Back to resultsSafety of the Herpes Zoster Subunit Vaccine in Lupus
Primary Purpose
Systemic Lupus Erythematosus
Status
Not yet recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Herpes Zoster Subunit (HZ/su) Vaccine
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Systemic Lupus Erythematosus focused on measuring Herpes Zoster Subunit Vaccine
Eligibility Criteria
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
Sites / Locations
- NYU Langone Health
- Oklahoma Medical Research Foundation
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
HZ/su Vaccine, then Placebo
Placebo, then HZ/su Vaccine
Arm Description
During the initial 24-week period (Period 1), participants will receive HZ/su injection at week 0 and week 8. During the second 24-week period (Period 2), participants will receive placebo saline injection at week 24 and week 32.
During the initial 24-week period (Period 1), participants will receive placebo saline injection at week 0 and week 8. During the second 24-week period (Period 2), participants will receive HZ/su injection at week 24 and week 32.
Outcomes
Primary Outcome Measures
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].
Secondary Outcome Measures
Occurrence of either Moderate or Severe Lupus Flares at Week 8
Classification of moderate or severe lupus flares based on rSFI.
Occurrence of either Moderate or Severe Lupus Flares at Week 24
Classification of moderate or severe lupus flares based on rSFI.
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.
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.
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.
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.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05559671
Brief Title
Safety of the Herpes Zoster Subunit Vaccine in Lupus
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
August 1, 2023 (Anticipated)
Primary Completion Date
August 1, 2026 (Anticipated)
Study Completion Date
August 1, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Systemic Lupus Erythematosus
Keywords
Herpes Zoster Subunit Vaccine
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
224 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
HZ/su Vaccine, then Placebo
Arm Type
Experimental
Arm Description
During the initial 24-week period (Period 1), participants will receive HZ/su injection at week 0 and week 8. During the second 24-week period (Period 2), participants will receive placebo saline injection at week 24 and week 32.
Arm Title
Placebo, then HZ/su Vaccine
Arm Type
Experimental
Arm Description
During the initial 24-week period (Period 1), participants will receive placebo saline injection at week 0 and week 8. During the second 24-week period (Period 2), participants will receive HZ/su injection at week 24 and week 32.
Intervention Type
Biological
Intervention Name(s)
Herpes Zoster Subunit (HZ/su) Vaccine
Other Intervention Name(s)
SHINGRIX
Intervention Description
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.
Intervention Type
Biological
Intervention Name(s)
Placebo
Intervention Description
Saline injection. Administered as two-time injection of 0.5 mL each at either weeks 0 and 8 or weeks 24 and 32.
Primary Outcome Measure Information:
Title
Occurrence of either Moderate or Severe Lupus Flares within 24 Weeks of First Dosing with HZ/su Vaccine
Description
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 Outcome Measure Information:
Title
Occurrence of either Moderate or Severe Lupus Flares at Week 8
Description
Classification of moderate or severe lupus flares based on rSFI.
Time Frame
Week 8
Title
Occurrence of either Moderate or Severe Lupus Flares at Week 24
Description
Classification of moderate or severe lupus flares based on rSFI.
Time Frame
Week 24
Title
Occurrence of Mild, Moderate, or Severe Lupus Flares within 24 Weeks of First Dosing with HZ/su Vaccine
Description
Classification of mild, moderate, or severe lupus flares based on rSFI.
Time Frame
Up to Week 48
Title
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
Description
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
Title
Occurrence of Increase in PGA Score by More than 0.3 Points within 24 Weeks of First Dosing with HZ/su Vaccine
Description
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
Title
Occurrence of Grade 3 or Higher Adverse Events as Per CTCAE or Solicited AIT within 24 Weeks of First Dosing with HZ/su Vaccine
Description
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
Title
Levels of Serum Varicella-Zoster Virus Anti-Glycoprotein E Antibodies at 4 Weeks after Last Dose of HZ/su Vaccine
Description
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)
Title
Levels of Serum Varicella-Zoster Virus Anti-Glycoprotein E Antibodies at 24 Weeks after First Dose of HZ/su Vaccine
Description
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)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Thomas Chalothron
Phone
646-501-7384
Email
Thomas.Chalothron@nyulangone.org
First Name & Middle Initial & Last Name or Official Title & Degree
Janine Sullivan
Phone
646-501-7390
Email
Janine.Sullivan@nyulangone.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amit Saxena, MD
Organizational Affiliation
NYU Langone Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
NYU Langone Health
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Oklahoma Medical Research Foundation
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to: Amit Saxena (Amit.Saxena@nyulangone.org). The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
IPD Sharing Time Frame
Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
IPD Sharing Access Criteria
The investigator who proposed to use the data will have access to the data upon reasonable request. Requests should be directed to Amit.Saxena@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.
Learn more about this trial
Safety of the Herpes Zoster Subunit Vaccine in Lupus
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