Ignite Creation Date:
2024-05-05 @ 11:46 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00121758
Status:
COMPLETED
Last Update Posted:
2008-06-06
First Post:
2005-07-18
Brief Title:
AIDS Vaccine Study Comparing Immunogenicity and Safety of 3 Doses of Lipopeptides Versus Placebo in Non Infected HIV 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:
Randomised Double Blinded Phase II AIDS Vaccine Study Comparing Immunogenicity and Safety of 3 Doses of Lipopeptide LIPO-5 Versus Placebo in Non Infected HIV Volunteers ANRS VAC 18
Status:
COMPLETED
Status Verified Date:
2008-06
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:
This study will test the safety and immune response to an experimental HIV vaccine LIPO-5 in healthy volunteers LIPO-5 contains 5 lipopeptides from gag nef and pol corresponding to more than 50 epitopes LIPO-5 has been shown to be immunogenic and well tolerated in a first phase I trial in non-HIV infected volunteers Lower doses of each peptide could have a similar immunogenicity
Detailed Description:
The aims of HIV lipopeptide vaccination approach are to improve cell mediated immune responses in order to obtain strong long lasting and polyepitopic responses and to focus these responses on highly conserved and immunogenic epitopes
Lipopeptides are chemically synthetized peptides bearing HIV epitopes covalently bound to a fatty acid moiety a monopalmtoyl chain in this case This lipid chain produces internalization of the lipopeptide into the cytoplasm of the antigen presenting cells Combinations of several lipopeptides containing sequences from different HIV proteins are used in vaccination trials in order to increase polyepitopic responses Lipopeptides have been synthetized by the French National Agency for Research on AIDS and Viral Hepatitis ANRS preventive program by the group of Helen Gras following a long and meticulous work of epitope screening performed by the team of Jean-Gérard Guillet at the Cochin Institute in Paris The epitopes were selected on the basis of their strong affinity for HLA class I molecule on their ability to form a stable complex with these molecules and on the capacity of these epitopes to be recognized by T cells The selected peptides are those containing the richest array of epitopes and those most frequently recognized by HIV infected patients Each peptide has a length of 23 to 32 amino acids AA
Different types of lipopeptides constructs have been tested in humans Among these constructs LIPO-5 contains 5 lipopeptides from gag nef and pol corresponding to more than 50 epitopes LIPO-5 has been shown to be immunogenic and well tolerated in a first phase I trial in non-HIV infected volunteers Lower doses of each peptide could have a similar immunogenicity
Lipopeptides are chemically synthetized peptides bearing HIV epitopes covalently bound to a fatty acid moiety a monopalmtoyl chain in this case This lipid chain produces internalization of the lipopeptide into the cytoplasm of the antigen presenting cells Combinations of several lipopeptides containing sequences from different HIV proteins are used in vaccination trials in order to increase polyepitopic responses Lipopeptides have been synthetized by the French National Agency for Research on AIDS and Viral Hepatitis ANRS preventive program by the group of Helen Gras following a long and meticulous work of epitope screening performed by the team of Jean-Gérard Guillet at the Cochin Institute in Paris The epitopes were selected on the basis of their strong affinity for HLA class I molecule on their ability to form a stable complex with these molecules and on the capacity of these epitopes to be recognized by T cells The selected peptides are those containing the richest array of epitopes and those most frequently recognized by HIV infected patients Each peptide has a length of 23 to 32 amino acids AA
Different types of lipopeptides constructs have been tested in humans Among these constructs LIPO-5 contains 5 lipopeptides from gag nef and pol corresponding to more than 50 epitopes LIPO-5 has been shown to be immunogenic and well tolerated in a first phase I trial in non-HIV infected volunteers Lower doses of each peptide could have a similar immunogenicity
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| ANRS VAC18 | None | None | None |