Inflammatory Bowel Disease (IBD)
Conditions
Brief summary
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.
Interventions
BIOLOGICALStandard dose Influenza vaccine (SDIV)
BIOLOGICALHigh dose influenza vaccine (HDIV)
Sponsors
University of Wisconsin, Madison
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
Yes
Inclusion criteria
CASES Specific Aim #1 Inclusion Criteria * A history of chronic (greater than 3 month) ulcerative colitis or Crohn's disease diagnosed and documented by the standard clinical, radiographic, endoscopic and histopathologic criteria. * Ages 18-64 * Currently taking anti-TNF therapy (infliximab, golilumab, adalimumab, or certolizumab) for at least 3 months *
Exclusion criteria
* Received season's influenza vaccine * Allergy to eggs or influenza vaccine * Currently use of systemic steroids in the past 3 months Specific Aim #2 Inclusion criteria * A history of chronic (greater than 3 month) ulcerative colitis or Crohn's disease diagnosed and documented by the standard clinical, radiographic, endoscopic and histopathologic criteria. * Ages 18-64 * Currently on vedolizumab therapy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Measure Antibody Concentrations in Immunosuppressed IBD Patients Who Receive High Dose and Standard of Care Dose Influenza Vaccine | Pre-immunization and 2-4 weeks post immunization | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Response Rate Against Influenza Vaccine in Patients With Inflammatory Bowel Disease: Number of Participants Positive for Seroconversion | 4 weeks | 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. |
| Seroprotection: Number of Participants With Antibody Concentration at Least 1:40 at Week 4 Postimmunization | 4 weeks | 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 |
| Seroprotection: Number of Participants With Antibody Titer of 160 at Week 4 Post-immunization | 4 weeks | Seroprotection is defined by the FDA as post-immunization concentration of 1:160 that confers protection from infection to 95% of the population. |
| Measure Antibody Concentrations in Immunosuppressed IBD Patients Who Receive High Dose and Standard of Care Dose Influenza Vaccine | 6 months post-immunization | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 20 |
| Vedolizumab Group A group of 20 patients who are currently on vedolizumab. All individuals in this group will receive SDIV | 19 |
| 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. | 25 |
| 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. | 15 |
| Total | 79 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 1 | 1 | 0 |
Baseline characteristics
| Characteristic | Control Group | Total | Standard Dose Influenza Vaccine (SDIV) | High Dose Influenza Vaccine (HDIV) | Vedolizumab Group |
|---|---|---|---|---|---|
| Age, Continuous | 40.35 years STANDARD_DEVIATION 9.89 | 37.81 years STANDARD_DEVIATION 12.74 | 39.35 years STANDARD_DEVIATION 11.98 | 34.96 years STANDARD_DEVIATION 12.92 | 36.57 years STANDARD_DEVIATION 16.16 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 19 Participants | 77 Participants | 14 Participants | 25 Participants | 19 Participants |
| Region of Enrollment United States | 20 participants | 79 participants | 15 participants | 25 participants | 19 participants |
| Sex: Female, Male Female | 10 Participants | 36 Participants | 5 Participants | 9 Participants | 12 Participants |
| Sex: Female, Male Male | 10 Participants | 43 Participants | 10 Participants | 16 Participants | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 25 | 0 / 15 |
| other Total, other adverse events | 13 / 24 | 8 / 15 |
| serious Total, serious adverse events | 0 / 25 | 0 / 15 |
Outcome results
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.
