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

Dinges W, Girard PM, Podzamczer D, Brockmeyer NH, Garcia F, Harrer T, Lelievre JD, Frank I, De Verdiere NC, Yeni GP, Ortega Gonzalez E, Rubio R, Clotet Sala B, Dejesus E, Jesus Perez-Elias M, Launay O, Pialoux G, Slim J, Weiss L, Bouchaud O, Felizarta F, Meurer A, Raffi F, Esser S, Katlama C, Koletar SL, Mounzer K, Swindells S, Baxter JD, Schneider S, Chas J, Molina JM, Koutsoukos M, Collard A, Bourguignon P, Roman F (2016)

Publication Type: Journal article

Publication year: 2016

Journal

Book Volume: 95

Pages Range: e2673

Journal Issue: 6

DOI: 10.1097/MD.0000000000002673

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, 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/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, CD4 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 CD4 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 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.

Authors with CRIS profile

Involved external institutions

Seattle Infectious Disease Clinic United States (USA) (US) GlaxoSmithKline (GSK) Belgium (BE) Avicenne Hospital / Hôpital Avicienne France (FR) Georges Pompidou European Hospital / Hôpital Européen Georges-Pompidou (HEGP) France (FR) St. Michael's Hospital Canada (CA) Assistance Publique-Hôpitaux de Paris (AP-HP) France (FR) University of Paris 5 - René Descartes / Université Paris V René Descartes France (FR) Hospital Universitario Ramón y Cajal Spain (ES) Orlando Immunology Center (OIC) United States (USA) (US) Hospital Universitari Germans Trias i Pujol Spain (ES) Hospital Universitario 12 de Octubre Spain (ES) Hospital Universitario y Politécnico de La Fe Spain (ES) Hôpital Bichat-Claude-Bernard (CHU, APHP) France (FR) University of Paris 7 - Denis Diderot / Université Paris VII Denis Diderot France (FR) University of Pennsylvania United States (USA) (US) Centre hospitalier universitaire Henri-Mondor (CHU Henri-Mondor) France (FR) Universitat de Barcelona (UB) / University of Barcelona Spain (ES) Ruhr-Universität Bochum (RUB) Germany (DE) Bellvitge University Hospital / Hospital Universitari de Bellvitge Spain (ES) Hôpital Saint-Antoine France (FR) Living Hope Clinical Foundation United States (USA) (US) Rowan University United States (USA) (US) University of Nebraska Medical Center (UNMC) United States (USA) (US) Philadelphia FIGHT United States (USA) (US) Ohio State University United States (USA) (US) Universitätsklinikum Essen Germany (DE) Club des directeurs Marketing & Communication de l'IT (CMIT) France (FR)

How to cite

APA:

Dinges, W., Girard, P.-M., Podzamczer, D., Brockmeyer, N.H., Garcia, F., Harrer, T.,... 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, 95(6), e2673. https://doi.org/10.1097/MD.0000000000002673

MLA:

Dinges, Warren, et al. "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 95.6 (2016): e2673.

BibTeX: Download