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

Warren Dinges, Pierre Marie Girard, Daniel Podzamczer, Norbert H. Brockmeyer, Felipe García, Thomas Harrer, Jean Daniel Lelievre, Ian Frank, Nathalie Colin De Verdière, Guy Patrick Yeni, Enrique Ortega Gonzalez, Rafael Rubio, Bonaventura Clotet Sala, Edwin DeJesus, Maria Jesus Pérez-Elias, Odile Launay, Gilles Pialoux, Jihad Slim, Laurence Weiss, Olivier BouchaudFranco Felizarta, Anja Meurer, François Raffi, Stefan Esser, Christine Katlama, Susan L. Koletar, Karam Mounzer, Susan Swindells, John D. Baxter, Stefan Schneider, Julie Chas, Jean Michel Molina, Marguerite Koutsoukos, Alix Collard, Patricia Bourguignon, François Roman

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6 Scopus citations

Abstract

The impact of the investigational human immunodeficiency virus type 1 (HIV-1) F4/AS01B 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/AS01B-2 group, N=64) or 3 (F4/ AS01B-3 group, N=62) doses of F4/AS01B or placebo (control group, N=64) at weeks 0, 4, and 28. Efficacy (HIV-1 VL, CD8+ 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/AS01B-2 and control group (0.073 log10 copies/mL [97.5% confidence interval (CI):-0.088; 0.235]), or F4/AS01B-3 and control group (-0.096 log10 copies/mL [97.5% CI:-0.257; 0.065]). No differences between groups were observed in HIV-1 VL change, CD8+ T-cell count, ART initiation, or HIV-related clinical events at intermediate timepoints. Among F4/AS01B 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/ AS01B-2 group: Angioedema). F4/AS01B induced polyfunctional F4-specific CD8+ T-cells, but had no significant impact on F4-specific CD8+ T-cell and anti-F4 antibody levels. F4/AS01B had a clinically acceptable safety profile, induced F4-specific CD8+ T-cell responses, but did not reduce HIV-1 VL, impact CD8+ T-cells count, delay ART initiation, or prevent HIV-1 related clinical events.

Original languageEnglish (US)
Article numbere2673
JournalMedicine (United States)
Volume95
Issue number6
DOIs
StatePublished - Feb 1 2016

ASJC Scopus subject areas

  • Medicine(all)

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    Dinges, W., Girard, P. M., Podzamczer, D., Brockmeyer, N. H., García, F., Harrer, T., Lelievre, J. D., Frank, I., De Verdière, N. C., Yeni, G. P., Gonzalez, E. O., Rubio, R., Sala, B. C., DeJesus, E., Pérez-Elias, M. J., Launay, O., Pialoux, G., Slim, J., Weiss, L., ... Roman, F. (2016). 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 (United States), 95(6), [e2673]. https://doi.org/10.1097/MD.0000000000002673