The COVID-19 VaccinE Response and Co-Administration in Rheumatology Patients (COVER-CoAd)

Based on the experience with influenza, pneumococcal, and shingles vaccinations in rheumatic disease populations, it is clear that some disease modifying anti-rheumatic drugs and the immunomodulatory therapies used to treat immune-mediated inflammatory diseases have the capacity to blunt immune responses to COVID-19 vaccines. Several studies have suggested that patients with autoimmune conditions may be at increased risk of poor COVID-19 outcomes. There is an urgent need to better clarify the immunogenicity and safety of COVID-19 vaccines in people living with rheumatic disease who use immunomodulatory therapies. Boosters at annual or other frequency are available, and there is a need to understand whether these vaccines can be given concurrently with other routine vaccines.

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 These will include patients with a past history of auto-immune disease that is no longer active, as well as those with other chronic conditions not associated with autoimmune condition such as osteoarthritis, osteoporosis, or other.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.