Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001026
Status:
COMPLETED
Last Update Posted:
2021-11-04
First Post:
1999-11-02
Brief Title:
A Phase I Multicenter Randomized Trial to Evaluate the Safety and Immunogenicity of a Recombinant Vaccinia-HIV Envelope Vaccine HIVAC-1e in Combination With a Panel of Subunit Recombinant HIV Envelope Vaccines in Vaccinia-Naive Individuals
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 Multicenter Randomized Trial to Evaluate the Safety and Immunogenicity of a Recombinant Vaccinia-HIV Envelope Vaccine HIVAC-1e in Combination With a Panel of Subunit Recombinant HIV Envelope Vaccines in Vaccinia-Naive Individuals
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:
Primary To determine whether combination vaccination ie priming with a vaccinia recombinant-containing HIV envelope HIVAC-1e followed by boosting with a recombinant subunit envelope protein gp160 or gp120 provides enhanced immunogenicity compared to subunit vaccination with the individual recombinant envelope proteins only To compare the relative immunogenicity of a panel of HIV envelope subunit vaccines when administered as boosters following recombinant HIV-vaccinia priming To evaluate the relative immunogenicity of one versus two doses of recombinant HIV-vaccinia prior to the subunit protein boost
Secondary To examine the safety of administering the individual subunit vaccines in combination with the HIV envelope vaccinia recombinant and to extend the population to whom these proteins have been administered
Previous studies suggest that priming with an HIV-vaccinia recombinant followed by boosting with subunit envelope proteins offers the most promising strategy to date for a safe and immunogenic vaccine in humans This study will further examine the combination vaccine approach and define an optimal prime-boost strategy
Secondary To examine the safety of administering the individual subunit vaccines in combination with the HIV envelope vaccinia recombinant and to extend the population to whom these proteins have been administered
Previous studies suggest that priming with an HIV-vaccinia recombinant followed by boosting with subunit envelope proteins offers the most promising strategy to date for a safe and immunogenic vaccine in humans This study will further examine the combination vaccine approach and define an optimal prime-boost strategy
Detailed Description:
Previous studies suggest that priming with an HIV-vaccinia recombinant followed by boosting with subunit envelope proteins offers the most promising strategy to date for a safe and immunogenic vaccine in humans This study will further examine the combination vaccine approach and define an optimal prime-boost strategy
Healthy volunteers are randomized to one of eight groups All patients receive initial immunization with HIVAC-1e followed by two boosts at months 8 and 12 of rgp120HIV-1SF2 BIOCINE rgp120HIV-1IIIB Genentech rgp120HIV-1MN Genentech or gp160 MN Immuno-AG Additionally half of the patients in each subunit vaccine group receive a repriming with HIVAC-1e at month 4 Subjects are followed for 18 months
Healthy volunteers are randomized to one of eight groups All patients receive initial immunization with HIVAC-1e followed by two boosts at months 8 and 12 of rgp120HIV-1SF2 BIOCINE rgp120HIV-1IIIB Genentech rgp120HIV-1MN Genentech or gp160 MN Immuno-AG Additionally half of the patients in each subunit vaccine group receive a repriming with HIVAC-1e at month 4 Subjects are followed for 18 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 |
|---|---|---|---|
| 10555 | REGISTRY | DAIDS ES Registry Number | None |