Long-term follow-up of HIV-1-infected adults who received the F4/AS01B HIV-1 vaccine candidate in two randomised controlled trials.

This Phase I/II, open, long-term follow-up study was conducted in antiretroviral therapy (ART)-naïve (N = 212) and ART-treated (N = 19) human immunodeficiency virus 1 (HIV-1)-infected adults, who received an HIV-1 investigational vaccine (F4/AS01B) or placebo in two previous studies (NCT00814762 and NCT01218113). After a minimum of two years and a maximum of four years of follow-up post-vaccination per patient, no significant differences were observed between F4/AS01B and placebo groups in terms of viral load, CD4+ T-cell count and incidence of specific clinical events. Vaccine-induced polyfunctional CD4+ T-cells persisted up to study end and no relevant vaccine-related safety events were reported in F4/AS01B groups. This study has been registered at ClinicalTrials.gov (NCT01092611).

RCT Entities:   Population Interventions Outcomes