Ignite Creation Date:
2024-05-05 @ 10:23 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000968
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
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
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 safety of vaccinia-derived HIV-1 recombinant envelope glycoprotein gp160 in human volunteers to evaluate the immunogenicity of this preparation in human volunteers 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
Healthy adult volunteers without identifiable high-risk behavior for HIV-1 infection are vaccinated In phase 1 at each participating unit four volunteers receive a dose of gp160 125 mcg two volunteers receive placebo Volunteers are monitored 1 month before proceeding to the second phase In phase 2 four volunteers receive gp160 50 mcg two volunteers receive placebo Primary immunization and two booster immunizations at day 30 and day 180 are done in an outpatient setting Volunteers are closely monitored for the first 2 weeks postimmunization primary and boosters and extensively followed for a minimum of 2 years Volunteers may be offered an additional boost of the same preparation at 18 months Per 072892 amendment 18 volunteers will receive 200 mcg gp160 in an unblinded study Volunteers in phase 2 who received four doses of 50 mcg gp160 receive an additional boost of 200 mcg gp160 at 18-19 months post initial vaccination Per 051394 amendment volunteers in phase 2 who received the additional 200 mcg boost receive another 200 mcg boost 18-24 months after the last injection St Louis University site only
Healthy adult volunteers without identifiable high-risk behavior for HIV-1 infection are vaccinated In phase 1 at each participating unit four volunteers receive a dose of gp160 125 mcg two volunteers receive placebo Volunteers are monitored 1 month before proceeding to the second phase In phase 2 four volunteers receive gp160 50 mcg two volunteers receive placebo Primary immunization and two booster immunizations at day 30 and day 180 are done in an outpatient setting Volunteers are closely monitored for the first 2 weeks postimmunization primary and boosters and extensively followed for a minimum of 2 years Volunteers may be offered an additional boost of the same preparation at 18 months Per 072892 amendment 18 volunteers will receive 200 mcg gp160 in an unblinded study Volunteers in phase 2 who received four doses of 50 mcg gp160 receive an additional boost of 200 mcg gp160 at 18-19 months post initial vaccination Per 051394 amendment volunteers in phase 2 who received the additional 200 mcg boost receive another 200 mcg boost 18-24 months after the last injection St Louis University site only
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 |
|---|---|---|---|
| 10543 | REGISTRY | DAIDS ES Registry Number | None |