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Preventative HIV Vaccine Candidate Triggers Desired Immune Responses in Humans and Monkeys, and Protects Monkeys from Infection

More than three decades after the identification of the human immunodeficiency virus (HIV), scientists are still working to develop a preventative vaccine that could finally put an end to the epidemic for which there are nearly two million new infections each year. In a new study, published online on July 6, 2016 in The Lancet, a team of researchers led by Beth Israel Deaconess Medical Center's (BIDMC’s) Dan H. Barouch, MD, PhD, Director of the Center for Virology and Vaccine Research, in collaboration with Janssen Vaccines & Prevention and other partners, evaluated a series of preventative HIV vaccine regimens in uninfected human volunteers in five countries. In a similarly designed study, Dr. Barouch and colleagues tested the same vaccine for its ability to protect rhesus monkeys challenged with an HIV-like virus from infection. The findings showed the vaccines induced robust and comparable immune responses in humans and monkeys and protected monkeys against acquisition of infection. "This study demonstrates that the mosaic Ad26/Ad26 plus gp140 vaccine candidate induced robust and comparable immune responses in human and monkeys," said Dr. Barouch, who is also Professor of Medicine at Harvard Medical School. "Moreover, the vaccine provided 67 percent protection against viral challenge in monkeys." The Lancet article is titled “Evaluation of a Mosaic HIV-1 Vaccine in a Multicentre, Randomised, Double-Blind, Placebo-Controlled, Phase 1/2a Clinical Trial (APPROACH) and in Rhesus Monkeys (NHP 13-19).”

Intended to provide broad protection from the many strains of HIV that are prevalent worldwide, the "mosaic" vaccine contains a patchwork of genetic sequences found among various HIV strains. Known as APPROACH, the phase 1/2a trial tested seven different Ad26/Env HIV vaccine regimens for their safety, tolerability, and the ability to elicit immune responses in 393 healthy adult volunteers in Rwanda, South Africa, Thailand, Uganda, and the United States. All vaccine regimens were well-tolerated and induced robust immune responses in the participants.

"Based on these data, the mosaic Ad26/Env HIV-1 vaccine has been advanced into a phase 2b clinical efficacy study to determine whether this vaccine will prevent HIV infection in humans in southern Africa," said Dr. Barouch. "We expect results in 2021. This is only the fifth HIV vaccine concept that will be tested for efficacy in humans in the 35+ year history of the global HIV epidemic."

The study is the result of a collaboration among researchers at BIDMC, Harvard Medical School and the Ragon Institute of Massachusetts General Hospital, MIT and Harvard; the United States Military HIV Research Program (MHRP) at the Walter Reed Army Institute of Research (WRAIR); the National Institute of Allergy and Infectious Diseases (NIAID); the International AIDS Vaccine Initiative; the HIV Vaccine Trials Network (HVTN), Janssen Vaccines & Prevention B.V., part of the Janssen Pharmaceutical Companies of Johnson & Johnson; and multiple other partners.

[Press release] [Lancet abstract]