Ignite Creation Date:
2024-05-05 @ 11:30 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00051922
Status:
COMPLETED
Last Update Posted:
2011-06-08
First Post:
2003-01-17
Brief Title:
Development of a New HIV Vaccine
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Evaluation of the Safety of a Polyvalent Vaccinia Virus HIV-1 Envelope Recombinant Vaccine PolyEnv1 in Healthy Adults
Status:
COMPLETED
Status Verified Date:
2011-06
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:
The purpose of the study is to determine the safety of a new HIV vaccine and to evaluate the immune response to the vaccine Only some HIV genes are used to make the vaccine and therefore the vaccine cannot itself cause HIV or AIDS
Detailed Description:
HIV-1 presents several challenges to vaccine design including 1 high mutation rates resulting in tremendous diversity of virus envelope the target of neutralizing antibody such that antibody elicited to one envelope may not protect from virus with a distinct envelope 2 envelope from infected persons differs from envelopes obtained from T-cell line cultures the usual source of envelope for vaccines and 3 envelope glycoprotein exists as oligomers on the virion surface not as the monomers used in previous vaccines This study will test a new vaccine that has been designed to meet these challenges by delivering diverse patient-derived oligomeric envelopes to induce multiple type-specific responses capable of recognizing native envelope on natural variants The vaccine vector used in this vaccine trial is recombinant vaccinia virus based on the NYCDH vaccinia isolate
Participants in this study will receive the PolyEnv1 HIV vaccine and will be followed for one year Laboratory tests will be performed at 10 study visits to monitor the participants immunologic response and assess the safety of the vaccine Patients will also have numerous HIV tests throughout the study period
Participants in this study will receive the PolyEnv1 HIV vaccine and will be followed for one year Laboratory tests will be performed at 10 study visits to monitor the participants immunologic response and assess the safety of the vaccine Patients will also have numerous HIV tests throughout the study period
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 |
|---|---|---|---|
| P01AI045142 | NIH | None | httpsreporternihgovquickSearchP01AI045142 |