Ignite Creation Date:
2024-05-05 @ 10:23 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000745
Status:
COMPLETED
Last Update Posted:
2021-11-04
First Post:
1999-11-02
Brief Title:
A Phase I Multicenter Randomized Double-Blind Placebo-Controlled Trial to Evaluate the Safety and Immunogenicity of HIV-1 Recombinant Envelope Glycoprotein gp160
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 Double-Blind Placebo-Controlled Trial to Evaluate the Safety and Immunogenicity of HIV-1 Recombinant Envelope Glycoprotein gp160
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 determine the reactivity and safety of HIV-1 recombinant envelope glycoprotein gp160 To determine the immunogenicity of gp160
Although recent advances have been made in antiviral therapy against AIDS there is currently no cure It is likely that ultimate control of the disease will depend 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 It is likely that ultimate control of the disease will depend 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 It is likely that ultimate control of the disease will depend on the development of safe and effective vaccines against HIV
Healthy volunteers are injected on days 0 30 and 180 with one of four preparations gp160 vaccine 40 mcg gp160 vaccine 80 mcg hepatitis B vaccine and placebo The hepatitis B vaccine group will serve as an additional control for immunological evaluations An optional fourth injection may be given 15-21 months following the initial inoculation
Healthy volunteers are injected on days 0 30 and 180 with one of four preparations gp160 vaccine 40 mcg gp160 vaccine 80 mcg hepatitis B vaccine and placebo The hepatitis B vaccine group will serve as an additional control for immunological evaluations An optional fourth injection may be given 15-21 months following the initial inoculation
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 |
|---|---|---|---|
| 10540 | REGISTRY | DAIDS ES Registry Number | None |