hannah:

Platforms & Pipelines: The miracle of mRNA: What’s possible beyond SARS-CoV-2—understanding mRNA, its history, and potential challenges for HIV vaccines.
Wednesday May 18, 2022
Recording and Slides: YouTube / Nina Russell’s Slides / Bart Haynes Slides

Processes: The changed landscape of clinical research: the potential for experimental medicine vaccine trials in the current research environment.
Tuesday May 24, 2022
Recording and Slides: YouTube / Robin Shattock’s Slides / Gail Broder’s Slides / Pontiano Kaleebu’s Slides

Prospects: What have we learned, why it matters and what it means? Understanding recent results in HIV vaccine research and implications for the future.
Tuesday May 31, 2022
Recording: YouTube

Thanks to the efforts of tens of thousands of volunteers, researchers and advocates, the world has learned infinitely more about the human immune system, vaccine science and HIV than was known when HIV Vaccine Awareness Day was first commemorated twenty-five years ago, in 1997. We take this moment to recognize the tremendous progress made collectively over the years and to recommit to accelerating the ethical development and equitable delivery of an HIV vaccine.

HVAD is coming up! AVAC has you covered

Wednesday, May 18 is HIV Vaccine Awareness Day (HVAD), an annual call to action for advocates, researchers and policy makers—and an opportunity to take stock of the status of vaccine research, what the field has learned and what lies ahead in the global effort to develop an HIV vaccine.

Just two years ago, for HVAD 2020, AVAC highlighted the connections between COVID-19 and HIV, and outlined their implications in Five “P”s to Watch. 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, we all need to act with urgency to develop new and faster models for advancing HIV vaccine science that can adapt quickly to what is learned. And the field must continue to push new models for equitably delivering the fruits of that science.

So, this HVAD, the “P”s continue to evolve. AVAC has created resources and programming to inform your advocacy, kicking off with a series of conversations to reframe and re-energize the search for an HIV vaccine, the four “P”s of progress in HIV vaccine R&D: platforms and pipelines, processes and prospects. Check out our new resources below and join us for our HVAD webinar series this month.

New Resources

Phase 1 mRNA HIV Vaccine Trials — a snapshot of early phase trials testing mRNA-based HIV vaccines.
Experimental Medicine Vaccine Trials: Opportunities and Challenges — a look at an innovative trial design to hopefully accelerate the discovery of viable vaccine candidates.

Webinar Series

The series will be chaired by long-time HIV vaccine advocate and AVAC co-founder Bill Snow and moderated by AVAC’s Director of Research Engagement Stacey Hannah:

Platforms & Pipelines
Wednesday May 18, 2022
The miracle of mRNA: What’s possible beyond SARS-CoV-2—understanding mRNA, its history, and potential challenges for HIV vaccines. With Bart Haynes (Duke University), Nina Russel (Bill & Melinda Gates Foundation) and Ntando Yola (Desmond Tutu Health Foundation and Advocacy for Prevention of HIV and AIDS [APHA]).
Recording and Slides: YouTube / Nina Russell’s Slides / Bart Haynes Slides

Processes
Tuesday May 24, 2022
The changed landscape of clinical research: the potential for experimental medicine vaccine trials in the current research environment. With Gail Broder (HVTN), Pontiano Kaleebu (MRC/UVRI & LSHTM Uganda Research Unit) and Robin Shattock (Imperial College London).
Recording and Slides: YouTube / Robin Shattock’s Slides / Gail Broder’s Slides / Pontiano Kaleebu’s Slides

Prospects
Tuesday May 31, 2022 @ 10:00am EDT
What have we learned, why it matters and what it means? Understanding recent results in HIV vaccine research and implications for the future. Unpacking results from Uhambo and Imbokodo trials and understanding the implications for the current pipeline of products. With Galit Alter (Harvard University), William Kilembe (Zambia-Emory HIV Research Project, ZEHRP), Ethel Makila (IAVI) and Dale Hu (NIH).
Recording: YouTube

And One More Webinar from Our Partners

Also on Wednesday, May 18th, join the Desmond Tutu Health Foundation in partnership with APHA, AVAC and other partners for an additional webinar looking at progress in HIV vaccine research featuring DTHF’s Linda Gail-Bekker and AVAC’s Maureen Luba.