Time frame: Pre-immunization and 2-4 weeks post immunization
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| High Dose of Influenza Vaccine (HDIV) Group | Measure Antibody Concentrations in Immunosuppressed IBD Patients Who Receive High Dose and Standard of Care Dose Influenza Vaccine | Influenza B Victoria,Pre-immunization | 10 Antibody Titer |
| High Dose of Influenza Vaccine (HDIV) Group | Measure Antibody Concentrations in Immunosuppressed IBD Patients Who Receive High Dose and Standard of Care Dose Influenza Vaccine | Influenza A H3N2, Pre-immunization | 80 Antibody Titer |
| High Dose of Influenza Vaccine (HDIV) Group | Measure Antibody Concentrations in Immunosuppressed IBD Patients Who Receive High Dose and Standard of Care Dose Influenza Vaccine | Influenza A H3N2, 2-4 weeks post immunization | 160 Antibody Titer |
| High Dose of Influenza Vaccine (HDIV) Group | Measure Antibody Concentrations in Immunosuppressed IBD Patients Who Receive High Dose and Standard of Care Dose Influenza Vaccine | Influenza B Yamagata, 2-4 weeks post immunization | 10 Antibody Titer |
| High Dose of Influenza Vaccine (HDIV) Group | Measure Antibody Concentrations in Immunosuppressed IBD Patients Who Receive High Dose and Standard of Care Dose Influenza Vaccine | Influenza B Yamagata, Pre-immunization | 10 Antibody Titer |
| High Dose of Influenza Vaccine (HDIV) Group | Measure Antibody Concentrations in Immunosuppressed IBD Patients Who Receive High Dose and Standard of Care Dose Influenza Vaccine | Influenza A H1N1, 2-4 weeks post immunization | 320 Antibody Titer |
| High Dose of Influenza Vaccine (HDIV) Group | Measure Antibody Concentrations in Immunosuppressed IBD Patients Who Receive High Dose and Standard of Care Dose Influenza Vaccine | Influenza A H1N1, pre-immunization | 160 Antibody Titer |
| High Dose of Influenza Vaccine (HDIV) Group | Measure Antibody Concentrations in Immunosuppressed IBD Patients Who Receive High Dose and Standard of Care Dose Influenza Vaccine | Influenza B Victoria, 2-4 weeks post immunization | 20 Antibody Titer |
| Standard Dose Influenza Vaccine (SDIV) Group | Measure Antibody Concentrations in Immunosuppressed IBD Patients Who Receive High Dose and Standard of Care Dose Influenza Vaccine | Influenza A H3N2, Pre-immunization | 40 Antibody Titer |
| Standard Dose Influenza Vaccine (SDIV) Group | Measure Antibody Concentrations in Immunosuppressed IBD Patients Who Receive High Dose and Standard of Care Dose Influenza Vaccine | Influenza A H1N1, pre-immunization | 160 Antibody Titer |
| Standard Dose Influenza Vaccine (SDIV) Group | Measure Antibody Concentrations in Immunosuppressed IBD Patients Who Receive High Dose and Standard of Care Dose Influenza Vaccine | Influenza A H1N1, 2-4 weeks post immunization | 160 Antibody Titer |
| Standard Dose Influenza Vaccine (SDIV) Group | Measure Antibody Concentrations in Immunosuppressed IBD Patients Who Receive High Dose and Standard of Care Dose Influenza Vaccine | Influenza A H3N2, 2-4 weeks post immunization | 80 Antibody Titer |
| Standard Dose Influenza Vaccine (SDIV) Group | Measure Antibody Concentrations in Immunosuppressed IBD Patients Who Receive High Dose and Standard of Care Dose Influenza Vaccine | Influenza B Victoria,Pre-immunization | 10 Antibody Titer |
| Standard Dose Influenza Vaccine (SDIV) Group | Measure Antibody Concentrations in Immunosuppressed IBD Patients Who Receive High Dose and Standard of Care Dose Influenza Vaccine | Influenza B Victoria, 2-4 weeks post immunization | 20 Antibody Titer |
| Standard Dose Influenza Vaccine (SDIV) Group | Measure Antibody Concentrations in Immunosuppressed IBD Patients Who Receive High Dose and Standard of Care Dose Influenza Vaccine | Influenza B Yamagata, Pre-immunization | 10 Antibody Titer |
