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2016-02

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cc by (c) Dinges et al., 2016
Si us plau utilitzeu sempre aquest identificador per citar o enllaçar aquest document: https://hdl.handle.net/2445/126890

The F4/AS01B HIV-1 Vaccine Candidate Is Safe and Immunogenic, But Does Not Show Viral Efficacy in Antiretroviral Therapy-Naive, HIV-1-Infected Adults: A Randomized Controlled Trial

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https://doi.org/10.1097/MD.0000000000002673

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The impact of the investigational human immunodeficiency virus type 1 (HIV-1) F4/AS01(B) vaccine on HIV-1 viral load (VL) was evaluated in antiretroviral therapy (ART)-naive HIV-1 infected adults.This phase IIb, observer-blind study (NCT01218113), included ART-naive HIV-1 infected adults aged 18 to 55 years. Participants were randomized to receive 2 (F4/AS01(B)_2 group, N=64) or 3 (F4/AS01(B)_3 group, N=62) doses of F4/AS01(B) or placebo (control group, N=64) at weeks 0, 4, and 28. Efficacy (HIV-1 VL, CD4(+) T-cell count, ART initiation, and HIV-related clinical events), safety, and immunogenicity (antibody and T-cell responses) were evaluated during 48 weeks.At week 48, based on a mixed model, no statistically significant difference in HIV-1 VL change from baseline was demonstrated between F4/AS01(B)_2 and control group (0.073 log(10)copies/mL [97.5% confidence interval (CI): -0.088; 0.235]), or F4/AS01(B)_3 and control group (-0.096 log(10)copies/mL [97.5% CI: -0.257; 0.065]). No differences between groups were observed in HIV-1 VL change, CD4(+) T-cell count, ART initiation, or HIV-related clinical events at intermediate timepoints. Among F4/AS01(B) recipients, the most frequent solicited symptoms were pain at injection site (252/300 doses), fatigue (137/300 doses), myalgia (105/300 doses), and headache (90/300 doses). Twelve serious adverse events were reported in 6 participants; 1 was considered vaccine-related (F4/AS01(B)_2 group: angioedema). F4/AS01(B) induced polyfunctional F4-specific CD4(+) T-cells, but had no significant impact on F4-specific CD8(+) T-cell and anti-F4 antibody levels.F4/AS01(B) had a clinically acceptable safety profile, induced F4-specific CD4(+) T-cell responses, but did not reduce HIV-1 VL, impact CD4(+) T-cells count, delay ART initiation, or prevent HIV-1 related clinical events.

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VIH (Virus), Vacunes

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HIV (Viruses), Vaccines

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Articles publicats en revistes (Institut d'lnvestigació Biomèdica de Bellvitge (IDIBELL))

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DINGES, Warren, GIRARD, Pierre-marie, PODZAMCZER PALTER, Daniel, BROCKMEYER, Norbert h., GARCÍA, Felipe, HARRER, Thomas, LELIEVRE, Jean-daniel, FRANK, Ian, COLIN DE VERDIERE, Nathalie, YENI, Guy-patrick, ORTEGA GONZALEZ, Enrique, RUBIO, Rafael, CLOTET, Bonaventura, DEJESUS, Edwin, PÉREZ ELÍAS, María jesús, LAUNAY, Odile, PIALOUX, Gilles, SLIM, Jihad, WEISS, Laurence, BOUCHAUD, Olivier, FELIZARTA, Franco, MEURER, Anja, RAFFI, François, ESSER, Stefan, KATLAMA, Christine, KOLETAR, Susan l., MOUNZER, Karam, SWINDELLS, Susan, BAXTER, John, SCHNEIDER, Stefan, CHAS, Julie, MOLINA, Jean-michel, KOUTSOUKOS, Marguerite, COLLARD, Alix, BOURGUIGNON, Patricia, ROMAN, François. The F4/AS01B HIV-1 Vaccine Candidate Is Safe and Immunogenic, But Does Not Show Viral Efficacy in Antiretroviral Therapy-Naive, HIV-1-Infected Adults: A Randomized Controlled Trial. _Medicine_. 2016. Vol. 95, núm. 6. [consulta: 25 de febrer de 2026]. [Disponible a: https://hdl.handle.net/2445/126890]

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