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

Publication date: Available online 30 March 2018
Source:Vaccine
Author(s): Thomas Harrer, Warren Dinges, François Roman
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).



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