Evaluating the safety of a herpes zoster vaccine in lupus patients
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
This study is testing if a herpes zoster vaccine is safe for people with lupus and if it helps their immune system respond well.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 224 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Sponsor | NYU Langone Health Academic / other |
| Drugs / interventions | rituximab, chemotherapy, cyclophosphamide |
| Locations | 2 sites (New York, New York and 1 other locations) |
| Trial ID | NCT05559671 on ClinicalTrials.gov |
What this trial studies
This interventional study aims to assess the safety and immunogenicity of the Herpes Zoster Subunit (HZ/su) vaccine in patients with Systemic Lupus Erythematosus (SLE). It is a randomized, double-blind, placebo-controlled, non-inferiority crossover design, where participants will receive either the vaccine or a placebo. The study will monitor the occurrence of moderate or severe SLE flare-ups within 24 weeks post-vaccination and compare the immune response to that observed in healthy individuals from previous trials. The goal is to determine if the vaccine is safe and effective for this specific patient population.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who have been diagnosed with Systemic Lupus Erythematosus.
Not a fit: Patients who have previously received the herpes zoster subunit vaccine or have an active herpes zoster infection may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a safe vaccination option against herpes zoster for lupus patients, potentially reducing their risk of infection.
How similar studies have performed: Other studies have shown promising results with similar vaccine approaches in different patient populations, but this specific application in lupus patients is novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
New York, New York and 1 other locations
- NYU Langone Health — New York, New York, United States (Recruiting)
- Oklahoma Medical Research Foundation — Oklahoma City, Oklahoma, United States (Recruiting)
Study contacts
- Principal investigator: Amit Saxena, MD — NYU Langone Health
- Study coordinator: Thomas Chalothron
- Email: Thomas.Chalothron@nyulangone.org
- Phone: 646-501-7384
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.