Phase 2
Completed N=20
Additional Recombinant COVID-19 Humoral and Cell-Mediated Immunogenicity in Immunosuppressed Populations
Source: ClinicalTrials.gov NCT06027229 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Oct 2025
Primary outcomePrimary: Change in Antibody Concentration From Baseline (Visit 1) at 1 Month (Visit 2) — 22968.5; 66639 Endotoxin Units per milliliter (EU/mL)
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Antibody Concentration From Baseline (Visit 1) at 1 Month (Visit 2) |
22968.5; 66639 | — |
| SECONDARY Seropositivity Rates |
20; 20; 20 | — |
| SECONDARY Percent of Participants Seronegative at Baseline and Subsequently Seropositive |
0; 0; 0 | — |
| SECONDARY Change in Interferon Gamma Responses at 1 Month Compared to Baseline |
28 | — |
| SECONDARY Change in Interferon Gamma Responses at 6 Months Compared to 1 Month |
-0.625 | — |
| SECONDARY Solicited Adverse Events (AEs) |
12 | — |
| SECONDARY Unsolicited Adverse Events |
1 | — |
| SECONDARY Potential Immune-Mediated Diseases (pIMDs) |
— | — |
| SECONDARY Serious Adverse Events (SAEs) |
— | — |
| SECONDARY Number of Participants Reporting Disease Flares of IBD |
— | — |
| SECONDARY Number of Participants Reporting Acute Rejection of Their Transplant |
— | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT06027229). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.