Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000871
Status:
COMPLETED
Last Update Posted:
2021-11-04
First Post:
1999-11-02
Brief Title:
A Phase II Safety and Immunogenicity Trial of Live Recombinant Canarypox ALVAC-HIV vCP205 With or Without HIV-1 SF-2 RGP120 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 II Safety and Immunogenicity Trial of Live Recombinant Canarypox ALVAC-HIV vCP205 With or Without HIV-1 SF-2 RGP120 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 expand the available data regarding the safety and immunogenicity of 2 HIV-1 vaccine strategies canarypox vector vCP205 or vCP205 with SF-2 rgp120 AS PER AMENDMENT 7298 To obtain immunogenicity and safety data on gp120 subunits that may induce enhanced neutralizing antibody response to primary isolates of HIV-1 in the context of previous immunization with a canarypox vector expressing HIV antigens vCP205 To evaluate cytotoxic T lymphocyte responses at 1 and 2 years after initial vaccination with vCP205 plus rgp120 SF-2 or vCP205 alone In previous ALVAC vCP205SF-2 rgp 120 studies patients have developed antibodies that neutralize homologous laboratory strains over 50 of patients have developed CD8 cytotoxic T-lymphocyte responses to HIV env and gag epitopes at some point in the study This Phase II study seeks to confirm these results among persons at lower or higher risk for HIV infection with a new lot of ALVAC vCP205 at a dose that is suitable for potential large-scale trials AS PER AMENDMENT 7298 Addition of AIDSVAX BB or AIDSVAX BE boosts starting at least 12 months after receiving rgp120 or ALVAC vaccines may induce enhanced neutralizing antibody response as deemed from prior studies and thus is planned as follow-up therapy
Detailed Description:
In previous ALVAC vCP205SF-2 rgp 120 studies patients have developed antibodies that neutralize homologous laboratory strains over 50 of patients have developed CD8 cytotoxic T-lymphocyte responses to HIV env and gag epitopes at some point in the study This Phase II study seeks to confirm these results among persons at lower or higher risk for HIV infection with a new lot of ALVAC vCP205 at a dose that is suitable for potential large-scale trials AS PER AMENDMENT 7298 Addition of AIDSVAX BB or AIDSVAX BE boosts starting at least 12 months after receiving rgp120 or ALVAC vaccines may induce enhanced neutralizing antibody response as deemed from prior studies and thus is planned as follow-up therapy
Volunteers are recruited and screened those who are enrolled are then stratified by their risk status into 2 groups individuals having lower-risk behavior for HIV and individuals having higher-risk behavior for HIV Volunteers are then randomly assigned to arm A B or C and receive immunizations at months 0 1 3 and 6 as follows
Group A- ALVAC vCP205 plus SF-2 rgp120 in MF59 Group B- ALVAC vCP205 plus saline placebo Group C- Placebo-ALVAC plus saline placebo AS PER AMENDMENT 7298 Beginning 12-18 months after initial vaccination then 2 6 and 12 months later 10 volunteers from group A receive saline placebo while 50 volunteers each from groups B and C are rerandomized within their respective groups and are treated as follows
Group B subgroup 1 - AIDSVAX BB Group B subgroup 2 - AIDSVAX BE Group B subgroup 3 - alum placebo Group C subgroup 1 - AIDSVAX BB Group C subgroup 2 - AIDSVAX BE Group C subgroup 3 - alum placebo Volunteers are followed for 2 years and are tested for humoral immune response to HIV-1 Neutralizing activity to HIV-1 is performed on a subset of volunteers monitored for CTL response AS PER AMENDMENT 7298 Volunteers receiving AIDSVAX BB and AIDSVAX BE will additionally be studied for formation of various neutralizing antibodies and parameters of cellular immunity AS PER AMENDMENT 43099 Because the subunit boosts that were added in version 30 are not available the subunit boost portion of version 30 is cancelled
Volunteers are recruited and screened those who are enrolled are then stratified by their risk status into 2 groups individuals having lower-risk behavior for HIV and individuals having higher-risk behavior for HIV Volunteers are then randomly assigned to arm A B or C and receive immunizations at months 0 1 3 and 6 as follows
Group A- ALVAC vCP205 plus SF-2 rgp120 in MF59 Group B- ALVAC vCP205 plus saline placebo Group C- Placebo-ALVAC plus saline placebo AS PER AMENDMENT 7298 Beginning 12-18 months after initial vaccination then 2 6 and 12 months later 10 volunteers from group A receive saline placebo while 50 volunteers each from groups B and C are rerandomized within their respective groups and are treated as follows
Group B subgroup 1 - AIDSVAX BB Group B subgroup 2 - AIDSVAX BE Group B subgroup 3 - alum placebo Group C subgroup 1 - AIDSVAX BB Group C subgroup 2 - AIDSVAX BE Group C subgroup 3 - alum placebo Volunteers are followed for 2 years and are tested for humoral immune response to HIV-1 Neutralizing activity to HIV-1 is performed on a subset of volunteers monitored for CTL response AS PER AMENDMENT 7298 Volunteers receiving AIDSVAX BB and AIDSVAX BE will additionally be studied for formation of various neutralizing antibodies and parameters of cellular immunity AS PER AMENDMENT 43099 Because the subunit boosts that were added in version 30 are not available the subunit boost portion of version 30 is cancelled
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 |
|---|---|---|---|
| AVEG 202 | Registry Identifier | DAIDS ES Registry Number | None |
| HIVNET 014 | None | None | None |
| 10589 | REGISTRY | None | None |