NCT00121121

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P75+ for phase_1 hiv-infections

Timeline
Completed

Started Jul 2004

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2004

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

July 13, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 21, 2005

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2005

Completed
Last Updated

March 15, 2007

Status Verified

November 1, 2005

First QC Date

July 13, 2005

Last Update Submit

March 14, 2007

Conditions

HIV InfectionsHIV Seronegativity

Keywords

HIV VaccinesHIV Seronegativity

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Comparaison of CD4 positive cells responses using

  • lymphoprolifĂ©ration 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

Interventions

Lipopeptides LIPO-4BIOLOGICAL

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hopital Cochin Centre Cochin-Pasteur d'Essais vaccinaux

Paris, 75014, France

Location

Related Publications (1)

  • Launay O, Durier C, Desaint C, Silbermann B, Jackson A, Pialoux G, Bonnet B, Poizot-Martin I, Gonzalez-Canali G, Cuzin L, Figuereido S, Surenaud M, Ben Hamouda N, Gahery H, Choppin J, Salmon D, Guerin C, Bourgault Villada I, Guillet JG; ANRS VAC16 Study Group. Cellular immune responses induced with dose-sparing intradermal administration of HIV vaccine to HIV-uninfected volunteers in the ANRS VAC16 trial. PLoS One. 2007 Aug 22;2(8):e725. doi: 10.1371/journal.pone.0000725.

    PMID: 17712402DERIVED

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Odile Launay, MD

    Hopital Cochin Paris, Centre Cochin-Pasteur d'essais vaccinaux

    PRINCIPAL INVESTIGATOR

  • Christine Durier, MD

    Inserm SC10

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

July 13, 2005

First Posted

July 21, 2005

Study Start

July 1, 2004

Study Completion

December 1, 2005

Last Updated

March 15, 2007

Record last verified: 2005-11

Locations

FR(1)