Three years ago, Dr. Julie McElrath and her colleagues decided their best shot at developing an effective HIV vaccine was to try and beat the virus on its own turf, by launching clinical trials in a country that had lost an entire generation to AIDS.
In 2009, McElrath and Dr. Peter Gilbert had helped researchers complete a breakthrough trial of a vaccine that made some people more than 30 percent less likely to contract HIV. The trial took place in Thailand, where nearly 500,000 people are HIV-positive, according to UNAIDS. As McElrath, Gilbert and their colleagues at the HIV Vaccine Trials Network – which is based at Fred Hutch – unraveled exactly why the vaccine was effective, they realized they needed to go into countries where the epidemic has hit the hardest.
“The vaccine can have the biggest benefit there, and studies can be done quickly and with fewer participants because the incidence is so high,” said McElrath, who directs Fred Hutch’s Vaccine and Infectious Disease Division and the HVTN’s laboratory arm.
Now the HVTN is launching trials of the most promising HIV vaccines ever developed, and they’re doing it in South Africa, where the virus infects more people than in any other country. There, more than five million people – or roughly 10 percent of the population – suffer from HIV, and nearly two million children have been orphaned by the disease, according to Statistics South Africa and UNAIDS.
The mission of the Hutch is the elimination of cancer and related diseases as a cause of human suffering and death. Those with HIV can be several thousand times more likely to develop various types of cancer, according to the National Cancer Institute.
If the new vaccines are effective, it will be a key step toward ending the HIV scourge in South Africa and worldwide.
“That’s the goal – to make insights that will lead to a vaccine that is far more effective than anything we’ve ever seen,” said Dr. Jim Kublin, the HVTN’s executive director.
The South Africa trials are the latest chapter in a vaccine push that started in 1999, when Fred Hutch President and Director Dr. Larry Corey launched the HVTN. Since then, the network has conducted more than 50 clinical trials. The HVTN’s researchers and their colleagues spent the past four years improving the Thai trial vaccines and adapting them to sub-Saharan Africa’s most common HIV strains.
The network will soon conduct Phase 1 and Phase 2 studies to confirm that the new vaccines are safe. If all goes well, the vaccines will move forward to larger Phase 2 and Phase 3 studies to determine their side effects and effectiveness. Scheduled to start in 2015, those trials could include as many as 10,000 participants and will examine whether the vaccines reduce a healthy person’s risk of contracting HIV.
The trials are anchored by a new, state-of-the-art vaccine lab that Fred Hutch spearheaded in Cape Town. The lab, which will be unveiled on Oct. 23, will analyze trial participants’ blood samples and study how their immune systems interact with the vaccine, and with the virus.
It cost approximately $3 million to complete the lab and the project received critical funding from the Bill & Melinda Gates Foundation and the National Institutes of Health. The facility will also be open to South African researchers, giving them training and access to cutting-edge technology that helps advance their own HIV studies.
The opening of the lab coincides with a conference co-hosted by the HVTN and the South African Medical Research Council. It marks the HVTN’s first meeting outside of the United States. The network is partnering with the South African government as it moves forward on its efforts to expand HIV vaccine research in the region.
“That’s a really important goal – to partner with African scientists and clinicians to lay a foundation for research that extends far beyond the HVTN,” said Dr. Erica Andersen-Nissen, the lab’s director.
If the South Africa trials prove the latest vaccines are effective, it could be the foundation for a new wave of vaccines that potentially disarm HIV worldwide. It’s a process that could happen quickly or last for years – it took more than four decades to develop a vaccine for polio, and HIV is a far more complicated virus.
“I’ve been involved in medicine for my entire life, and I’ve never seen an endeavor like this – there is a huge community of people who are 100 percent committed to discovering a vaccine,” Kublin said. “It might not happen immediately, but it’s within our grasp.”