NCT03618056

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

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
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) · NIH
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

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.

Conditions

• HIV Infections
• Systemic Lupus Erythematosus

Interventions

Type	Name	Description
BIOLOGICAL	AIDSVAX® B/E	Administered by intramuscular injection

Timeline

• Start date: 2018-12-19
• Primary completion: 2020-07-17
• Completion: 2020-07-17
• First posted: 2018-08-07
• Last updated: 2022-02-07
• Results posted: 2021-12-29

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study