| Standard Dose Influenza Vaccine (SDIV) Group | Measure Antibody Concentrations in Immunosuppressed IBD Patients Who Receive High Dose and Standard of Care Dose Influenza Vaccine | Influenza B Yamagata, 2-4 weeks post immunization | 20 Antibody Titer |
| Vedolizumab Group | Measure Antibody Concentrations in Immunosuppressed IBD Patients Who Receive High Dose and Standard of Care Dose Influenza Vaccine | Influenza A H1N1, 2-4 weeks post immunization | 320 Antibody Titer |
| Vedolizumab Group | Measure Antibody Concentrations in Immunosuppressed IBD Patients Who Receive High Dose and Standard of Care Dose Influenza Vaccine | Influenza B Yamagata, 2-4 weeks post immunization | 40 Antibody Titer |
| Vedolizumab Group | Measure Antibody Concentrations in Immunosuppressed IBD Patients Who Receive High Dose and Standard of Care Dose Influenza Vaccine | Influenza B Yamagata, Pre-immunization | 20 Antibody Titer |
| Vedolizumab Group | Measure Antibody Concentrations in Immunosuppressed IBD Patients Who Receive High Dose and Standard of Care Dose Influenza Vaccine | Influenza B Victoria,Pre-immunization | 20 Antibody Titer |
| Vedolizumab Group | Measure Antibody Concentrations in Immunosuppressed IBD Patients Who Receive High Dose and Standard of Care Dose Influenza Vaccine | Influenza A H3N2, Pre-immunization | 80 Antibody Titer |
| Vedolizumab Group | Measure Antibody Concentrations in Immunosuppressed IBD Patients Who Receive High Dose and Standard of Care Dose Influenza Vaccine | Influenza B Victoria, 2-4 weeks post immunization | 20 Antibody Titer |
| Vedolizumab Group | Measure Antibody Concentrations in Immunosuppressed IBD Patients Who Receive High Dose and Standard of Care Dose Influenza Vaccine | Influenza A H3N2, 2-4 weeks post immunization | 320 Antibody Titer |
| Vedolizumab Group | Measure Antibody Concentrations in Immunosuppressed IBD Patients Who Receive High Dose and Standard of Care Dose Influenza Vaccine | Influenza A H1N1, pre-immunization | 160 Antibody Titer |
| Control Group | Measure Antibody Concentrations in Immunosuppressed IBD Patients Who Receive High Dose and Standard of Care Dose Influenza Vaccine | Influenza A H3N2, 2-4 weeks post immunization | 160 Antibody Titer |
| Control Group | Measure Antibody Concentrations in Immunosuppressed IBD Patients Who Receive High Dose and Standard of Care Dose Influenza Vaccine | Influenza B Victoria,Pre-immunization | 20 Antibody Titer |
| Control Group | Measure Antibody Concentrations in Immunosuppressed IBD Patients Who Receive High Dose and Standard of Care Dose Influenza Vaccine | Influenza B Yamagata, 2-4 weeks post immunization | 20 Antibody Titer |
| Control Group | Measure Antibody Concentrations in Immunosuppressed IBD Patients Who Receive High Dose and Standard of Care Dose Influenza Vaccine | Influenza B Victoria, 2-4 weeks post immunization | 20 Antibody Titer |
| Control Group | Measure Antibody Concentrations in Immunosuppressed IBD Patients Who Receive High Dose and Standard of Care Dose Influenza Vaccine | Influenza A H1N1, pre-immunization | 160 Antibody Titer |
| Control Group | Measure Antibody Concentrations in Immunosuppressed IBD Patients Who Receive High Dose and Standard of Care Dose Influenza Vaccine | Influenza A H3N2, Pre-immunization | 80 Antibody Titer |
| Control Group | Measure Antibody Concentrations in Immunosuppressed IBD Patients Who Receive High Dose and Standard of Care Dose Influenza Vaccine | Influenza B Yamagata, Pre-immunization | 20 Antibody Titer |
| Control Group | Measure Antibody Concentrations in Immunosuppressed IBD Patients Who Receive High Dose and Standard of Care Dose Influenza Vaccine | Influenza A H1N1, 2-4 weeks post immunization | 320 Antibody Titer |
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.
