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Safety of Intradermal Versus Intramuscular Administration of HIV Lipopeptides in HIV Uninfected Adult Volunteers

This study has been completed.
Sponsor:
Information provided by:
French National Agency for Research on AIDS and Viral Hepatitis
ClinicalTrials.gov Identifier:
NCT00121121
First received: July 13, 2005
Last updated: March 14, 2007
Last verified: November 2005
History of Changes
  Purpose

Intramuscular (IM) administration of HIV lipopeptide vaccines have been shown to be able to induce HIV-1-specific T cell-mediated immune responses. The objective of this trial was to evaluate the safety and immunogenicity of LIPO-4 vaccine (HIV lipopeptides including 4 peptides from Gag, Pol, RT and Nef HIV-1 proteins, each peptide linked to TT) intradermally (ID) compared to IM administration.


Condition Intervention Phase
HIV Infections
HIV Seronegativity
 Biological: Lipopeptides LIPO-4
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A Phase Ib Vaccine Trial Evaluating the Safety and Immunogenicity of HIV Lipopeptides by Two Administration Routes (Intramuscular And Intradermal) in Healthy Adult Volunteers. ANRS VAC16 Trial

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

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

Primary Outcome Measures:
  • Clinical and biological safety (over or equal to degree two of a adverse event grading scale) of LIPO-4 by ID and IM routes during the study

Secondary Outcome Measures:
  • Comparaison of CD4 positive cells responses using
  • lymphoprolifération test and CD8 positive cells responses using the capacity of these cells to synthesize IFN following stimulation with peptides of interest (ELISPOT IFN test) following IM or ID administration at weeks 2, 6, 14, 24, and 48

Estimated Enrollment: 70
Study Start Date: July 2004
Estimated Study Completion Date: December 2005
Detailed Description:

Dose-sparing strategies that use intradermal (ID) delivery of vaccines may be one approach for improving a vaccines immunogenicity and reducing the cost of vaccines.

In this study, 68 HIV-negative healthy adult volunteers, 21-55 years old, all belonging to the "Volunteers for a Vaccine" network set up by ANRS, were randomized to receive at weeks 0, 4, and 12, either 3 IM doses of 0.5 ml of LIPO-4 containing 500 µg of each peptide (n= 35 volunteers), or 3 ID doses of 0.1 ml, containing 100 µg of each peptide (n=33 volunteers). Total follow-up was 48 weeks. Safety was assessed clinically and by laboratory tests. Participants were given diary cards to record adverse events. HIV-1 immune responses were assessed by ELISPOT and lymphoproliferative assay at weeks 0, 2, 6, 14, 24, and 48

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • HIV uninfected
  • Acceptable methods of contraception for females of reproductive potential
  • Good general health
  • Signed written inform consent

Exclusion Criteria:

  • Risk to be infected by HIV virus
  • Uveitis, chronic lyme disease, active syphilis, active mycobacterial diseases or sarcoidosis
  • Autoimmune disease or immunodeficiency
  • Medical history of food allergy, Lyell's or Steven Johnson's disease, unstable asthma
  • Active, generalized eczema or chronic urticaria
  • Blood products within 2 months prior to first study vaccine administration
  • HIV vaccines in prior HIV vaccine trial or participation in an immunomodulator study
  • Vaccines within 30 days prior to first study vaccine administration
  • Pregnant
  • Long-term immunosuppressive or immunomodulator medications or within 6 months to first study vaccine administration
  • Blood transfusion within 6 months to first study vaccine administration
  • Treated with extracted pituitary hormones
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00121121

Locations
France
Hopital Cochin Centre Cochin-Pasteur d'Essais vaccinaux
Paris, France, 75014
Sponsors and Collaborators
French National Agency for Research on AIDS and Viral Hepatitis
Investigators
Principal Investigator: Odile Launay, MD Hopital Cochin Paris, Centre Cochin-Pasteur d'essais vaccinaux
Study Director: Christine Durier, MD Inserm SC10
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00121121     History of Changes
Other Study ID Numbers: ANRS VAC16
Study First Received: July 13, 2005
Last Updated: March 14, 2007
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 May 22, 2013