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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-06-30

Study Completion Date

2005-04-30

Brief Summary

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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.

Detailed Description

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It's probable that a mucosal approach is necessary for prophylactic HIV vaccine protecting against sexually transmitted infection. Although mucosal immune responses have been almost non-existent in trials of HIV vaccine candidates in which the antigen was delivered systematically.

Several animal models have also demonstrated the importance or a mucosal IgA response for protection against viral infections. Mucosal S IgA are essential effectors having different mechanisms of action agglutination of pathogens, interaction with cellular receptor, transcytosis of immune complexes, intracellular clearance of virus.

Gp 160 induces the majority of neutralizing Abs activity in patients serum and the immunogenicity of gp 160 can be improved by using and adjuvant such as DC-chol because of its properties to increase the permeation of the nasal epithelium and to facilitate systemic delivery of the vaccine antigen.

Before beginning mucosal vaccine trial, we previously tested and validated procedures to collect and process secretion fluids on 6 HIV-1 infected women (K. Petitprez et al, 4th European mucosal immunology group meeting, Lyon France, 8-10 october 2004).

Conditions

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HIV Infections

Keywords

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HIV Vaccines HIV Seronegativity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Interventions

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HIV-1 gp 160

Intervention Type BIOLOGICAL

DC-Chol

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* Pregnancy

Minimum Eligible Age

21 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Principal Investigators

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Gilles Pialoux, MD

Role: PRINCIPAL_INVESTIGATOR

Hopital Tenon Paris

Locations

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Hopital Tenon

Paris, , France

Site Status

Countries

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France

Other Identifiers

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ANRS VAC14

Identifier Type: -

Identifier Source: org_study_id