Ignite Creation Date:
2024-05-05 @ 10:18 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000904
Status:
COMPLETED
Last Update Posted:
2021-11-04
First Post:
1999-11-02
Brief Title:
Safety and Effectiveness of Anti-HIV Vaccines in HIV-Negative Adults
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 Compare the Safety and Immunogenicity of the Live Recombinant Canarypox ALVAC-HIV Vaccines vCP205 vCP1433 and vCP1452 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:
The purpose of this study is to find out whether three different anti-HIV vaccines are safe and whether they help prevent HIV infection These vaccines are called vCP205 vCP1433 and vCP1452 Some patients also receive another anti-HIV vaccine gp160 The vaccines are made up of small pieces of HIV which help the body learn to recognize and destroy HIV You cannot get HIV from these vaccines
There are two different ways a vaccine can protect the body from infection First a vaccine may help the immune system make antibodies which are proteins that recognize invading viruses or bacteria Second a vaccine may help the body make immune cells that destroy infected cells The second type of vaccine is more powerful against HIV In this study doctors will see whether vCP205 vCP1433 vCP1452 and gp160 are good vaccines by seeing whether they help the body make immune cells
There are two different ways a vaccine can protect the body from infection First a vaccine may help the immune system make antibodies which are proteins that recognize invading viruses or bacteria Second a vaccine may help the body make immune cells that destroy infected cells The second type of vaccine is more powerful against HIV In this study doctors will see whether vCP205 vCP1433 vCP1452 and gp160 are good vaccines by seeing whether they help the body make immune cells
Detailed Description:
Previous studies in humans have shown that immunization with certain vaccine combinations that is ALVAC-HIV construct and an envelope subunit vaccine can elicit CTL activity antibody-dependent cellular toxicity ADCC neutralizing antibodies and other antibody responses more often and at higher levels than either vaccine alone This study examines improved vaccine candidates that can elicit broader longer-lasting CTL activity in the majority of vaccine recipients
Volunteers are randomized to one of four groups Group I receives vCP205 Group II receives vCP1433 Group III receives vCP1452 Group IV receives an ALVAC rabies vaccine as a control Immunizations are administered at Months 0 1 3 and 6 At Months 3 and 6 patients in Groups I II and III also receive gp160 MNLAI-2 the subunit boost vaccine Group IV receives another placebo vaccine Participants have regular clinic visits and blood is drawn to determine humoral and cellular immune responses to the vaccines AS PER AMENDMENT 102398 A cell-mediated immunity substudy has been added at selected institutions following the fourth vaccination at 6 months this study will assess the newer assays of CD8 T cells and the kinetic response following immunization The 6-month immunization may be rescheduled by up to 14 days to accommodate clinical laboratory or volunteer scheduling issues AS PER AMENDMENT 61799 Three study arms are added Group V receives vCP1452 at Months 013 and 6 Group VI receives vCP205 at Months 013 and 6 Group VII receives placebo at Months 013 and 6 Patients in Groups V VI and VII do not receive the subunit boost gp160 MNLAI-2 Consenting volunteers enrolled in the three new groups at Johns Hopkins University undergo PET scanning as part of an ancillary study
Volunteers are randomized to one of four groups Group I receives vCP205 Group II receives vCP1433 Group III receives vCP1452 Group IV receives an ALVAC rabies vaccine as a control Immunizations are administered at Months 0 1 3 and 6 At Months 3 and 6 patients in Groups I II and III also receive gp160 MNLAI-2 the subunit boost vaccine Group IV receives another placebo vaccine Participants have regular clinic visits and blood is drawn to determine humoral and cellular immune responses to the vaccines AS PER AMENDMENT 102398 A cell-mediated immunity substudy has been added at selected institutions following the fourth vaccination at 6 months this study will assess the newer assays of CD8 T cells and the kinetic response following immunization The 6-month immunization may be rescheduled by up to 14 days to accommodate clinical laboratory or volunteer scheduling issues AS PER AMENDMENT 61799 Three study arms are added Group V receives vCP1452 at Months 013 and 6 Group VI receives vCP205 at Months 013 and 6 Group VII receives placebo at Months 013 and 6 Patients in Groups V VI and VII do not receive the subunit boost gp160 MNLAI-2 Consenting volunteers enrolled in the three new groups at Johns Hopkins University undergo PET scanning as part of an ancillary study
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 |
|---|---|---|---|
| 10583 | REGISTRY | DAIDS ES Registry Number | None |
| AVEG 034A | None | None | None |