Safety of the Herpes Zoster Subunit Vaccine in Lupus

Last updated: February 4, 2025
Sponsor: NYU Langone Health
Overall Status: Active - Recruiting

Phase

4

Condition

Systemic Lupus Erythematosus

Chickenpox (Varicella Zoster Infection)

Shingles

Treatment

Herpes Zoster Subunit (HZ/su) Vaccine

Placebo

Clinical Study ID

NCT05559671
22-00922
  • Ages 18-90
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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 timethey sign consent until end of the study period unless the subject is surgicallysterile (e.g., bilateral oophorectomy or complete hysterectomy), has a sterile malepartner, is at least 1 year postmenopausal, or practices sustained abstinenceconsistent with the subject's customary lifestyle. Postmenopausal is defined as atleast 1 year since last menses and the subject has an elevated follicle-stimulatinghormone (FSH) level greater than the threshold laboratory value of post-menopausalwomen at screening.

Exclusion

Exclusion Criteria:

  1. Prior administration of the Herpes Zoster subunit vaccine (Shingrix) or theVaricella-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 screeningvisit

  6. Any vaccine, including the final/booster dose of any SARS-CoV-2 vaccine, within sixweeks enrollment

  7. Receipt of rituximab or cyclophosphamide within nine months of enrollment

  8. Participation in an interventional clinical trial of SLE or other therapeuticswithin 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 ofenrollment

  10. Are pregnant, nursing, or planning a pregnancy while enrolled in the study

  11. Known primary or secondary immunodeficiency (malignancy, HIV, common variable immunedeficiency) or medications used during cancer chemotherapy

Study Design

Total Participants: 224
Treatment Group(s): 2
Primary Treatment: Herpes Zoster Subunit (HZ/su) Vaccine
Phase: 4
Study Start date:
December 21, 2023
Estimated Completion Date:
January 31, 2027

Connect with a study center

  • NYU Langone Health

    New York, New York 10016
    United States

    Active - Recruiting

  • Oklahoma Medical Research Foundation

    Oklahoma City, Oklahoma 73104
    United States

    Active - Recruiting

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