Introducing the VARG: Focusing local lens on global advocacy for HIV vaccines

It has been said that advocates haven’t played a strong enough role in the HIV vaccine field. While this could be debated, it is true that the role of a vaccine advocate is complicated. How can advocates push to support slow-paced, expensive science, that over its history can be seen as having more low points than highs?

These questions and this conundrum simply highlight the need for focused, strategic advocacy to push forward the goal of vaccine development.

Two weeks ago, a group of HIV vaccine advocates known as the Vaccine Advocacy Resource Group (VARG) came together in Johannesburg to meet this need. They discussed the field, dialogued with researchers, and aired concerns and questions about the field’s current status and key developments. The VARG is a global team of AIDS prevention research advocates—made up of 11 individuals from countries key to vaccine research and well connected in those countries to broader HIV advocacy. Since its formation in 2012, the VARG has been convened virtually, and the chance to meet face-to-face for the first time could have been one of the reasons the room buzzed with excitement as the meeting began.

Another reason for the buzz could have been the current state of the field. With vaccine (P5 and Janssen) and antibody research (VRC01-AMP study) fields at exciting junctures, VARG members had a lot to discuss. Some of their questions included:

  • What will the results of the AMP study mean for the future of passive immunization? And for vaccine development? Will people really sit for an infusion for 30 to 60 minutes?
  • Why is there so much attention around the go/no-go decision making criteria in HVTN 100? What happens if the data indicate a no-go for HVTN 702?
  • Would the Clade C vaccine to be tested in HVTN 702 be relevant to other regions? What would the implications be for other countries if the vaccine is found efficacious in South Africa, the only country where 702 would be conducted?
  • How are vaccine research groups addressing the inclusion of PrEP in efficacy trials? How will stakeholders be involved as trials are planned and PrEP rollout evolves globally?

Vaccine efficacy trial results are a few years away, but we’re now at a time where advocacy roles are becoming clearer and clearer. VARG members left the meeting together with a new sense of priorities and actions. Watch this space!

To read more about the trials and science mentioned above, please visit www.avac.org/vaccines.

Reflection on bNAbs and Broadening the Toolbox

Josh Agee is the PrEP Coordinator at My Brother’s Keeper in Mississippi where he educates individuals about PrEP, assess their risk of HIV and navigates insurance plans for PrEP users. He is currently a Fellow at the Black AIDS Institute’s African American HIV University.

#CROI2016 was truly an amazing experience for me. I had the chance to learn about new scientific advancement and new tools that could expand the prevention options for my community. The new treatment and prevention strategies are exciting and offer a level of promise that my community is looking for since the current options aren’t doing enough for us.

Sometimes I reflect on history and where this epidemic has been and where it might be going. I think about the things that we once thought were beyond our grasp but now seem within our reach. I think how we’ve progressed from AZT to PrEP to potentially using broadly neutralizing antibodies (bNAbs) for prevention. Researchers first identified an HIV bNAb in 2009 from a person living with HIV. Subsequently, bNAbs were proven to be highly effective in neutralizing HIV in vitro in the lab and were able to neutralize over 90 percent of HIV strains. Science has given us the promise that this could be a new strategy, and we now have begun moving the testing of bNAbs out of the labs and into clinical trials.

At the conference it was discussed, as is the case of HIV treatment, which uses several classes of antiretrovirals per regimen, that a combination of antibodies might also be effective. These monoclonal bNAbs might be more efficient combined with other monoclonal bNAbs to increase their coverage of known HIV strains. The more, the merrier might be the way to go in this strategy. It is time to see if it is something that shows promise and might be our next big breakthrough. The only way to know if this will be an effective strategy is to test this in a real world setting. Future studies with bNAbs will include administering them to populations that are at high risk for HIV acquisition. This particular research stood out to me. It is a different approach that sparked my curiosity to see where this research might take the field.

