February 28, 2014
NIH Announces It Has Discontinued Immunizations in AIDS Vaccine Clinical Trial HVTN 505
The US National Institute of Allergy and Infectious Diseases (NIAID) announced today that a Phase IIb clinical trial, HVTN 505, evaluating a sequential regimen of two HIV vaccine candidates has been halted. The decision was based on the outcome of an interim analysis that indicated the regimen is not likely to prevent HIV infection or suppress the amount of HIV in the blood of vaccine recipients who became infected with HIV.
The study was conducted by the HIV Vaccine Trials Network (HVTN) and funded by NIAID. The prime-boost regimen comprised a DNA-based vaccine candidate and an adenovirus serotype 5-based candidate, both developed by the Vaccine Research Center (VRC) of NIAID.
Though disappointed by this outcome, IAVI applauds the sponsors of the trial for completing an important, well conducted and carefully designed study. HVTN 505 was the fourth evaluation to date of an AIDS vaccine concept in an efficacy trial. “We know that these trials, even those that do not achieve their goals, play an important role in informing HIV vaccine development,” said IAVI CEO Margie McGlynn. “The sponsors of this study and the researchers and volunteers who made it possible deserve our praise for their dedication and commitment. The world needs an AIDS vaccine, and in order to develop one we must persist in the clinical evaluation of promising vaccine strategies.”
An AIDS vaccine will be an essential tool in the fight against HIV and AIDS. The expansion of access to antiretroviral drugs has saved millions of lives around the world in recent years. Yet for every two people who gain access to such drugs, five are newly infected with HIV. Nearly 2,700 people are infected with the virus every day. The development and rollout of new prevention tools, most importantly vaccines, in combination with proven existing interventions would do much to help reverse the tide of the HIV pandemic. Recent research has established that an AIDS vaccine is possible, and researchers have lately made significant progress toward the design of potentially more effective vaccine candidates against HIV.
For more information, please visit www.niaid.nih.gov.