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

Vaccine. 2018 May 3;36(19):2683-2686. doi: 10.1016/j.vaccine.2018.03.043. Epub 2018 Mar 30.

Abstract

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).

Keywords: Efficacy; HIV type 1 vaccine; Immunogenicity; Persistence; Recombinant fusion protein; Safety.

Publication types

  • Clinical Trial, Phase I
  • Clinical Trial, Phase II
  • Multicenter Study
  • Observational Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • AIDS Vaccines / therapeutic use*
  • CD4-Positive T-Lymphocytes / immunology
  • Follow-Up Studies
  • HIV Infections / drug therapy
  • HIV Infections / therapy*
  • HIV-1 / immunology
  • HIV-1 / pathogenicity
  • Humans
  • Placebos
  • Viral Load

Substances

  • AIDS Vaccines
  • Placebos

Associated data

  • ClinicalTrials.gov/NCT01092611