Ignite Creation Date:
2024-05-05 @ 4:35 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00270218
Status:
COMPLETED
Last Update Posted:
2021-10-14
First Post:
2005-12-21
Brief Title:
Safety of and Immune Response to Two Different HIV Vaccines Each Followed by a Adenoviral Vaccine Boost 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 Clinical Trial to Evaluate Immune Response Kinetics and Safety of Two Different Primes Adenoviral Vector Vaccine VRC-HIVADV014-00-VP and DNA Vaccine VRC-HIVDNA009-00-VP Each Followed by Adenoviral Vector Boost in Healthy HIV-1 Uninfected Adults
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 adenoviral vector HIV vaccine or a DNA HIV vaccine each followed by an adenoviral vector HIV vaccine boost in HIV uninfected adults
Detailed Description:
Evaluating the immunogenicity of HIV vaccines is critical to improving vaccine design and development The adenoviral vector HIV vaccine VRC-HIVADV014-00-VP has shown immunogenicity in early studies and appeared safe and well tolerated at three different doses in a prior dose-escalation vaccine trial in HIV uninfected adults The DNA HIV vaccine VRC-HIVDNA009-00-VP has shown immunogenicity in multiple clinical trials in one trial the DNA vaccine demonstrated a nearly 100 CD4 T-cell response rate The DNA plasmids in both vaccines code for proteins from HIV subtypes A B and C which together represent 90 of new HIV infections This study will determine the safety and immune response to the administration of an adenoviral vector HIV vaccine or a DNA HIV vaccine each followed by an adenoviral vaccine boost in HIV uninfected adults
This study will last 1 year Participants will be randomly assigned to one of two groups Within each group participants will be randomly assigned to receive either vaccine or control injections Group 1 participants will receive either placebo or the adenoviral HIV vaccine at study entry and Month 6 Group 2 participants will receive either placebo or the DNA HIV vaccine at study entry and Month 1 and the adenoviral HIV vaccine at Month 6 Participants will be asked to record their temperatures and other side effects in a symptom log on the day of each vaccination and for 3 days thereafter to report any side effects
Group 1 participants will have 16 study visits and a physical exam and HIV and pregnancy prevention counseling will occur at each visit Participants will also be asked about any side effects and medications they are taking Blood collection will occur at most visits Urine collection will occur at selected visits Participants will be asked to complete a social impact assessment at Months 2 6 and 12 and a testing and belief questionnaire at Months 6 and 12
This study will last 1 year Participants will be randomly assigned to one of two groups Within each group participants will be randomly assigned to receive either vaccine or control injections Group 1 participants will receive either placebo or the adenoviral HIV vaccine at study entry and Month 6 Group 2 participants will receive either placebo or the DNA HIV vaccine at study entry and Month 1 and the adenoviral HIV vaccine at Month 6 Participants will be asked to record their temperatures and other side effects in a symptom log on the day of each vaccination and for 3 days thereafter to report any side effects
Group 1 participants will have 16 study visits and a physical exam and HIV and pregnancy prevention counseling will occur at each visit Participants will also be asked about any side effects and medications they are taking Blood collection will occur at most visits Urine collection will occur at selected visits Participants will be asked to complete a social impact assessment at Months 2 6 and 12 and a testing and belief questionnaire at Months 6 and 12
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 |
|---|---|---|---|
| 10060 | REGISTRY | DAIDS ES | None |