Shingles vaccine study shows promise for rheumatoid arthritis patients

NCT ID NCT03604406

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

154 people

The number who actually took part.

Started

May 2014

Finished

Jan 2026

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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

  • Arthritis Associates

    Hixson, Tennessee, 37343, United States

  • Jayashree Sinha, MD

    Clovis, New Mexico, 88101, United States

  • Oregon Health & Science University

    Portland, Oregon, 97239, United States

  • St. Luke's Health System

    Boise, Idaho, 83702, United States

  • St. Paul Rheumatology

    Eagan, Minnesota, 55121, United States

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