Ignite Creation Date:
2024-05-05 @ 11:38 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00091416
Status:
COMPLETED
Last Update Posted:
2021-10-14
First Post:
2004-09-08
Brief Title:
Safety of and Immune Response to an HIV-1 Vaccine Boost VRC-HIVADV014-00-VP in HIV Uninfected Adults Who Participated in HVTN 052
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 Clinical Trial to Evaluate the Safety of a Multiclade Recombinant Adenoviral Vector HIV-1 Vaccine Administered to Healthy HIV-1 Uninfected Adult Participants Who Received DNA Plasmid Vaccine or Placebo in the HVTN 052 Clinical Trial
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 test the safety of and immune response to an HIV-1 vaccine VRC-HIVADV014-00-VP when given as a vaccine booster to HIV uninfected adults who participated in HVTN 052
Detailed Description:
The worldwide HIV epidemic highlights the importance of developing an affordable globally successful vaccine for HIV prevention The VRC-HIVADV014-00-VP adenoviral vector vaccine used in this study was developed to stimulate strong virus-specific CD8 cytotoxic T-lymphocyte CTL responses thought to be crucial in an effective preventive HIV vaccine The purpose of this study is to determine the safety and immunogenicity of a VRC-HIVADV014-00-VP vaccine boost given to healthy HIV uninfected individuals who participated in HVTN 052 which evaluated the VRC-HIVDNA009-00-VP DNA plasmid vaccine In that study participants received either 3 injections of vaccine 2 injections of vaccine and 1 injection of placebo or 3 injections of placebo over a 2-month period
This study will last one year Participants will be randomly assigned to receive vaccine boost or placebo by intramuscular injection The injections will be given 6 to 9 months after each participants first HVTN 052 study injection preferably as close to 6 months after the first HVTN 052 injection as possible After a screening visit study visits will occur at enrollment when the injection will be given at Week 2 and at Months 1 3 6 and 12 Blood collection physical exam and medication assessment will occur at every study visit urine collection will occur at selected visits
This study will last one year Participants will be randomly assigned to receive vaccine boost or placebo by intramuscular injection The injections will be given 6 to 9 months after each participants first HVTN 052 study injection preferably as close to 6 months after the first HVTN 052 injection as possible After a screening visit study visits will occur at enrollment when the injection will be given at Week 2 and at Months 1 3 6 and 12 Blood collection physical exam and medication assessment will occur at every study visit urine collection will occur at selected 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 |
|---|---|---|---|
| 10123 | REGISTRY | DAIDS ES Registry Number | None |