A new clinical trial for an AIDS vaccine will take place in Africa and the United States. The program, announced this week, is a collaboration between the International AIDS Vaccine Initiative (IAVI), which will lead the trial, biopharmaceutical company Crucell (Leiden, Netherlands), Harvard Medical School’s Beth Israel Deaconess Medical Center, and the Ragon Institute, an organization dedicated to HIV/AIDS research.
The trial will study a combination of two vaccine candidates, Ad26.ENVA.01 (manufactured by Crucell) and Ad35-ENV (developed by IAVI), in healthy adults who do not have HIV. The trial will focus on the vaccines’ safety and effectiveness as a prime-boost regimen. The goal of a prime-boost combination is that one vaccine is administered to prime the immune system and elicit a certain immune response before a second, or booster, dose is given to enhance the overall immune response.
A previous clinical trial based on a prime-boost combination took place in Thailand and represents the first time an AIDS vaccine showed promise in reducing the risk of infection. Results released in September 2009 showed that the combination of vaccines lowered the risk of acquiring HIV by roughly 30%. Additional data were presented at the AIDS Vaccine 2009 Conference and published in the New England Journal of Medicine. The research team wrote that, “Although the results show only a modest benefit, they offer insight for future research.”
Also announced this week was that the International AIDS Vaccine Initiative (IAVI) appointed Michael Caulfield executive director of the IAVI AIDS Vaccine Design and Development Laboratory (DDL). Caulfield previously held research positions at Merck (Whitehouse Station, NJ) and the Cleveland Clinic. As leader of the DDL, he will be responsible for IAVI’s translational research and vaccine discovery, as well as for expanding its R&D team.
“Mike’s joining at a critical time for the field,” said Wayne Koff, IAVI’s chief scientific officer, in a press release. “We’re in the middle of a renaissance in AIDS vaccine design and development.”
In related news, scientists at the National Institutes of Health (NIH) announced the discovery of two human antibodies that can stop more than 90% of HIV strains from infecting human cells in the laboratory. The team, part of the Vaccine Research Center, a division of the National Institute of Allergy and Infectious Diseases at NIH, also demonstrated how one of the antibodies does this. The scientists said the antibodies could be used to design improved HIV vaccines, or could be further developed to prevent or treat HIV infection, according to the group’s press release. The work was published in Science in two articles, found here and here.
The NIH team’s discovery plus the results of the Thailand vaccine trial are examples of exciting progress in the field of AIDS vaccine research. Many are hopeful that the Crucell clinical trial will add to the upswing of encouraging results.
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