Additional Recombinant COVID-19 Humoral and Cell-Mediated Immunogenicity in Immunosuppressed Populations

Completed · Phase 2

Conditions studied: Immunosuppression, COVID-19

In brief

To determine whether providing a recombinant booster COVID-19 vaccine improves sustained humoral and cell-mediated immunogenicity against SARS-CoV-2 in immunosuppressed patients with Inflammatory Bowel Disease (IBD) and/or solid organ transplant recipients. 120 participants will be enrolled and can expect to be on study for 6 months.

Key facts

Study ID

NCT06027229

Run by

University of Wisconsin, Madison

People needed

21

Starts

2023-11-20

Expected to finish

2024-09-09

Last updated by the study team

2025-10-20

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• UW School of Medicine and Public Health — Madison, Wisconsin, United States

Full record on ClinicalTrials.gov

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