Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000886
Status:
COMPLETED
Last Update Posted:
2021-10-29
First Post:
1999-11-02
Brief Title:
A Phase I Safety and Immunogenicity Trial of HIV-1 gp120 C4-V3 Hybrid Polyvalent Peptide Immunogen Mixed in Mineral Oil Containing Mannose Mono-Oleate IFA
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Phase I Safety and Immunogenicity Trial of HIV-1 gp120 C4-V3 Hybrid Polyvalent Peptide Immunogen Mixed in Mineral Oil Containing Mannose Mono-Oleate IFA
Status:
COMPLETED
Status Verified Date:
2021-10
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:
To evaluate the safety of HIV-1 gp120 C4-V3 hybrid polyvalent peptide immunogen C4-V3 peptides formulated in mineral oil containing mannose mono-oleate IFA in HIV-1 uninfected volunteers To evaluate the humoral and cellular immune responses to the C4-V3 peptides as measured by the induction of 1 or more of the following neutralizing antibodies to HIV-1 MN and RF cross-neutralizing antibodies to primary isolates of HIV-1 HIV-1 antigen-specific lymphoproliferation CD8 and CD4 cytotoxic T lymphocyte CTL activity specific for HIV-1 gp120 or V3 peptides corresponding to the vaccine strains of HIV-1 induction of HLA-B7 and HLA-A2 restricted CD8CTLs and induction of HIV-specific DTH responses
The test immunogen C4-V3 peptides is constructed from 4 sequences of the HIV-1 V3 gp120 loop shared by approximately 80 of North American HIV-1 strains Because of the critical role that this region plays in generating anti-HIV sequences it is hypothesized that the test immunogen C4-V3 peptides will be capable of inducing a broad range of cross-reactive neutralizing antibodies in the majority of recipients
The test immunogen C4-V3 peptides is constructed from 4 sequences of the HIV-1 V3 gp120 loop shared by approximately 80 of North American HIV-1 strains Because of the critical role that this region plays in generating anti-HIV sequences it is hypothesized that the test immunogen C4-V3 peptides will be capable of inducing a broad range of cross-reactive neutralizing antibodies in the majority of recipients
Detailed Description:
The test immunogen C4-V3 peptides is constructed from 4 sequences of the HIV-1 V3 gp120 loop shared by approximately 80 of North American HIV-1 strains Because of the critical role that this region plays in generating anti-HIV sequences it is hypothesized that the test immunogen C4-V3 peptides will be capable of inducing a broad range of cross-reactive neutralizing antibodies in the majority of recipients
Twenty-eight volunteers are randomized to receive two 05 ml injections of C4-43 peptides in IFA or placebo IFA alone administered intramuscularly at 0 1 6 and 12 months At least 50 of all volunteers 6 per Groups I and II 2 Group III must be HLA-B7 phenotype
Twenty-eight volunteers are randomized to receive two 05 ml injections of C4-43 peptides in IFA or placebo IFA alone administered intramuscularly at 0 1 6 and 12 months At least 50 of all volunteers 6 per Groups I and II 2 Group III must be HLA-B7 phenotype
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 |
|---|---|---|---|
| 10570 | REGISTRY | DAIDS ES Registry Number | None |