Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001055
Status:
COMPLETED
Last Update Posted:
2021-11-04
First Post:
1999-11-02
Brief Title:
A Phase I Safety and Immunogenicity Trial of Live Recombinant Canarypox ALVAC-HIV vCP205 in HIV-1 Uninfected Adult Volunteers
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 Live Recombinant Canarypox ALVAC-HIV vCP205 in HIV-1 Uninfected Adult Volunteers
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 and immunogenicity of ALVAC-HIV MN120TMG vCP205 in comparison to ALVAC-RG rabies glycoprotein vCP65 as a control when administered in HIV-1 negative volunteers
ALVAC-HIV vCP205 is a second generation candidate vaccine that can be used to induce a humoral and cellular response against several antigens This recombinant construct is based on the canarypox vector termed ALVAC and expresses gp120 of the HIV MN strain plus the transmembrane portion of the LAI strain as well as gag and protease
ALVAC-HIV vCP205 is a second generation candidate vaccine that can be used to induce a humoral and cellular response against several antigens This recombinant construct is based on the canarypox vector termed ALVAC and expresses gp120 of the HIV MN strain plus the transmembrane portion of the LAI strain as well as gag and protease
Detailed Description:
ALVAC-HIV vCP205 is a second generation candidate vaccine that can be used to induce a humoral and cellular response against several antigens This recombinant construct is based on the canarypox vector termed ALVAC and expresses gp120 of the HIV MN strain plus the transmembrane portion of the LAI strain as well as gag and protease
Volunteers are randomized to receive doses of ALVAC-HIV vCP205 or ALVAC-HIV vCP65 control or both according to varying schedules over 12 months was 6 months amended 111795 with a 12 month follow up AS PER AMENDMENT 52998 One additional follow-up visit is required at 30-36 months
Volunteers are randomized to receive doses of ALVAC-HIV vCP205 or ALVAC-HIV vCP65 control or both according to varying schedules over 12 months was 6 months amended 111795 with a 12 month follow up AS PER AMENDMENT 52998 One additional follow-up visit is required at 30-36 months
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 10572 | REGISTRY | DAIDS ES Registry Number | None |