NCT00121758

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
156

participants targeted

Target at P50-P75 for phase_2 hiv-infections

Timeline
Completed

Started Sep 2004

Typical duration for phase_2 hiv-infections

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

September 1, 2004

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

July 18, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 21, 2005

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2007

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
Last Updated

June 6, 2008

Status Verified

June 1, 2008

Enrollment Period

3.2 years

First QC Date

July 18, 2005

Last Update Submit

June 5, 2008

Conditions

HIV Infections

Keywords

HIV VaccinesHIV Seronegativity

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (4)

  • 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)

Interventions

LIPO-5BIOLOGICAL

Eligibility Criteria

Age21 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CIC de Vaccinologie Cochin Pasteur

Paris, 75014, France

Location

Related Publications (2)

  • Richert L, Hue S, Hocini H, Raimbault M, Lacabaratz C, Surenaud M, Wiedemann A, Tisserand P, Durier C, Salmon D, Lelievre JD, Chene G, Thiebaut R, Levy Y; ANRS Vaccine Network/Vaccine Research Institute. Cytokine and gene transcription profiles of immune responses elicited by HIV lipopeptide vaccine in HIV-negative volunteers. AIDS. 2013 Jun 1;27(9):1421-31. doi: 10.1097/QAD.0b013e32835f5b60.

    PMID: 23759749DERIVED

  • Salmon-Ceron D, Durier C, Desaint C, Cuzin L, Surenaud M, Hamouda NB, Lelievre JD, Bonnet B, Pialoux G, Poizot-Martin I, Aboulker JP, Levy Y, Launay O; ANRS VAC18 trial group. Immunogenicity and safety of an HIV-1 lipopeptide vaccine in healthy adults: a phase 2 placebo-controlled ANRS trial. AIDS. 2010 Sep 10;24(14):2211-23. doi: 10.1097/QAD.0b013e32833ce566.

    PMID: 20625264DERIVED

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

  • Dominique Salmon, MD

    Hopital Cochin Paris. Centre des essais vaccinaux Cochin Pasteur

    PRINCIPAL INVESTIGATOR

  • Christine Durier

    Inserm SC10

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

July 18, 2005

First Posted

July 21, 2005

Study Start

September 1, 2004

Primary Completion

November 1, 2007

Study Completion

December 1, 2007

Last Updated

June 6, 2008

Record last verified: 2008-06

Locations

FR(1)