Time frame: 6 months post-immunization
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| High Dose of Influenza Vaccine (HDIV) Group | Measure Antibody Concentrations in Immunosuppressed IBD Patients Who Receive High Dose and Standard of Care Dose Influenza Vaccine | Influenza A H1N1, 6 months post immunization | 160 Antibody Titer |
| High Dose of Influenza Vaccine (HDIV) Group | Measure Antibody Concentrations in Immunosuppressed IBD Patients Who Receive High Dose and Standard of Care Dose Influenza Vaccine | Influenza A H3N2, 6 months post immunization | 80 Antibody Titer |
| High Dose of Influenza Vaccine (HDIV) Group | Measure Antibody Concentrations in Immunosuppressed IBD Patients Who Receive High Dose and Standard of Care Dose Influenza Vaccine | Influenza B Victoria, 6 months post immunization | 20 Antibody Titer |
| High Dose of Influenza Vaccine (HDIV) Group | Measure Antibody Concentrations in Immunosuppressed IBD Patients Who Receive High Dose and Standard of Care Dose Influenza Vaccine | Influenza B Yamagata, 6 months post immunization | 20 Antibody Titer |
| Standard Dose Influenza Vaccine (SDIV) Group | Measure Antibody Concentrations in Immunosuppressed IBD Patients Who Receive High Dose and Standard of Care Dose Influenza Vaccine | Influenza A H3N2, 6 months post immunization | 80 Antibody Titer |
| Standard Dose Influenza Vaccine (SDIV) Group | Measure Antibody Concentrations in Immunosuppressed IBD Patients Who Receive High Dose and Standard of Care Dose Influenza Vaccine | Influenza B Victoria, 6 months post immunization | 20 Antibody Titer |
| Standard Dose Influenza Vaccine (SDIV) Group | Measure Antibody Concentrations in Immunosuppressed IBD Patients Who Receive High Dose and Standard of Care Dose Influenza Vaccine | Influenza B Yamagata, 6 months post immunization | 20 Antibody Titer |
| Standard Dose Influenza Vaccine (SDIV) Group | Measure Antibody Concentrations in Immunosuppressed IBD Patients Who Receive High Dose and Standard of Care Dose Influenza Vaccine | Influenza A H1N1, 6 months post immunization | 160 Antibody Titer |
| Vedolizumab Group | Measure Antibody Concentrations in Immunosuppressed IBD Patients Who Receive High Dose and Standard of Care Dose Influenza Vaccine | Influenza B Victoria, 6 months post immunization | 40 Antibody Titer |
| Vedolizumab Group | Measure Antibody Concentrations in Immunosuppressed IBD Patients Who Receive High Dose and Standard of Care Dose Influenza Vaccine | Influenza A H3N2, 6 months post immunization | 160 Antibody Titer |
| Vedolizumab Group | Measure Antibody Concentrations in Immunosuppressed IBD Patients Who Receive High Dose and Standard of Care Dose Influenza Vaccine | Influenza B Yamagata, 6 months post immunization | 20 Antibody Titer |
| Vedolizumab Group | Measure Antibody Concentrations in Immunosuppressed IBD Patients Who Receive High Dose and Standard of Care Dose Influenza Vaccine | Influenza A H1N1, 6 months post immunization | 160 Antibody Titer |
| Control Group | Measure Antibody Concentrations in Immunosuppressed IBD Patients Who Receive High Dose and Standard of Care Dose Influenza Vaccine | Influenza B Yamagata, 6 months post immunization | 20 Antibody Titer |
| Control Group | Measure Antibody Concentrations in Immunosuppressed IBD Patients Who Receive High Dose and Standard of Care Dose Influenza Vaccine | Influenza A H3N2, 6 months post immunization | 80 Antibody Titer |
| Control Group | Measure Antibody Concentrations in Immunosuppressed IBD Patients Who Receive High Dose and Standard of Care Dose Influenza Vaccine | Influenza A H1N1, 6 months post immunization | 160 Antibody Titer |
| Control Group | Measure Antibody Concentrations in Immunosuppressed IBD Patients Who Receive High Dose and Standard of Care Dose Influenza Vaccine | Influenza B Victoria, 6 months post immunization | 20 Antibody Titer |
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.
