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

This study has been completed.
Sponsor:
Collaborator:
Aventis Pharmaceuticals
Information provided by:
French National Agency for Research on AIDS and Viral Hepatitis
ClinicalTrials.gov Identifier:
NCT00121758
First received: July 18, 2005
Last updated: June 5, 2008
Last verified: June 2008
  Purpose

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.


Condition Intervention Phase
HIV Infections
Biological: LIPO-5
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
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)

Resource links provided by NLM:


Further study details as provided by French National Agency for Research on AIDS and Viral Hepatitis:

Primary Outcome Measures:
  • Percentage of patients with CD8 immune response on ELISPOT IFN-gamma at week (W) 48

Secondary Outcome Measures:
  • Local and general adverse events
  • Percentage of subjects with CD4 immune response against different peptides of LIPO-5
  • Percentage of subjects with sustained response at week 48
  • Percentage of subjects with response against more than 1 peptide (multiepitopic response)

Estimated Enrollment: 156
Study Start Date: September 2004
Study Completion Date: December 2007
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
Detailed 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.

  Eligibility

Ages Eligible for Study:   21 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00121758

Locations
France
CIC de Vaccinologie Cochin Pasteur
Paris, France, 75014
Sponsors and Collaborators
French National Agency for Research on AIDS and Viral Hepatitis
Aventis Pharmaceuticals
Investigators
Principal Investigator: Dominique Salmon, MD Hopital Cochin Paris. Centre des essais vaccinaux Cochin Pasteur
Study Chair: Christine Durier Inserm SC10
  More Information

No publications provided by French National Agency for Research on AIDS and Viral Hepatitis

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00121758     History of Changes
Other Study ID Numbers: 2004-000233-10, ANRS VAC18
Study First Received: July 18, 2005
Last Updated: June 5, 2008
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by French National Agency for Research on AIDS and Viral Hepatitis:
HIV Vaccines
HIV Seronegativity

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases

ClinicalTrials.gov processed this record on September 30, 2014