Shingles vaccine study shows promise for rheumatoid arthritis patients
NCT ID NCT03604406
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looked at how safe and effective two shingles vaccines (Zostavax and Shingrix) are in people with rheumatoid arthritis who are taking the drug abatacept. About 154 adults took part, and researchers measured their immune response and any side effects. The goal was to see if these vaccines work well in this specific group of patients.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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154 people
The number who actually took part.
- Started
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May 2014
- Finished
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Jan 2026
- 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 years and older
- 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 include: * be \>= 50 years of age or older (for the Zostavax® sub-study only) * be \>= 18 years of age or older (for the Shingrix® sub-study only) * be currently treated with abatacept therapy at the time of enrollment * Eligible women must be post-menopausal (\> 1 year since last menstrual period) or have a surgical history of bilateral oophorectomy or hysterectomy (for the Zostavax® sub-study only). * Female participants of childbearing potential may be enrolled in the study if the participant (for the Shingrix® sub-study only): * Has practiced adequate contraception for 30 days prior to vaccination; and * Has a negative urine pregnancy test on the day of the first vaccination; and * Has agreed to continue adequate contraception during the primary treatment period and for 2 months after completion of the vaccination series (Week 16) * Patients must have a history of prior chicken pox (for the Zostavax® sub-study only; for patients who do not recall prior chicken pox, a positive varicella IgG serology can be used to document prior exposure) Exclusion criteria include: * prior Zostavax® receipt (for the Zostavax® sub-study only; the Shingrix® sub-study will allow prior Zostavax® receipt if 6 months or greater prior to enrollment) * active contraindications to vaccination including allergy or sensitivity to gelatin or any other vaccine component * acute illness or infection * HIV/AIDS * current systemic corticosteroid use (including any oral or parenteral use in the previous 28 days) \[NOTE: this exclusion applies only for the Zostavax® portion of the study\] * methotrexate use \> 25 mg/week * dose of DMARDs not stable for \> 30 days * concomitant TNF antagonist use * receiving radiation or chemotherapy for cancer treatment * current leukemia * lymphoma, or other cancer affecting bone marrow or lymphatic system * cellular immunodeficiency * current use (within the last 30 days) of anti-viral medications against the herpesvirus family * Received any live virus vaccine within 28 days prior to study entry (Zostavax® sub-study only) * Administration or planned administration of any live vaccine \<28 days before the first study vaccination or through 28 days after the second study vaccination (Shingrix ® sub-study only) * received any inactivated vaccine within 7 days prior to study entry (Zostavax® sub-study only) * Received any inactivated vaccine +/- 14 days of each study injection (Shingrix ® sub-study only) * known household contacts who may be susceptible to a live virus vaccine (e.g. pregnant women) \[NOTE: this exclusion for the Zostavax® sub-study only\]
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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.
Contacts and locations
Locations
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Arthritis Associates
Hixson, Tennessee, 37343, United States
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Jayashree Sinha, MD
Clovis, New Mexico, 88101, United States
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Oregon Health & Science University
Portland, Oregon, 97239, United States
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St. Luke's Health System
Boise, Idaho, 83702, United States
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St. Paul Rheumatology
Eagan, Minnesota, 55121, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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