Status:
COMPLETED
Additional Recombinant COVID-19 Humoral and Cell-Mediated Immunogenicity in Immunosuppressed Populations
Lead Sponsor:
University of Wisconsin, Madison
Collaborating Sponsors:
Novavax
Conditions:
Immunosuppression
COVID-19
Eligibility:
All Genders
18-85 years
Phase:
PHASE2
Brief Summary
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 Bowe...
Detailed Description
This will be a single-center, prospective, unblinded, non-randomized study of 120 immunosuppressed patients who are planning to receive a recombinant COVID-19 vaccine booster dose as standard of care ...
Eligibility Criteria
Inclusion
- • 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
- 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
Key Trial Info
Start Date :
November 20 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 9 2024
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT06027229
Start Date
November 20 2023
End Date
September 9 2024
Last Update
October 20 2025
Active Locations (1)
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1
UW School of Medicine and Public Health
Madison, Wisconsin, United States, 53792