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¹ Division of Immunology and Allergy, Department of Medicine, Centre Hospitalier Universitaire Vaudois, University of Lausanne, 1011 Lausanne, Switzerland
² MRC Clinical Trials Unit, London NW1 2DA, UK
³ Imperial College, St. Mary's Hospital, London SW7 2AZ, UK
⁴ Institut de Virologie, Université Louis Pasteur, F-67070 Strasbourg, France
⁵ Department of Microbiology, Tumor and Cell Biology, Karolinska Institutet, 171 77 Stockholm, Sweden
⁶ Institute of Medical Microbiology, University of Regensburg, 93053 Regensburg, Germany
⁷ Department of Molecular and Cellular Biology, Centro Nacional de Biotecnología, CSIC, 28049 Madrid, Spain
⁸ Department of Virology, BPRC, 2280 GH Rijswijk, Netherlands
⁹ University of Cambridge, Cambridge CB2 1TN, UK
¹⁰ sanofi pasteur, 69367 Lyon, France
¹¹ sanofi pasteur, Toronto, Ontario M2R 3T4, Canada

CORRESPONDENCE Giuseppe Pantaleo: giuseppe.pantaleo{at}chuv.ch

The EuroVacc 02 phase I trial has evaluated the safety and immunogenicity of a prime-boost regimen comprising recombinant DNA and the poxvirus vector NYVAC, both expressing a common immunogen consisting of Env, Gag, Pol, and Nef polypeptide domain from human immunodeficiency virus (HIV)-1 clade C isolate, CN54. 40 volunteers were randomized to receive DNA C or nothing on day 0 and at week 4, followed by NYVAC C at weeks 20 and 24. The primary immunogenicity endpoints were measured at weeks 26 and 28 by the quantification of T cell responses using the interferon enzyme-linked immunospot assay. Our results indicate that the DNA C plus NYVAC C vaccine regimen was highly immunogenic, as indicated by the detection of T cell responses in 90% of vaccinees and was superior to responses induced by NYVAC C alone (33% of responders). The vaccine-induced T cell responses were (a) vigorous in the case of the env response (mean 480 spot-forming units/10⁶ mononuclear cells at weeks 26/28), (b) polyfunctional for both CD4 and CD8 T cell responses, (c) broad (the average number of epitopes was 4.2 per responder), and (d) durable (T cell responses were present in 70% of vaccinees at week 72). The vaccine-induced T cell responses were strongest and most frequently directed against Env (91% of vaccines), but smaller responses against Gag-Pol-Nef were also observed in 48% of vaccinees. These results support the development of the poxvirus platform in the HIV vaccine field and the further clinical development of the DNA C plus NYVAC C vaccine regimen.

A. Harari and P.-A. Bart equally contributed this work.

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