A Randomized Placebo-Controlled Efficacy Study of a Prime Boost Therapeutic Vaccination Strategy in HIV-1-Infected Individuals: VRI02 ANRS 149 LIGHT Phase II Trial

Author:

Lévy Y.1234ORCID,Lacabaratz C.123,Lhomme E.156,Wiedemann A.123,Bauduin C.7,Fenwick C.18ORCID,Foucat E.123,Surenaud M.123,Guillaumat L.123,Boilet V.7,Rieux V.9,Bouchaud O.10,Girard P.-M.11,Molina J.-M.12,Morlat P.13,Hocqueloux L.14,Richert L.156,Pantaleo G.18ORCID,Lelièvre J. D.1234,Thiébaut, R.156

Affiliation:

1. Vaccine Research Institute-VRI, Hôpital Henri Mondor, Créteil, France

2. INSERM, Unité U955, Créteil, France

3. Université Paris-Est, Faculté de Médecine, UMR-S 955, Créteil, France

4. Assistance Publique-Hôpitaux de Paris (AP-HP), Groupe Henri-Mondor Albert-Chenevier, Service d’Immunologie clinique, Créteil, France

5. University of Bordeaux, Department of Public Health, Inserm Bordeaux Population Health Research Centre, Inria SISTM, Bordeaux, France

6. Pôle de Santé Publique, CHU de Bordeaux, Bordeaux, France

7. University of Bordeaux, ISPED, Inserm, Population Health Research Center, Team MORPH3EUS, UMR 1219, CIC-EC 1401, Bordeaux, France

8. Division of Immunology and Allergy, Department of Medicine, Centre Hospitalier Universitaire Vaudois and University of Lausanne, Lausanne, Switzerland

9. Inserm-ANRS, Vaccine Research Office, Paris, France

10. Hôpital Avicenne, AP-HP, Université Paris 13, Bobigny, France

11. Hôpital Saint Antoine, AP-HP, INSERM UMR S_1136, Paris, France

12. Hôpital Saint-Louis, AP-HP, Université Paris Diderot INSERM U941, Paris, France

13. CHU de Bordeaux, Bordeaux, France

14. CHR d’Orléans, La Source, France

Abstract

In this placebo-controlled phase II randomized clinical trial, we evaluated the safety and immunogenicity of a therapeutic prime-boost vaccine strategy using a recombinant DNA vaccine (GTU-MultiHIV B clade) followed by a boost vaccination with a lipopeptide vaccine (HIV-LIPO-5) in HIV-infected patients on combined antiretroviral therapy. We show here that this prime-boost strategy is well tolerated, consistently with previous studies in HIV-1-infected individuals and healthy volunteers who received each vaccine component individually.

Funder

Vaccine Research Institute, Investissement d'Avenir program managed by the ANR, France

Agence Nationale de Recherches sur le Sida et les Hépatites Virales

Publisher

American Society for Microbiology

Subject

Virology,Insect Science,Immunology,Microbiology

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