Number of Vaccines Trials: Then and now

A snapshot of the number of vaccine trials conducted globally between 1997 and 2017.

Where Does Oral PrEP Fit in to Vaccine and AMP Trials?

A global map showing current efficacy trial countries and their status of PrEP implementation.

Vaccine Approaches in Early-Phase Development

An outline of various approaches to vaccine development that are in earlier phase research, e.g., phase I or II trials; development pathways for these candidates are uncertain at this time.

Vaccines and Antibodies on Efficacy Pathways

A timeline of current efficacy programs for vaccines and antibodies, highlighting the P5 program testing pox-protein candidates, the Janssen program testing mosaic-based candidates, and the AMP studies testing the antibody VRC01.

Advocacy in Uncertain Times: A call to action

It’s almost here! HIV Vaccine Awareness Day (HVAD) is upon us. This Thursday will mark the day’s 20th anniversary and cap off AVAC’s month-long “vaccine immersion”. On Thursday, we will host the final webinar in our series, featuring Julie Ake of the US Military HIV Research Program. (Update: link to the recording.)

HVAD comes amidst a week when advocates for health and human rights are aghast at a new US guideline on expansion of the Global Gag Rule—a policy that is anti-woman and anti-public health, and that will now impact many more recipients of US funding. As AVAC states in a blog, we are committed to the rights and health of girls and women worldwide, and stand strong with our allies in this fight.

Our HVAD resources are designed for allies everywhere to use in the fight for rights-based, science-forward, sustainable solutions to the epidemic. They include our updated HVAD toolkit, which features our HVAD call to action, Advocacy in Uncertain Times, a new publication on HIV vaccine advocacy and priorities for the field—required reading for HIV prevention and vaccine advocates alike!

HVAD 2017 Toolkit

  • Advocacy in Uncertain Times: A call to action—AVAC’s report for HVAD on the state of the HIV vaccine research and development field, including key priorities for advancing research and sustaining support. (Click here to download all graphics from this report.)
  • HIV Vaccines: Key Messages for HVAD 2017—Bullet points on today’s pressing issues; great for informed audiences who need compelling outreach messages.
  • HIV Vaccines: An Introductory Fact Sheet—Part of AVAC’s basic fact sheet series, a two-pager of basic information and research updates; great for distribution to lay audiences.
  • HIV Vaccines: The Basics—Introductory PowerPoint slide set with basic concepts, an overview of research status and recent developments; great for use by research representatives and vaccine stakeholders for presenting information to wider audiences.
  • Vaccine Science for Busy Advocates: bNAbs—a one-pager reviewing highlights, next steps and key terms; great for lay audiences who are looking to understand complex technical issues.

Missed any of the previous webinars in the series? Visit www.avac.org/hvad for the slides and recordings.

And HVAD is active on social media this year! Follow the hashtags #HIVVaccineAware and #HVAD2017 on Twitter and Facebook for more messages and resources this HVAD.

At AVAC, we thank you for your work and partnership today and every day. We’re committed to ending the AIDS epidemic, and that means finding an HIV vaccine. We couldn’t do it without you.

AVAC’s Month-Long Vaccine Immersion Continues: Webinar series, cheat sheets and more! 

[UPDATE:] Recordings of webinars already held are now available below.

Join us in our month-long “deep dive” into the dynamic field of HIV vaccine research with the next installment in our HIV Vaccine Awareness Day webinar series coming up this Thursday—a review of the NIH’s Vaccine Research Center with Barney Graham. And read on for links to key resources, including quick references and a recording of our first webinar.

Webinar series lineup:

  • Friday, April 28: Ad26 Mosaic Program—Janssen’s Maria Pau discusses preparations for the next efficacy trial.
    YouTube / Audio / Slides
  • Thursday, May 4: The History—and Future—of the NIH’s Vaccine Research Center with Barney Graham.
    YouTube / Audio / Slides
  • Monday, May 8: Building on (and Building!) Success—Status of HVTN 702 with Fatima Laher.
    YouTube / Audio / Slides
  • Thursday, May 11: “Plan B”-NAb? An Overview of Antibody Research with Lynn Morris.
    YouTube / Audio / Slides
  • Thursday, May 18: An Overview of Vaccine Development from Julie Ake of MHRP.
    YouTube / Audio / Slides

Last Friday, the series launched with an overview from Janssen’s Maria Pau on the Ad26/Mosaic vaccine program—notable both for its science and for active leadership from industry. Two of the upcoming webinars will fill advocates in on bNAb research. Broadly neutralizing antibodies—bNAbs—are anti-HIV proteins now being tested for efficacy as HIV prevention through direct “passive” infusions. The upcoming discussions will help answer burning questions for HVAD 2017:

  • Which bNAb candidates should we be watching in the coming years?
  • What do bNAbs mean for HIV vaccine research? Are these current trials, testing direct infusion of bNAbs, a pathway to a new product or a way to advance the HIV vaccine field—or both?
  • What will current large-scale efficacy trials of vaccines and bNAbs tell us?

