Safety of the Herpes Zoster Subunit Vaccine in Lupus

Launched by NYU LANGONE HEALTH · Sep 26, 2022

Keywords

ClinConnect Summary

This clinical trial is studying the safety of a vaccine called the Herpes Zoster subunit vaccine (HZ/su) in people with Systemic Lupus Erythematosus (SLE), a condition that affects the immune system. Researchers want to see if this vaccine is as safe as a placebo (an inactive substance) and whether it produces a strong enough immune response in SLE patients. The trial will involve adults aged 18 and older who have been diagnosed with SLE and are not currently experiencing severe flares of their condition.

Eligible participants will need to provide consent and meet specific criteria, such as being at least 18 years old and having a confirmed diagnosis of SLE. Women in the study will need to use effective birth control during the trial. If you decide to take part, you will receive either the vaccine or a placebo, and neither you nor the researchers will know which one you received until the end of the study. This trial is currently recruiting participants, and it aims to ensure that the vaccine is safe for those living with lupus while also measuring how well it works.

Gender

ALL

Eligibility criteria

• 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