The call for needing another option could not have been clearer than when the CDC made its announcement about lifetime risk for individuals. With the CDC’s release that 1 in 2 black MSM are projected to acquire HIV in their lifetime, it is imperative that we broaden our prevention toolbox and make it accessible to the community. These staggering numbers have also prompted me to take more action in my community as I realize the state of our emergency. I plan to do more innovative community outreach and educate our community on HIV treatment and prevention. While keeping a close eye on options and making sure my community is aware that help is on the way. And more options to meet their needs are coming.

Conducting Research With a Heart: The stories of CROI 2016 Award Recipients

Morenike Ukpong, Associate Professor at Obafemi Awolowo University and Coordinator of the New HIV Vaccine and Microbicide Advocacy Society in Ife, Nigeria, writes why she believes CROI 2016 made strides in taking community concerns into consideration. This blog is one in a series written by community scholars who attended CROI 2016.

One of the struggles in the field of biomedical HIV prevention research for years has been the need for research teams to truly make people and communities a central theme in their work: think less about the data, publications, conference presentations and think more of the people you work with and work for. At 2016 CROI, I sincerely felt we have made significant positive strides in that area—not token forms of community engagement, but true consideration of concerns and interests of the people and communities through whom data for change are generated.

It started with Monday’s Workshop for New Investigators and Trainees where Sharon Hillier (MTN) clearly highlighted the significant role of community in changing the landscape of HIV prevention. At the same preconference meeting, Laurel Sprague (Sero Project), Sethembiso Mthembu (ICW) and Keith Green (University of Chicago) all brilliantly highlighted how the social context of the lives of people—our history, stress, experienced trauma, stigma people living with HIV and other vulnerable communities face—impact the way we as community members respond to research implementation. They discussed how this social context impacts on the truth generated through the data collected, and how research outcomes are translated and used by all of us in the community. And then, at the Clinical Trial Design workshop, Patrick Sullivan (Emory) reiterated the need to look for the human faces behind the big data you may want to use for making heroic public health changes—look for the faces in the data and ask their permission for the use of their data.

For me, the three speakers recognized for their work and who gave opening lectures at the 2016 conference were embodiments of this message of making people central to the theme of the research. We must conduct research to address human needs. “Think, plan and conduct it with them for them” was the clear message I heard.

Bruce Walker (Ragon Institute) discussed the FRESH study ongoing in South Africa where women undertook capacity-building programs, got empowered to get employment, yet contributed to a study that enabled researchers to detect acute infection and understand more about T-cell control for HIV vaccine and cure research. Of course, all HIV-positive persons got treatment immediately following diagnosis so that they could benefit from the outcome of the START study (which showed that starting HIV treatment immediately after diagnosis reduced the risk for HIV-associated diseases). Gerald Friedland (Yale) also discussed how he identified with the epidemic of HIV and tuberculosis in Bronx, USA and Tugela Ferry, South Africa where epidemics of poverty arising from neglect of people and their basic needs—health, housing, transport. Kenneth Cole also narrated how the concern for people, their lives and the need for HIV cure was central to his work at amfAR though he is a fashion designer. Clearly, we can all do something irrespective of our profession.

As I reflected on these great people, their talks, their programs and their passion, I conclude that my years of advocacy with many, many, many other brilliant advocates, to make people and communities central to the heart of research was (and still is) a worthy cause. Helping young investigators understand how the social context of people’s life need to inform the design and implementation of HIV treatment, prevention and cure research will truly get us to the end of the HIV epidemic sooner rather than later.

New Px Wire: What to Watch in 2016

There are few, if any, quiet years in HIV prevention research and implementation. 2016 promises to be another year of big deal data, whether it’s findings from clinical trials, funding levels or readouts from PEPFAR’s first year of a geographically focused program plan. We write about this and a lot more to watch for in our new issue of Px Wire.

Click here to download the new issue.

We take a look at the bigger picture in our centerspread. Check it out for the most current version of AVAC’s classic timeline of biomedical HIV prevention research. But don’t get too attached—some of the trials mentioned in the timeline will have updates presented next week at the annual Conference on Retroviruses and Opportunistic Infections. We’ll always have an updated version in our Infographics Gallery—and save the date for a March 1 webinar to discuss the latest data and what’s next?

