Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00054860
Status:
COMPLETED
Last Update Posted:
2021-10-14
First Post:
2003-02-11
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:
National Institute of Allergy and Infectious Diseases NIAID
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 viruss 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:
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 |
|---|---|---|---|
| 10197 | REGISTRY | DAIDS ES Registry Number | None |