Phase I Trial of Adenovirus-based Prime-boost Regimen Begins in Boston

A Phase I trial designed to test the safety of two vaccine candidates and their ability to induce immune responses to HIV recently began at Brigham and Women’s Hospital in Boston. Vaccinations of volunteers in the trial, known as IAVI B003/IPCAVD-004, began in October, following approval by the US Food and Drug Administration and Harvard’s institutional review board. Pending regulatory approval, investigators will also enroll additional volunteers for the trial in Africa. The overall goal is to enroll approximately 212 HIV-uninfected individuals at low risk of HIV infection at as many as six clinical research centers.

The two vaccine candidates use different types of adenovirus (Ad26 and Ad35), a common cold virus, as a vector to deliver non-infectious HIV genes into the body with the goal of inducing an immune response against HIV. The two candidates will be tested either in combination or alone. One candidate, referred to as Ad26.ENVA.01, was developed by Dan Barouch, an associate professor of medicine at the Beth Israel Deaconess Medical Center (BIDMC) and Harvard Medical School, and manufactured by the Dutch biopharmaceutical company Crucell. The other, referred to as Ad35-ENV, was developed by IAVI and manufactured by the French biopharmaceutical company Transgene.

Data from ongoing clinical trials that were presented at the recent AIDS Vaccine 2010 conference in Atlanta suggest that both Ad26 and Ad35 candidate vaccines are safe and immunogenic.

The trial is a joint effort by IAVI, BIDMC, the Ragon Institute, Harvard University, Massachusetts Institute of Technology, the National Institute of Allergy and Infectious Diseases’ (NIAID) Division of AIDS (DAIDS), the HIV Vaccine Trials Network (HVTN), and Crucell. It is funded by the HVTN, DAIDS, the Ragon Institute, and IAVI. —Andreas von Bubnoff