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| ID | Type | Description | Link |
|---|---|---|---|
| Influenza in IBD | Other Identifier | Study Team |
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Inflammatory bowel disease (IBD) is a chronic inflammatory disorder of the gastrointestinal tract which includes Crohn's disease (CD) and ulcerative colitis (UC). A recent epidemiological investigation estimates that nearly 4 million people worldwide are affected and approximately 1.4 million of these cases occur in the United States. IBD can lead to debilitating symptoms, hospitalizations, decreased quality of life, frequent procedures and/or surgery. Treatment options consist of immunosuppressive therapy, such as systemic corticosteroids, immunomodulators (thiopurines and methotrexate) and/or biologics, such as tumor necrosis factor alpha (TNF) agents or an integrin inhibitor, vedolizumab. They can achieve clinical remission and decrease the risk of complications, but also increase the risk for opportunistic infections, including influenza.
Multiple studies have shown lower influenza vaccine responses in patients with IBD compared to healthy individuals; IBD patients treated with TNF agents or combination therapy (TNF inhibitors and immunomodulators) are very likely to mount a poor immune response. Influenza serum antibody concentration correlates with protection from infection following vaccination. Therefore, increasing influenza antibody responses in patients with IBD would appear to be critical to improving protection from influenza. A high dose (HD) influenza vaccine containing four times more hemagglutinin was licensed based on its ability to induce higher antibody concentrations compared to standard dose (SD) in adults 65 years or older.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Group | Other | A group of 20 healthy individuals without IBD, other chronic diseases, or immunosuppressive therapy will be enrolled. All healthy individuals will receive standard dose influenza vaccine SDIV. |
|
| Vedolizumab Group + standard dose influenza vaccine (SDIV) | Other | A group of 20 patients who are currently on vedolizumab. All individuals in this group will receive SDIV |
|
| High dose influenza vaccine (HDIV) | Other | This arm will be a double blind randomized controlled trial of High dose influenza vaccine (HDIV) for IBD patients on TNF monotherapy. 40 patients will be enrolled and randomized in a 5:3 fashion to HDIV or SDIV. Randomization will generated by a random number generator and investigator will be blinded to randomization scheme. |
|
| Standard dose influenza vaccine (SDIV) | Other | This arm will be a double blind randomized controlled trial of standard dose influenza vaccine (SDIV) for IBD patients on TNF monotherapy. 40 patients will be enrolled and randomized in a 5:3 fashion to HDIV or SDIV. Randomization will generated by a random number generator and investigator will be blinded to randomization scheme. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard dose Influenza vaccine (SDIV) | Biological |
|
| Measure | Description | Time Frame |
|---|---|---|
| Measure Antibody Concentrations in Immunosuppressed IBD Patients Who Receive High Dose and Standard of Care Dose Influenza Vaccine | Influenza vaccine antibody concentration will be measured in immunosuppressed IBD patients who receive high dose and standard of care dose influenza vaccine. Higher antibody concentrations are associated with better protection from infection. | Pre-immunization and 2-4 weeks post immunization |
| Measure | Description | Time Frame |
|---|---|---|
| Response Rate Against Influenza Vaccine in Patients With Inflammatory Bowel Disease: Number of Participants Positive for Seroconversion | Vaccine response rates for influenza vaccines in patients with inflammatory bowel disease will be accessed by number of patients who has shown significant seroconversion. Seroconversion is defined as a four fold increase in antibody concentration from preimmunization to 4 weeks post immunization. |
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CASES Specific Aim #1 Inclusion Criteria
Specific Aim #2 Inclusion criteria
Exclusion Criteria
Control group Inclusion criteria
Control group Exclusion criteria
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| Name | Affiliation | Role |
|---|---|---|
| Freddy Caldera | University of Wisconsin School of Medicine and Public Health, Madison | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Wisconsin Hospital & Clinics | Madison | Wisconsin | 53792 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31504526 | Result | Caldera F, Hillman L, Saha S, Wald A, Grimes I, Zhang Y, Sharpe AR, Reichelderfer M, Hayney MS. Immunogenicity of High Dose Influenza Vaccine for Patients with Inflammatory Bowel Disease on Anti-TNF Monotherapy: A Randomized Clinical Trial. Inflamm Bowel Dis. 2020 Mar 4;26(4):593-602. doi: 10.1093/ibd/izz164. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Control Group | A group of 20 healthy individuals without IBD, other chronic diseases, or immunosuppressive therapy will be enrolled. All healthy individuals will receive standard dose influenza vaccine SDIV. |
