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

French National Agency for Research on AIDS and Viral Hepatitis

Status and phase

Terminated

Phase 1

Conditions

HIV Infections

Treatments

Biological: DC-Chol

Biological: HIV-1 gp 160

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00122564

ANRS VAC14

Details and patient eligibility

About

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.

Full description

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).

Sex

Female

Ages

21 to 50 years old

Volunteers

Accepts Healthy Volunteers

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