Ignite Creation Date:
2025-12-25 @ 12:12 AM
Ignite Modification Date:
2025-12-25 @ 10:14 PM
Study NCT ID:
NCT03560258
Status:
COMPLETED
Last Update Posted:
2022-04-26
First Post:
2018-06-06
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
HIV-1-Gag Conserved-Element DNA Vaccine (p24CE) Vaccine Study
Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Organization:
Study Overview
Official Title:
HIV-1-Gag Conserved-Element DNA Vaccine (p24CE) as Therapeutic Vaccination in HIV-Infected Persons With Viral Suppression on Antiretroviral Therapy
Status:
COMPLETED
Status Verified Date:
2022-03
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 evaluated the safety, immunogenicity, and preliminary assessment of efficacy of a novel vaccine encoding conserved elements (CE) of the HIV-1 Gag core protein, p24Gag, as a therapeutic vaccine in HIV-1 infected persons who were on antiretroviral therapy (ART). The study aimed to induce potent virus-specific cytotoxic T lymphocytes (CTL) responses.
Detailed Description:
This study evaluated the safety, immunogenicity, and preliminary assessment of efficacy of a novel vaccine encoding conserved elements (CE) of the HIV-1 Gag core protein, p24Gag, as a therapeutic vaccine in HIV-1 infected persons who were on antiretroviral therapy (ART).
The study randomly assigned participants to one of three groups. Participants in Arm 1 received p24CE1/2 pDNA vaccine at Weeks 0 and 4, followed by p24CE1/2 pDNA admixed with full-length p55\^gag pDNA vaccine at Weeks 12 and 24. Participants in Arm 2 received full-length p55\^gag pDNA vaccine at Weeks 0, 4, 12, and 24. Participants in Arm 3 received placebo at Weeks 0, 4, 12, and 24.
Study visits occurred at Weeks 0, 4, 6, 12, 24, 26, and 48 and included physical examinations and blood and urine collection. Some participants underwent leukapheresis and stool sample collection.
The study randomly assigned participants to one of three groups. Participants in Arm 1 received p24CE1/2 pDNA vaccine at Weeks 0 and 4, followed by p24CE1/2 pDNA admixed with full-length p55\^gag pDNA vaccine at Weeks 12 and 24. Participants in Arm 2 received full-length p55\^gag pDNA vaccine at Weeks 0, 4, 12, and 24. Participants in Arm 3 received placebo at Weeks 0, 4, 12, and 24.
Study visits occurred at Weeks 0, 4, 6, 12, 24, 26, and 48 and included physical examinations and blood and urine collection. Some participants underwent leukapheresis and stool sample collection.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 38398 | REGISTRY | DAIDS-ES Registry Number | View |