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| ID | Type | Description | Link |
|---|---|---|---|
| Protocol Version 10/5/2024 | Other Identifier | UW Madison | |
| SMPH/MEDICINE/GASTROENT | Other Identifier | UW Madison | |
| A534250 | Other Identifier | UW Madison |
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| Name | Class |
|---|---|
| Novavax | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Participants with IBD | Experimental | Male and females aged 18 to 85 who have IBD and receive the study intervention. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NVX-CoV2372 | Biological | Novavax COVID-19 Vaccine Booster for Omicron XBB.1.5 |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | baseline and 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Seropositivity Rates | Seropositive will be defined by positive anti-receptor binding domain (RBD) IgG antibodies specific to SARS-CoV-2 performed by Labcorp. | baseline, 1 month, 6 months |
| Percent of Participants Seronegative at Baseline and Subsequently Seropositive |
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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.
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
Solid organ transplant recipient (on any dose of the following regimens: patients can be on more than one of the regimens below)
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Freddy Caldera, DO, MS | UW School of Medicine and Public Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UW School of Medicine and Public Health | Madison | Wisconsin | 53792 | United States |
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21 participants were assessed for eligibility, 1 patient was withdrawn due to inadvertent administration of an messenger ribonucleic acid (mRNA) vaccine.
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| ID | Title | Description |
|---|---|---|
| FG000 | Immunosuppressed Participants | Male and females aged 18 to 85 who are solid organ transplant recipients or have Irritable Bowel Disease (IBD) and receive the study intervention. NVX-CoV2372: Novavax COVID-19 Vaccine Booster for Omicron XBB.1.5 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Immunosuppressed Participants | Male and females aged 18 to 85 who are solid organ transplant recipients or have IBD and receive the study intervention. NVX-CoV2372: Novavax COVID-19 Vaccine Booster for Omicron XBB.1.5 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | Posted | Mean | 95% Confidence Interval | Endotoxin Units per milliliter (EU/mL) | baseline and 1 month |
|
|
up to 180 days post-booster
Participants were instructed to contact the study team if they experienced fever, chills, or rash. 7 days after each vaccination, participants were contacted to assess for solicited adverse events and to document any unsolicited adverse events. Local reactions (e.g., injection site pain, redness, swelling) and systemic symptoms (e.g., fever, headache, fatigue, myalgia) were recorded for 7 days following each dose, while unsolicited adverse events were monitored for 30 days.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Immunosuppressed Participants | Male and females aged 18 to 85 who are solid organ transplant recipients or have IBD and receive the study intervention. NVX-CoV2372: Novavax COVID-19 Vaccine Booster for Omicron XBB.1.5 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection Site Pain | Injury, poisoning and procedural complications | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Freddy Caldera, DO, PhD, MS | UW School of Medicine and Public Health | (608) 263-1995 | fcaldera@medicine.wisc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 5, 2024 | Jul 28, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C000711928 | NVX-CoV2373 adjuvated lipid nanoparticle |
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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. |
| 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. | 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. | 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.
| 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. | 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. | 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. | 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. | 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. | up to 6 months |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Body Mass Index (BMI) | Mean | Standard Deviation | kilograms per meter squared |
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| Smoking Status | Count of Participants | Participants |
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| Type of Immunosuppression | Count of Participants | Participants |
|
| Type of IBD | Only participants with IBD are counted in this measure. | Count of Participants | Participants |
|
| Previous Surgical Resection | Count of Participants | Participants |
|
| Length of IBD | Only participants with IBD are counted in this measure. | Mean | Standard Deviation | years |
|
| Current IBD Medications | 17 participants have IBD | Count of Participants | Participants |
|
| Type of Transplant | 3 participants had solid organ transplant | Count of Participants | Participants |
|
| Current Transplantation Medications | 3 participants had solid organ transplant | Count of Participants | Participants |
|
| History of COVID-19 infection | Count of Participants | Participants |
|
| Number of COVID-19 Vaccines Received | Mean | Full Range | vaccinations |
|
|
|
| Secondary | Seropositivity Rates | Seropositive will be defined by positive anti-receptor binding domain (RBD) IgG antibodies specific to SARS-CoV-2 performed by Labcorp. | Posted | Count of Participants | Participants | baseline, 1 month, 6 months |
|
|
|
| Secondary | 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. | Posted | Count of Participants | Participants | baseline, 1 month, 6 months |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | cells per million | baseline and 1 month |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | cells per million | 1 month, 6 months |
|
|
|
| Secondary | 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.
| Posted | Count of Participants | Participants | up to 7 days on study |
|
|
|
| Secondary | 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. | Posted | Count of Participants | Participants | up to 30 days on study |
|
|
|
| Secondary | Potential Immune-Mediated Diseases (pIMDs) | The number of participants reporting pIMDs from the booster dose to the study end will be summarized. | Posted | Count of Participants | Participants | up to 6 months |
|
|
|
| Secondary | 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. | Posted | Count of Participants | Participants | up to 6 months |
|
|
|
| Secondary | 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. | 17 participants had IBD | Posted | Count of Participants | Participants | up to 6 months |
|
|
|
| Secondary | 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. | 3 participants had solid organ transplants | Posted | Count of Participants | Participants | up to 6 months |
|
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|
| 0 |
| 20 |
| 0 |
| 20 |
| 12 |
| 20 |
| Headache | General disorders | Systematic Assessment |
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| Paresthesia | General disorders | Systematic Assessment |
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| Gastrointestinal Symptoms | General disorders | Systematic Assessment |
|
| Shivering or Chills | General disorders | Systematic Assessment |
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| Arthralgia | General disorders | Systematic Assessment |
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| Myalgia | General disorders | Systematic Assessment |
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| Fatigue | General disorders | Systematic Assessment |
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| Injection Site Swelling | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Hematemesis | Gastrointestinal disorders | Systematic Assessment |
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| Hematochezia | Gastrointestinal disorders | Systematic Assessment |
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| Hematuria | Renal and urinary disorders | Systematic Assessment |
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| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| Title | Measurements |
|---|
|