The initial grant of roughly $700,000 Corey secured from the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), funded the establishment of a core operations center at Fred Hutch, which is responsible for choosing the vaccines to be tested, designing clinical trials and protocols, processing trial samples and interpreting results.
The network, which is primarily funded by NIAID, works with researchers in various countries to run trials. While the dozen NIAID-funded sites across the U.S. are associated with universities, hospitals and health organizations, some of the smaller sites lack the same infrastructure. In Iquitos, a city in the Peruvian rainforest reachable only by boat or plane, the HVTN clinic is run by two independent researchers.
While the network now attracts some of the brightest minds working in the field, it has had its share of challenges. The HVTN was controversial in the early days even within the Hutch, Chief Operating Officer Banks Warden said.
“Anything that wasn’t cancer, people wondered why the Hutch was involved,” he said.
HIV can be tied to cancer -- an estimated 25 percent of cancers worldwide are linked to infectious diseases. Those with HIV can be several thousand times more likely to develop various types of cancer, according to the National Cancer Institute, also part of the NIH.
The nature of a search for an HIV vaccine is inherently difficult and complex. HIV vaccine trials require large numbers of healthy participants willing to trust that they won’t be harmed – versus, for example, terminal cancer patients for whom a clinical trial may represent a last hope.
Determining how many participants are needed to find out whether a vaccine works is challenging, as is ensuring that participants accurately report behaviors that put themselves at risk of getting or transmitting HIV.
The work is further complicated by a lack of animal models that reflect how HIV progresses in humans, said Dr. James Kublin, the HVTN’s executive director.
“We don’t have the experimental models that reflect the dynamics of HIV infection without looking at thousands of people,” Kublin said. “This work is fraught with all sorts of challenges and difficulties.”