We hope you’ll review our new resources and take part in these HVAD 2022 webinars.

And stay tuned for more HVAD resources and perspectives to come out later in the week!

Phase 1 mRNA HIV Vaccine Trials

A breakdown of current HIV mRNA trials and a primer on the basics of mRNA technology.

Platforms and Pipelines, Processes and Progress: The 4 P’s to Watch in HIV Vaccine R&D in 2022

On this World AIDS Vaccine Day, the field of global health faces a much-changed world. The extraordinary successes in COVID-19 vaccine development, which stemmed from the scientific knowledge and networks created by the HIV response, have advanced vaccine development by leaps, with innovation, commitment and coordination that accelerated the research and development process at unimaginable speed. The pandemic also exposed the entrenched barriers to vaccine access at a scale never seen before. Misinformation, stigma, greed, and the humbler problems of coordination and planning have hampered delivery of COVID vaccines, just as they have HIV prevention.

The response to COVID-19 makes clear, the world must do better. Scientific advances and equity must go further to deliver HIV prevention and a future HIV vaccine. However, in the past two years, results from major HIV vaccine trials have both upended what we know and reframed the questions we must ask. We need to act with urgency to develop new and faster models for advancing HIV vaccine science that can adapt quickly to what is learned. And we need to continue to push new models for equitably delivering the fruits of that science.

This HVAD, AVAC is kicking off a series of conversations to reframe and reenergize the search for an HIV vaccine.

In 2020, AVAC saw the connections between COVID-19 and HIV, and outlined their implications in Five “P”s to Watch.

In 2022, those insights remain central to what lay ahead, and we’ve built on them as we consider the state of the HIV vaccine field today. We’re bringing together some of the most creative minds in the field—advocates, researchers, policy makers and vaccine funders – to explore four angles we’re watching as we make progress towards an HIV vaccine.

Webinars and New Resources

Platforms & pipelines for developing new approaches to HIV vaccine research.

COVID-19 ushered in a new “Golden Age” in research on vaccines using a previously unproven delivery platform – messenger RNA (mRNA). mRNA vaccines hit the target in COVID, but will they work in HIV? What antigen or combination of antigens should it deliver to be effective? Join this webinar or use this fact sheet to learn more about what researchers have learned, what remains to be discovered about mRNA and HIV vaccines, and about the HIV mRNA HIV vaccine studies now underway.

Webinar
Wednesday, May 18 with Bart Haynes (Duke), Nina Russel (Bill & Melinda Gates Foundation) and Ntando Yola (DTHF).

Recording and Slides: YouTube / Nina Russell’s Slides / Bart Haynes Slides

Processes that offer innovation on the traditional phase I/II/III approach to research.

Biomedical research has evolved more rapidly in recent years than in any time in human history. New bioengineered platforms and products are changing the ways diseases are treated and prevented. And new global commitments to sharing information and data are finally moving the needle toward making research a truly global enterprise. In many ways, though, HIV vaccine trial design remains stuck in the 20th century.

New approaches to research such as experimental medicine vaccine trials (EMVTs) offer the prospect of answering crucial questions safely and quickly. But the commercial, legal and regulatory frameworks are not designed to move HIV vaccine research through the pipeline with greater certainty, ease and speed. And community engagement models for these next-gen research approaches are still in development. Join us to discuss the opportunities and challenges of new approaches to vaccine research, and how advocates can help maximize the potential of a 21st century HIV vaccine research agenda.

Webinar
Tuesday May 24, 2022 with Gail Broder (HVTN), Pontiano Kaleebu (MRC/UVRI & LSHTM Uganda Research Unit) and Robin Shattock (Imperial College).

Recording and Slides: YouTube / Robin Shattock’s Slides / Gail Broder’s Slides / Pontiano Kaleebu’s Slides

Prospects for HIV vaccine products in development, and for new approaches that may need more support.