| FG001 | Vedolizumab Group | A group of 20 patients who are currently on vedolizumab. All individuals in this group will receive SDIV |
| FG002 | High Dose Influenza Vaccine (HDIV) | This arm will be a double blind randomized controlled trial of High dose influenza vaccine (HDIV) for IBD patients on TNF monotherapy. 40 patients will be enrolled and randomized in a 5:3 fashion to HDIV or SDIV. Randomization will generated by a random number generator and investigator will be blinded to randomization scheme. |
| FG003 | Standard Dose Influenza Vaccine (SDIV) | This arm will be a double blind randomized controlled trial of standard dose influenza vaccine (SDIV) for IBD patients on TNF monotherapy. 40 patients will be enrolled and randomized in a 5:3 fashion to HDIV or SDIV. Randomization will generated by a random number generator and investigator will be blinded to randomization scheme. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Control Group | A group of 20 healthy individuals without IBD, other chronic diseases, or immunosuppressive therapy will be enrolled. All healthy individuals will receive standard dose influenza vaccine SDIV. |
| BG001 | Vedolizumab Group |
| 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 | Measure Antibody Concentrations in Immunosuppressed IBD Patients Who Receive High Dose and Standard of Care Dose Influenza Vaccine | Influenza vaccine antibody concentration will be measured in immunosuppressed IBD patients who receive high dose and standard of care dose influenza vaccine. Higher antibody concentrations are associated with better protection from infection. | Posted | Median | Inter-Quartile Range | Antibody Titer | Pre-immunization and 2-4 weeks post immunization |
|
Up to 7 days
AEs were recorded after administration of the vaccine from days 0-6 using the adverse event dairy. Adverse event data is reported for 24 participants in the HDIV arm as 1 participant did not submit the diary card for adverse event reporting. Adverse event are reported just for anti-TNF monotherapy group HDIV and SDIV since these were the primary outcome.No AEs were collected for vedolizumab group and control group as they were secondary outcomes which were dependent on primary outcomes.
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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 | High Dose Influenza Vaccine (HDIV) | This arm will be a double blind randomized controlled trial of High dose influenza vaccine (HDIV) for IBD patients on TNF monotherapy. 40 patients will be enrolled and randomized in a 5:3 fashion to HDIV or SDIV. Randomization will generated by a random number generator and investigator will be blinded to randomization scheme. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Local reactions: Pain | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| FREDDY CALDERA, ASST PROFESSOR , GASTROENTEROLOGY | University of Wisconsin 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 | Yes | No | No | Study Protocol | Jan 27, 2017 | Jun 18, 2019 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 13, 2015 | Aug 8, 2019 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
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| ID | Term |
|---|---|
| D007252 | Influenza Vaccines |
| ID | Term |
|---|---|
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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| High dose influenza vaccine (HDIV) | Biological |
|
| 4 weeks |
| Seroprotection: Number of Participants With Antibody Concentration at Least 1:40 at Week 4 Postimmunization | Seroprotection is defined as an antibody concentration of at least 1:40 at 4 weeks post-immunization which confers protection from infection in about 50% of individuals | 4 weeks |
| Seroprotection: Number of Participants With Antibody Titer of 160 at Week 4 Post-immunization | Seroprotection is defined by the FDA as post-immunization concentration of 1:160 that confers protection from infection to 95% of the population. | 4 weeks |
| Measure Antibody Concentrations in Immunosuppressed IBD Patients Who Receive High Dose and Standard of Care Dose Influenza Vaccine | Influenza vaccine antibody concentration will be measured in immunosuppressed IBD patients who receive high dose and standard of care dose influenza vaccine. Higher antibody concentrations are associated with better protection from infection. | 6 months post-immunization |
A group of 20 patients who are currently on vedolizumab. All individuals in this group will receive SDIV |