Time frame: 4 weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| High Dose of Influenza Vaccine (HDIV) Group | Response Rate Against Influenza Vaccine in Patients With Inflammatory Bowel Disease: Number of Participants Positive for Seroconversion | Influenza A H1N1 | 1 participants |
| High Dose of Influenza Vaccine (HDIV) Group | Response Rate Against Influenza Vaccine in Patients With Inflammatory Bowel Disease: Number of Participants Positive for Seroconversion | At least two viruses | 1 participants |
| High Dose of Influenza Vaccine (HDIV) Group | Response Rate Against Influenza Vaccine in Patients With Inflammatory Bowel Disease: Number of Participants Positive for Seroconversion | At least one virus | 7 participants |
| High Dose of Influenza Vaccine (HDIV) Group | Response Rate Against Influenza Vaccine in Patients With Inflammatory Bowel Disease: Number of Participants Positive for Seroconversion | Influenza A H3N2 | 6 participants |
| High Dose of Influenza Vaccine (HDIV) Group | Response Rate Against Influenza Vaccine in Patients With Inflammatory Bowel Disease: Number of Participants Positive for Seroconversion | Three viruses | 0 participants |
| High Dose of Influenza Vaccine (HDIV) Group | Response Rate Against Influenza Vaccine in Patients With Inflammatory Bowel Disease: Number of Participants Positive for Seroconversion | Influenza B Victoria | 1 participants |
| High Dose of Influenza Vaccine (HDIV) Group | Response Rate Against Influenza Vaccine in Patients With Inflammatory Bowel Disease: Number of Participants Positive for Seroconversion | Influenza B Yamagata | 0 participants |
| Standard Dose Influenza Vaccine (SDIV) Group | Response Rate Against Influenza Vaccine in Patients With Inflammatory Bowel Disease: Number of Participants Positive for Seroconversion | At least two viruses | 7 participants |
| Standard Dose Influenza Vaccine (SDIV) Group | Response Rate Against Influenza Vaccine in Patients With Inflammatory Bowel Disease: Number of Participants Positive for Seroconversion | Influenza B Yamagata | 0 participants |
| Standard Dose Influenza Vaccine (SDIV) Group | Response Rate Against Influenza Vaccine in Patients With Inflammatory Bowel Disease: Number of Participants Positive for Seroconversion | Influenza B Victoria | 4 participants |
| Standard Dose Influenza Vaccine (SDIV) Group | Response Rate Against Influenza Vaccine in Patients With Inflammatory Bowel Disease: Number of Participants Positive for Seroconversion | At least one virus | 15 participants |
| Standard Dose Influenza Vaccine (SDIV) Group | Response Rate Against Influenza Vaccine in Patients With Inflammatory Bowel Disease: Number of Participants Positive for Seroconversion | Three viruses | 2 participants |
| Standard Dose Influenza Vaccine (SDIV) Group | Response Rate Against Influenza Vaccine in Patients With Inflammatory Bowel Disease: Number of Participants Positive for Seroconversion | Influenza A H3N2 | 11 participants |
| Standard Dose Influenza Vaccine (SDIV) Group | Response Rate Against Influenza Vaccine in Patients With Inflammatory Bowel Disease: Number of Participants Positive for Seroconversion | Influenza A H1N1 | 9 participants |
| Vedolizumab Group | Response Rate Against Influenza Vaccine in Patients With Inflammatory Bowel Disease: Number of Participants Positive for Seroconversion | Influenza B Yamagata | 1 participants |
| Vedolizumab Group | Response Rate Against Influenza Vaccine in Patients With Inflammatory Bowel Disease: Number of Participants Positive for Seroconversion | Influenza A H1N1 | 4 participants |
| Vedolizumab Group | Response Rate Against Influenza Vaccine in Patients With Inflammatory Bowel Disease: Number of Participants Positive for Seroconversion | Influenza A H3N2 | 7 participants |