Thanks to the efforts to tens of thousands of volunteers, researchers and advocates, the world has learned infinitely more about the human immune system, vaccine science and HIV than was known when HIV Vaccine Awareness Day was first commemorated twenty-five years ago, in 1997. Given the current state of HIV vaccine science, the broader HIV prevention landscape, and what’s been learned through COVID, how should HIV vaccine research move into the future? How can we best use that hard-earned knowledge to make choices about HIV vaccines in development now, and chart a course for which products on the horizon have the best chances of achieving their ultimate goal?

Webinar
Tuesday May 31, 2022 with Galit Alter (Harvard), William Kilembe (ZEHRP), Ethel Makila (IAVI) and Dale Hu (NIH).

Recording: YouTube

Join Us for Our HVAD 2022 Webinar Series

[UPDATED]: This blog post has been updated with webinar recordings where available.

The 25th anniversary of HIV Vaccine Awareness Day on May 18 is nearly upon us. Nothing about HIV vaccine research has ever been easy, and this past year has shown us how difficult this research is—and how essential it continues to be.

So, join us for our HVAD webinar series this month to mark important milestones in HIV vaccine development and discuss the path forward. The series will be chaired by Bill Snow and Stacey Hannah and will offer expert perspective on four angles that are critical to vaccine development: Platforms & Pipelines, Processes and Prospects.

Platforms & Pipelines
Wednesday May 18, 2022 @ 10:00am EDT
The miracle of mRNA: What’s possible beyond SARS-CoV-2—understanding mRNA, its history and potential challenges for HIV vaccines. With Bart Haynes (Duke), Nina Russel (Bill & Melinda Gates Foundation) and Ntando Yola (DTHF).
Recording and Slides: YouTube / Nina Russell’s Slides / Bart Haynes’ Slides

Processes
Tuesday May 24, 2022
The changed landscape of clinical research: the potential for experimental medicine vaccine trials in the current research environment. With Gail Broder (HVTN), Pontiano Kaleebu (MRC/UVRI & LSHTM Uganda Research Unit) and Robin Shattock (Imperial College London).
Recording and Slides: YouTube / Robin Shattock’s Slides / Gail Broder’s Slides / Pontiano Kaleebu’s Slides

Prospects
Tuesday May 31, 2022 @ 10:00am EDT
What have we learned, why it matters and what it means? Understanding recent results in HIV vaccine research and implications for the future. Unpacking results from Uhambo and Imbokodo trials and understanding the implications for the current pipeline of products. With Galit Alter (Harvard), William Kilembe (ZEHRP), Ethel Makila (IAVI) and Mary Marovich (NIAID).
Recording: YouTube

And watch this space for more HVAD resources!

Reading, Resources and Webinars

At AVAC, we are seeing remarkable new developments and opportunities to engage in HIV and COVID research, development and advocacy. Here is a round-up of what’s been happening, essential reading and resources to help in your advocacy efforts, and some upcoming webinars to join.

In PrEP

Dapivirine Vaginal Ring Approved in South Africa

The South African Health Products Regulatory Authority (SAHPRA) approved the monthly dapivirine vaginal ring for use by women to reduce their HIV risk. South Africa joins Zimbabwe as the first countries to announce approval of the ring, which is already recommended by the World Health Organization as an additional prevention option. The ring’s developer, the International Partnership for Microbicides, has also submitted additional applications for review by several other Eastern and Southern African countries, and advocates are actively engaged in making the ring accessible, including the fabulous new EmpoweRing campaign from our colleagues at ICWEA. AVAC’s Nandi Luthuli told Herald Live, “we know that the most effective intervention is the one someone picks for themselves among an array of effective choices.”

