Ignite Creation Date:
2024-05-05 @ 11:32 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00076947
Status:
COMPLETED
Last Update Posted:
2008-03-21
First Post:
2004-02-06
Brief Title:
Safety of the EnvPro HIV Vaccine in Healthy Volunteers
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Evaluation of Tolerability and Safety of a Recombinant Purified HIV Envelope Vaccine
Status:
COMPLETED
Status Verified Date:
2005-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to determine the safety of a new HIV vaccine The vaccine in this study is mixed with a chemical called alum to improve the bodys response to the vaccine Healthy adults who are not infected with HIV may participate in the study
Detailed Description:
EnvPro is a recombinant purified envelope protein vaccine with an aluminum hydroxide alum adjuvant Aluminum hydroxide is licensed as an adjuvant in other vaccines such as the hepatitis B vaccine This study will examine the safety and tolerability of EnvPro with alum adjuvant in healthy HIV uninfected adults
All participants in this study will receive vaccine injections in the upper arm muscle Participants will receive a second vaccine injection eight weeks after the first injection Blood tests will be performed at study visits before the vaccine is given during the eight weeks between injections and at selected times for up to three years after the vaccine is given
All participants in this study will receive vaccine injections in the upper arm muscle Participants will receive a second vaccine injection eight weeks after the first injection Blood tests will be performed at study visits before the vaccine is given during the eight weeks between injections and at selected times for up to three years after the vaccine is given
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 |
|---|---|---|---|
| EnvPro | None | None | None |