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NCT Number: NCT05559671

Safety of the Herpes Zoster Subunit Vaccine in Lupus

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.

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Key information

Conditions

Systemic Lupus Erythematosus Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Lupus Erythematosus, Systemic Skin and Connective Tissue Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

NYU Langone Health, New York, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Provision of informed consent prior to any study specific procedures
  • Female or male ≥18 years of age at the time of signing the informed consent
  • Meet the 2019 EULAR/ACR Classification Criteria for SLE
  • 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

  • Prior administration of the Herpes Zoster subunit vaccine (Shingrix) or the Varicella-Zoster virus vaccine live (Zostavax)
  • Clinical HZ infection within 12 months prior to screening or during screening
  • Hybrid SLEDAI >12 at screening visit
  • Presence of a mild, moderate, or severe flare per the rSFI at time of screenin
  • Increase in clinical SLEDAI parameters at time of enrollment relative to screening visit
  • Any vaccine, including the final/booster dose of any SARS-CoV-2 vaccine, within six weeks enrollment
  • Receipt of rituximab or cyclophosphamide within nine months of enrollment
  • Participation in an interventional clinical trial of SLE or other therapeutics within six months of enrollment
  • Moderate to severe infectious febrile illness or use of systemic antibiotics (antibacterial, antiviral, antifungal, or antiparasitic agent) within 4 weeks of enrollment
  • Are pregnant, nursing, or planning a pregnancy while enrolled in the study
  • Known primary or secondary immunodeficiency (malignancy, HIV, common variable immune deficiency) or medications used during cancer chemotherapy

Treatment and study plan

Herpes Zoster Subunit (HZ/su) Vaccine

Biological

Manufactured by GSK Biologicals SA. Administered as two-time injection of 0.5 mL each at either weeks 0 and 8 or weeks 24 and 32.

Other names: SHINGRIX

Placebo

Biological

Saline injection. Administered as two-time injection of 0.5 mL each at either weeks 0 and 8 or weeks 24 and 32.

Primary outcomes

  1. Occurrence of either Moderate or Severe Lupus Flares within 24 Weeks of First Dosing with HZ/su Vaccine

    Time frame: Up to Week 48

    Classification of moderate or severe lupus flares based on revised Safety of Estrogens in Lupus Erythematosus, National Assessment (SELENA) Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) Flare Index [rSFI].

Secondary outcomes

  1. Occurrence of either Moderate or Severe Lupus Flares at Week 8

    Time frame: Week 8

    Classification of moderate or severe lupus flares based on rSFI.

  2. Occurrence of either Moderate or Severe Lupus Flares at Week 24

    Time frame: Week 24

    Classification of moderate or severe lupus flares based on rSFI.

  3. Occurrence of Mild, Moderate, or Severe Lupus Flares within 24 Weeks of First Dosing with HZ/su Vaccine

    Time frame: Up to Week 48

    Classification of mild, moderate, or severe lupus flares based on rSFI.

  4. 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

    The British Isles Lupus Assessment Group (BILAG) 2004 scores disease involvement within nine organ systems. Each of the 101 items are rated as 0 (not present), 1 (improving), 2 (same), 3 (worse), or 4 (new) in the last 4 weeks, compared with the previous 4 weeks.

  5. 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

    Physician's Global Assessment (PGA) is a 10-cm visual analogue scale (VAS) anchored at 0 (none) and 3 (severe) with intermediate lines at 1 (mild) and 2 (moderate). Higher scores indicate greater severity of disease activity.

  6. 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

    Common terminology criteria for adverse events (CTCAE) and solicited assessments of intensity and toxicity (AIT) used to grade severity of adverse events.

  7. 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)

    Antibody levels measured using patient blood samples.

  8. 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)

    Antibody levels measured using patient blood samples.

Study contacts

Contact information is provided by the study sponsor or research team.

Janine Sullivan

CONTACT

[email protected]

646-501-7390

Thomas Chalothron

CONTACT

[email protected]

646-501-7384

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Sep 29, 2022
Registry last updated
Dec 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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