Ignite Creation Date:
2024-05-05 @ 11:30 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00069030
Status:
COMPLETED
Last Update Posted:
2021-10-14
First Post:
2003-09-12
Brief Title:
Safety of and Immune Response to an HIV Vaccine VRC-HIVDNA009-00-VP Administered With Interleukin-2Immunoglobulin IL-2Ig DNA Adjuvant in 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 the Safety and Immunogenicity of the HIV-1 DNA Vaccine VRC-HIVDNA009-00-VP Gag-Pol-Nef-multiclade Env With the Plasmid Cytokine Adjuvant VRC-ADJDNA004-IL2-VP IL-2Ig
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:
This study will test the safety of and immune system response to a new HIV vaccine The vaccine in this study is made from HIV DNA produced in a laboratory Only part of the viruss DNA is used in the vaccine and the vaccine itself cannot cause HIV infection or AIDS In addition to HIV DNA the vaccine contains interleukin-2 IL-2 DNA fused to a portion of immunoglobulin Ig DNA IL-2 is a chemical that stimulates the immune system and may improve response to the vaccine
Study hypothesis The IL-2Ig plasmid will be very well tolerated in humans
Study hypothesis The IL-2Ig plasmid will be very well tolerated in humans
Detailed Description:
Over 90 of the 40 million people infected with HIV live in developing countries and have little or no access to antiretroviral medications The worldwide HIVAIDS epidemic will 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 The DNA vaccine in this study VRC-HIVDNA009-00-VP Gag-Pol-Nef-multiclade Env uses multiple gene products to increase the breadth of the immune response across different HIV subtypes The DNA plasmids in VRC-HIVDNA009-00-VP code for proteins from HIV subtypes A B and C which together represent 90 of new HIV infections in the world
The study vaccine is administered with an adjuvant The adjuvant is a DNA plasmid encoding interleukin 2 IL-2 fused to the Fc portion of IgG for enhanced stability This IL-2Ig adjuvant may augment the immune systems response to the vaccine
Participants in this study will be randomly assigned to receive either the vaccine and adjuvant the vaccine and placebo the adjuvant and placebo or placebo alone All injections will be administered by needle-free injection in the upper arm Participants will receive four does of vaccine one at their first study visit and then at Months 1 2 and 6 Participants will have a follow-up visit 2 days after each injection Some participants may receive another injection at this follow-up visit All study participants will be followed for 18 months and will have 16 to 20 study visits Study visits will last 12 to 2 hours and will include blood and urine tests and a physical exam Participants will also have six HIV tests over the course of the study
The study vaccine is administered with an adjuvant The adjuvant is a DNA plasmid encoding interleukin 2 IL-2 fused to the Fc portion of IgG for enhanced stability This IL-2Ig adjuvant may augment the immune systems response to the vaccine
Participants in this study will be randomly assigned to receive either the vaccine and adjuvant the vaccine and placebo the adjuvant and placebo or placebo alone All injections will be administered by needle-free injection in the upper arm Participants will receive four does of vaccine one at their first study visit and then at Months 1 2 and 6 Participants will have a follow-up visit 2 days after each injection Some participants may receive another injection at this follow-up visit All study participants will be followed for 18 months and will have 16 to 20 study visits Study visits will last 12 to 2 hours and will include blood and urine tests and a physical exam Participants will also have six HIV tests over the course of the study
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 |
|---|---|---|---|
| 10120 | REGISTRY | DAIDS ES Registry Number | httpsreporternihgovquickSearch5K08AI051223-03 |
| 5K08AI051223-03 | NIH | None | None |