Ignite Creation Date:
2024-05-05 @ 11:46 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00125970
Status:
COMPLETED
Last Update Posted:
2021-10-15
First Post:
2005-06-30
Brief Title:
HVTN Protocol 204 - A Phase II Clinical Trial to Evaluate the Safety and Immunogenicity of a Multiclade HIV-1 DNA Plasmid Vaccine VRC-HIVDNA016-00-VP Followed by a Multiclade Recombinant Adenoviral Vector HIV-1 Vaccine Boost VRCHIVADV014-00-VP in HIV-1 Uninfected Adult Participants
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
HVTN Protocol 204 - A Phase II Clinical Trial to Evaluate the Safety and Immunogenicity of a Multiclade HIV-1 DNA Plasmid Vaccine VRC-HIVDNA016-00-VP Followed by a Multiclade Recombinant Adenoviral Vector HIV-1 Vaccine Boost VRCHIVADV014-00-VP 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 the study is to determine the safety of and immune response to a DNA HIV vaccine followed by an adenoviral vector HIV vaccine 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 DNA vaccines are inexpensive to construct readily produced in large quantities and stable for long periods of time This study will evaluate the safety and immunogenicity of an experimental multiclade HIV vaccine VRC-HIVDNA016-00-VP followed by a similarly structured adenovirus-vectored vaccine boost VRC-HIVADV014-00-VP in HIV uninfected adults The DNA plasmids in both the vaccines code for proteins from HIV subtypes A B and C which together represent 90 of new HIV infections in the world Participants in this study will be recruited in North America South America and Africa
Each volunteer will participate in the study for 36 months Participants will be randomly assigned to one of two groups Group 1 participants will receive the DNA HIV vaccine at study entry and at Months 1 and 2 At Month 6 Group 1 participants will receive an injection of the adenoviral vector HIV vaccine Group 2 participants will receive placebo at study entry and Months 1 2 and 6 There will be 17 study visits which will occur at study entry and every 2 weeks thereafter until Day 70 at Month 6 and every 2 weeks thereafter until Day 210 and Months 95 12 18 24 30 and 36 A physical exam adverse events reporting HIV and pregnancy prevention counseling and medication history will occur at each visit Blood and urine collection will occur at selected visits
Each volunteer will participate in the study for 36 months Participants will be randomly assigned to one of two groups Group 1 participants will receive the DNA HIV vaccine at study entry and at Months 1 and 2 At Month 6 Group 1 participants will receive an injection of the adenoviral vector HIV vaccine Group 2 participants will receive placebo at study entry and Months 1 2 and 6 There will be 17 study visits which will occur at study entry and every 2 weeks thereafter until Day 70 at Month 6 and every 2 weeks thereafter until Day 210 and Months 95 12 18 24 30 and 36 A physical exam adverse events reporting HIV and pregnancy prevention counseling and medication history will occur at each visit 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 |
|---|---|---|---|
| 10061 | REGISTRY | DAIDS ES Registry Number | None |