Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000767
Status:
COMPLETED
Last Update Posted:
2021-10-28
First Post:
1999-11-02
Brief Title:
A Multicenter Randomized Placebo-Controlled Double-Blind Trial to Evaluate the Safety and Immunogenicity of a Recombinant Vaccinia-HIV-1 IIIB EnvGagPol Vaccine TBC-3B
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Multicenter Randomized Placebo-Controlled Double-Blind Trial to Evaluate the Safety and Immunogenicity of a Recombinant Vaccinia-HIV-1 IIIB EnvGagPol Vaccine TBC-3B
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 in healthy HIV-1 seronegative vaccinia-immune and vaccinia-naive volunteers the safety and immunogenicity of an HIV-1 candidate vaccine TBC-3B consisting of a live recombinant vaccinia virus expressing the env gag and pol genes of HIV-1 IIIB strain To evaluate the potential of boosting with one of a variety of HIV-1 recombinant subunit peptide or pseudovirion vaccines if available to augment the immune responses of the vaccinees
Antigenic drift defined as the genetic variation of the HIV-1 envelope gene that results in antigenic variation during natural infection may confound attempts to achieve protective immunity using a vaccine based solely on HIV-1 envelope proteins Inclusion of conserved core and polymerase proteins along with envelope protein in a candidate vaccine may address some of the problems with antigenic variability A prime-boost immunization approach using a novel priming immunogen expressing env gag and pol genes of the HIV-1 IIIB strain will be attempted in this study
Antigenic drift defined as the genetic variation of the HIV-1 envelope gene that results in antigenic variation during natural infection may confound attempts to achieve protective immunity using a vaccine based solely on HIV-1 envelope proteins Inclusion of conserved core and polymerase proteins along with envelope protein in a candidate vaccine may address some of the problems with antigenic variability A prime-boost immunization approach using a novel priming immunogen expressing env gag and pol genes of the HIV-1 IIIB strain will be attempted in this study
Detailed Description:
Antigenic drift defined as the genetic variation of the HIV-1 envelope gene that results in antigenic variation during natural infection may confound attempts to achieve protective immunity using a vaccine based solely on HIV-1 envelope proteins Inclusion of conserved core and polymerase proteins along with envelope protein in a candidate vaccine may address some of the problems with antigenic variability A prime-boost immunization approach using a novel priming immunogen expressing env gag and pol genes of the HIV-1 IIIB strain will be attempted in this study
In Part I vaccinia-immune volunteers are randomized to one of two regimens Group A receives priming with TBC-3B on days 0 and 56 followed by boosting on day 224 8 months with one of the following TBC-3B an alternative immunogen such as pseudovirion particles or a recombinant HIV-1 subunit or peptide vaccine or placebo Group B receives priming with control vaccine DryVax followed by boosting with an appropriate placebo At least 50 percent of subjects in Part I will be observed for a minimum of 8 weeks before subsequent volunteers are enrolled in Part II PER 111894 AMENDMENT Part I boosting is given on day 392 PER 51995 AMENDMENT Part I boosting is given on day 756 if not available on day 392 if the appropriate product is not available then the study will end on day 756 In Part II vaccinia-naive volunteers are randomized to one of three regimens Group C receives TBC-3B on day 0 and saline placebo on day 56 Group D receives TBC-3B on days 0 and 56 Both Group C and D receive boosting with TBC-3B or an alternative immunogen on day 224 Group E receives control vaccine DryVax on days 0 and 56 followed by appropriate placebo on day 224 Per 061094 addendum volunteers will be contacted once or twice per year for at least 5 years to check on health status
NOTE Part I Part A of the protocol has closed to accrual
In Part I vaccinia-immune volunteers are randomized to one of two regimens Group A receives priming with TBC-3B on days 0 and 56 followed by boosting on day 224 8 months with one of the following TBC-3B an alternative immunogen such as pseudovirion particles or a recombinant HIV-1 subunit or peptide vaccine or placebo Group B receives priming with control vaccine DryVax followed by boosting with an appropriate placebo At least 50 percent of subjects in Part I will be observed for a minimum of 8 weeks before subsequent volunteers are enrolled in Part II PER 111894 AMENDMENT Part I boosting is given on day 392 PER 51995 AMENDMENT Part I boosting is given on day 756 if not available on day 392 if the appropriate product is not available then the study will end on day 756 In Part II vaccinia-naive volunteers are randomized to one of three regimens Group C receives TBC-3B on day 0 and saline placebo on day 56 Group D receives TBC-3B on days 0 and 56 Both Group C and D receive boosting with TBC-3B or an alternative immunogen on day 224 Group E receives control vaccine DryVax on days 0 and 56 followed by appropriate placebo on day 224 Per 061094 addendum volunteers will be contacted once or twice per year for at least 5 years to check on health status
NOTE Part I Part A of the protocol has closed to accrual
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 10561 | REGISTRY | None | None |
| AVEG 014AB | Registry Identifier | DAIDS ES Registry Number | None |