RECRUITING

Safety of the Herpes Zoster Subunit Vaccine in Lupus

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Systemic Lupus ErythematosusHerpes Zoster Subunit Vaccine

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2023-12-21
Study Completion:2027-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05559671

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.

Ages Eligible for Study:18 Years to 90 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Provision of informed consent prior to any study specific procedures
  2. 2. Female or male ≥18 years of age at the time of signing the informed consent
  3. 3. Meet the 2019 EULAR/ACR Classification Criteria for SLE
  4. 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. 1. Prior administration of the Herpes Zoster subunit vaccine (Shingrix) or the Varicella-Zoster virus vaccine live (Zostavax)
  2. 2. Clinical HZ infection within 12 months prior to screening or during screening
  3. 3. Hybrid SLEDAI \>12 at screening visit
  4. 4. Presence of a mild, moderate, or severe flare per the rSFI at time of screenin
  5. 5. Increase in clinical SLEDAI parameters at time of enrollment relative to screening visit
  6. 6. Any vaccine, including the final/booster dose of any SARS-CoV-2 vaccine, within six weeks enrollment
  7. 7. Receipt of rituximab or cyclophosphamide within nine months of enrollment
  8. 8. Participation in an interventional clinical trial of SLE or other therapeutics within six months of enrollment
  9. 9. Moderate to severe infectious febrile illness or use of systemic antibiotics (antibacterial, antiviral, antifungal, or antiparasitic agent) within 4 weeks of enrollment
  10. 10. Are pregnant, nursing, or planning a pregnancy while enrolled in the study
  11. 11. Known primary or secondary immunodeficiency (malignancy, HIV, common variable immune deficiency) or medications used during cancer chemotherapy

Contacts and Locations

Study Contact

Thomas Chalothron
CONTACT
646-501-7384
Thomas.Chalothron@nyulangone.org
Janine Sullivan
CONTACT
646-501-7390
Janine.Sullivan@nyulangone.org

Principal Investigator

Amit Saxena, MD
PRINCIPAL_INVESTIGATOR
NYU Langone Health

Study Locations (Sites)

NYU Langone Health
New York, New York, 10016
United States
Oklahoma Medical Research Foundation
Oklahoma City, Oklahoma, 73104
United States

Collaborators and Investigators

Sponsor: NYU Langone Health

  • Amit Saxena, MD, PRINCIPAL_INVESTIGATOR, NYU Langone Health

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

Study Start Date2023-12-21
Study Completion Date2027-01

Study Record Updates

Study Start Date2023-12-21
Study Completion Date2027-01

Terms related to this study

Keywords Provided by Researchers

  • Herpes Zoster Subunit Vaccine

Additional Relevant MeSH Terms

  • Systemic Lupus Erythematosus