Safety of the Herpes Zoster Subunit Vaccine in Lupus
This randomized, double-blind, placebo-controlled, non-inferiority crossover study will assess the Herpes Zoster Sunbit (HZ/su) vaccine in SLE patients in order to assess 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:
🦠 Systemic Lupus Erythematosus
🗓️ Study Start (Actual) 21 December 2023
🗓️ Primary Completion (Estimated) January 2027
✅ Study Completion (Estimated) January 2027
👥 Enrollment (Estimated) 224
🔬 Study Type INTERVENTIONAL
📊 Phase PHASE4
Locations:
📍 New York, New York, United States
📍 Oklahoma City, Oklahoma, United States

📋 Eligibility Criteria

Description

    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
Ages Eligible for Study: 18 Years to 90 Years (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 26 September 2022
  • First Submitted that Met QC Criteria 26 September 2022
  • First Posted 29 September 2022

Study Record Updates

  • Last Update Submitted that Met QC Criteria 16 February 2024
  • Last Update Posted 20 February 2024
  • Last Verified February 2024