We know not everyone hears bNAb and immediately understands the term. This year, AVAC has updated our series, Vaccine Science for Busy Advocates, to provide quick, clear explanations, with a focus on topics corresponding to our webinars. Click here to access Busy Advocates: bNAbs. Download it, review the terms and be ready with your questions on May 4 and May 11.

There’s a lot to know. But the research is promising, and we need steady hands on deck to ask smart questions and sustain support. Continue with us over the next several weeks on the countdown to HVAD to play your part.

Funding Opportunity: Innovation for HIV Vaccine Discovery (R01)

Purposes: To support high risk/high impact, early discovery research on HIV vaccine approaches; a Go/No-Go approach to funding high risk research significantly different from most R01 projects; and encourage involvement of investigators new to the HIV vaccine field to build interdisciplinary approaches. For more information, click here.

A Steady Hand of Advocacy in Uncertain Times: HIV Vaccine Awareness Day 2017

[UPDATED] This post now includes recordings of previously held webinars.

This year will mark the 20th anniversary of HIV Vaccine Awareness Day (HVAD). On this May 18, as HIV prevention advocates we find ourselves in new terrain when it comes to vaccine research—both in terms of scientific progress and the challenging political environment. We’ll be highlighting these important issues in an HVAD webinar series leading up to and ending on May 18—read on for full information and to register.

As we look back on the 20 years since President Bill Clinton called for accelerating HIV vaccine development, AVAC recognizes that, now more than ever, we need steady hands and supportive voices to back this long-term, challenging, essential endeavor. Can you help us identify the next HIV vaccine champions? Are you one of them?

This year we are celebrating HVAD, not only on May 18, but throughout the month leading up to it (and beyond). We promise not to inundate you! But we recognize the “breadth and potency” of the current research landscape and the many events that will happen around the globe to mark the momentous day. We want to keep you in the loop.

We’ll provide research literacy tools; share AVAC’s take on developments in the field; and host a series of webinars to discuss key issues in vaccine research and advocacy. Please register, mark your calendars, and have your questions ready.

Recordings of previous webinars available here:

  • Ad26 Mosaic Program—Janssen’s Maria Pau discusses preparations for the next efficacy trial
    April 28YouTube / Audio / Slides
  • The History—and Future—of the NIH’s Vaccine Research Center with Barney Graham
    May 4YouTube / Audio / Slides
  • Building on (and Building!) Success—Status of HVTN 702 with Fatima Laher
    May 8YouTube / Audio / Slides
  • “Plan B”-NAb? An Overview of Antibody Research with Lynn Morris
    May 11YouTube / Audio / Slides
  • An Overview of Vaccine Development with Julie Ake of MHRP
    May 18YouTube / Audio / Slides

We hope you’re looking forward to the month ahead as much as we are! Talk soon.

HVTN Regional Meeting – A View from the Outside

This blog is the first in a series of reflections from AVAC staff and members of the Vaccine Advocacy Resource Group (VARG) on the regional meeting of the HIV Vaccine Trials Network (HVTN), which took place in Johannesburg from February 28 to 1 March 2017.

AMP. Licensure. Enrollment targets. Success.

These were a few of the buzz words from the HIV Vaccine Trials Network (HVTN) regional meeting last month. This meeting, the first of three the network will convene in 2017, was held in Johannesburg, highlighting the HVTN’s build out of programs in sub-Saharan Africa—and the significance of an HIV vaccine for this region.

As network meetings go, the audience for this meeting was largely internal; a chance for HVTN core staff and leadership to celebrate key milestones, particularly around the network’s two large efficacy studies—HVTN 702 and the Antibody Mediated Prevention Trials (AMP)—with their clinical site partners.

While advocates are not the primary audience, the HVTN allows us to attend plenaries and other open sessions. AVAC and civil society partners look to these meetings to hear updates, interact with research teams, and continue to build our research literacy and our translation and liaison roles in the HIV vaccine field.

To advocates—both from AVAC and the Vaccine Advocacy Resource Group (VARG), a global team of HIV prevention advocates—looking in from the outside, this meeting underscored the intensity of resources necessary to make clinical trials happen and allowed us to get a sense of how the vaccine field sees itself.

What follows are impressions from AVAC and a few VARG members from our times in meeting rooms—and in hallways.

