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Study of HIV-1 Rgp-160 Administered by Mucosal Routes in Healthy Volunteers

NCT00122564 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2005-11-11

No results posted yet for this study

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.

Conditions

  • HIV Infections

Interventions

BIOLOGICAL

HIV-1 gp 160

BIOLOGICAL

DC-Chol

Sponsors & Collaborators

  • Aventis Pharmaceuticals

    collaborator INDUSTRY

  • French National Agency for Research on AIDS and Viral Hepatitis

    lead OTHER_GOV

Principal Investigators

  • Gilles Pialoux, MD · Hopital Tenon Paris

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2003-06-30
Completion
2005-04-30

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00122564 on ClinicalTrials.gov