Updates on Injectable Cabotegravir for PrEP

Following US FDA approval of injectable cabotegravir for PrEP in December, there has been a cascade of activities—and a huge need for advocacy! Multiple additional regulatory agencies are reviewing the application; WHO convened their Guidelines Review Group meeting earlier this month, and guidelines are expected mid-year; and Unitaid announced funding for the first two implementation science projects to introduce injectable PrEP, in Brazil and South Africa. A key lesson from oral PrEP over the past decade has been the essential role of civil society; and advocates released a number of important statements—AfroCAB released two sign-on statements: Communities demand ViiV/GSK accelerate access to CAB-LA in LMICs and ViiV continues to not meet our demands to ensure CAB-LA is accessible for our communities, and a leading group Southern African women’s health advocates released a statement by Southern African Women Advocates in Advance of ViiV Convening. Stay tuned for our updated call to action and roadmap to ensure injectable PrEP and the ring get introduced faster and more strategically.

In Vaccines

New HIV Vaccine Study Using mRNA Platform Launched

The NIH also announced a new study to test three mRNA-based HIV vaccine candidates. This study follows an announcement in January from IAVI about another mRNA-based HIV vaccine study. AVAC is preparing a suite of materials on the latest in HIV vaccine research, development and advocacy for HIV Vaccine Awareness Day in May, so stay tuned. In the meantime, check out this snapshot that compares the two studies.

In COVID

New Resources for Journalists

The COVID-19 pandemic spawned an infodemic inside the onslaught of COVID-related information. Journalists struggle to identify reliable information in the everchanging pandemic landscape. With support from the Rockefeller Foundation, AVAC is expanding our partnership with Internews and our Media Cafe program conveners to support journalists covering HIV prevention science to include reporting on COVID. Check out the curated resources to help journalists find high-quality, understandable information.

WEBINAR: COVID-19 GPP Resources, 6 April at 9am ET/3pm SAST

While there are some resources that address stakeholder engagement in COVID-19 research, they may not adequately reflect the needs of advocates. Join AVAC and partners for a conversation to discuss advocates’ needs and shape the development of future resources. Register here.

WEBINAR: New COVID-19 Vaccines Trials in Sub-Saharan Africa, 6 April at 1oam ET/4pm SAST

Join us for a special webinar on the Ubuntu trial, hosted by the COVID Advocates Advisory Board (CAAB) and our Coalition to Accelerate and Support Prevention Research (CASPR). Led by the COVID-19 Prevention Network (CoVPN), Ubuntu is a new, landmark COVID-19 vaccine trial in sub-Saharan Africa investigating the efficacy of mRNA vaccines in people living with HIV against the omicron variant. Register here.

In Cure

WEBINAR: Breaking Down the Latest in HIV Cure Research, 5 April at 11am ET/5pm SAST

At CROI 2022, a number of exciting updates on HIV cure research were announced, including the most recent case of HIV remission after a stem cell transplant. Join a conversation with researchers as they break down the recent case of HIV cure, which is the first such cure in a woman. Speakers will also provide updates from an ongoing trial studying pediatric remission. Join to learn what these advances mean for science and for people living with HIV. Register here.

In Integration of Sexual Reproductive Health and HIV

WEBINAR: Consultation on the Dual Prevention Pill, 12 April at 8:30am ET/2:30pm SAST
Join FP2030 and AVAC for a conversation about The Dual Prevention Pill (DPP), a daily oral pill that is currently being developed for the simultaneous prevention of unintended pregnancy and HIV acquisition. This consultative webinar will highlight unique perspectives from stakeholder in the fields of family planning and sexual & reproductive health. Register here.

Just Published: Catalyzing action on HIV/SRH integration: lessons from Kenya, Malawi, and Zimbabwe to spur investment

We’re excited to announce this new publication – Catalyzing action on HIV/SRH integration: lessons from Kenya, Malawi, and Zimbabwe to spur investment – in the Global Health Action journal. This publication builds on the partnership between our HIV Prevention Market Manager project, ministry of health officials in Kenya, Malawi and Zimbabwe, and Georgetown University’s Center for Innovation in Global Health, and is a call to catalyze actions by development partners in support of national strategies to integrate HIV and SRH information and services.

We hope these resources offer you the context and tools you need to use your passion and add your voice to the work ahead.