Evaluating the safety of a herpes zoster vaccine in lupus patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study aims to assess the safety and immunogenicity of the Herpes Zoster Subunit (HZ/su) vaccine in patients with Systemic Lupus Erythematosus (SLE). It is a randomized, double-blind, placebo-controlled, non-inferiority crossover design, where participants will receive either the vaccine or a placebo. The study will monitor the occurrence of moderate or severe SLE flare-ups within 24 weeks post-vaccination and compare the immune response to that observed in healthy individuals from previous trials. The goal is to determine if the vaccine is safe and effective for this specific patient population.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Provision of informed consent prior to any study specific procedures
2. Female or male ≥18 years of age at the time of signing the informed consent
3. Meet the 2019 EULAR/ACR Classification Criteria for SLE
4. Female subjects must use 1 effective method of avoiding pregnancy, from the time they sign consent until end of the study period unless the subject is surgically sterile (e.g., bilateral oophorectomy or complete hysterectomy), has a sterile male partner, is at least 1 year postmenopausal, or practices sustained abstinence consistent with the subject's customary lifestyle. Postmenopausal is defined as at least 1 year since last menses and the subject has an elevated follicle-stimulating hormone (FSH) level greater than the threshold laboratory value of post-menopausal women at screening.

Exclusion Criteria:

1. Prior administration of the Herpes Zoster subunit vaccine (Shingrix) or the Varicella-Zoster virus vaccine live (Zostavax)
2. Clinical HZ infection within 12 months prior to screening or during screening
3. Hybrid SLEDAI \>12 at screening visit
4. Presence of a mild, moderate, or severe flare per the rSFI at time of screenin
5. Increase in clinical SLEDAI parameters at time of enrollment relative to screening visit
6. Any vaccine, including the final/booster dose of any SARS-CoV-2 vaccine, within six weeks enrollment
7. Receipt of rituximab or cyclophosphamide within nine months of enrollment
8. Participation in an interventional clinical trial of SLE or other therapeutics within six months of enrollment
9. Moderate to severe infectious febrile illness or use of systemic antibiotics (antibacterial, antiviral, antifungal, or antiparasitic agent) within 4 weeks of enrollment
10. Are pregnant, nursing, or planning a pregnancy while enrolled in the study
11. Known primary or secondary immunodeficiency (malignancy, HIV, common variable immune deficiency) or medications used during cancer chemotherapy

Where it's running

• NYU Langone Health
  New York, New York, United States Recruiting
• Oklahoma Medical Research Foundation
  Oklahoma City, Oklahoma, United States Recruiting

Study contacts

• Principal investigator: Amit Saxena, MD — NYU Langone Health
• Study coordinator: Thomas Chalothron
• Email: Thomas.Chalothron@nyulangone.org
• Phone: 646-501-7384

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.