Ignite Creation Date:
2024-05-05 @ 11:32 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00071851
Status:
COMPLETED
Last Update Posted:
2021-10-14
First Post:
2003-11-03
Brief Title:
Safety of and Immune Response to an HIV-1 DNA Vaccine VRC HIVDNA009-00-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 IB Clinical Trial to Evaluate the Safety and Immunogenicity of a Multiclade HIV-1 DNA Plasmid Vaccine VRC-HIVDNA009-00-VP Administered at 2 Different Dosing Schedules 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 test the safety of and immune response to an HIV-1 vaccine VRC-HIVDNA009-00-VP in HIV uninfected participants Two different doses of the vaccine will be tested
Detailed Description:
The worldwide HIV epidemic highlights the importance of developing an affordable globally successful vaccine for HIV prevention The VRC-HIVDNA009-00-VP vaccine used in this study was developed to incorporate HIV genes from multiple virus clades representing the viral subtypes responsible for about 90 of new HIV infections in the world The purpose of this study is to determine the safety and immunogenicity of VRC-HIVDNA009-00-VP in healthy HIV uninfected individuals
Participants will be randomly assigned to one of three groups and will be followed for one year Study injections will be given by needle-free intramuscular injection at the start of study and at Months 1 and 2 Group 1 will receive 3 injections of the study vaccine Group 2 will receive 2 injections of the study vaccine at start and Month 2 and injection of placebo at Month 1 Group 3 will receive 3 injections of placebo After a screening visit study visits will occur at enrollment initial injection followed by 5 visits every 14 days for the first 25 months with three additional visits at Months 6 9 and 12 All participants will undergo physical exams blood and urine tests to assess measures of health and blood tests to assess HIV infection and immune response to the injections
Participants will be randomly assigned to one of three groups and will be followed for one year Study injections will be given by needle-free intramuscular injection at the start of study and at Months 1 and 2 Group 1 will receive 3 injections of the study vaccine Group 2 will receive 2 injections of the study vaccine at start and Month 2 and injection of placebo at Month 1 Group 3 will receive 3 injections of placebo After a screening visit study visits will occur at enrollment initial injection followed by 5 visits every 14 days for the first 25 months with three additional visits at Months 6 9 and 12 All participants will undergo physical exams blood and urine tests to assess measures of health and blood tests to assess HIV infection and immune response to the injections
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 |
|---|---|---|---|
| 10198 | REGISTRY | DAIDS ES Registry Number | None |