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Can rheumatic patients safely get multiple vaccines at once? new study investigates

NCT ID NCT05543642

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 This study
Running, but no longer taking on new participants.
Completed
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 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.

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 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

129 people

The number who actually took part.

Started

Oct 2022

Expected to finish

Aug 2026

An estimate. End dates often move.

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: * 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

  • Altoona Center for Clinical Research

    Duncansville, Pennsylvania, 16635, United States

  • Center for Rheumatic Diseases

    Northport, Alabama, 35473, United States

  • Cumberland Rheumatology

    Crossville, Tennessee, 38555, United States

  • Jayashree Sinha, MD

    Clovis, New Mexico, 88101, United States

  • Oregon Health & Science University

    Portland, Oregon, 97239, United States

  • Southwest Florida Rheumatology

    Riverview, Florida, 33569, United States

  • St. Luke's Rheumatology

    Boise, Idaho, 83702, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.