Study of HIV-1 Rgp-160 Administered by Mucosal Routes in Healthy Volunteers
|ClinicalTrials.gov Identifier: NCT00122564|
Recruitment Status : Terminated
First Posted : July 22, 2005
Last Update Posted : November 11, 2005
|Condition or disease||Intervention/treatment||Phase|
|HIV Infections||Biological: HIV-1 gp 160 Biological: DC-Chol||Phase 1|
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).
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||36 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||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)|
|Study Start Date :||June 2003|
|Study Completion Date :||April 2005|
- Systemic and mucosal safety evaluated by 3 independent physicians at week 0, 4, 6 and 48 and 2 days after each mucosal administration
- Immune response by ELISA for anti-gp 160 IgA or IgG and by functional in vitro assay
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00122564
|Paris, France, 75012|
|Principal Investigator:||Gilles Pialoux, MD||Hopital Tenon Paris|