The full issue of Px Wire, as well as our archive of old issues and information on ordering print copies, can be found at www.avac.org/pxwire.

As always, we welcome your questions and comments at avac@avac.org.

Develop, Demonstrate, Deliver: Model shows AIDS vaccine is essential to conclusively end epidemic

ARV-based HIV prevention implementation is on a roll, with WHO recommending daily oral PrEP as an option for all people at substantial risk of HIV acquisition—and also calling for immediate offer of treatment to all people living with HIV. TDF/FTC (brand-name Truvada) is now approved for HIV prevention as PrEP in France, Kenya, South Africa and the United States—with more countries sure to follow in 2016.

Vaccine Efficacy Modelling

These advances may lead people to ask whether the world still needs an AIDS vaccine as part of the strategy for ending the epidemic? And will a vaccine be needed in five or ten years time—the likely timeframe for results on today’s leading candidates to end the epidemic? For prevention advocates who don’t want to settle for a limited set of options, and who understand the potential revolutionary impact of a vaccine, a new modeling analysis, published this month in the open-access journal PLoS ONE, provides some clear answers to this question.

The paper, Exploring the Potential Health Impact and Cost-Effectiveness of AIDS Vaccine within a Comprehensive HIV/AIDS Response in Low- and Middle-Income Countries, was authored by IAVI, Avenir Health and AVAC, with financial support from USAID.

It looks at the potential impact of an effective AIDS vaccine in the context of expanded coverage of early treatment, PrEP and other existing strategies reflected in the UNAIDS Investment Framework Enhanced (IFE). The IFE, published in 2014, assumed scale-up of ART according to WHO 2013 guidelines along with VMMC and the potential introduction of PrEP, and an AIDS vaccine. [Note: the 2013 WHO guidelines indicated treatment for individuals with a CD4 count of 500 or less; the updated guidelines released in 2015 indicate offering treatment to all HIV-positive individuals, regardless of CD4 count.]

The paper reflects that if UNAIDS IFE goals were fully achieved, new annual HIV infections in LMICs would decline
from 2.0 million in 2014 to 550,000 in 2070. A 70 percent efficacious vaccine introduced in 2027 with three doses, strong uptake and five years of protection would reduce annual new infections by 44 percent over the first decade, by 65 percent the first 25 years and by 78 percent to 122,000 in 2070. Vaccine impact would be much greater if the assumptions in UNAIDS IFE were not fully achieved. An AIDS vaccine would be cost-effective within a wide range of scenarios.

This paper suggests that even a modestly effective vaccine would reduce infections significantly and be cost-effective, even as other interventions are broadly implemented. This confirms what AVAC and others have often said before: no single option will or can end the epidemic.

AVAC on World AIDS Day: We’re 20. We’re not giving up.

When AVAC was founded in 1995, we were called the AIDS Vaccine Advocacy Coalition. Our singular goal was to advance swift, ethical research for a vaccine that was then — and is today — essential to bring the epidemic to a conclusive end.

Twenty years later, AVAC is still focused on swift and ethical research, but our scope has expanded. Along with vaccines, we advocate for PrEP, microbicides, voluntary medical male circumcision and more.

Through it all, our message has been the same: prevention is the center of the AIDS response. Not just any prevention but smart, evidence-based, community-owned, rights-based strategies.

We do this work because it’s essential. We are able to do it because of our robust partnerships worldwide. We will keep doing it — with your help — until the epidemic has, finally, come to an end.

We’ve experienced 20 years of breakthroughs and disappointments in prevention research. A vaccine that many had given up on was the first to provide modest protection. One microbicide everyone hoped for didn’t pan out. Male circumcision and PrEP studies overcame skepticism and, together with antiretroviral therapy, paved the way for a prevention revolution.

Through it all, AVAC has worked with partners to maintain the field’s focus and press for continued research into an AIDS vaccine, a cure and more.

When AVAC was founded, the only biomedical HIV prevention options for adults were male and female condoms. The pathway for introducing any new strategy was largely unmapped. No one knew where the gaps would be—between trial result and country action, between guidance and financial support. Now we do.

