Ignite Creation Date:
2025-12-24 @ 11:37 PM
Ignite Modification Date:
2026-02-21 @ 9:24 PM
Study NCT ID:
NCT03618056
Status:
COMPLETED
Last Update Posted:
2022-02-07
First Post:
2018-08-01
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Evaluating HIV-1 Neutralization Antibody Breadth in Response to HIV gp120 Protein Vaccine in HIV-uninfected Adults With Quiescent Systemic Lupus Erythematosus
Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Organization:
Study Overview
Official Title:
A Phase 1b Open Label Clinical Trial to Evaluate HIV-1 Neutralization Antibody Breadth in Response to HIV gp120 Protein Vaccine in HIV-uninfected Adults With Quiescent Systemic Lupus Erythematosus
Status:
COMPLETED
Status Verified Date:
2022-01
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 evaluate the breadth and potency of HIV-1 neutralizing antibody (nAb) responses and examine the safety and tolerability of an HIV gp120 protein vaccine (AIDSVAX® B/E) in HIV-uninfected adults diagnosed with Systemic Lupus Erythematosus (SLE) who have stable disease.
Detailed Description:
This study will evaluate the breadth and potency of HIV-1 neutralizing antibody (nAb) responses and examine the safety and tolerability of an HIV gp120 protein vaccine (AIDSVAX® B/E) in HIV-uninfected adults diagnosed with Systemic Lupus Erythematosus (SLE) who have stable disease.
All participants will receive 600 mcg/mL of AIDSVAX® B/E at Months 0, 1, and 6.
Study visits will occur at Months 0, 0.25, 0.5, 1, 1.25, 1.5, 3, 6, 6.25, 6.5, 7.5, 8.5, and 12. Visits may include physical examinations, blood and urine collection, pregnancy testing, HIV testing, risk reduction counseling, assessments, and questionnaires.
All participants will receive 600 mcg/mL of AIDSVAX® B/E at Months 0, 1, and 6.
Study visits will occur at Months 0, 0.25, 0.5, 1, 1.25, 1.5, 3, 6, 6.25, 6.5, 7.5, 8.5, and 12. Visits may include physical examinations, blood and urine collection, pregnancy testing, HIV testing, risk reduction counseling, assessments, and questionnaires.
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 |
|---|---|---|---|---|
| 38162 | REGISTRY | DAIDS-ES Registry Number | View |