| Vedolizumab Group | Response Rate Against Influenza Vaccine in Patients With Inflammatory Bowel Disease: Number of Participants Positive for Seroconversion | Influenza B Victoria | 2 participants |
| Vedolizumab Group | Response Rate Against Influenza Vaccine in Patients With Inflammatory Bowel Disease: Number of Participants Positive for Seroconversion | At least one virus | 9 participants |
| Vedolizumab Group | Response Rate Against Influenza Vaccine in Patients With Inflammatory Bowel Disease: Number of Participants Positive for Seroconversion | At least two viruses | 3 participants |
| Vedolizumab Group | Response Rate Against Influenza Vaccine in Patients With Inflammatory Bowel Disease: Number of Participants Positive for Seroconversion | Three viruses | 1 participants |
| Control Group | Response Rate Against Influenza Vaccine in Patients With Inflammatory Bowel Disease: Number of Participants Positive for Seroconversion | Influenza B Victoria | 0 participants |
| Control Group | Response Rate Against Influenza Vaccine in Patients With Inflammatory Bowel Disease: Number of Participants Positive for Seroconversion | Three viruses | 0 participants |
| Control Group | Response Rate Against Influenza Vaccine in Patients With Inflammatory Bowel Disease: Number of Participants Positive for Seroconversion | At least two viruses | 3 participants |
| Control Group | Response Rate Against Influenza Vaccine in Patients With Inflammatory Bowel Disease: Number of Participants Positive for Seroconversion | Influenza A H3N2 | 6 participants |
| Control Group | Response Rate Against Influenza Vaccine in Patients With Inflammatory Bowel Disease: Number of Participants Positive for Seroconversion | Influenza A H1N1 | 4 participants |
| Control Group | Response Rate Against Influenza Vaccine in Patients With Inflammatory Bowel Disease: Number of Participants Positive for Seroconversion | At least one virus | 7 participants |
| Control Group | Response Rate Against Influenza Vaccine in Patients With Inflammatory Bowel Disease: Number of Participants Positive for Seroconversion | Influenza B Yamagata | 0 participants |
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
Time frame: 4 weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| High Dose of Influenza Vaccine (HDIV) Group | Seroprotection: Number of Participants With Antibody Concentration at Least 1:40 at Week 4 Postimmunization | Influenza A H1N1 | 15 participants |
| High Dose of Influenza Vaccine (HDIV) Group | Seroprotection: Number of Participants With Antibody Concentration at Least 1:40 at Week 4 Postimmunization | At least two virus | 15 participants |
| High Dose of Influenza Vaccine (HDIV) Group | Seroprotection: Number of Participants With Antibody Concentration at Least 1:40 at Week 4 Postimmunization | At least one virus | 15 participants |
| High Dose of Influenza Vaccine (HDIV) Group | Seroprotection: Number of Participants With Antibody Concentration at Least 1:40 at Week 4 Postimmunization | Influenza A H3N2 | 15 participants |
| High Dose of Influenza Vaccine (HDIV) Group | Seroprotection: Number of Participants With Antibody Concentration at Least 1:40 at Week 4 Postimmunization | Three viruses | 8 participants |
| High Dose of Influenza Vaccine (HDIV) Group | Seroprotection: Number of Participants With Antibody Concentration at Least 1:40 at Week 4 Postimmunization | Influenza B Victoria | 8 participants |
| High Dose of Influenza Vaccine (HDIV) Group | Seroprotection: Number of Participants With Antibody Concentration at Least 1:40 at Week 4 Postimmunization | Influenza B Yamagata | 6 participants |
