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

This study has been terminated.
Sponsor:
Collaborator:
Aventis Pharmaceuticals
Information provided by:
French National Agency for Research on AIDS and Viral Hepatitis
ClinicalTrials.gov Identifier:
NCT00122564
First received: July 19, 2005
Last updated: November 10, 2005
Last verified: November 2005

July 19, 2005
November 10, 2005
June 2003
Not Provided
Systemic and mucosal safety evaluated by 3 independent physicians at week 0, 4, 6 and 48 and 2 days after each mucosal administration
Systemic and mucosal safety evaluated by 3 independant physicians at week 0,4,6 and 48 and 2 days after each mucosal administration
Complete list of historical versions of study NCT00122564 on ClinicalTrials.gov Archive Site
Immune response by ELISA for anti-gp 160 IgA or IgG and by functional in vitro assay
Immune response by ELISA for anti-gp 160 IgA or IgG and by functional in vitro assay.
Not Provided
Not Provided
 
Study of HIV-1 Rgp-160 Administered by Mucosal Routes in Healthy Volunteers
Phase I Study Evaluating the Systemic and Mucosal Safety and Immunogenicity of a Recombinant HIV-1 Gp 160 (MN/LAI) Administered by Transmucosal (Nasal or Vaginal) Routes, Alone or Formulated With DC-Chol, in HIV Negative Volunteers (ANRS VAC14)

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.

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).

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
HIV Infections
  • Biological: HIV-1 gp 160
  • Biological: DC-Chol
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
36
April 2005
Not Provided

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
Female
21 Years to 50 Years
Yes
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00122564
ANRS VAC14
Not Provided
Not Provided
French National Agency for Research on AIDS and Viral Hepatitis
Aventis Pharmaceuticals
Principal Investigator: Gilles Pialoux, MD Hopital Tenon Paris
French National Agency for Research on AIDS and Viral Hepatitis
November 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP