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Tests treatment safety and results for Systemic Lupus Erythematosus
Official title Safety of the Herpes Zoster Subunit Vaccine in Lupus
ClinicalTrials.gov ID: NCT05559671
What this study is testing
What is Herpes Zoster Subunit (HZ/su) Vaccine?
Herpes Zoster Subunit (HZ/su) Vaccine is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for systemic lupus erythematosus.
Also referred to as SHINGRIX.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 90
You may be able to join if
- 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 people must use 1 effective method of avoiding pregnancy, from the time they sign consent until end of the study period unless the subject is...
You likely can't join if
- 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
See the full eligibility 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 people 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...
- 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 treatment 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
The study team makes the final eligibility decision.
Where it's taking place
- New York, New York, United States
- Oklahoma City, Oklahoma, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 90 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New York, New York, United States; Oklahoma City, Oklahoma, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.