Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00002204
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
1999-11-02
Brief Title:
A Phase I Observer-Blind Placebo-Controlled Study of the Chiron Vaccine HIV p24MF59 Administered to Healthy HIV-Seronegative Adults
Sponsor:
Chiron Corporation
Organization:
NIH AIDS Clinical Trials Information Service
Study Overview
Official Title:
A Phase I Observer-Blind Placebo-Controlled Study of the Chiron Vaccine HIV p24MF59 Administered to Healthy HIV-Seronegative Adults
Status:
COMPLETED
Status Verified Date:
1999-06
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 tolerability of the Chiron vaccine human immunodeficiency virus HIV p2425 or 50 microgramsMF59 in healthy HIV-1 seronegative adults To evaluate the immunogenicity of the HIV p2450 microgramsMF59 vaccine
Detailed Description:
This study evaluates the safety and immunogenicity of the Chiron vaccine HIV p24MF59 In Part A 15 volunteers are randomly assigned to receive either HIV p24MF59 or a placebo at 0 1 and 6 months 10 volunteers receive the vaccine and 5 volunteers receive the placebo If no serious adverse events are observed within 1 week after the first injection in these first 15 patients Part B is initiated In Part B 25 volunteers are randomly assigned to receive HIV p24MF59 or a placebo at 0 1 and 6 months 20 volunteers receive the vaccine and 5 volunteers receive the placebo
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 |
|---|---|---|---|
| V24P1 | None | None | None |