“This clinical trial will determine whether this vaccine candidate will prevent HIV infection in young women in sub-Saharan Africa” - Dan Barouch
The investigational regimen is designed to induce responses to different strains of the virus found in many regions of the world. The new study is the first to test whether the vaccine is able to reduce the incidence of HIV infection.
“One of the major challenges for HIV vaccine development is the tremendous genetic diversity of the virus,” explained Bruce Walker, the HMS Phillip T. and Susan M. Ragon Professor of Medicine at Mass General and director of the Ragon Institute.
“Viruses from patients in Boston may be 40 percent different from viruses found in Africa, so developing a vaccine that can protect against these diverse strains is an enormous, unprecedented challenge,” Walker said.
Called the Imbokodo trial from the Zulu word for rock—echoing a South African proverb that refers to the strength of women and their importance in the community—the new study has begun enrolling young women in South Africa, the country with the greatest prevalence of HIV infection worldwide.
Regulatory approval is being sought in Malawi, Mozambique, Zambia and Zimbabwe. The trial is being conducted at clinical sites coordinated by the HIV Vaccine Trials Network in collaboration with scientists in southern Africa.
Imbokodo has a goal of enrolling 2,600 uninfected, sexually active women, ages 18-35, who will receive vaccinations at four timepoints over one year—either the experimental, mosaic-based vaccine regimen or a placebo—to determine whether the vaccine regimen can reduce the incidence of HIV infection.
The vaccine regimen being tested, originally developed in the laboratory of Ragon Institute founding member Dan Barouch, HMS professor of medicine at Beth Israel Deaconess, includes a mosaic vaccine—so called because it contains genetic sequences from different HIV strains prevalent in many parts of the world.
“A safe and effective global HIV vaccine will almost certainly be needed to end the HIV epidemic,” said Barouch, who is also director of the Center for Virology and Vaccine Research at Beth Israel Deaconess.
“This clinical trial will determine whether this vaccine candidate will prevent HIV infection in young women in sub-Saharan Africa,” he added.
Barouch began pursuing the mosaic vaccine strategy in 2007, and early versions of mosaic vaccines tested in several animal models showed very promising results prior to initial human testing.
Earlier this year, Barouch and partners reported preliminary results of the phase 1/2a APPROACH study at the 9th International AIDS Society Conference on HIV Science, indicating that the experimental vaccine appeared to be well tolerated and that the most promising regimens triggered the desired antibody responses in all of the healthy volunteers who received them.
The Janssen Pharmaceutical Companies of Johnson & Johnson collaborated with Barouch on the development of the mosaic vaccine. The APPROACH trial was sponsored by the Janssen Pharmaceutical Companies of Johnson & Johnson with support from the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health, the Ragon Institute and other partners.
The Imbokodo study is being sponsored by Janssen Vaccines & Prevention B.V., the National Institute for Allergy and Infectious Diseases and the Bill and Melinda Gates Foundation. Additional funding is being provided by the Ragon Institute, the U.S. Military HIV Research Program at the Walter Reed Army Institute of Research and the U.S. Army Medical Materiel Development Activity.