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Medicine (Baltimore). 2016 Feb;95(6):e2673. doi: 10.1097/MD.0000000000002673.

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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From the Seattle Travel and Preventive Medicine, Seattle Infectious Disease Clinic, Seattle, WA, USA (WD); Service des Maladies Infectieuses, Hôpital Saint Antoine, Assistance Publique Hôpitaux de Paris; and INSERM, UMR_S 1136, Institut Pierre Louis d'Epidémiologie et de Santé Publique, Paris, France (P-MG); HIV Unit, Infectious Disease Service, Hospital Universitari de Bellvitge, L'Hospitalet, 08907 Barcelona, Spain (DP); Department of Dermatology, Venerology, and Allergology, St. Josef-Hospital, Ruhr-Universität Bochum, Bochum, Germany (NHB); Hospital Clínic, IDIBAPS, University of Barcelona, Barcelona, Spain (FG); Department of Internal Medicine 3, Universitätsklinikum Erlangen, Friedrich-Alexander-University Erlangen-Nuremberg, Germany (TH); Service d'Immunologie Clinique, Hôpital Henri Mondor, Créteil, France (J-DL); University of Pennsylvania, Philadelphia, PA, USA (IF); Service des Maladies Infectieuses et Tropicales, Hôpital Saint Louis, University of Paris Diderot Paris 7, Sorbonne Paris Cité and INSERM U941 (NCDV, J-MM); Hôpital Bichat Claude Bernard, Service des Maladies Infectieuses et Tropicales A, Paris, France (G-PY); Servicio de Enfermedades Infecciosas, Hospital General Universitario de Valencia, Valencia (EOG); Servicio de Enfermedades Infecciosas, Hospital 12 De Octubre, Madrid, Spain (RR); IrsiCaixa AIDS Research Institute, Hospital Germans Trias i Pujol, Uvic-UCC, Barcelona, Spain (BCS); Orlando Immunology Center, Orlando, FL, USA (EDS); Servicio de Enfermedades Infecciosas, Hospital Ramón Y Cajal, IRYCIS Madrid, Spain (MJPE); Université Paris Descartes, Sorbonne Paris Cité, Inserm, CIC 1417 and F-CRIN, Innovative Clinical Research Network in Vaccinology (I-REIVAC); and Assistance Publique Hôpitaux de Paris, Hôpital Cochin (OL); Maladies Infectieuses et Tropicales Co-infections, Hôpital Tenon, Paris, France (GP, JC); Saint Michael's Medical Center, Newark, NJ, USA (JS); Service d'immunologie Clinique, Hôpital Européen Georges


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.

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