Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001037
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 MN HIV-1 Recombinant Envelope Glycoprotein rgp160 of Human Immunodeficiency Virus at Two Different Vaccination 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 MN HIV-1 Recombinant Envelope Glycoprotein rgp160 of Human Immunodeficiency Virus at Two Different Vaccination 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 determine the safety and immunogenicity of 200 mcg MN rgp160 vaccine Immuno-AG versus placebo administered on two immunization schedules to healthy volunteers Per 061594 amendment to determine the safety and immunogenicity of 800 versus 200 mcg given as a fourth immunization at 9 or 11 months after the third injection ie at month 17
A gp160 vaccine developed from the IIIB strain of HIV-1 has been found to be safe and immunogenic in healthy adults Since the MN strain of HIV-1 is representative of a larger proportion of HIV-1 isolates in the United States than is the IIIB strain evaluation of a gp160 vaccine derived from the MN strain is important
A gp160 vaccine developed from the IIIB strain of HIV-1 has been found to be safe and immunogenic in healthy adults Since the MN strain of HIV-1 is representative of a larger proportion of HIV-1 isolates in the United States than is the IIIB strain evaluation of a gp160 vaccine derived from the MN strain is important
Detailed Description:
A gp160 vaccine developed from the IIIB strain of HIV-1 has been found to be safe and immunogenic in healthy adults Since the MN strain of HIV-1 is representative of a larger proportion of HIV-1 isolates in the United States than is the IIIB strain evaluation of a gp160 vaccine derived from the MN strain is important
Volunteers are randomized to receive 200 mcg MN rgp160 or placebo at months 0 1 and 6 or at months 0 2 and 8 For each immunization schedule ten volunteers receive vaccine and two volunteers receive placebo Per amendment volunteers receive a fourth immunization of 800 or 200 mcg or placebo at 9 or 11 months after the third injection ie at month 17 and are followed for 6 months afterward
Volunteers are randomized to receive 200 mcg MN rgp160 or placebo at months 0 1 and 6 or at months 0 2 and 8 For each immunization schedule ten volunteers receive vaccine and two volunteers receive placebo Per amendment volunteers receive a fourth immunization of 800 or 200 mcg or placebo at 9 or 11 months after the third injection ie at month 17 and are followed for 6 months afterward
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 |
|---|---|---|---|
| 10559 | REGISTRY | DAIDS ES Registry Number | None |