ImmunosuppressionPhase 2NCT06027229
Additional Recombinant COVID-19 Humoral and Cell-Mediated Immunogenicity in Immunosuppressed Populations
A Phase 2 study testing NVX-CoV2372 in people with Immunosuppression and COVID-19, run by University of Wisconsin, Madison at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Immunosuppression, COVID-19
- What is being tested?
- NVX-CoV2372
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Nov 2023to 9 Sep 2024
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
UW School of Medicine and Public Health
Madison, Wisconsin, 53792
About this study
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.
Read the 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 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.
- Conditions
- Immunosuppression, COVID-19
- Being tested
- NVX-CoV2372
- Keywords
- Immunogenicity, IBD, solid organ transplant
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NVX-CoV2372Biological
Also called Novavax COVID-19 Vaccine
Novavax COVID-19 Vaccine Booster for Omicron XBB.1.5
| Study group | Role | What they receive |
|---|---|---|
| Participants who have had Solid Organ Transplants | Experimental | Male and females aged 18 to 85 who are solid organ transplant recipients and receive the study intervention. Receives: Biological: NVX-CoV2372 |
| Participants with IBD | Experimental | Male and females aged 18 to 85 who have IBD and receive the study intervention. Receives: Biological: NVX-CoV2372 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Antibody Concentration From Baseline (Visit 1) at 1 Month (Visit 2)
Antibody concentrations 1 month after the recombinant vaccine booster (V2) in patients with IBD and solid organ transplant recipients compared to their baseline visit (V1).
Measured: baseline and 1 month
Secondary outcomes (10)
Seropositivity Rates
Seropositive will be defined by positive anti-receptor binding domain (RBD) IgG antibodies specific to SARS-CoV-2 performed by Labcorp.
Measured: baseline, 1 month, 6 months
Percent of Participants Seronegative at Baseline and Subsequently Seropositive
Percentages (and 2-sided 95% Confidence Intervals) of participants who were seronegative at baseline and became seropositive after immunization will be evaluated in each group. For initially seropositive subjects at V1, antibody concentration at post-vaccination (V2) ≥ 4 fold the pre-vaccination antibody concentration.
Measured: baseline, 1 month, 6 months
Change in Interferon Gamma Responses at 1 Month Compared to Baseline
An interferon gamma response will be considered any measurable response, reported is change in cells per million from baseline to 1 month.
Measured: baseline and 1 month
Change in Interferon Gamma Responses at 6 Months Compared to 1 Month
An interferon gamma response will be considered any measurable response, reported is change in cells per million from 1 month to 6 months.
Measured: 1 month, 6 months
Solicited Adverse Events (AEs)
The number of participants reporting each solicited local AE and each solicited systemic AE within seven days (Days 1-7) after the booster dose and overall will be summarized.
- Solicited local AEs included injection site pain, redness, and swelling.
- Solicited systemic AEs included fatigue, myalgia, arthralgia, headache, shivering/chills, fever, and gastrointestinal symptoms (nausea, vomiting, diarrhea, and abdominal pain).
Measured: up to 7 days on study
Unsolicited Adverse Events
The number of participants reporting unsolicited AEs within 30 days (Days 1-30) after the booster dose and overall will be summarized for both the study groups.
Measured: up to 30 days on study
Potential Immune-Mediated Diseases (pIMDs)
The number of participants reporting pIMDs from the booster dose to the study end will be summarized.
Measured: up to 6 months
Serious Adverse Events (SAEs)
The number of participants reporting SAEs and fatal SAEs from the booster dose administration to the study end will be summarized for both the study groups.
Measured: up to 6 months
Number of Participants Reporting Disease Flares of IBD
Disease activity will be assessed by monitoring disease activity using the Short Crohn's Activity Index (SCAI)18 for patients with Crohn's disease or the Simple Clinical Colitis Activity Index (SCCAI) questionnaire for patients with Ulcerative colitis at the baseline visit (V1), V2, and V3 visits. The incidence of IBD flares will be evaluated in all patients receiving recombinant boosters. This will be quantified by patients who were in clinical remission who develop a disease flare after receiving a recombinant COVID-19 booster.
