Efficacy assessment of a cell-mediated immunity HIV-1 vaccine (the Step Study): a double-blind, randomised, placebo-controlled, test-of-concept trial.

Publication Type:

Journal Article


Lancet, Volume 372, Issue 9653, p.1881-93 (2008)


2008, Adolescent, Adult, AIDS Vaccines, Center-Authored Paper, Clinical Research Division, Double-Blind Method, Female, HIV Antigens, HIV Infections, HIV-1, Humans, Immunity, Cellular, Male, Middle Aged, Proportional Hazards Models, Public Health Sciences Division, Risk Factors, Sexual Behavior, Vaccine and Infectious Disease Institute, Young Adult


Observational data and non-human primate challenge studies suggest that cell-mediated immune responses might provide control of HIV replication. The Step Study directly assessed the efficacy of a cell-mediated immunity vaccine to protect against HIV-1 infection or change in early plasma HIV-1 levels.