Actively Recruiting
Safety of the Herpes Zoster Subunit Vaccine in Lupus
Led by NYU Langone Health · Updated on 2025-12-26
224
Participants Needed
2
Research Sites
188 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This randomized, double-blind, placebo-controlled, non-inferiority crossover study will evaluate the Herpes Zoster Sunbit (HZ/su) vaccine in SLE patients in order to evaluate safety and immunogenicity in patients with variable baseline clinical activities, ages and immunosuppressant exposures. The investigators hypothesize that HZ/su administration will be non-inferior to placebo with respect to the risk of moderate or severe SLE flare(s) occurring within 24 weeks of receiving the first dose of the assigned treatment. In addition, the investigators hypothesize that immunogenicity of the vaccine in SLE patients will be at least 50% of levels observed in healthy subjects from prior large clinical trials.
CONDITIONS
Official Title
Safety of the Herpes Zoster Subunit Vaccine in Lupus
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provide informed consent before any study procedures
- Be male or female aged 18 years or older at consent
- Meet the 2019 EULAR/ACR Classification Criteria for SLE
- Female participants must use one effective pregnancy prevention method during the study unless surgically sterile, have a sterile male partner, be at least 1 year postmenopausal, or practice sustained abstinence
You will not qualify if you...
- Previous receipt of the Herpes Zoster subunit vaccine (Shingrix) or the live Varicella-Zoster virus vaccine (Zostavax)
- Herpes zoster infection within 12 months before or during screening
- Hybrid SLEDAI score greater than 12 at screening
- Presence of any mild, moderate, or severe lupus flare at screening
- Increase in clinical SLEDAI parameters at enrollment compared to screening
- Vaccination with any vaccine, including SARS-CoV-2 booster, within 6 weeks before enrollment
- Rituximab or cyclophosphamide treatment within 9 months before enrollment
- Participation in other interventional SLE or therapeutic trials within 6 months before enrollment
- Moderate to severe infectious febrile illness or systemic antibiotic use within 4 weeks before enrollment
- Pregnancy, nursing, or planned pregnancy during the study
- Known primary or secondary immunodeficiency or use of cancer chemotherapy medications
AI-Screening
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Trial Site Locations
Total: 2 locations
1
NYU Langone Health
New York, New York, United States, 10016
Actively Recruiting
2
Oklahoma Medical Research Foundation
Oklahoma City, Oklahoma, United States, 73104
Actively Recruiting
Research Team
T
Thomas Chalothron
CONTACT
J
Janine Sullivan
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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