New COVID-19 booster studied for vulnerable patients

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: • Patient has a history of ulcerative colitis (UC), Crohn's disease, pouchitis, or indeterminate colitis diagnosed by standard clinical, radiographic, endoscopic, and histopathologic criteria. And / or patient is a solid organ transplant recipient (e.g. lung, kidney, liver) * Have received at least three doses of a COVID-19 vaccine. * Three messenger RNA (mRNA) vaccines, or * One or two viral vector vaccine and one or two mRNA vaccines. * Female participant of non-childbearing potential (pre-menarche, current tubal ligation, hysterectomy, oophorectomy or post-menopause) and childbearing potential (if they had: practiced adequate contraception for 1 month prior to vaccination and agreement to use such for an additional 8 weeks after administration of the Novavax COVID-19 vaccine). Non-pregnant females with a negative pregnancy test who are willing to practice adequate contraception 8 weeks after administration of the Novavax COVID-19 vaccine. * On one of the following treatment regimens * IBD * Thiopurine Therapy Group: on azathioprine at least 2.0mg/kg or 6MP 1.0mg/kg * Anti-TNF Therapy Group: on maintenance therapy infliximab (at least 8 every 8 weeks), golimumab (at least monthly), adalimumab (at least every 2 weeks), or certolizumab (at least monthly) * Anti-TNF Combination Therapy Group: on anti-TNF therapy as described above along with either 15mg of methotrexate or azathioprine at least 1.0mg/kg or 6MP 0.5mg/kg. * Vedolizumab Therapy Group: either vedolizumab monotherapy at least every 8 week dosing or combination therapy Group: on vedolizumab therapy at with azathioprine or methotrexate * Ustekinumab Therapy Group: either ustekinumab monotherapy or combination therapy with methotrexate or azathioprine. * Tofacitinib Therapy Group: on tofacitinib at least 5mg orally, twice per day * Risankizumab Therapy: 360mg at least every 8 weeks * Upadactinib Therapy Group: on upadactinib at least 15mg orally * Ozanimod: 0.92mg once daily * Solid organ transplant recipient (on any dose of the following regimens: patients can be on more than one of the regimens below) * Mycophenolate * Tacrolimus or cyclosporine * Sirolimus or everolimus * Azathioprine * Corticosteroids * Belatacept Exclusion Criteria: * Allergy to recombinant COVID-19 vaccine or any component of it * Patient cannot or will not provide written informed consent. * Unable to provide appropriate informed consent because of illiteracy or impairment in decision-making capacity. * Active antibody-mediated or cellular rejection within the past six months * Recent IBD flare requiring initiation of systemic corticosteroids within the past month. * Previous history of myocarditis or pericarditis ever. * Patients who are pregnant * Patients who are lactating * Patients with an active COVID-19 infection * Patients with a COVID-19 infection within the past two months