| Standard Dose Influenza Vaccine (SDIV) Group | Seroprotection: Number of Participants With Antibody Concentration at Least 1:40 at Week 4 Postimmunization | At least two virus | 25 participants |
| Standard Dose Influenza Vaccine (SDIV) Group | Seroprotection: Number of Participants With Antibody Concentration at Least 1:40 at Week 4 Postimmunization | Influenza B Yamagata | 6 participants |
| Standard Dose Influenza Vaccine (SDIV) Group | Seroprotection: Number of Participants With Antibody Concentration at Least 1:40 at Week 4 Postimmunization | Influenza B Victoria | 6 participants |
| Standard Dose Influenza Vaccine (SDIV) Group | Seroprotection: Number of Participants With Antibody Concentration at Least 1:40 at Week 4 Postimmunization | At least one virus | 25 participants |
| Standard Dose Influenza Vaccine (SDIV) Group | Seroprotection: Number of Participants With Antibody Concentration at Least 1:40 at Week 4 Postimmunization | Three viruses | 9 participants |
| Standard Dose Influenza Vaccine (SDIV) Group | Seroprotection: Number of Participants With Antibody Concentration at Least 1:40 at Week 4 Postimmunization | Influenza A H3N2 | 25 participants |
| Standard Dose Influenza Vaccine (SDIV) Group | Seroprotection: Number of Participants With Antibody Concentration at Least 1:40 at Week 4 Postimmunization | Influenza A H1N1 | 25 participants |
| Vedolizumab Group | Seroprotection: Number of Participants With Antibody Concentration at Least 1:40 at Week 4 Postimmunization | Influenza B Yamagata | 11 participants |
| Vedolizumab Group | Seroprotection: Number of Participants With Antibody Concentration at Least 1:40 at Week 4 Postimmunization | Influenza A H1N1 | 19 participants |
| Vedolizumab Group | Seroprotection: Number of Participants With Antibody Concentration at Least 1:40 at Week 4 Postimmunization | Influenza A H3N2 | 19 participants |
| Vedolizumab Group | Seroprotection: Number of Participants With Antibody Concentration at Least 1:40 at Week 4 Postimmunization | Influenza B Victoria | 10 participants |
| Vedolizumab Group | Seroprotection: Number of Participants With Antibody Concentration at Least 1:40 at Week 4 Postimmunization | At least one virus | 19 participants |
| Vedolizumab Group | Seroprotection: Number of Participants With Antibody Concentration at Least 1:40 at Week 4 Postimmunization | At least two virus | 19 participants |
| Vedolizumab Group | Seroprotection: Number of Participants With Antibody Concentration at Least 1:40 at Week 4 Postimmunization | Three viruses | 13 participants |
| Control Group | Seroprotection: Number of Participants With Antibody Concentration at Least 1:40 at Week 4 Postimmunization | Influenza B Victoria | 10 participants |
| Control Group | Seroprotection: Number of Participants With Antibody Concentration at Least 1:40 at Week 4 Postimmunization | Three viruses | 11 participants |
| Control Group | Seroprotection: Number of Participants With Antibody Concentration at Least 1:40 at Week 4 Postimmunization | At least two virus | 20 participants |
| Control Group | Seroprotection: Number of Participants With Antibody Concentration at Least 1:40 at Week 4 Postimmunization | Influenza A H3N2 | 20 participants |
| Control Group | Seroprotection: Number of Participants With Antibody Concentration at Least 1:40 at Week 4 Postimmunization | Influenza A H1N1 | 20 participants |
| Control Group | Seroprotection: Number of Participants With Antibody Concentration at Least 1:40 at Week 4 Postimmunization | At least one virus | 20 participants |
| Control Group | Seroprotection: Number of Participants With Antibody Concentration at Least 1:40 at Week 4 Postimmunization | Influenza B Yamagata | 8 participants |
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.
