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.

NCT05559671

Safety of the Herpes Zoster Subunit Vaccine in Lupus

Recruiting
PHASE4Ages 18–90InterventionalTreatment
NYU Langone Health
~224 participants
Updated 2025-12-26 on ClinicalTrials.gov
What's tested:Herpes Zoster Subunit (HZ/su) VaccinePlacebo

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Occurrence of either Moderate or Severe Lupus Flares within 24 Weeks of First Dosing with HZ/su Vaccine
Measured over Up to Week 48
Systemic Lupus Erythematosus
2 sites across 2 states
New York1
Oklahoma1
  • Amit Saxena, MD · PRINCIPAL_INVESTIGATOR · NYU Langone Health

Opens a ready-to-send draft in your own email app — review before sending.

  • 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 \[rSFI\].