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Evaluating HIV-1 Neutralization Antibody Breadth in Response to HIV gp120 Protein Vaccine in HIV-uninfected Adults With Quiescent Systemic Lupus Erythematosus

HIV Infections Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03618056
Study type Interventional
Source National Institute of Allergy and Infectious Diseases (NIAID)
Contact
Status Completed
Phase Phase 1
Start date December 19, 2018
Completion date July 17, 2020
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