Time frame: 4 weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| High Dose of Influenza Vaccine (HDIV) Group | Seroprotection: Number of Participants With Antibody Titer of 160 at Week 4 Post-immunization | At least two virus | 5 participants |
| High Dose of Influenza Vaccine (HDIV) Group | Seroprotection: Number of Participants With Antibody Titer of 160 at Week 4 Post-immunization | Three viruses | 0 participants |
| High Dose of Influenza Vaccine (HDIV) Group | Seroprotection: Number of Participants With Antibody Titer of 160 at Week 4 Post-immunization | Influenza B Victoria | 0 participants |
| High Dose of Influenza Vaccine (HDIV) Group | Seroprotection: Number of Participants With Antibody Titer of 160 at Week 4 Post-immunization | Influenza A H3N2 | 6 participants |
| High Dose of Influenza Vaccine (HDIV) Group | Seroprotection: Number of Participants With Antibody Titer of 160 at Week 4 Post-immunization | Influenza A H1N1 | 12 participants |
| High Dose of Influenza Vaccine (HDIV) Group | Seroprotection: Number of Participants With Antibody Titer of 160 at Week 4 Post-immunization | At least one virus | 13 participants |
| High Dose of Influenza Vaccine (HDIV) Group | Seroprotection: Number of Participants With Antibody Titer of 160 at Week 4 Post-immunization | Influenza B Yamagata | 0 participants |
| Standard Dose Influenza Vaccine (SDIV) Group | Seroprotection: Number of Participants With Antibody Titer of 160 at Week 4 Post-immunization | Influenza A H1N1 | 24 participants |
| Standard Dose Influenza Vaccine (SDIV) Group | Seroprotection: Number of Participants With Antibody Titer of 160 at Week 4 Post-immunization | Three viruses | 0 participants |
| Standard Dose Influenza Vaccine (SDIV) Group | Seroprotection: Number of Participants With Antibody Titer of 160 at Week 4 Post-immunization | At least one virus | 25 participants |
| Standard Dose Influenza Vaccine (SDIV) Group | Seroprotection: Number of Participants With Antibody Titer of 160 at Week 4 Post-immunization | Influenza A H3N2 | 21 participants |
| Standard Dose Influenza Vaccine (SDIV) Group | Seroprotection: Number of Participants With Antibody Titer of 160 at Week 4 Post-immunization | Influenza B Yamagata | 0 participants |
| Standard Dose Influenza Vaccine (SDIV) Group | Seroprotection: Number of Participants With Antibody Titer of 160 at Week 4 Post-immunization | Influenza B Victoria | 0 participants |
| Standard Dose Influenza Vaccine (SDIV) Group | Seroprotection: Number of Participants With Antibody Titer of 160 at Week 4 Post-immunization | At least two virus | 20 participants |
| Vedolizumab Group | Seroprotection: Number of Participants With Antibody Titer of 160 at Week 4 Post-immunization | At least two virus | 16 participants |
| Vedolizumab Group | Seroprotection: Number of Participants With Antibody Titer of 160 at Week 4 Post-immunization | Influenza A H1N1 | 19 participants |
| Vedolizumab Group | Seroprotection: Number of Participants With Antibody Titer of 160 at Week 4 Post-immunization | Influenza A H3N2 | 16 participants |
| Vedolizumab Group | Seroprotection: Number of Participants With Antibody Titer of 160 at Week 4 Post-immunization | Influenza B Victoria | 0 participants |
| Vedolizumab Group | Seroprotection: Number of Participants With Antibody Titer of 160 at Week 4 Post-immunization | Influenza B Yamagata | 1 participants |
| Vedolizumab Group | Seroprotection: Number of Participants With Antibody Titer of 160 at Week 4 Post-immunization | At least one virus | 19 participants |
| Vedolizumab Group | Seroprotection: Number of Participants With Antibody Titer of 160 at Week 4 Post-immunization | Three viruses | 1 participants |
| Control Group | Seroprotection: Number of Participants With Antibody Titer of 160 at Week 4 Post-immunization | Influenza B Yamagata | 0 participants |
| Control Group | Seroprotection: Number of Participants With Antibody Titer of 160 at Week 4 Post-immunization | Influenza B Victoria | 0 participants |
| Control Group | Seroprotection: Number of Participants With Antibody Titer of 160 at Week 4 Post-immunization | At least two virus | 15 participants |
| Control Group | Seroprotection: Number of Participants With Antibody Titer of 160 at Week 4 Post-immunization | Influenza A H3N2 | 17 participants |
| Control Group | Seroprotection: Number of Participants With Antibody Titer of 160 at Week 4 Post-immunization | Influenza A H1N1 | 18 participants |
| Control Group | Seroprotection: Number of Participants With Antibody Titer of 160 at Week 4 Post-immunization | Three viruses | 0 participants |
| Control Group | Seroprotection: Number of Participants With Antibody Titer of 160 at Week 4 Post-immunization | At least one virus | 20 participants |