Can rheumatic patients safely get multiple vaccines at once? new study investigates
NCT ID NCT05543642
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looks at how well COVID-19 booster vaccines work in people with rheumatic diseases (like arthritis) who take medications that affect their immune system. Researchers want to see if getting the COVID-19 booster at the same time as other routine vaccines (like tetanus or hepatitis A) is safe and produces a strong immune response. About 129 adults in the U.S. will participate, comparing different vaccine schedules.
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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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129 people
The number who actually took part.
- Started
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Oct 2022
- Expected to finish
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Aug 2026
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 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.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Patients must meet all of the inclusion criteria at the time of screening * Must be 18 years of age or older * Must live in the United States * Scheduled for SARS-CoV-2 booster vaccination * Patients in Rheumatic Disease arm (arm 4) must have inflammatory arthritis (e.g. rheumatoid arthritis, psoriatic arthritis, other) and be receiving stable doses of one of the following medication classes: TNF antagonists, B-cell depletion agents, IL-6 inhibitors, JAK inhibitors, IL-12/23 or IL-23 blockers, IL-17 inhibitors, methotrexate, sulfasalazine, leflunamide, or chronic prednisone (\>15mg/day). Stable dosing is defined as no change in dose in the 30 days prior to enrolment. * For Arms 1-3: patients seen by rheumatologists who do not have active rheumatic disease requiring immunosuppressive therapy. These will include patients with a past history of auto-immune disease that is no longer active, as well as those with other chronic conditions not associated with autoimmune condition such as osteoarthritis, osteoporosis, or other. * Patients in the Co-administration arms (arms 2 and 3) must meet ACIP recommendations for the use of HAVRIX® (i.e. not previously vaccinated) and BOOSTRIX® (i.e. last immunization \>9 years ago). * Patients who, in the opinion of the investigator, can and will comply with the requirements of the protocol (e.g. completion of the REDCap/diary cards, capable of receiving text messages and/or have a personal email address, return for follow-up visits). Exclusion Criteria: * Active infection with SARS-CoV-2 (symptom onset or first positive test in the 14 days prior to recruitment) / disease * Any known contraindication to SARS-CoV-2 (booster) vaccination, including severe allergy to vaccine components * Prior use of adenoviral COVID-19 vaccination * Known or history of HIV/AIDS * Currently receiving radiation or chemotherapy for any type of malignancy * Receipt of any immunizations other than SARS-CoV-2 within two weeks prior planned SARS-CoV-2 vaccination, or scheduled within 10 weeks after visit 1 * Significant underlying illness that would be expected to prevent completion of the study (e.g., life-threatening disease likely to limit survival to \< 1 year) * Patients who have a previous history of pericarditis/myocarditis associated with vaccination * Any other reason that, in the opinion of the site investigator, would interfere with required study related evaluations (e.g. uncontrolled comorbidity) * Prior receipt of any hepatitis A containing vaccine * Prior receipt of diphtheria, acellular pertussis, or tetanus vaccination within the last 9 years * History of physician-diagnosed or laboratory confirmed pertussis within the past 5 years; any history of diphtheria, tetanus disease, or hepatitis A.
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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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Altoona Center for Clinical Research
Duncansville, Pennsylvania, 16635, United States
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Center for Rheumatic Diseases
Northport, Alabama, 35473, United States
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Cumberland Rheumatology
Crossville, Tennessee, 38555, 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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Southwest Florida Rheumatology
Riverview, Florida, 33569, United States
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St. Luke's Rheumatology
Boise, Idaho, 83702, United States
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Other studies related to the condition(s) this trial covers.
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