Safety of the Herpes Zoster Subunit Vaccine in Lupus

• Register: ClinicalTrials.gov
• Last refreshed on: 17 February 2025
• Main ID: NCT05559671
• Date of registration: 26/09/2022
• Prospective Registration: Yes
• Primary sponsor: NYU Langone Health
• Public title: Safety of the Herpes Zoster Subunit Vaccine in Lupus
• Scientific 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
• Date of first enrolment: December 21, 2023
• Target sample size: 224
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/ct2/show/NCT05559671
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: Phase 4

Countries of recruitment

United States

Contacts

• Name: Amit Saxena, MD
• Affiliation: NYU Langone Health

• Name: Thomas Chalothron

• Name: Cristina Arriens

Key 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


Age minimum: 18 Years
Age maximum: 90 Years
Gender: All

Health Condition(s) or Problem(s) studied

Systemic Lupus Erythematosus

Intervention(s)

Biological: Herpes Zoster Subunit (HZ/su) Vaccine

Biological: Placebo

Primary Outcome(s)

Occurrence of either Moderate or Severe Lupus Flares within 24 Weeks of First Dosing with HZ/su Vaccine [Time Frame: Up to Week 48]

Secondary Outcome(s)

Levels of Serum Varicella-Zoster Virus Anti-Glycoprotein E Antibodies at 4 Weeks after Last Dose of HZ/su Vaccine [Time Frame: 4 Weeks after Last Dose of HZ/su Vaccine (Week 12 for Vaccine, then Placebo Arm; Week 36 for Placebo, then Vaccine Arm)]

Occurrence of Grade 3 or Higher Adverse Events as Per CTCAE or Solicited AIT within 24 Weeks of First Dosing with HZ/su Vaccine [Time Frame: Up to Week 48]

Occurrence of New or Worsening Disease Activity in Any Organ System as Identified by BILAG 2004 within 24 Weeks of First Dosing with HZ/su Vaccine [Time Frame: Up to Week 48]

Occurrence of either Moderate or Severe Lupus Flares at Week 24 [Time Frame: Week 24]

Occurrence of Mild, Moderate, or Severe Lupus Flares within 24 Weeks of First Dosing with HZ/su Vaccine [Time Frame: Up to Week 48]

Levels of Serum Varicella-Zoster Virus Anti-Glycoprotein E Antibodies at 24 Weeks after First Dose of HZ/su Vaccine [Time Frame: 24 Weeks after First Dose of HZ/su vaccine (Week 24 for Vaccine, then Placebo Arm; Week 48 for Placebo, then Vaccine Arm)]

Occurrence of either Moderate or Severe Lupus Flares at Week 8 [Time Frame: Week 8]

Occurrence of Increase in PGA Score by More than 0.3 Points within 24 Weeks of First Dosing with HZ/su Vaccine [Time Frame: Up to Week 48]

Secondary ID(s)

22-00922

Source(s) of Monetary Support

Please refer to primary and secondary sponsors