AIDS Vaccine Study Comparing Immunogenicity and Safety of 3 Doses of Lipopeptides Versus Placebo in Non Infected HIV Volunteers

French National Agency for Research on AIDS and Viral Hepatitis

Status and phase

Completed

Phase 2

Conditions

HIV Infections

Treatments

Biological: LIPO-5

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00121758

2004-000233-10

ANRS VAC18

Details and patient eligibility

About

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.

Full description

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.

Enrollment

156 estimated patients

Sex

All

Ages

21 to 55 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Healthy volunteers selected by ANRS (French National Agency for Research on AIDS and Viral Hepatitis)
For woman of child-bearing age: use of effective contraception
Ability to sign informed consent
Beneficiary subjects of social security regimen-- Hepatitis B, hepatitis C, HIV, HTLV1 infection and syphilis negative
Hemoglobin over 12.5 g/dl for women and over 13.5 g/dl for men

Exclusion criteria

Previous participation in an HIV clinical trial
Volunteers with risk to contract HIV infection during the trial
Previous vaccination in the last month, and volunteers requiring vaccination during the trial
Gift of blood in the last 2 months
Eczema, urticaria
Medical history of food allergy, Lyell or Stevens Johnson syndrome and aggravated asthma
Previous (last 6 months) or ongoing administration of immunological treatment, chemotherapy, radiotherapy or corticosteroid
Medical history of autoimmune disease
Clinical or biological aftermath of previous disease
Medical history of uveitis
Transfusion in the last 6 months