lmost 2 million.
That's how many people around the world are infected with HIV each year, despite great advancements in treatment and prevention. And in sub-Saharan Africa, young women are twice as likely to be living with HIV than men.
Which is why there's no time to waste on the quest for a preventive vaccine.
And that quest is well underway, thanks to a promising investigational preventive HIV vaccine from the Janssen Pharmaceutical Companies of Johnson & Johnson, which is now in a Phase 2b (later stage) efficacy study in five countries in sub-Saharan Africa.
The Imbokodo study—supported by a public-private partnership led by Janssen Vaccines & Prevention B.V., the Bill & Melinda Gates Foundation, the National Institutes of Health and the HIV Vaccine Trials Network (HVTN)—aims to evaluate the safety of the mosaic-based vaccine regimen and whether it is able to reduce the incidence of HIV. To do so, the study set out to enroll 2,600 young women in the region—a milestone that researchers have recently achieved.
For HIV Vaccine Awareness Day, professor Glenda Gray, CEO and president, South African Medical Research Council, and chair of the Imbokodo study, spoke to us about why she thinks the trial is promising, and how being part of an initiative for women, by women, with the potential for global impact, is so meaningful.
What sparked your personal interest in HIV work?
As a young pediatrician working in Soweto in the late '80s and early '90s, I was exposed to health activism under apartheid. And when HIV started to emerge, I could see how it was decimating South Africa’s families. HIV affected vulnerable populations. It affected women. It affected poor people. It affected people who didn't have any agency or voice.
I was confronted daily with children and babies who were infected with HIV, who were brought in by their young mothers, who did not know what was happening. They did not know they were infected with HIV.
So, I became passionate about the cause. I began to focus on HIV and AIDS in my medical work, and researched ways to prevent mother-to-child HIV transmission. Because I believed there was a way to bring a preventive intervention to women and their children, in 2000, I got involved in HIV vaccine research and led the first clinical trials involving HIV vaccines in the Republic of South Africa.
My goal is to ultimately eliminate pediatric HIV; but first we need to find a preventive vaccine that could work in adults.
What makes the vaccine in the Imbokodo study promising?
HIV is a difficult virus to prevent. One reason is that no human we know of has been naturally cured of HIV, so we're not certain yet what kind of immune response you need to induce to prevent the disease. And we don't have fully validated animal models that can predict what happens in humans.
Another reason is that HIV replicates so fast that our immune system is always one step behind it. We have great difficulty keeping up with the virus, so we need an intervention that can find an immune response that's activated as soon as someone is exposed to HIV.
I believe this vaccine is promising because it’s the first attempt to induce an immune response that's very broad.
Women are most affected and most vulnerable to HIV acquisition, particularly in sub-Saharan Africa ... having a vaccine that protects the most vulnerable would be a significant accomplishment.Share
Why is the trial composed exclusively of young women? And why is this meaningful?
Women are most affected and most vulnerable to HIV acquisition, particularly in sub-Saharan Africa, due to social dynamics and cultural practices. That's not to say that men aren't at risk, but having a vaccine that protects the most vulnerable would be a significant accomplishment.
It is also important to note that the majority of staff working on this trial are also women. Women are impacted most, so it makes sense that women should contribute in a meaningful way to the solution. This study demonstrates that women care about women-related issues, and that female scientists are willing to work in areas of science where women stand to benefit the most.
Having young women on this study who are researchers, doctors and investigators is critical because it builds the capacity for science in sub-Saharan Africa, where there traditionally hasn't been much gender parity.
The name of the trial, Imbokodo, is the Zulu word for rock. It's part of a well-known South African proverb that means "you strike a woman, you strike a rock," alluding to the strength and importance of women. In my opinion, the women who have volunteered to participate in Imbokodo are the true heroes of this effort.
The trial just reached full enrollment. What does this mean, and why is it exciting?
Full enrollment is an essential landmark in Phase 2b clinical trials, which rigorously evaluate efficacy and safety, so it's exciting that we met this milestone. And plans for an additional Phase 3 (late stage) study, in different populations and parts of the world, are in the planning stage.
Looking at the big picture, as HIV researchers, we aim to provide the impetus, enthusiasm and inspiration needed to achieve the goal of a preventive vaccine.
If the Janssen vaccine is found to work, it will be an important medical advancement. So, it means a lot to be able to do this and to contribute to science in this way.
The vaccine team at Janssen is incredibly inspirational. They've taken personal interest, coming to visit sites and making an effort to meet the doctors involved and listen to their experiences. It’s been like working with an extended family.