Crohn Disease, Herpes Zoster, Inflammatory Bowel Diseases, Ulcerative Colitis
Conditions
Brief summary
Inflammatory bowel disease (IBD) is a chronic inflammatory state of the gastrointestinal tract affecting 1.6-3.1 million people in the United States. Patients with IBD are treated with immunosuppressants that increase their risk of herpes zoster (HZ), also known as shingles. Those with IBD have a two-fold increased risk for HZ compared to age matched controls. Because most IBD patients are treated with systemic immunosuppressants, which are an independent risk factor for HZ, the live attenuated HZ vaccine was not recommended. However, the release of the new inactivated HZ vaccine, Shingrix (GlaxoSmithKline), presents new opportunities for preventive care.
Detailed description
The purpose of this study is to determine the immunogenicity of the herpes zoster subunit vaccine in inflammatory bowel disease patients on vedolizumab compared to those on anti-tumor necrosis factor (TNF) monotherapy. The study will evaluate humoral and cell mediated immunity in patients with IBD on vedolizumab who receive the two-dose herpes zoster vaccine. The investigators will evaluate short term, one month after second vaccination dose and sustained immunogenicity at 6 and 12 months post vaccination. The central hypothesis of this proposal is that IBD patients on vedolizumab should be able to mount a normal vaccine response comparable to those on anti-TNF monotherapy who might benefit from a third dose of the subunit vaccine as has been evaluated in HIV and transplant populations. The hypothesis is that IBD patients on vedolizumab will be able to mount a superior response to those on anti-TNF therapy. A recent study showed that hepatitis B vaccine immunogenicity was not affected by vedolizumab. The study population will include adult patients aged 18 to 70 with IBD (diagnosed by standard clinical, radiographic, endoscopic, and histopathologic criteria) receiving care at University of Wisconsin Hospital and Clinics. There is no randomization or use of placebo in this study. Two study groups will be established: * Group A: Patients with IBD on anti-TNF monotherapy * Group B: Patients with IBD on vedolizumab monotherapy Eligible patients with IBD will be recruited from the University of Wisconsin Hospital and Clinics.
Interventions
BIOLOGICALShingrix
Biological: SHINGRIX SHINGRIX is a vaccine indicated for prevention of herpes zoster (shingles) in adults aged 18 years and older. SHINGRIX is a suspension for injection supplied as a single-dose vial of lyophilized glycoprotein e (ge) antigen component to be reconstituted with the accompanying vial of AS01B adjuvant suspension component. A single dose after reconstitution is 0.5 mL. Dose and Schedule: Two doses (0.5 mL each) administered intramuscularly according to the following schedule: A first dose at Month 0 followed by a second dose administered anytime between 2 and 6 months later.
Sponsors
University of Wisconsin, Madison
Boston Medical Center
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Patient is between the ages of 18-70 years, inclusive. 2. History of primary varicella infection (chicken pox) Confirmed by a previous history of positive varicella zoster virus (VZV) Immunoglobulin G antibody or history of chicken pox 3. Patient has a history of ulcerative colitis (UC) or Crohn's disease diagnosed by standard clinical, radiographic, endoscopic, and histopathologic criteria. 4. Patient is receiving one of the following treatments for their IBD Group A: Anti-TNF monotherapy (adalimumab, certolizumab, golimumab, infliximab) Group B: Vedolizumab monotherapy 5. Patient has been on stable treatment for IBD for at least three months.
Exclusion criteria
1. Previous receipt of any HZ vaccine 2. Allergy to zoster vaccine or a component of it 3. Other underlying chronic medical condition that could affect immunogenicity to vaccines (rheumatoid arthritis, etc.) 4. History of herpes zoster or post herpetic neuralgia within the past year. 5. Patient cannot or will not provide written informed consent. 6. Patient is being administered immunomodulators currently or within the past three months 7. Patient has been taking any dose of oral or intravenous steroids within 30 days prior to immunization. 8. Patient has received polyclonal immunoglobulin therapy or blood products within the last year. 9. Patient is pregnant per self-reporting or older than age 70 years 10. Unable to provide appropriate informed consent due to being illiterate or impairment in decision-making capacity.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Cell Mediated Immunity | It will be measured from pre-immunization to 1 month after receiving second dose of booster vaccine post-immunization. | The primary objective will be the change in cell mediated immunity (CMI) as measured by ELISPOT from pre-immunization to one month after receiving second dose of vaccine. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent of Participants With a Change in Antibody Concentration Post Immunization | pre-immunization to one month 2nd dose post-immunization | A secondary outcome will be the change in varicella zoster virus (VZV) antibody concentration comparing pre-immunization to post immunization antibody concentration. |
| Percent of Participants With a Change in Antibody Concentration That is Sustained at 6 Months | Baseline to 6 months post-immunization | Sustained change in VZV antibody concentration at 6 months after receiving a second dose of booster vaccine post-immunization will be assessed. |
