Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00027365
Status:
COMPLETED
Last Update Posted:
2021-10-14
First Post:
2001-12-04
Brief Title:
An Investigational Combination Vaccine Given to People Who Are Not Infected With HIV
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 Safety and Immunogenicity Trial of a Combination Vaccine NefTat and gp120w61d Formulated With AS02A GlaxoSmithKline Biologicals Given Intramuscularly in HIV-1 Uninfected Adult Participants
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:
The purpose of this study is to see if the investigational vaccines NefTat and gp120w61d are safe and tolerable in humans and to see how the immune system responds to the vaccines
There have been advances in the treatment and prevention of HIV but the spread of HIVAIDS is getting worse HIVAIDS is the main infectious cause of death in the world A vaccine to prevent HIV disease is the best way to try to deal with this situation Several vaccine products have been tested but only 2 are still in trial There is a need for a new product
There have been advances in the treatment and prevention of HIV but the spread of HIVAIDS is getting worse HIVAIDS is the main infectious cause of death in the world A vaccine to prevent HIV disease is the best way to try to deal with this situation Several vaccine products have been tested but only 2 are still in trial There is a need for a new product
Detailed Description:
Despite recent advances in the treatment and prevention of HIV disease the epidemic is worsening throughout most of the world HIVAIDS is the leading cause of death in sub-Saharan Africa and the leading infectious cause of death in the world An effective and inexpensive vaccine to prevent HIV disease remains as the best option to try to deal with this expanding epidemic A number of vaccine products have been tested however only 2 have progressed to a Phase III trial underscoring the need for new vaccine strategies
Prior to study entry participants have their risk status for HIV infection determined by a series of questions Further eligibility is determined by results of physical exam laboratory tests and further questions Blood is drawn on each study visit Participants are assigned randomly to 1 of 4 study groups
Group I NefTat or placebo Groups II III and IV NefTat and gp120 or placebo Each group receives a different concentration of gp120
All immunizations are admixed with AS02A adjuvant Vaccinations are administered intramuscularly at 3 time points entry 1 month and 3 months Product safety and immunogenicity are performed at designated time points participants have about 11 clinic visits
Prior to study entry participants have their risk status for HIV infection determined by a series of questions Further eligibility is determined by results of physical exam laboratory tests and further questions Blood is drawn on each study visit Participants are assigned randomly to 1 of 4 study groups
Group I NefTat or placebo Groups II III and IV NefTat and gp120 or placebo Each group receives a different concentration of gp120
All immunizations are admixed with AS02A adjuvant Vaccinations are administered intramuscularly at 3 time points entry 1 month and 3 months Product safety and immunogenicity are performed at designated time points participants have about 11 clinic visits
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 |
|---|---|---|---|
| 10196 | REGISTRY | DAIDS ES Registry Number | None |