Ignite Creation Date:
2024-05-05 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00141024
Status:
COMPLETED
Last Update Posted:
2021-10-14
First Post:
2005-08-30
Brief Title:
Safety of and Immune Response to the Experimental Preventive HIV Vaccine EP HIV-1090 in Healthy HIV-1 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 Recombinant Protein Vaccine EP-1043 and the DNA Vaccine EP HIV-1090 Given Alone or in Combination 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 the study is to determine the safety of and immune response to the investigational HIV vaccine EP HIV-1090 in HIV uninfected adults
Detailed Description:
The worldwide HIVAIDS epidemic may only be controlled through the 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 EP HIV-1090 is a DNA HIV CTL vaccine the proteins for which its genes code are designed to interact with CD8 cells CTL and cause CD8 cell proliferation The DNA plasmids in EP HIV-1090 code for proteins conserved among HIV subtypes A B C D F and G which encompass the HLA subtypes of 85 of the worldwide general population
Participants will be enrolled in this study for 1 year Group 4 participants will receive EP HIV-1090 or placebo at study entry and Months 1 3 and 6 There will be 11 study visits that will occur at screening study entry and Months 05 1 15 3 35 6 65 9 and 12 A physical exam and risk reductionpregnancy prevention counseling will occur at each visit Participants will be asked about their adverse experiences from vaccination at each visit Blood and urine collection will occur at selected visits
Participants will be enrolled in this study for 1 year Group 4 participants will receive EP HIV-1090 or placebo at study entry and Months 1 3 and 6 There will be 11 study visits that will occur at screening study entry and Months 05 1 15 3 35 6 65 9 and 12 A physical exam and risk reductionpregnancy prevention counseling will occur at each visit Participants will be asked about their adverse experiences from vaccination at each visit Blood and urine collection will occur at selected visits
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 |
|---|---|---|---|
| 10059 | REGISTRY | DAIDS ES Registry Number | None |