The Search Continues and Science Advances on HVAD 2016

Today, the US National Institutes of Health (NIH) announced that it will fund a large-scale efficacy trial in South Africa to test the prime-boost vaccine regimen that is a modified version of the RV144 vaccine that showed modest efficacy in 2009. This will be the first large-scale HIV vaccine trial to take place in South Africa in almost a decade, and an exciting development for the country and the field. In addition to the announcement, NIH also posted questions and answers about the new study.

Still have questions or want to hear more about what this all means? Then join us on Tuesday, May 31, at 10am US Eastern/4pm South Africa time (see www.timeanddate.com for the time in your area), for a webinar with Linda-Gail Bekker from the Desmond Tutu HIV Foundation and the lead investigator on the current HVTN 100 vaccine trial.

Register for the webinar here.

The announcement of the trial, known as HVTN 702, comes on HIV Vaccine Awareness Day, the annual event that allows us all to recommit ourselves to accelerate the search for an HIV vaccine. As we wrote on Monday, today and every day, we should all say, “I’m committed to ending the AIDS epidemic, and that means finding an HIV vaccine.”

The announcement that HVTN 702 will take place comes nearly seven years after the announcement of efficacy data from RV144. In the intervening years, global scientific collaborations have probed the responses from RV144 and developed plans, in combination with industry, to optimize the regimen so that it might work better, provide more durable protection and is tailored for the HIV subtype C that is most common in Southern Africa.

Today’s decision is based on an interim analysis of HVTN 100, a current trial in South Africa led by the NIH-funded HIV Vaccine Trials Network (HVTN) that is looking for immune responses and safety in South African volunteers of the modified vaccine combination. HVTN 702 will start later this year and will measure safety and efficacy in 5,400 participants.

Under the current plan, it will be at least four years before there are data from HVTN 702. Check out our new AIDS Vaccine Research Overview that shows the HVTN 100/702 trials in context of the larger field. Other HVAD materials are here. In addition, check out some of these new HVAD articles that just came out:

As is so often and so rightly said in this field: much accomplished; much to do!

HIV Vaccine Research: An Update

A quick, colorful and comprehensive overview of HIV vaccine research. Four pages, five top-line updates, this is a speedy read, designed to give a sense of the momentum and major issues coming up in the year to come.

Preparing for HIV Vaccine Awareness Day 2016

It’s that time again—HIV Vaccine Awareness Day. AVAC has worked with partners to develop a range of tools and resources for this day and for year-round advocacy. We hope you’ll find them useful whether you unfurl banners, strike up a band, hold a fishing boat race, host a town hall forum, or just turn to your closest neighbor and say, on May 18, “I’m committed to ending the AIDS epidemic, and that means finding an HIV vaccine.”

This year’s HVAD tools and resources include:

Technology and Health Coverage

Out of all the different book and movie genres, my favorite is science fiction. There’s something about “futuristic” technology and how society reacts to it that fascinates me. So when I had the opportunity to attend the Global HIV Vaccine Enterprise’s “Innovative Uses of Technology in HIV Clinical Trials” meeting, I didn’t want to miss out. As technology and global health both expand—and in some places converge—I find myself more and more drawn to understanding how the global health field might benefit or be hindered by this growth in technology.

The meeting, which was part of the Enterprise’s “Timely Topics” series, concentrated on how using new technologies like biometrics, mobile phone messaging, cell phones, tablets and smart pill bottles could help clinicians, researchers and clients. Here are four key takeaways:

1. Just because we have technology doesn’t mean that researchers should use it. This idea was particularly stressed when discussing data collection. We now have the ability to collect responses through technologies like tablets or SMS. However, this doesn’t mean that we should disregard paper methods. Technology can be harder to use because it may malfunction, may not be viewed favorably by locals, get stolen or even be inaccessible when batteries run out or power goes out. We need to be sure that we are thinking about the usability of technologies and whether or not they truly add worth.

2. Policy needs to catch up with technology / Health technology companies need to ensure there are protocols in place: It’s scary to think that technology is often ahead of policy. Though it is perhaps impossible to think of every worst-case scenario, governments should start thinking of health privacy laws. In addition, health technology companies and those who utilize the technologies should put sound protocols in place should data be hacked or misused. Though biometrics (a technique using physical characteristics to identify a person), seems like a safer way to guard identity because the human body is unique to every individual, companies must proceed with caution and consider robust and secure measures.

3. Those working in the global health field and technologies need to work together to push companies to create compatible structures and platforms, at the very least within country: As the speakers stood in front to present, one of the repeated questions pertained to the compatibility of the different technologies or data systems. Unfortunately, not all of the software used seemed to be compatible. Though these new technologies are currently being tested with smaller populations, going forward, governments, clinical trial sites and companies need to decide on how to make these systems compatible. Otherwise, data sets may not be transferrable and money wasted on either starting from scratch or having someone convert data.

4. Messaging needs to be well thought out and expectations managed: I’m a big proponent of using technology to improve global health. However, I also know that transparent communication is key to growing relations and trust. That’s why I was a little bit wary as to the messaging that is potentially being conveyed when introducing something as new as biometric scanning. Are the possible cons of biometrics thoroughly listed out before participants willingly give up scans of their eyes or finger prints? Are donors and implementers aware of the responsibility and gravity of what will happen if the information were ever to get into the wrong hands? After all, things like our eyes and fingerprints cannot be reset like passwords can.

The conference was eye-opening to the different ways that technology can impact global health. The convergence of technology and health is definitely a growing field that we should be watching out for in excitement. However, we also need to pause and think before jumping into new innovations.

You can view the meeting presentations here.

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 [email protected].

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.