Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000946
Status:
COMPLETED
Last Update Posted:
2021-10-29
First Post:
1999-11-02
Brief Title:
A Study to Test the Safety of Three Experimental HIV Vaccines
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 Trial to Evaluate the HIV-1 SF-2 Recombinant p24 Subunit Vaccine Chiron Vaccines Administered as a Novel Boost in Prime-Boost Vaccination Regimens With ALVAC-HIV vCP205 Pasteur Merieux Connaught and HIV-1 SF-2 rgp120 in MF59 Chiron Vaccines
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:
The purpose of this study is to test three experimental HIV vaccines This study will look at whether it is safe to give these vaccines together and how the immune system responds to the vaccines
There are a number of studies being performed to test HIV vaccines The vaccines that seem to be the most promising are canarypox vaccines known as ALVAC vaccines The three experimental HIV vaccines used in this study are called ALVAC-HIV vCP205 HIV-1 SF-2 p24 and HIV-1 SF-2 rgp120 The HIV-1 SF-2 p24 and HIV-1 SF-2 rgp120 vaccines are mixed with an adjuvant which is a substance that increases immune response
There are a number of studies being performed to test HIV vaccines The vaccines that seem to be the most promising are canarypox vaccines known as ALVAC vaccines The three experimental HIV vaccines used in this study are called ALVAC-HIV vCP205 HIV-1 SF-2 p24 and HIV-1 SF-2 rgp120 The HIV-1 SF-2 p24 and HIV-1 SF-2 rgp120 vaccines are mixed with an adjuvant which is a substance that increases immune response
Detailed Description:
There are currently several Phase I and II clinical trials being performed within AVEG to evaluate different HIV-1 vaccine candidates The HIV-1 vaccination approach that is furthest along the clinical development pathway is the so-called prime-boost regimen of live recombinant canarypox priming ALVAC-HIV vCP205 with recombinant subunit protein boosting HIV-1 SF-2 rgp120 in MF59 adjuvant The protein boost enhances neutralizing antibody responses against laboratory strains of HIV-1 in assays performed in vitro as well as enhancing CD4 cell response and increasing the frequency of CD8 cytotoxic T lymphocytes CTLs In all of the ALVAC-HIV trials of the prime-boost regimen completed to date the protein boost has been the HIV-1 SF-2 rgp120 subunit protein This study is designed to explore whether boosting of live recombinant canarypox vaccination with a novel protein subunit recombinant HIV-1 SF-2 p24 can enhance the CD4 and CD8 cell responses directed against HIV-1 antigens
Volunteers are randomized to 1 of 5 groups All volunteers receive a total of 4 immunizations administered at Months 0 1 3 and 6 Each group receives a different combination of vaccines as follows
Group 1 ALVAC-HIV vCP205 plus HIV-1 SF-2 p24 Group 2 ALVAC-HIV vCP205 plus MF59 adjuvant and citrate vehicle control for HIV-1 SF-2 p24 and HIV-1 SF-2 rgp120 at Months 0 and 1 then ALVAC-HIV vCP205 plus HIV-1 SF-2 p24 at months 3 and 6
Group 3 ALVAC-HIV vCP205 plus control at Months 0 and 1 then ALVAC-HIV vCP205 plus HIV-1 SF-2 p24 combined with HIV-1 SF-2 rgp120 at Months 3 and 6
Group 4 ALVAC-HIV vCP205 plus control at Months 0 and 1 then ALVAC-HIV vCP205 plus HIV-1 SF-2 rgp 120 at Months 3 and 6
Group 5 ALVAC-RG vCP65 control for ALVAC-HIV vCP205 plus control at Months 013 and 6
The study lasts for approximately 18 months patients receive clinical evaluations to measure vaccine safety at 11 study visits at specified time intervals
Volunteers are randomized to 1 of 5 groups All volunteers receive a total of 4 immunizations administered at Months 0 1 3 and 6 Each group receives a different combination of vaccines as follows
Group 1 ALVAC-HIV vCP205 plus HIV-1 SF-2 p24 Group 2 ALVAC-HIV vCP205 plus MF59 adjuvant and citrate vehicle control for HIV-1 SF-2 p24 and HIV-1 SF-2 rgp120 at Months 0 and 1 then ALVAC-HIV vCP205 plus HIV-1 SF-2 p24 at months 3 and 6
Group 3 ALVAC-HIV vCP205 plus control at Months 0 and 1 then ALVAC-HIV vCP205 plus HIV-1 SF-2 p24 combined with HIV-1 SF-2 rgp120 at Months 3 and 6
Group 4 ALVAC-HIV vCP205 plus control at Months 0 and 1 then ALVAC-HIV vCP205 plus HIV-1 SF-2 rgp 120 at Months 3 and 6
Group 5 ALVAC-RG vCP65 control for ALVAC-HIV vCP205 plus control at Months 013 and 6
The study lasts for approximately 18 months patients receive clinical evaluations to measure vaccine safety at 11 study visits at specified time intervals
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 |
|---|---|---|---|
| 10581 | REGISTRY | DAIDS ES Registry Number | None |