Safety of the Herpes Zoster Subunit Vaccine in Lupus

Description

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

Systemic Lupus Erythematosus

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Study Overview

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Study Details

Study overview

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.

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Non-inferiority Crossover Study Evaluating the Safety and Immunogenicity of the Herpes Zoster Subunit Vaccine in Patients With Systemic Lupus Erythematosus

Safety of the Herpes Zoster Subunit Vaccine in Lupus

Condition
Systemic Lupus Erythematosus
Intervention / Treatment

-

Contacts and Locations

New York

NYU Langone Health, New York, New York, United States, 10016

Oklahoma City

Oklahoma Medical Research Foundation, Oklahoma City, Oklahoma, United States, 73104

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • 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

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

NYU Langone Health,

Amit Saxena, MD, PRINCIPAL_INVESTIGATOR, NYU Langone Health

Study Record Dates

2027-01