Ignite Creation Date:
2024-05-05 @ 11:45 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00121121
Status:
COMPLETED
Last Update Posted:
2007-03-15
First Post:
2005-07-13
Brief Title:
Safety of Intradermal Versus Intramuscular Administration of HIV Lipopeptides in HIV Uninfected Adult 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:
A Phase Ib Vaccine Trial Evaluating the Safety and Immunogenicity of HIV Lipopeptides by Two Administration Routes Intramuscular And Intradermal in Healthy Adult Volunteers ANRS VAC16 Trial
Status:
COMPLETED
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:
Intramuscular IM administration of HIV lipopeptide vaccines have been shown to be able to induce HIV-1-specific T cell-mediated immune responses The objective of this trial was to evaluate the safety and immunogenicity of LIPO-4 vaccine HIV lipopeptides including 4 peptides from Gag Pol RT and Nef HIV-1 proteins each peptide linked to TT intradermally ID compared to IM administration
Detailed Description:
Dose-sparing strategies that use intradermal ID delivery of vaccines may be one approach for improving a vaccines immunogenicity and reducing the cost of vaccines
In this study 68 HIV-negative healthy adult volunteers 21-55 years old all belonging to the Volunteers for a Vaccine network set up by ANRS were randomized to receive at weeks 0 4 and 12 either 3 IM doses of 05 ml of LIPO-4 containing 500 µg of each peptide n 35 volunteers or 3 ID doses of 01 ml containing 100 µg of each peptide n33 volunteers Total follow-up was 48 weeks Safety was assessed clinically and by laboratory tests Participants were given diary cards to record adverse events HIV-1 immune responses were assessed by ELISPOT and lymphoproliferative assay at weeks 0 2 6 14 24 and 48
In this study 68 HIV-negative healthy adult volunteers 21-55 years old all belonging to the Volunteers for a Vaccine network set up by ANRS were randomized to receive at weeks 0 4 and 12 either 3 IM doses of 05 ml of LIPO-4 containing 500 µg of each peptide n 35 volunteers or 3 ID doses of 01 ml containing 100 µg of each peptide n33 volunteers Total follow-up was 48 weeks Safety was assessed clinically and by laboratory tests Participants were given diary cards to record adverse events HIV-1 immune responses were assessed by ELISPOT and lymphoproliferative assay at weeks 0 2 6 14 24 and 48
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