A Phase 2 interventional study of NVX-CoV2372 in Immunosuppression and COVID-19, sponsored by University of Wisconsin, Madison. Completed at 1 site in United States. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2025-10-20.
Sponsored by University of Wisconsin, Madison · Phase 2, Interventional, and Prevention
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.
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.
7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.
This study's enrollment of 21 is below the median of 100 across 4,099 interventional studies indexed under COVID-19.
Browse COVID-19 studies →University of Wisconsin, Madison is the lead sponsor of 1,161 studies on the registry; 182 are open to participants now.
Of its 151 completed or terminated interventional studies of FDA-regulated products, 114 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
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.
On one of the following treatment regimens
IBD
Solid organ transplant recipient (on any dose of the following regimens: patients can be on more than one of the regimens below)
Exclusion Criteria:
Male and females aged 18 to 85 who are solid organ transplant recipients and receive the study intervention.
Biological: NVX-CoV2372
Male and females aged 18 to 85 who have IBD and receive the study intervention.
Biological: NVX-CoV2372
Novavax COVID-19 Vaccine Booster for Omicron XBB.1.5
Also known as: Novavax COVID-19 Vaccine
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).
Time frame: baseline and 1 month
Seropositivity Rates
Seropositive will be defined by positive anti-receptor binding domain (RBD) IgG antibodies specific to SARS-CoV-2 performed by Labcorp.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: up to 6 months
| Milestone | Immunosuppressed Participants |
|---|---|
| Started | 20 |
| Follow-up | 20 |
| Analysis population | 20 |
| Completed | 20 |
| Not completed | 0 |
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).
| Endotoxin Units per milliliter (EU/mL) | Immunosuppressed Participants |
|---|---|
| baseline | 22968.5 (12081.4 to 43666.4) |
| 1 month | 66639 (37915.5 to 117124.0) |
Seropositive will be defined by positive anti-receptor binding domain (RBD) IgG antibodies specific to SARS-CoV-2 performed by Labcorp.
| Participants | Immunosuppressed Participants |
|---|---|
| baseline | 20 |
| 1 month | 20 |
| 6 months | 20 |
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.
| Participants | Immunosuppressed Participants |
|---|---|
| baseline | 0 |
| 1 month | 0 |
| 6 months | 0 |
An interferon gamma response will be considered any measurable response, reported is change in cells per million from baseline to 1 month.
| cells per million | Immunosuppressed Participants |
|---|---|
| Change in Interferon Gamma Responses at 1 Month Compared to Baseline | 28 ± 101 |
An interferon gamma response will be considered any measurable response, reported is change in cells per million from 1 month to 6 months.
| cells per million | Immunosuppressed Participants |
|---|---|
| Change in Interferon Gamma Responses at 6 Months Compared to 1 Month | -0.625 ± 164 |
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).
| Participants | Immunosuppressed Participants |
|---|---|
| Solicited Adverse Events (AEs) | 12 |
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.
| Participants | Immunosuppressed Participants |
|---|---|
| Unsolicited Adverse Events | 1 |
The number of participants reporting pIMDs from the booster dose to the study end will be summarized.
| Participants | Immunosuppressed Participants |
|---|---|
| Potential Immune-Mediated Diseases (pIMDs) | 0 |
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.
| Participants | Immunosuppressed Participants |
|---|---|
| Serious Adverse Events (SAEs) | 0 |
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.
| Participants | Immunosuppressed Participants |
|---|---|
| Number of Participants Reporting Disease Flares of IBD | 0 |
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.
| Participants | Immunosuppressed Participants |
|---|---|
| Number of Participants Reporting Acute Rejection of Their Transplant | 0 |
Collected over up to 180 days post-booster. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Immunosuppressed Participants | 0/20 (0%) | 0/20 (0%) | 12/20 (60%) |
| Event | Immunosuppressed Participants |
|---|---|
| HeadacheGeneral disorders | 10/20 |
| ArthralgiaGeneral disorders | 9/20 |
| Injection Site PainInjury, poisoning and procedural complications | 8/20 |
| FatigueGeneral disorders | 8/20 |
| MyalgiaGeneral disorders | 5/20 |
| Gastrointestinal SymptomsGeneral disorders | 4/20 |
| Shivering or ChillsGeneral disorders | 2/20 |
| ParesthesiaGeneral disorders | 1/20 |
| Injection Site SwellingInjury, poisoning and procedural complications | 1/20 |
| HematemesisGastrointestinal disorders | 1/20 |
| Age, Continuous(years) | Immunosuppressed Participants |
|---|---|
| Mean | 47.6 ± 14.9 |
| Sex: Female, Male(Participants) | Immunosuppressed Participants |
|---|---|
| Female | 9 |
| Male | 11 |
| Ethnicity (NIH/OMB)(Participants) | Immunosuppressed Participants |
|---|---|
| Hispanic or Latino | 0 |
| Not Hispanic or Latino | 20 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Immunosuppressed Participants |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 20 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | Immunosuppressed Participants |
|---|---|
| United States | 20 |
| Body Mass Index (BMI)(kilograms per meter squared) | Immunosuppressed Participants |
|---|---|
| Mean | 79.59 ± 10.2 |
| Smoking Status(Participants) | Immunosuppressed Participants |
|---|---|
| Never | 14 |
| Former | 6 |
| Current | 0 |
| Type of Immunosuppression(Participants) | Immunosuppressed Participants |
|---|---|
| IBD | 17 |
| Solid Organ Transplantation | 3 |
8 further baseline measures are reported on the registry.
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University of Wisconsin, Madison