| BG002 | High Dose Influenza Vaccine (HDIV) | This arm will be a double blind randomized controlled trial of high dose influenza vaccine (HDIV) for IBD patients on TNF monotherapy. 40 patients will be enrolled and randomized in a 5:3 fashion to HDIV or SDIV. Randomization will generated by a random number generator and investigator will be blinded to randomization scheme. |
| BG003 | Standard Dose Influenza Vaccine (SDIV) | This arm will be a double blind randomized controlled trial of standard dose influenza vaccine (SDIV) for IBD patients on TNF monotherapy. 40 patients will be enrolled and randomized in a 5:3 fashion to HDIV or SDIV. Randomization will generated by a random number generator and investigator will be blinded to randomization scheme. |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 |
| Standard Dose Influenza Vaccine (SDIV) Group |
This arm will be a double blind randomized controlled trial of standard dose influenza vaccine (SDIV) for IBD patients on TNF monotherapy. 40 patients will be enrolled and randomized in a 5:3 fashion to HDIV or SDIV. Randomization will generated by a random number generator and investigator will be blinded to randomization scheme. |
| OG002 | Vedolizumab Group | A group of 20 patients who are currently on vedolizumab. All individuals in this group will receive SDIV |
| OG003 | Control Group | A group of 20 healthy individuals without IBD, other chronic diseases, or immunosuppressive therapy will be enrolled. All healthy individuals will receive standard dose influenza vaccine SDIV. |
|
|
| Secondary | Response Rate Against Influenza Vaccine in Patients With Inflammatory Bowel Disease: Number of Participants Positive for Seroconversion | Vaccine response rates for influenza vaccines in patients with inflammatory bowel disease will be accessed by number of patients who has shown significant seroconversion. Seroconversion is defined as a four fold increase in antibody concentration from preimmunization to 4 weeks post immunization. | Posted | Number | participants | 4 weeks |
|
|
|
| Secondary | Seroprotection: Number of Participants With Antibody Concentration at Least 1:40 at Week 4 Postimmunization | Seroprotection is defined as an antibody concentration of at least 1:40 at 4 weeks post-immunization which confers protection from infection in about 50% of individuals | Posted | Number | participants | 4 weeks |
|
|
|
| Secondary | Seroprotection: Number of Participants With Antibody Titer of 160 at Week 4 Post-immunization | Seroprotection is defined by the FDA as post-immunization concentration of 1:160 that confers protection from infection to 95% of the population. | Posted | Number | participants | 4 weeks |
|
|
|
| Secondary | Measure Antibody Concentrations in Immunosuppressed IBD Patients Who Receive High Dose and Standard of Care Dose Influenza Vaccine | Influenza vaccine antibody concentration will be measured in immunosuppressed IBD patients who receive high dose and standard of care dose influenza vaccine. Higher antibody concentrations are associated with better protection from infection. | Posted | Median | Inter-Quartile Range | Antibody Titer | 6 months post-immunization |
|
|
|
| 0 |
| 25 |
| 0 |
| 25 |
| 13 |
| 24 |
| EG001 | Standard Dose Influenza Vaccine (SDIV) | This arm will be a double blind randomized controlled trial of standard dose influenza vaccine (SDIV) for IBD patients on TNF monotherapy. 40 patients will be enrolled and randomized in a 5:3 fashion to HDIV or SDIV. Randomization will generated by a random number generator and investigator will be blinded to randomization scheme. | 0 | 15 | 0 | 15 | 8 | 15 |
| Local reaction: Redness | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Swelling | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| fever | General disorders | Non-systematic Assessment |
|
| Headache | General disorders | Non-systematic Assessment |
|
| Muscle Aches | General disorders | Non-systematic Assessment |
|
| Arthralgia | General disorders | Non-systematic Assessment |
|
| Fatigue | General disorders | Non-systematic Assessment |
|
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| Influenza A H3N2 |
|
| Influenza B Victoria |
|
| Influenza B Yamagata |
|
| At least one virus |
|
| At least two viruses |
|
| Three viruses |
|
| Influenza A H3N2 |
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| Influenza B Victoria |
|
| Influenza B Yamagata |
|
| At least one virus |
|
| At least two virus |
|
| Three viruses |
|
| Influenza A H3N2 |
|
| Influenza B Victoria |
|
| Influenza B Yamagata |
|
| At least one virus |
|
| At least two virus |
|
| Three viruses |
|
| Influenza A H3N2, 6 months post immunization |
|
| Influenza B Victoria, 6 months post immunization |
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| Influenza B Yamagata, 6 months post immunization |
|