Safety of the Herpes Zoster Subunit Vaccine in Lupus

Systemic Lupus Erythematosus Clinical Trial

Official 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05559671
• Other study ID #: 22-00922
• Status: Recruiting
• Phase: Phase 4
• Start date: December 21, 2023
• Est. completion date: January 2027

Study information

• Verified date: February 2024
• Source: NYU Langone Health
• Contact: Thomas Chalothron
• Phone: 646-501-7384
• Email: Thomas.Chalothron[@]nyulangone.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 224
• Est. completion date: January 2027
• Est. primary completion date: January 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Herpes Zoster
• Lupus Erythematosus, Systemic
• Systemic Lupus Erythematosus

Intervention

Biological:
• Herpes Zoster Subunit (HZ/su) Vaccine
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.
• Placebo
Saline injection. Administered as two-time injection of 0.5 mL each at either weeks 0 and 8 or weeks 24 and 32.

Locations

Country	Name	City	State
United States	NYU Langone Health	New York	New York
United States	Oklahoma Medical Research Foundation	Oklahoma City	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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].	Up to Week 48
Secondary	Occurrence of either Moderate or Severe Lupus Flares at Week 8	Classification of moderate or severe lupus flares based on rSFI.	Week 8
Secondary	Occurrence of either Moderate or Severe Lupus Flares at Week 24	Classification of moderate or severe lupus flares based on rSFI.	Week 24
Secondary	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.	Up to Week 48
Secondary	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.	Up to Week 48
Secondary	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.	Up to Week 48
Secondary	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.	Up to Week 48
Secondary	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.	4 Weeks after Last Dose of HZ/su Vaccine (Week 12 for Vaccine, then Placebo Arm; Week 36 for Placebo, then Vaccine Arm)
Secondary	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.	24 Weeks after First Dose of HZ/su vaccine (Week 24 for Vaccine, then Placebo Arm; Week 48 for Placebo, then Vaccine Arm)