Safety of the Herpes Zoster Subunit Vaccine in Lupus

Phase 4RecruitingNCT05559671

NYU Langone Health224 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

224

Conditions

Systemic Lupus Erythematosus

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 90 Years

Medical Language ↔ Plain English

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

Locations (2)

NYU Langone Health

New York, New York, United States

RECRUITING

Oklahoma Medical Research Foundation

Oklahoma City, Oklahoma, United States

RECRUITING

Outcomes

Primary Outcomes

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

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 \[rSFI\].

Time frame: Up to Week 48

Secondary Outcomes

Occurrence of either Moderate or Severe Lupus Flares at Week 8

Classification of moderate or severe lupus flares based on rSFI.

Time frame: Week 8

Occurrence of either Moderate or Severe Lupus Flares at Week 24

Classification of moderate or severe lupus flares based on rSFI.

Time frame: Week 24

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

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

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

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.

Time frame: Up to Week 48

Occurrence of Increase in PGA Score by More than 0.3 Points within 24 Weeks of First Dosing with HZ/su Vaccine

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.

Time frame: Up to Week 48

Occurrence of Grade 3 or Higher Adverse Events as Per CTCAE or Solicited AIT within 24 Weeks of First Dosing with HZ/su Vaccine

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

Time frame: Up to Week 48

Levels of Serum Varicella-Zoster Virus Anti-Glycoprotein E Antibodies at 4 Weeks after Last Dose of HZ/su Vaccine

Antibody levels measured using patient blood samples.

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)

Levels of Serum Varicella-Zoster Virus Anti-Glycoprotein E Antibodies at 24 Weeks after First Dose of HZ/su Vaccine

Antibody levels measured using patient blood samples.

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)

Safety of the Herpes Zoster Subunit Vaccine in Lupus

Overview

Conditions

Interventions

Eligibility

Locations (2)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts