Additional Recombinant COVID-19 Humoral and Cell-Mediated Immunogenicity in Immunosuppressed Popu… (NCT06027229) | Clinical Trial Compass
CompletedPhase 2
Additional Recombinant COVID-19 Humoral and Cell-Mediated Immunogenicity in Immunosuppressed Populations
United States21 participantsStarted 2023-11-20
Plain-language 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 Bowel Disease (IBD) and/or solid organ transplant recipients. 120 participants will be enrolled and can expect to be on study for 6 months.
Who can participate
Age range18 Years – 85 Years
SexALL
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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.
* Vedolizu…
What they're measuring
1
Change in Antibody Concentration From Baseline (Visit 1) at 1 Month (Visit 2)