Can lupus patients safely get the shingles vaccine? new trial aims to find out
NCT ID NCT05559671
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether the shingles vaccine (Shingrix) is safe and triggers a good immune response in people with lupus, a condition that affects the immune system. About 224 adults with lupus will receive either the vaccine or a placebo, and researchers will monitor for lupus flare-ups over 24 weeks. The goal is to see if the vaccine is as safe as a placebo and if it produces enough antibodies to protect against shingles.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Herpes Zoster Subunit (HZ/su) Vaccine (Shingrix)
- What this could lead to
- If successful, this could show that the shingles vaccine is safe for people with lupus, helping protect them from shingles without causing serious disease flare-ups.
- What could go wrong
- This is a Phase 4 study, so the vaccine is already approved for others, but it's still uncertain how it will affect lupus patients. There is a risk of lupus flares or that the vaccine may not work as well in this group.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 224 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Dec 2023
- Expected to finish
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Jul 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 90 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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NYU Langone Health
RECRUITINGNew York, New York, 10016, United States
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Oklahoma Medical Research Foundation
RECRUITINGOklahoma City, Oklahoma, 73104, United States
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