Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001056
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 a 200-mcg Dose
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 a 200-mcg Dose
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 and immune response to vaccinia-derived HIV-1 recombinant envelope glycoprotein gp160 at a dose of 200 mcg in human volunteers 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 the 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 the 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 the 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 randomly assigned to receive three injections of either 200 mcg gp160 vaccine or a placebo At each participating site four volunteers receive vaccine and 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 2 years Volunteers may be offered an additional booster of the same preparation at 12 months
Healthy adult volunteers without identifiable high-risk behavior for HIV-1 infection are randomly assigned to receive three injections of either 200 mcg gp160 vaccine or a placebo At each participating site four volunteers receive vaccine and 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 2 years Volunteers may be offered an additional booster of the same preparation at 12 months
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 |
|---|---|---|---|
| 10544 | REGISTRY | DAIDS ES Registry Number | None |