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.

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.

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.

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.

AIDS vaccine developers do not, as a rule, set favorable pre-clinical monkey data as the sole basis for a go/no-go decision on whether to move forward in human trials. At the same time, favorable data can provide an important signal for advancing into product development. Monkey studies can provide critical immunological data hinting at how, not just whether, a vaccine might work in humans.

A new monkey study, Protective efficacy of adenovirus-protein vaccines against SIV challenges in rhesus monkeys, published July 2 in the journal Science sheds new light on a vaccine candidate being developed by Janssen Pharmaceuticals, part of Johnson & Johnson. The study was led by Dan Barouch from Beth Israel Deaconess Medical Center and the Ragon Institute of Massachusetts General Hospital, MIT and Harvard.

While the new data are from an animal model, the candidate vaccine strategy—Adenovirus type 26 (Ad26) and Modified Vaccinia Ankara (MVA) as vectors, in combination with an envelope (env) protein boost—is also being tested in humans in a Phase 1/2a international clinical study. (On AVAC’s recent webinar—Vaccines in Vivo: Advances in AIDS Vaccine Research—Janssen’s clinical head for HIV vaccines provided an overview of their research and development program, and the link provides a recording of his presentation and slides.)

The preclinical studies just published showed complete protection in half of the rhesus monkeys after six rectal challenges with SIV, a virus similar to HIV that infects monkeys. Similar adenovirus-based candidates have not demonstrated this degree of protection. These studies also showed the env protein boost enhanced antibody FC effector functions, which is believed to be a key factor in the functionality of antibody responses.

While these data are encouraging, the important work of testing this vaccine in human clinical trials is just beginning. So perhaps even more exciting than these preclinical results is that the corporate partner (Janssen) is actively engaged in funding the current human trial and seems committed to continued investment—and it has been almost a decade since a large vaccine developer invested significantly in clinical trials for AIDS vaccine development.