Measured: up to 6 months
Number of Participants Reporting Acute Rejection of Their Transplant
Participants will be asked if they have been diagnosed with acute rejection after their baseline visit (V1). Episodes of acute rejection will be collected by searching electronic medical records and asking patients at each clinic visit (V2 and V3). Acute rejection will be defined as a notation of a new episode of acute rejection (cellular or antibody-mediated), a steroid bolus and taper in the absence of another indication, or administration of a T or B cell depleting agent or immune globulin. This will be quantified by patients who were who developing acute rejection of their transplant after receiving a recombinant COVID-19 booster.
Measured: up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2023
- Study start20 Nov 2023
- Primary completion24 Apr 2024
- Study completion9 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for ImmunosuppressionStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- Novavax
- Responsible party
- Sponsor
- Investigators
- Freddy Caldera, DO, MS, Principal investigator, UW School of Medicine and Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06027229
- Sponsor's protocol ID
- 2023-1208
- Other IDs
- Protocol Version 10/5/2024, SMPH/MEDICINE/GASTROENT, A534250
- Status last verified
- Apr 2025
- First submitted
- 31 Aug 2023
- Last updated
- 20 Oct 2025
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Additional Recombinant COVID-19 Humoral and Cell-Mediated Immunogenicity in Immunosuppressed Populations
- ClinicalTrials.gov ID
- NCT06027229
- Acronym / sponsor ID
- 2023-1208
- Conditions
- Immunosuppression, COVID-19
- Keywords
- Immunogenicity, IBD, solid organ transplant
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- Novavax
- Study start
- 20 Nov 2023 (actual)
- Primary completion
- 24 Apr 2024 (actual)
- Study completion
- 9 Sep 2024 (actual)
- First posted
- 7 Sep 2023 (actual)
- Results
- Posted 20 Oct 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Participants who have had Solid Organ Transplants | Experimental | Biological: NVX-CoV2372Male and females aged 18 to 85 who are solid organ transplant recipients and receive the study intervention. |
| Participants with IBD | Experimental | Biological: NVX-CoV2372Male and females aged 18 to 85 who have IBD and receive the study intervention. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (24 listed)
- 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.
- 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
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NVX-CoV2372Also: Novavax COVID-19 VaccineNovavax COVID-19 Vaccine Booster for Omicron XBB.1.5 | Biological | Participants who have had Solid Organ Transplants, Participants with IBD |
Primary outcome
Change in Antibody Concentration From Baseline (Visit 1) at 1 Month (Visit 2)
Time frame: baseline and 1 month
Antibody concentrations 1 month after the recombinant vaccine booster (V2) in patients with IBD and solid organ transplant recipients compared to their baseline visit (V1).
10 secondary outcomes
Seropositivity Rates
Time frame: baseline, 1 month, 6 months
Percent of Participants Seronegative at Baseline and Subsequently Seropositive
Time frame: baseline, 1 month, 6 months
Change in Interferon Gamma Responses at 1 Month Compared to Baseline
Time frame: baseline and 1 month
Change in Interferon Gamma Responses at 6 Months Compared to 1 Month
Time frame: 1 month, 6 months
Solicited Adverse Events (AEs)
Time frame: up to 7 days on study
Unsolicited Adverse Events
Time frame: up to 30 days on study
Potential Immune-Mediated Diseases (pIMDs)
Time frame: up to 6 months
Serious Adverse Events (SAEs)
Time frame: up to 6 months
Number of Participants Reporting Disease Flares of IBD
Time frame: up to 6 months
Number of Participants Reporting Acute Rejection of Their Transplant
Time frame: up to 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Freddy Caldera, DO, MS principal investigator
UW School of Medicine and Public Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing NVX-CoV2372 in people with Immunosuppression and COVID-19, run by University of Wisconsin, Madison at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 24 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Oct 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Antibody Concentration From Baseline (Visit 1) at 1 Month (Visit 2) (time frame: baseline and 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2025.