Over two decades, AVAC has not only identified the gaps; we’ve worked to bridge them, so that products reach people in programs that work — without delay.

Twenty years ago, advocacy for HIV prevention hardly existed. So AVAC helped build a global network of advocates equipped with effective advocacy strategies and the latest evidence.

With our support, they are putting prevention on the agenda in countries and communities around the globe.

When the world lacked a plan for ending AIDS, we helped create one.

Now we’re holding global leaders accountable for results — demanding the resources, policies and evidence-based plans needed to deliver all of today’s prevention options to the people who need them, and to plan for the rapid rollout of new options as they emerge.

Communities’ support for prevention research can never be taken for granted — it has to be earned. For 20 years, we’ve helped build trust between researchers, funders and communities to speed the ethical development and rollout of new prevention options.

And when controversy threatened to derail those efforts, AVAC provided leadership and resources to help get them back on track.

Your gift to AVAC will support our efforts to accelerate the development and delivery of HIV prevention options to men and women worldwide. With your help, we can continue to convene, collaborate and communicate a strong, clear and cohesive vision for HIV prevention today, tomorrow and to end the epidemic.

It will take all of us working together to end AIDS. Please join us.

An HIV Vaccine: Imagining the Future of HIV Prevention

In this article, South African HIV prevention activist and member of the Vaccine Advocacy Resource Group—a small, global group of advocates specifically focused on the HIV vaccine research field—Tian Johnson reflects on his participation in the recent HVTN Conference in Cape Town, his hope for a vaccine and the necessity of advocates’ involvement in the search. This first appeared in NGO Pulse.

My sister Miranda, died of AIDS in 2007 at the age of 35, a year older than I am now. She was a mother to three boys who had yet to reach their teens when she took her last breath. That last breath came in a hospital that, even after a prolonged stay, was unable to provide her with the most basic care.

My family, as is often still the case with in many other families, spoke in hushed tones about the cause of her death: pneumonia, tuberculosis (TB)… anything but AIDS. It was almost as if the mention of her name and the disease in the same sentence would erase everything she was and everything good that she had done. She was a sister to me (which alone required the patience of a saint) and a mother who did everything she could to provide her boys with the best childhood she could – far from the turmoil that was our shared upbringing.

As I landed in Cape Town for the bi annual meetings of the HIV Vaccine Trials Network – a global network whose goal is to develop a safe, effective vaccine as rapidly as possible for prevention of HIV infections globally – I wondered what a world with a vaccine for HIV could look like. What would it mean for millions of women like Miranda, living with or at risk of contracting HIV?

I have worked in HIV prevention for nearly two decades now. So, as I imagine a world with an HIV vaccine, part of me cannot help but be sceptical. I wonder if it would have made a difference to Miranda at all. Would she have been able to access the vaccine? Would the nurse or doctor giving her the vaccine have judged her? In all likelihood, the same nurse probably would have judged her when she asked for a contraceptive just a few weeks before coming in for the vaccine. I wonder if Miranda would be able to live with the stigma of being ‘that woman’ who got the ‘AIDS Vaccine’ at the clinic. Would her husband have gone with her? Would he take the vaccine too?

The other, more idealistic part of me imagines that she could access the vaccine with ease, that she would have been received like a hero at her local clinic by health workers proud of her: this beautiful Afrikan goddess who had chosen to make the journey that day to get herself vaccinated, to keep herself safe, to keep herself alive. Alive for me, her brother. Alive for her three boys.

From a distance, the vaccine world is a scary place. It is a deeply scientific and privileged world (a world that I think needs many, many more black faces in it!). Talk of ‘non-human primate’ (monkey) trials, and acronyms like RV144 can be pretty intimidating for an activist who is programmed to just get on with it and start advocating for universal access to a vaccine!

Part of my journey as a member of the Vaccine Advocacy Research Group (the VARG, if you want to sound cool) is to bring advocates from related areas of HIV prevention advocacy into the vaccine fold in order to build our capacity and to support activists to access the researchers. As we get one step closer to creating a vaccine that prevents HIV, the existence of groups like the VARG is increasingly important. The VARG is supported by AVAC (a global NGO) that supports advocates and community members to play a leading role in defining the HIV research agenda.

