Community is key for new, large HIV vaccine trial

Hutch News

Quest for an HIV vaccine

Community trust is key as researchers start a new trial across 15 sites in South Africa

Nov. 29, 2016
Dr. Linda-Gail Bekker

Dr. Linda-Gail Bekker, deputy director of the Desmond Tutu HIV Centre, is co-chair of a just-launched HIV vaccine clinical trial in South Africa

Photo by Robert Hood / Fred Hutch News Service

The tin-shacked shantytowns are just 15 miles across the scrubland flats from Cape Town, South Africa’s stunningly beautiful tourist capital, but they seem as distant from the coastal city’s golden beaches, mountain vistas and pricey real estate as a settlement on the moon. A relic of apartheid for housing blacks and people of mixed race, the crowded townships and squatter camps today make up the Cape Town area’s largest residential quarter, home to about a million people eking out a living amid too few jobs and too much violent crime.

Against this backdrop of dire poverty, the modern and spacious Emavundleni Research Centre in the New Crossroads township stands out — which was exactly Dr. Linda-Gail Bekker’s intention.

As one of South Africa’s top HIV researchers and the first woman from Africa to head the International AIDS Society, Bekker knows from more than 20 years in the field that researchers have to work hand in hand with the communities most affected if they want to halt an epidemic. And the townships are ground zero for HIV/AIDS in Cape Town.    

Bekker and three other South African scientists this month launched a clinical trial at the Emavundleni center and 14 other sites across South Africa which, if successful, could lead to the first licensed vaccine against HIV.

The new trial, called HVTN 702, builds on the success of the so-called Thai vaccine, a two-vaccine regimen named after the country in which it was tested. Those who received that vaccine had a 31 percent lower risk of becoming infected with HIV 3½ years after vaccination, compared to placebo recipients. Although not enough protection to warrant licensing, the results, reported in 2009, were widely hailed as a breakthrough in the long struggle to develop a vaccine against the rapidly mutating virus.

For the South Africa trial, the Thai regimen was altered with the aim of making the vaccine more protective as well as longer-lasting. Government regulators have said they would consider licensing an HIV vaccine if it protects at least 50 percent of those who receive it.

Seldom has community involvement been more important than now in enlisting trial support and participation.

“We try to reduce the inconvenience to the participants by doing the research on their doorstep,” Bekker said in an interview at the Desmond Tutu HIV Centre at the University of Cape Town, where she is deputy director as well as chief operating officer of the nonprofit Desmond Tutu HIV Foundation. “That is why we built that prevention center right in the heart of the HIV epidemic in Cape Town. It means a great deal to the community that we’re down in the trenches together. We’re invested. We’re here for the long haul.”

The trial is funded by the U.S. National Institute of Allergy and Infectious Diseases, or NIAID, the Bill & Melinda Gates Foundation and the South African Medical Research Council. It is being conducted by the NIAID-funded HIV Vaccine Trials Network, or HVTN, which is headquartered at Fred Hutchinson Cancer Research Center, and it is being led by South African Medical Research Council President Dr. Glenda Gray, a co-director of the HVTN and head of its Africa programs.

NIAID Director Dr. Anthony Fauci has described the decades-long quest to develop an HIV vaccine as “scientifically one of the most difficult challenges that we have ever faced.” Now the challenge becomes testing the vaccine. The 15 sites need to enroll 5,400 HIV-negative men and women who are willing to undergo a five-shot vaccine regimen over a year and then be followed for two additional years to see if the regimen protects them against infection. Results of the trial are expected by late 2020.

Just as the science has taken years, the investment in winning the community’s cooperation began long before the first trial participants began receiving the first injections this month.

“I always tell the younger investigators and team members, ‘A reputation takes a long time to build, and it can be ruined overnight,’” Bekker said. “One mistake can destroy years of trust-building. If the science has to take a back seat because something doesn’t feel right or we’re not ready to implement something, then that’s how it has to be. Community comes first.”

Battling crime, rumors —  and HIV

A years-long trial involving 5,400 participants would be an ambitious undertaking anywhere. But some barriers are particular to the townships that suffer the brunt of South Africa’s HIV infections. One challenge cited frequently is the high crime rate, which can hinder efforts to do outreach and education. 

Siyabonga Ngqame

Siyabonga Ngqame is a community liasion officer for the University of Cape Town's Emavundleni Research Centre.

Photo by Robert Hood / Fred Hutch News Service

“We have to ensure that people are safe from HIV, but to get to these people, we have to ensure that we are safe from crime,” said Siyabonga Ngqame, who is employed by the Emavundleni center to do community outreach. “Therefore, we are fighting two things at the same time.”

Members of the outreach staff choose an area to focus on, then build networks and relationships. “The people who are known in an area are a little bit safer than strangers,” Ngqame said. The research center itself is seen as a safe space for trial participants to come.

In communities where few people have more than seven years of schooling, center outreach workers find themselves explaining science and dispelling superstitions.

“In our area, a small number of people are well-educated,” Ngqame said. “But a majority of people we contact are not. We get some people who can’t read or write. There are many skeptics about what is happening.”

Each HVTN clinical trial site has a community advisory board, or CAB, to keep the vital line of communication open between the people who live in the areas where the clinical trials are conducted and the researchers. They serve as the eyes and ears of the communities they represent, bringing their concerns to researchers and explaining in turn to community members how clinical trials work.

