NCT05559671 Safety of the Herpes Zoster Subunit Vaccine in Lupus
| NCT ID | NCT05559671 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | NYU Langone Health |
| Condition | Systemic Lupus Erythematosus |
| Study Type | INTERVENTIONAL |
| Enrollment | 224 participants |
| Start Date | 2023-12-21 |
| Primary Completion | 2027-07-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 224 participants in total. It began in 2023-12-21 with a primary completion date of 2027-07-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Amit Saxena, MD
PRINCIPAL INVESTIGATOR
NYU Langone Health
Frequently Asked Questions
Who can join the NCT05559671 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 90 Years, studying Systemic Lupus Erythematosus. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05559671 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT05559671 currently recruiting?
Yes, NCT05559671 is actively recruiting participants. Contact the research team at Thomas.Chalothron@nyulangone.org for enrollment information.
Where is the NCT05559671 trial being conducted?
This trial is being conducted at New York, United States, Oklahoma City, United States.
Who is sponsoring the NCT05559671 clinical trial?
NCT05559671 is sponsored by NYU Langone Health. The principal investigator is Amit Saxena, MD at NYU Langone Health. The trial plans to enroll 224 participants.
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