Ignite Creation Date:
2025-12-25 @ 2:08 AM
Ignite Modification Date:
2025-12-26 @ 4:54 AM
Study NCT ID:
NCT00054860
Status:
COMPLETED
Last Update Posted:
2021-10-14
First Post:
2003-02-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety of and Immune System Response to an HIV Vaccine (EP HIV-1090) in HIV Uninfected Adults
Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Organization:
Study Overview
Official Title:
A Phase I Dose-Escalation Clinical Trial to Evaluate the Safety and Immunogenicity of the EP HIV-1090 DNA Vaccine in Healthy, 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 an HIV DNA vaccine (EP HIV-1090) and to test whether or not the vaccine can stimulate immune system responses in HIV uninfected people. This vaccine uses only parts of the virus's DNA and cannot cause HIV infection.
Detailed Description:
Epidemiological and animal model data support the hypothesis that HIV specific cytotoxic T lymphocyte (CTL) responses contribute to control and clearance of the virus. Vaccines designed specifically to induce CTL responses are likely to be well suited for protection against HIV infection and disease progression. EP HIV-1090 is a DNA vaccine composed of 21 highly specific CTL epitopes. The vaccine is designed to optimize the immune response in people expressing one of three HLA Class I antigen subtypes: HLA-A2, -A3, and -B7. This design is predicted to induce an immune response in 85% of individuals in the general population. There is also a helper T lymphocyte (HTL) facilitating epitope (PADRE) in the vaccine. The vaccine is formulated with a water soluble polymer (polyvinylpyrrolidone) that protects the DNA and facilitates cellular uptake. This study will assess the safety of and immune response to different doses of EP HIV-1090 in healthy, HIV uninfected adults.
Participants in this study will be randomized to receive either one of three different doses of vaccine or placebo. Participants will receive vaccinations or placebo at study entry and Months 1, 3, and 6. Both vaccinations and placebo are administered by intramuscular injection. Participants will be followed for 18 months and will have 12 study visits. Each study visit will include a physical exam, medical history, and blood and urine tests. Each participant will have four HIV tests during the study. Women will have at least five pregnancy tests during the study.
Participants in this study will be randomized to receive either one of three different doses of vaccine or placebo. Participants will receive vaccinations or placebo at study entry and Months 1, 3, and 6. Both vaccinations and placebo are administered by intramuscular injection. Participants will be followed for 18 months and will have 12 study visits. Each study visit will include a physical exam, medical history, and blood and urine tests. Each participant will have four HIV tests during the study. Women will have at least five pregnancy tests during the study.
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 10197 | REGISTRY | DAIDS ES Registry Number | View |