Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002428
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
1999-11-02
Brief Title:
A Phase III Safety and Immunogenicity Trial of UBI Microparticulate Monovalent HIV-1 MN Branched Peptide Vaccine in HIV-1 Seronegative Human Subjects
Sponsor:
United Biomedical
Organization:
NIH AIDS Clinical Trials Information Service
Study Overview
Official Title:
A Phase III Safety and Immunogenicity Trial of UBI Microparticulate Monovalent HIV-1 MN Branched Peptide Vaccine in HIV-1 Seronegative Human Subjects
Status:
COMPLETED
Status Verified Date:
1996-03
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 immunogenicity of a combination of microparticulate monovalent HIV-1 MN synthetic branched peptide candidate vaccine for oral administration and monovalent HIV-1 MN synthetic branched peptide vaccine in alum for intramuscular administration in intermediate or higher risk HIV-negative volunteers
Detailed Description:
Volunteers receive one of two schedules of vaccines or placebo administered at days 0 28 and 168 Specifically group 1 receives oral microparticulate monovalent vaccine over 3 consecutive days on days 0 1 and 2 and 28 29 and 30 with the intramuscular monovalent vaccine given on day 168 Group 2 receives the intramuscular vaccine first on day 0 followed by the oral form given on days 28 29 and 30 and 168 169 and 170 Volunteers are followed for 1 year
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 |
|---|---|---|---|
| UBI V106 | None | None | None |