Long-term follow-up of HIV-1-infected adults who received the F4/AS01B HIV-1 vaccine candidate in two randomised controlled trials |
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| Affiliation: | 1. Department of Internal Medicine 3, Universitätsklinikum Erlangen, Friedrich-Alexander-University Erlangen-Nürnberg (FAU), Germany;2. Seattle Infectious Disease Clinic, Seattle, WA, USA;3. GSK, Wavre/Rixensart, Belgium |
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| 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). |
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| Keywords: | HIV type 1 vaccine Recombinant fusion protein Persistence Efficacy Immunogenicity Safety AE" },{" #name" :" keyword" ," $" :{" id" :" k0040" }," $$" :[{" #name" :" text" ," _" :" adverse event ART" },{" #name" :" keyword" ," $" :{" id" :" k0050" }," $$" :[{" #name" :" text" ," _" :" antiretroviral therapy ATP" },{" #name" :" keyword" ," $" :{" id" :" k0060" }," $$" :[{" #name" :" text" ," _" :" according-to-protocol CI" },{" #name" :" keyword" ," $" :{" id" :" k0070" }," $$" :[{" #name" :" text" ," _" :" confidence interval GMC" },{" #name" :" keyword" ," $" :{" id" :" k0080" }," $$" :[{" #name" :" text" ," _" :" geometric mean concentration HIV-1" },{" #name" :" keyword" ," $" :{" id" :" k0090" }," $$" :[{" #name" :" text" ," _" :" human immunodeficiency virus 1 pIMD" },{" #name" :" keyword" ," $" :{" id" :" k0100" }," $$" :[{" #name" :" text" ," _" :" potential immune-mediated disease SAE" },{" #name" :" keyword" ," $" :{" id" :" k0110" }," $$" :[{" #name" :" text" ," _" :" serious adverse event SD" },{" #name" :" keyword" ," $" :{" id" :" k0120" }," $$" :[{" #name" :" text" ," _" :" standard deviation TVC" },{" #name" :" keyword" ," $" :{" id" :" k0130" }," $$" :[{" #name" :" text" ," _" :" total vaccinated cohort VL" },{" #name" :" keyword" ," $" :{" id" :" k0140" }," $$" :[{" #name" :" text" ," _" :" viral load |
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