NCT00122564

Brief Summary

It is probable that a mucosal approach is necessary for a prophylactic HIV vaccine protecting against sexually transmitted infection. Mucosal immune responses have been almost non-existent in trials of HIV vaccine candidates in which the antigen was delivered systemically. This study will test the safety and immune response of a recombinant HIV-1gp160 by nasal and mucosal routes alone or formulated with DC-Chol in healthy volunteers.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
36

participants targeted

Target at P50-P75 for phase_1 hiv-infections

Timeline
Completed

Started Jun 2003

Geographic Reach
1 country

1 active site

Status
terminated

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2003

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2005

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 19, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 22, 2005

Completed
Last Updated

November 11, 2005

Status Verified

November 1, 2005

First QC Date

July 19, 2005

Last Update Submit

November 10, 2005

Conditions

HIV Infections

Keywords

HIV VaccinesHIV Seronegativity

Outcome Measures

Primary Outcomes (1)

  • Systemic and mucosal safety evaluated by 3 independent physicians at week 0, 4, 6 and 48 and 2 days after each mucosal administration

Secondary Outcomes (1)

  • Immune response by ELISA for anti-gp 160 IgA or IgG and by functional in vitro assay

Interventions

HIV-1 gp 160BIOLOGICAL
DC-CholBIOLOGICAL

Eligibility Criteria

Age21 Years - 50 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Women chosen in a uniform selection process specifically designed by the ANRS (French National Agency for Research on AIDS and Viral Hepatitis)
  • For women of child-bearing age : use of effective contraception
  • Normal clinical status
  • Ability to accept collection of secretion fluids;
  • Ability to sign informed consent

You may not qualify if:

  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hopital Tenon

Paris, 75012, France

Location

MeSH Terms

Conditions

HIV Infections

Interventions

3-(N-(N',N'-dimethylaminoethane)carbamoyl)cholesterol

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

  • Gilles Pialoux, MD

    Hopital Tenon Paris

    PRINCIPAL INVESTIGATOR

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 19, 2005

First Posted

July 22, 2005

Study Start

June 1, 2003

Study Completion

April 1, 2005

Last Updated

November 11, 2005

Record last verified: 2005-11

Locations

FR(1)