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Immunogenicity and safety of an HIV-1 lipopeptide vaccine in healthy adults: a phase 2 placebo-controlled ANRS trial

Salmon-Céron, Dominiquea,*; Durier, Christineb,*; Desaint, Corinnec; Cuzin, Lised; Surenaud, Mathieue; Hamouda, Nadine Bene; Lelièvre, Jean-Danielf; Bonnet, Bénédicteg; Pialoux, Gillesh; Poizot-Martin, Isabellei; Aboulker, Jean-Pierreb; Lévy, Yvesf; Launay, Odilea,c for the ANRS VAC18 trial group

doi: 10.1097/QAD.0b013e32833ce566
Clinical Science

Background: French National Agency for Research on AIDS and Viral Hepatitis's HIV-LIPO-5 vaccine includes five HIV-1 peptides, containing multiple CD8+ and CD4+ T-cell epitopes and coupled to a palmitoyl tail. Whether HIV-LIPO-5 immunogenicity varies with the dose is unknown.

Methods: HIV-negative volunteers were randomized to receive HIV-LIPO-5 vaccine at 50 μg/lipopeptide (N = 32), 150 μg/lipopeptide (N = 32), 500 μg/lipopeptide (N = 33) or placebo (N = 34) at weeks 0, 4, 12 and 24. HIV-1-specific CD8+ (interferon-γ ELISpot on peripheral blood mononuclear cells cultured for 12 days) and CD4+ responses (peripheral blood mononuclear cell lymphoproliferation) were assessed at baseline, after each injection and at week 48.

Results: Local reactions were dose-dependent but no differences in systemic reactions appeared between groups. Sustained (at least on two separate occasions) CD8+ response rates to at least one given HIV-1 pool were obtained in 22 of 32 (69%), 21 of 33 (64%) and 21 of 34 (62%) individuals for LIPO-5 50, 150 and 500 groups, respectively (P ≤ 0.0001 for all comparisons to the placebo). Cumulative CD4+ response rates were obtained in 15 of 32 (47%), 18 of 33 (55%) and 15 of 34 (44%) individuals (P < 0.0001 for all comparisons to placebo). At week 48, CD8+ responses persisted in 47 of 91 (52%) HIV-LIPO-5 recipients.

Conclusion: Doses of 50, 150 and 500 μg of French National Agency for Research on AIDS and Viral Hepatitis's HIV-LIPO-5 vaccine were able to elicit HIV-specific sustained CD8+ and CD4+ T-cell responses in healthy adults. Safety is good and all doses appear appropriate in further ‘prime-boost’ trials.

aUniversité Paris Descartes, Assistance Publique Hôpitaux de Paris (APHP), Hôpital Cochin, Paris, France

bInserm SC10, Villejuif, France

cCIC de Vaccinologie Cochin-Pasteur, Paris, France

dHôpital Purpan, Toulouse, France

eInstitut Cochin, Université Paris Descartes, CNRS (UMR 8104), Inserm U567, Paris, France

fHôpital Henri Mondor, Université Paris-Est, Créteil, France

gHôpital Hôtel Dieu, Nantes, France

hHôpital Tenon, Paris, France

iHôpital Sainte-Marguerite, Marseille, France

jANRS, Paris, France.

*D.S.-C. and C.D. contributed equally to the writing of this article.

Received 25 March, 2010

Revised 25 May, 2010

Accepted 6 June, 2010

Correspondence to Professor Dominique Salmon-Céron, Infectious Diseases, Internal Medicine Department, APHP, Cochin Hospital, 27 rue du Fbg Saint-Jacques, 75014 Paris, France. E-mail:

© 2010 Lippincott Williams & Wilkins, Inc.