Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000957
Status:
COMPLETED
Last Update Posted:
2021-11-04
First Post:
1999-11-02
Brief Title:
A Phase I Multicenter Clinical Trial to Evaluate the Safety and Immunogenicity of Vaccinia Derived HIV-1 Recombinant Envelope Glycoprotein gp160 of Human Immunodeficiency Virus Evaluation of Accelerated Schedules
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 Clinical Trial to Evaluate the Safety and Immunogenicity of Vaccinia Derived HIV-1 Recombinant Envelope Glycoprotein gp160 of Human Immunodeficiency Virus Evaluation of Accelerated Schedules
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 the safety and immune response to vaccinia-derived HIV-1 recombinant envelope glycoprotein gp160 using an accelerated dosage schedule to evaluate duration of antibody response and its relationship to the dose and frequency of inoculation
Although recent advances have been made in antiviral therapy against AIDS there is currently no cure for AIDS It is likely that ultimate control of the disease depends on the development of safe and effective vaccines against HIV
Although recent advances have been made in antiviral therapy against AIDS there is currently no cure for AIDS It is likely that ultimate control of the disease depends on the development of safe and effective vaccines against HIV
Detailed Description:
Although recent advances have been made in antiviral therapy against AIDS there is currently no cure for AIDS It is likely that ultimate control of the disease depends on the development of safe and effective vaccines against HIV
Thirty healthy adult volunteers without identifiable high-risk behavior for HIV-1 are randomly assigned to receive vaccination with gp160 50 mcg according to one of the following schedules Group 1 receives vaccine on days 0 28 56 and 140 and placebo on days 84 and 112 Group 2 receives vaccine on days 0 28 56 84 and 112 and placebo on day 140 Subjects are followed for 1 year after the last injection Per 051394 amendment 10 subjects at the St Louis University site receive an additional boost 18-24 months after the last injection
Thirty healthy adult volunteers without identifiable high-risk behavior for HIV-1 are randomly assigned to receive vaccination with gp160 50 mcg according to one of the following schedules Group 1 receives vaccine on days 0 28 56 and 140 and placebo on days 84 and 112 Group 2 receives vaccine on days 0 28 56 84 and 112 and placebo on day 140 Subjects are followed for 1 year after the last injection Per 051394 amendment 10 subjects at the St Louis University site receive an additional boost 18-24 months after the last injection
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 |
|---|---|---|---|
| 10545 | REGISTRY | DAIDS ES Registry Number | None |