AMP. The AMP trials are in an exciting place—exceeding enrollment targets across all sites, both in the Americas and Southern Africa, and maintaining high retention and adherence. While we are thrilled about the trials’ current success, and intrigued by passive immunization as a potential prevention strategy, we felt a gap in communication from the trial’s architects about how to situate it in the broader field. AMP is testing a 30-60 minute infusion of an antibody called VRC01 that is administered every two months for just under two years. While there was much discussion about this particular antibody and others in development, it’s not yet clear how researchers will build on the AMP results to deliver a feasible prevention option. We were left with questions about what will happen with VRC01 if the trial shows efficacy, as its dosing schedule makes it hard to imagine as a real world tool. There are also more powerful antibodies and easier methods of administering them that are being explored. We want to be sure that the goals and follow up steps of AMP are well articulated and understood. Watch this space—it is sure to evolve quickly!

HVTN 702. The first vaccine efficacy trial in seven years is now in its 22nd week of enrollment. As 702 sites continue to get started and data from the precursor trials, RV 144 and HVTN 100, continue to provide more clarity on mechanisms of improving immunogenicity, we note a need for cautious optimism. While 702 presents a possibility for moving toward a licensed vaccine, we were a bit concerned about the hopes being raised about this trial, and feel strongly that the messages should convey realistic expectations. Licensure is the ultimate goal, but we have to closely watch, and accurately translate, the data for ourselves and to our communities. If we’ve learned one thing from HIV vaccine research, it’s that we never know what to expect!

PrEP Access. Finally, let’s talk about oral PrEP—researchers certainly did at this meeting. Access to PrEP is (slowly) becoming a reality in trial communities all over the world—and the HVTN, and all trialists, are grappling with how to incorporate PrEP into trials, especially as this context evolves at national, community, and individual levels. As research advocates, we know that the trial context rarely reflects the real world. While we commend the AMP and 702 teams for exploring ways to connect trial participants to mechanisms for PrEP access, we see a necessity for a more rigorous and urgent commitment to link national and local PrEP programs to participants who need and want it.

Note: This is a crucial area that advocates are watching, and where they can and need to help research teams. Without taking PrEP into account and ensuring that communities have input, clinical trials run the risk of being viewed as skirting larger community needs as well as ethical and human rights obligations.

Now that the meeting is wrapped, and we’ve had a couple of weeks to reflect, we’re left with the feeling that the field appears too siloed. The conversations around antibodies and vaccine candidates seem to be happening in isolation from larger dynamism in the field and the very communities where trials are taking place. The rich and rapidly iterating prevention research environment needs an HIV vaccine—and an HIV vaccine needs this exciting environment.

What’s New on AVAC.org

AVAC.org has a host of new resources providing concise updates, informed perspective and handy tools. Take a look at the highlights below and get up to speed on a range of strategic issues.

New Resources

  • AVAC, in partnership with the Clinton Health Access Initiative (CHAI), is taking on new work focused on supporting innovation in the prevention “market”—including the programs that deliver new products and the pipeline of products in trials. This two-page intro to the “HIV Prevention Market Manager” gives an overview of this new body of work.
  • To get a flavor of the work the Prevention Market Manager team is focused on, check out this new resource: End-User Research Landscape Mapping and Findings. The term “end user” is used by people who work on developing and marketing products. It refers to the individual who’s ultimately going to make the decision to seek out and use a given product or intervention. This resource gives a sense of the range of efforts trying to understand what is and isn’t known about one key set of “end users” for new prevention options—adolescent girls and young women in sub-Saharan Africa.

From the Infographics Gallery

  • Introduction to Long-Acting Injectables is an updated graphic to guide you through the basics of antiretrovirals that are being developed as long-acting injectables for both treatment and prevention.

Strong Voices in P-Values

  • Progress and justice for women and girls has come under attack by the new US administration via the reinstatement and proposed expansion of the Global Gag Rule. In Standing Together Against the Global Gag Rule the AVAC team reaffirms its commitment to the fight for bodily autonomy, for justice, for choice and voice for women and girls.
  • In New and Touted HIV bNAb: Big deal or news blip?, veteran science writer and HIV journalist Mark Mascolini delves into the nuances of vaccine research using broadly neutralizing antibodies. You will learn more than just what these are; Mascolini looks at the big promises and the small print.
  • Lindsay Roth, a long-time organizer and advocate for sex workers’ rights, gives any lay reader on the subject of sex work an opportunity to gain a deeper understanding of the issues at stake in Getting Set to Defend and Advance Sex Workers’ Rights in 2017 and Beyond. Roth’s reporting shows how HIV prevention, human rights and economic justice can only succeed together.