Although the world still does not have an HIV vaccine, research has been underway for many years, much of it built on work that is happening in South Africa. And just this month, the School of Medicine at the University of Maryland in Baltimore launched the first phase of clinical trials for an exciting new product. In this trial the vaccine is intended tackle virus at the moment of infection, when there is a greater chance of neutralising it. Some pretty impressive people are leading this work including Dr. Gallo, who was part of the team that identified HIV as the cause of AIDS, and developed the HIV blood test.

As ground-breaking science happens around the world, we have a moral obligation to ensure that advocates are brought along for the journey in a meaningful way. Spaces must be created for learning and sharing and opportunities made for mentoring and engagement – as we have found out in the past, creating these spaces takes time and resources – resources that are usually the first to be cut when budgets are tight. The reality is that no matter how impressive the science is, it will have been in vain if it does not fit into people’s daily lives and realities. Sadly, this is what we have seen too often over the years with male and female condoms, treatment and other HIV prevention methods. A product can only work if it gets used. A key barrier to a product getting used is stigma, perhaps the most difficult aspect of uptake and use. As long as sexuality is scandalised and individuals do not see their health, success, and prosperity as being linked to that of their neighbours, we truly have a momentous task ahead of us. The work of changing minds and hearts is never easy, but it is essential. And its work that advocates and activists must lead, hand-in-hand with scientists.

As the first vaccine is likely many years away, we must keep the discussion alive. We need to force ourselves to imagine what the future of HIV prevention could look like: so much of it emanating from world-class South African science and supported by the South African Government. Imagine having a basket of options that we could pick and choose from depending on where we are in our lives: a daily pill to prevent HIV, an annual vaccine to do the same, a female condom when I want and a male condom when I want, a vaginal or a rectal gel to stop me from getting HIV. Whatever world we imagine, we need to keep on doing just that. They say when you become a parent you do everything you can to ensure that your own children have a better life then you had. So we need to keep on working, keep on moving forward, not just for us now but for those who are growing up in this challenging world. Boys like my nephews, who can access options that my sister, their mother, never had.

I am glad I spent a week at the HVTN meetings. They were insightful and at times filled with equal parts of hope and anxiety at the momentous task ahead of us as we collaborate, learn, engage and take time to listen to the multitude of lessons this virus has and continues to teach us about our resilience and tenacity to push ahead in spite of it. As we look forward to many more years of research and advocacy in the quest for an HIV vaccine, we will also keep the faces and memories of those that did not make it along the way first and foremost in our minds. And we must imagine and ACT to realise a better future.

Vaccines in Vivo: Advances in AIDS Vaccine Research

On May 18, advocates around the world observed HIV Vaccine Awareness Day (HVAD)—an annual commemoration of the need for and commitment to the ongoing search for a vaccine. AVAC convened a webinar—Vaccines in Vivo: Advances in AIDS Vaccine Research—and updated a number of materials, including our “HVAD Toolkit” for those interested in easy-to-digest research updates. This year brought the launch of long-awaited initiation of clinical trials building on positive results from the RV144 “Thai” trial. This effort is led by the Pox-Protein Public-Private Partnership (P5), including the HIV Vaccine Trials Network, who joined the webinar to provide a status update of their current vaccine research and development program. We also featured Janssen, part of Johnson & Johnson, to provide an overview of the research program they are moving forward that focuses on a cross-clade vaccine product.

Injectable Options and Preventable Confusion: An update on the pipeline of antibodies, long-acting ARVS and vaccines

On July 19, AVAC convened a satellite session, Injectable Options and Preventable Confusion: An Update and Interactive Discussion on the Pipeline of Antibodies, Long-acting ARVS and Vaccines. This session, part of the IAS Conference on HIV Pathogenesis, Treatment and Prevention, featured presentations on trials of long-acting injectable PrEP agents by Mike Cohen (HPTN and UNC), Larry Corey (HVTN) gave an update on HIV vaccine research and John Mascola (NIAID Vaccine Research Center) reviewed the state of passive antibody infusions for prevention. The presentations were then discussed by a panel that included Brian Kanyemba (Desmond Tutu HIV Foundation), Veronica Noseda (Sidaction) and Jerome Singh (CAPRISA).

