Ignite Creation Date:
2024-05-05 @ 11:46 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00122564
Status:
TERMINATED
Last Update Posted:
2005-11-11
First Post:
2005-07-19
Brief Title:
Study of HIV-1 Rgp-160 Administered by Mucosal Routes in Healthy Volunteers
Sponsor:
French National Agency for Research on AIDS and Viral Hepatitis
Organization:
French National Agency for Research on AIDS and Viral Hepatitis
Study Overview
Official Title:
Phase I Study Evaluating the Systemic and Mucosal Safety and Immunogenicity of a Recombinant HIV-1 Gp 160 MNLAI Administered by Transmucosal Nasal or Vaginal Routes Alone or Formulated With DC-Chol in HIV Negative Volunteers ANRS VAC14
Status:
TERMINATED
Status Verified Date:
2005-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed Description:
Its 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None