To determine whether providing a recombinant booster COVID-19 vaccine improves sustainedhumoral and cell-mediated immunogenicity against SARS-CoV-2 in immunosuppressed patientswith Inflammatory Bowel Disease (IBD) and/or solid organ transplant recipients. 120participants will be enrolled and can expect to be on study for 6 months.
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 and are willing to participate in the study. At least 35
patients will have inflammatory bowel disease and at least 35 patients will be a solid
organ transplant recipient. After obtaining informed consent, individuals who meet the
inclusion criteria and none of the exclusion criteria will be invited to participate in
the study. Blood samples will be collected from each participant at the baseline visit
(V1), at 1 month post-booster (V2 visit), and 6 months post-booster (V3).
Aim 1: 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 IBD and/or solid organ transplant recipients.
The investigators hypothesize that solid organ transplant recipients receiving a
combination of immunosuppressive regimens will have lower antibody concentrations than
patients with IBD because previous work has shown that patients with IBD have higher
rates of seroconversion than solid organ transplant recipients.
Per Protocol Amendment Approved 10/23/24: The 2024-2025 season activities will not
proceed as originally planned due to the withdrawal of financial support. Study will be
completed with 21 participants per updated analyses.
Biological: NVX-CoV2372
Novavax COVID-19 Vaccine Booster for Omicron XBB.1.5
Other Name: Novavax COVID-19 Vaccine
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 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
UW School of Medicine and Public Health
Madison, Wisconsin, United States
Freddy Caldera, DO, MS, Principal Investigator
UW School of Medicine and Public Health