Ignite Creation Date:
2024-05-05 @ 11:45 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00124007
Status:
COMPLETED
Last Update Posted:
2021-11-01
First Post:
2005-07-22
Brief Title:
Safety of and Immune Response to an Adenoviral HIV Vaccine VRC-HIVADV014-00-VP With or Without a Plasmid HIV Vaccine VRC-HIVDNA016-00-VP in HIV Uninfected Adults
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 Randomized Placebo-Controlled Double-Blind Trial to Evaluate the Safety and Immunogenicity of a Multiclade HIV-1 DNA Plasmid Vaccine Followed by Recombinant Multiclade HIV-1 Adenoviral Vector Vaccine or the Multiclade HIV-1 Adenoviral Vector Vaccine Alone in Healthy Adult Volunteers Not Infected With HIV
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 determine the safety of and immune response to an investigational HIV vaccine VRC-HIVADV014-00-VP with or without a second investigational HIV vaccine VRC-HIVDNA016-00-VP in HIV uninfected adults
Detailed Description:
The worldwide HIVAIDS epidemic may only be controlled through development of a safe and effective vaccine that will prevent HIV infection This study will evaluate the safety and immunogenicity of an experimental adenovirus-vectored multiclade HIV vaccine VRC-HIVADV014-00-VP followed with either a similarly structured DNA plasmid HIV vaccine VRC-HIVDNA016-00-VP or a placebo The DNA plasmids in both vaccines code for proteins from HIV subtypes A B and C which together represent 90 of new HIV infections in the world HIV uninfected volunteers will be recruited in Kenya and Rwanda
Volunteers will participate in this study for 1 year Participants will be randomly assigned to one of four groups
Group A participants will receive a low dose of the adenovirus-vectored vaccine or placebo at study entry
Group B participants will receive a higher dose of the adenovirus-vectored vaccine or placebo at study entry
Group C participants will receive the DNA plasmid vaccine or placebo at study entry and Months 1 and 2 They will receive either a low dose of the adenovirus-vectored vaccine or placebo at Month 6
Group D participants will receive the DNA plasmid vaccine or placebo at study entry and Months 1 and 2 They will receive either a higher dose of the adenovirus-vectored vaccine or placebo at Month 6
All participants will undergo vital signs measurements before and after receiving each vaccination
Participants in Groups A and B will have 9 study visits over 12 months A physical exam adverse events reporting and medical and medication history will occur at each visit HIV testing and counseling and blood and urine collection will occur at selected visits
Participants in Groups C and D will have 17 study visits over 12 months A physical exam adverse events reporting and medical and medication history will occur at each visit HIV testing and counseling and blood and urine collection will occur at selected visits
Volunteers will participate in this study for 1 year Participants will be randomly assigned to one of four groups
Group A participants will receive a low dose of the adenovirus-vectored vaccine or placebo at study entry
Group B participants will receive a higher dose of the adenovirus-vectored vaccine or placebo at study entry
Group C participants will receive the DNA plasmid vaccine or placebo at study entry and Months 1 and 2 They will receive either a low dose of the adenovirus-vectored vaccine or placebo at Month 6
Group D participants will receive the DNA plasmid vaccine or placebo at study entry and Months 1 and 2 They will receive either a higher dose of the adenovirus-vectored vaccine or placebo at Month 6
All participants will undergo vital signs measurements before and after receiving each vaccination
Participants in Groups A and B will have 9 study visits over 12 months A physical exam adverse events reporting and medical and medication history will occur at each visit HIV testing and counseling and blood and urine collection will occur at selected visits
Participants in Groups C and D will have 17 study visits over 12 months A physical exam adverse events reporting and medical and medication history will occur at each visit HIV testing and counseling and blood and 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 |
|---|---|---|---|
| 10380 | REGISTRY | DAIDS ES Registry Number | None |