Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000956
Status:
COMPLETED
Last Update Posted:
2021-11-04
First Post:
1999-11-02
Brief Title:
A Phase I Multicenter 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 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 evaluate the safety and immune response to 640 and 1280 mcg HIV-1 recombinant envelope glycoprotein gp160 To evaluate the duration of antibody response and its relationship to dose and frequency of inoculation
Evaluation of previous patients who received doses of 40 or 80 mcg gp160 vaccine indicates that although serum anti-gp160 antibody responses were detected the level and duration of those responses were limited A preliminary observation suggests that weak functional antibody responses may develop following the 18 month booster of 40 or 80 mcg therefore a dose of gp160 vaccine having potentially greater immunogenicity is of particular interest
Evaluation of previous patients who received doses of 40 or 80 mcg gp160 vaccine indicates that although serum anti-gp160 antibody responses were detected the level and duration of those responses were limited A preliminary observation suggests that weak functional antibody responses may develop following the 18 month booster of 40 or 80 mcg therefore a dose of gp160 vaccine having potentially greater immunogenicity is of particular interest
Detailed Description:
Evaluation of previous patients who received doses of 40 or 80 mcg gp160 vaccine indicates that although serum anti-gp160 antibody responses were detected the level and duration of those responses were limited A preliminary observation suggests that weak functional antibody responses may develop following the 18 month booster of 40 or 80 mcg therefore a dose of gp160 vaccine having potentially greater immunogenicity is of particular interest
In the initial phase of the study 20 healthy volunteers receive 640 mcg gp160 vaccine and 5 healthy volunteers receive alum placebo At least 30 days later 20 additional volunteers receive 1280 mcg gp160 vaccine and 5 volunteers receive placebo Injections are given on days 0 30 180 and 365
In the initial phase of the study 20 healthy volunteers receive 640 mcg gp160 vaccine and 5 healthy volunteers receive alum placebo At least 30 days later 20 additional volunteers receive 1280 mcg gp160 vaccine and 5 volunteers receive placebo Injections are given on days 0 30 180 and 365
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 |
|---|---|---|---|
| 10542 | REGISTRY | DAIDS ES Registry Number | None |