The session provided a moment to consider what might be coming for HIV prevention. The speakers provided a guide to the prevention pipeline. The three approaches that the speakers highlighted—injectable PrEP, an HIV vaccine and passive antibodies—are in trials now. All three approaches, even if they show efficacy, are years from being implemented. But the HIV field must be ready, and must prepare now.

These updates were particularly relevant at a conference that was focused heavily on ART—whether the START results establishing the health benefits of early treatment, or the expanding implementation of daily oral PrEP globally and in different populations.

The lessons from and, ideally, successes of implementation of early treatment and PrEP that will emerge in the months and years after this discussion will provide a roadmap for these new options if they become available. Speakers emphasized the challenge of success. As Glenda Gray said at the session “We are used to failure in HIV prevention but market failure for effective interventions is the thing that worries me the most.”

Traversing the AIDS Vaccine Terrain in Vancouver

Amid the excitement in Vancouver over the START and PrEP results, conference-goers did hear several specific updates on progress in HIV vaccines. Here are a few highlights advocates seeking to track the vaccine field should check out.

One great place to start is with the slides from a presentation on delivered by Dr. Anthony Fauci, head of the US National Institute of Allergy and Infectious Diseases. The slide set, with Dr. Fauci’s instantly-recognizable font size and simple layout, has some familiar images from previous presentations—including the always-useful depiction of the HIV prevention continuum—but also provides crystal-clear explanations of the “empirical/intuitive” and “rational” pathways of vaccine development focused on producing antibodies against the virus. In the former category is the RV144-like regimen moving ahead in trials in southern Africa. In the latter are broadly neutralizing antibodies being studied in passive immunization and preclinical work. A commentary in Science published just after the conference by Dr. Facui and Dr. Hilary Marston provides additional perspective and depth to the discussion. 

RV144 was the name of the 16,000 person trial that took place in Thailand and found evidence of modest protection in data released in 2009. Just before Vancouver got underway, the research team involved with the trial published new data on why this protection might have occurred. Every person has a distinct genetic make-up that affects how our immune systems function. In analyzing volunteers’ HLA gentoypes (these contain the “instructions” for proteins that help regulate the immune system), the investigators identified specific genetic signatures associated with vaccine efficacy. This type of research can help scientists figure out how to make vaccines work even more effectively in the future.

The rational pathways also got attention at a Wednesday session, “Advances in B-cells and Antibodies,”” including an update from Joseph Jardine of Scripps Research Institute, on upstream work aimed at increasing the potency of the VRC-01 broadly neutralizing antibody. VRC-01 is a purified form of a potent antibody isolated from an individual living with HIV; it is in Phase I trials in adults and, as described at a cure satellite symposium, a safety and pharmacokinetic trial in infants is now enrolling.

Vaccine science is heady stuff and presentations of the hill-and-valley contours of antibodies can seem very far from the rural and urban landscapes where people live, work, encounter HIV and perhaps enroll in trials. A presentation on hypothetical willingness to participate in vaccine trials from the Perinatal HIV Research Unit in Soweto, South Africa, focused on that terrain. Pointing out the urgent need for HIV prevention strategies in 15-24 year olds, particularly young women, the research team asked people in this age group whether they would enroll in a trial. About half would, saying altruism would motivate them. About a quarter said that they wouldn’t, because they were worried about “becoming ill.”

Bridging the gap between landscapes of molecules and townships has always been the work of AIDS vaccine research. This bridging was highlighted by Glenda Gray, president of the South African Medical Research Council, in her Wednesday plenary on Advancing HIV Vaccines into Efficacy Studies—and though it was a quiet year, we can clearly expect more updates in Durban 2016 as the South African trials continue and basic science also proceeds.