HIV Infections Clinical Trial
Official title:
Randomised Double Blinded Phase II AIDS Vaccine Study Comparing Immunogenicity and Safety of 3 Doses of Lipopeptide (LIPO-5) Versus Placebo in Non Infected HIV Volunteers (ANRS VAC 18)
This study will test the safety and immune response to an experimental HIV vaccine, LIPO-5, in healthy volunteers. LIPO-5 contains 5 lipopeptides from gag, nef and pol corresponding to more than 50 epitopes. LIPO-5 has been shown to be immunogenic and well tolerated in a first phase I trial in non-HIV infected volunteers. Lower doses of each peptide could have a similar immunogenicity.
The aims of HIV lipopeptide vaccination approach are to improve cell mediated immune
responses in order to obtain strong, long lasting and polyepitopic responses and to focus
these responses on highly conserved and immunogenic epitopes.
Lipopeptides are chemically synthetized peptides, bearing HIV epitopes, covalently bound to
a fatty acid moiety, a monopalmtoyl chain in this case. This lipid chain produces
internalization of the lipopeptide into the cytoplasm of the antigen presenting cells.
Combinations of several lipopeptides containing sequences from different HIV proteins are
used in vaccination trials in order to increase polyepitopic responses. Lipopeptides have
been synthetized by the French National Agency for Research on AIDS and Viral Hepatitis
(ANRS) preventive program by the group of Helen Gras following a long and meticulous work of
epitope screening performed by the team of Jean-Gérard Guillet at the Cochin Institute in
Paris. The epitopes were selected on the basis of their strong affinity for HLA class I
molecule, on their ability to form a stable complex with these molecules, and on the
capacity of these epitopes to be recognized by T cells. The selected peptides are those
containing the richest array of epitopes and those most frequently recognized by HIV
infected patients. Each peptide has a length of 23 to 32 amino acids (AA).
Different types of lipopeptides constructs have been tested in humans. Among these
constructs, LIPO-5 contains 5 lipopeptides from gag, nef and pol corresponding to more than
50 epitopes. LIPO-5 has been shown to be immunogenic and well tolerated in a first phase I
trial in non-HIV infected volunteers. Lower doses of each peptide could have a similar
immunogenicity.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention
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