One common question that recruiters encounter has to do with why blood is drawn from trial participants. (It is to study immune responses.)

“People have questions about what are you going to do with the blood because blood is used for witchcraft practices. You have to be really sensitive because of the traditional taboos,” said the Rev. David Galetta, who chairs the Desmond Tutu HIV Foundation CAB, where he has volunteered since 2004, and co-chairs the HVTN’s global CAB. “And there’s always the question about the amount of blood. You’ve got to break it down, not into millimeters but into teaspoons, something people understand.”

The Rev. David Galetta

The Rev. David Galetta

Robert Hood / Fred Hutch News Service

Another concern that has to be assuaged is whether the vaccine itself can give someone AIDS. It can’t. Unlike some vaccines that use weakened or killed versions of a virus, the lab-made HIV vaccine does not contain any HIV. Additionally, the vaccine being tested was found to cause no other safety problems in an earlier, smaller trial led by Bekker.

Trickier to explain is that participants in an HIV vaccine trial might test positive for HIV when they are not in fact infected — the source of some of the rumors that the vaccine causes infection. Like most vaccines, the one in the clinical trial is designed to prompt the body to produce antibodies. And the most affordable and commonly used test for HIV looks for HIV antibodies rather than HIV itself.

For this reason, trial participants need to be tested only at clinical trial sites, which use more sophisticated and specific tests, rather than at other clinics. The outreach staff works with outside clinics to raise awareness of this issue and to ask people who come in for testing whether they are in a vaccine trial.

‘A vaccine is the ultimate hope’

Being in a clinical trial may raise concerns, but it also carries advantages. Participants receive a small stipend to cover transportation costs and to make up for any lost wages for time spent in the clinic. It is deliberately kept low so as not to coerce people to participate, but in areas with few jobs, it can be welcome.

In addition, participants get health screenings without standing in a long line at a public clinic. And all participants, whether randomly assigned to receive the experimental vaccine or a placebo, are counseled on HIV prevention, They are also offered options such as condoms and referrals for male circumcision and antiretroviral drugs to take immediately after suspected exposure or as a preventive measure. (Because it is unethical to deliberately expose people to HIV, testing to see whether a vaccine provides protection involves waiting several years and seeing how many people become infected naturally despite prevention counseling. Anyone who is infected will receive treatment and follow-up care.)  

“The screening process and the results that come from that overall screening, that’s a great benefit for a lot of people that wouldn’t have happened if they go to a normal clinic,” said Galetta. In addition, many trial participants, whether in Cape Town or Seattle, come to appreciate the care and attention they receive and the relationships they develop with the clinical trial staff.

There is one other benefit that is harder to quantify.

“The research is giving hope to people,” Galetta said. “I’m a minister to people in my community. I know the burden HIV has on people’s lives. A vaccine is the ultimate hope.”

In many parts of the United States, complacency has set in about the HIV epidemic 35 years after the first AIDS cases were reported. The development of antiretroviral drug cocktails in the mid-1990s has turned HIV from a death sentence to a chronic disease, at least for those who have access to and can tolerate the drugs. Although scientists, health officials and advocates warn that the epidemic isn’t over and that 40,000 to 50,000 new infections occur in the U.S. each year, HIV is no longer headline news.

South Africa is not complacent. It has the largest number of people living with HIV in the world — almost 7 million people out of a population of about 55 million. (By comparison, an estimated 1.2 million people with HIV live in the United States, population 322 million, according to the Centers for Disease Control and Prevention.) Though late to promote the use of antiretroviral drugs, South Africa has made great strides in recent years, reaching 3.4 million people — the largest treatment program of any country. But still, that is only half the people who need it. Meanwhile, more than 1,000 people become infected with HIV every day.

The motivation to find a vaccine — to be part of the solution — is high.

“HIV is the biggest killer of our current generation,” said Ngqame. “All the people I know have a family member or friend who has died from HIV. Therefore, they are looking for something to end HIV.”

Getting it done by being part of the solution

Sean Wana

Sean Wana

Robert Hood / Fred Hutch News Service

At 33, Sean Wana has lived his whole life in Nyanga, the township next to Crossroads. Its name in the Xhosa language means “moon,” but it is better known as the murder capital of South Africa.  

But what is on Wana’s mind is not crime but HIV. That is why he joined the CAB.

“Some of my colleagues, some of my relatives, are affected. That affects me as well because these people are my community, my family,” he said. “I feel it were better for me to have it rather than them. You understand that feeling?”

In her work over the years, Bekker has found Wana’s attitude to be the prevalent one in the communities most affected by HIV.  

“Overwhelmingly over the years, we’ve continually found that people are willing to participate in prevention research. They want to be part of the solution,” she said. “Our community values the concept of a vaccine. They’re understood as preventing disease, and people see their worth.”

Since the global epidemic began in 1981, an estimated 35 million people worldwide have died of AIDS-related illnesses and 37 million more are living with HIV. A vaccine would be “a game changer for the world,” said Bekker.

She added, “We’ve got to get it done."

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Fred Hutch News Service writer Mary Engel and photographer Robert Hood were in Durban and Cape Town, South Africa, where this story was reported, in July for the 21st International AIDS conference, AIDS2016.

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