Safety of the Herpes Zoster Subunit Vaccine in Lupus
This study is looking at the safety of the Herpes Zoster Subunit (HZ/su) Vaccine, which helps prevent shingles, in people with Systemic Lupus Erythematosus (SLE). Researchers want to see if this vaccine is as safe as a placebo (a saline injection) for people with lupus, specifically regarding the risk of moderate or severe lupus flares. They also want to see how well the vaccine helps the immune system in people with lupus. You may be able to join if you are 18 to 90 years old and have been diagnosed with SLE. The study aims to enroll 224 participants. The current status of the study is unclear.
- Study design
- This is a randomized, double-blind, placebo-controlled crossover study, meaning participants will be randomly assigned to receive either the vaccine or a placebo, and neither you nor your doctor will know which you receive. The study plans to enroll 224 participants.
- What's involved
- You would receive two injections of either the vaccine or a placebo, given at specific times (weeks 0 and 8 or weeks 24 and 32).
- Compensation
- Not stated in the trial record.
- Follow-up
- Researchers will monitor you for moderate or severe lupus flares for up to 48 weeks after your first dose.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Safety of the Herpes Zoster Subunit Vaccine in Lupus
At a glance
Conditions
Where it's being run
2 sites across 2 statesStudy leadership
- Amit Saxena, MD · PRINCIPAL_INVESTIGATOR · NYU Langone Health
Who to contact
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What this trial measures
- Occurrence of either Moderate or Severe Lupus Flares within 24 Weeks of First Dosing with HZ/su VaccineUp 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 \[rSFI\].