| Percent of Participants With Sustained Cell Mediated Immunity Measured Via ELISPOT After Immunization. | Baseline to 6 months post-immunization 2nd dose of vaccine. | Sustained change in CMI at 6 months will be assessed after receiving a second dose of booster vaccine post-immunization. CMI will be measured via ELISPOT |
| Number of Participants Who Experienced Vaccine Related Adverse Events After Dose 2 | Dose 2 (anytime from Month 2 to Month 6) | To evaluate for adverse effects following immunization patients will receive phone calls from study personnel to ascertain vaccine-related adverse effects. Dose and Schedule: Two doses (0.5 mL each) administered intramuscularly according to the following schedule: A first dose at Month 0 followed by a second dose administered anytime between 2 and 6 months later. |
| Number of Participants Experiencing a Change in Disease Activity Post Immunization Reported | at the baseline visit and one month after receipt of each vaccine | The Simple Clinical Colitis Activity Index (SCCAI) will be used to measure disease activity. It is a questionnaire with six subscore topics with scores defined by UC signs and symptoms from 0 to 4 for a range of scores from 0 to 17. Total scores are interpreted as: Remission = score of 0 to 4 points, Mild Activity = score of 5 to 7 points, Moderate Activity = Score of 8 to 16 points, and Severe Activity = Score of \> 16 points. Number of participants experiencing a change will be reported. |
| Number of Participants Who Experienced Vaccine Related Adverse Events After Dose 1 | Dose 1 (Month 0) | To evaluate for adverse effects following immunization patients will receive phone calls from study personnel to ascertain vaccine-related adverse effects. Dose and Schedule: Two doses (0.5 mL each) administered intramuscularly according to the following schedule: A first dose at Month 0 followed by a second dose administered anytime between 2 and 6 months later. |
Countries
United States
Participant flow
Recruitment details
Participants were enrolled at UW Health from May 2019 to July 2023
Participants by arm
| Arm | Count |
|---|---|
| Vedolizumab Patients with IBD on vedolizumab monotherapy will be given the shingrix vaccine.
Dose and Schedule: Two doses (0.5 mL each) administered intramuscularly according to the following schedule: A first dose at Month 0 followed by a second dose administered anytime between 2 and 6 months later. | 16 |
| Anti-TNF Monotherapy Patients with IBD on Anti-TNF monotherapy will be given the shingrix vaccine. Dose and Schedule: Two doses (0.5 mL each) administered intramuscularly according to the following schedule: A first dose at Month 0 followed by a second dose administered anytime between 2 and 6 months later. | 17 |
| Total | 33 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 2 | 2 |
Baseline characteristics
| Characteristic | Vedolizumab | Anti-TNF Monotherapy | Total |
|---|---|---|---|
| Age, Continuous | 55 years | 62 years | 58 years |
| Charlson Comorbidity Score | 1.5 units on a scale | 3 units on a scale | 2.1 units on a scale |
| Current Irritable Bowel Disease (IBD) Medication Adalimumab | 0 Participants | 9 Participants | 9 Participants |
| Current Irritable Bowel Disease (IBD) Medication Certolizumab | 0 Participants | 3 Participants | 3 Participants |
| Current Irritable Bowel Disease (IBD) Medication Infliximab | 0 Participants | 5 Participants | 5 Participants |
| Current Irritable Bowel Disease (IBD) Medication Sulfasalazine | 0 Participants | 0 Participants | 0 Participants |
| Current Irritable Bowel Disease (IBD) Medication Vedolizumab | 16 Participants | 0 Participants | 16 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 0 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 15 Participants | 17 Participants | 32 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Length of disease | 162 months | 344 months | 243 months |
| Participants with Crohn's Disease | 8 Participants | 14 Participants | 22 Participants |
| Positive history of herpes zoster | 2 Participants | 4 Participants | 6 Participants |
| Previous IBD Medications 5-ASA | 12 Participants | 4 Participants | 16 Participants |
| Previous IBD Medications Methotrexate or azathioprine | 9 Participants | 4 Participants | 13 Participants |
| Previous IBD Medications Previous anti-TNF | 13 Participants | 0 Participants | 13 Participants |
| Previous IBD surgery | 2 Participants | 12 Participants | 14 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 16 Participants | 16 Participants | 32 Participants |
| Region of Enrollment United States | 16 participants | 17 participants | 33 participants |
| Sex: Female, Male Female | 9 Participants | 4 Participants | 13 Participants |
| Sex: Female, Male Male | 7 Participants | 13 Participants | 20 Participants |
| Smoking Status Current Smoker | 1 Participants | 1 Participants | 2 Participants |
| Smoking Status Former Smoker | 4 Participants | 6 Participants | 10 Participants |
| Steroid use in past year | 6 Participants | 2 Participants | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk |
|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 15 | 0 / 15 | 0 / 15 | 0 / 15 | 0 / 15 | 0 / 15 | 0 / 14 | 0 / 15 |
| other Total, other adverse events | 10 / 15 | 13 / 15 | 10 / 15 | 7 / 15 | 0 / 15 | 0 / 15 | 0 / 14 | 0 / 15 |
| serious Total, serious adverse events | 0 / 15 | 0 / 15 | 0 / 15 | 0 / 15 | 0 / 15 | 0 / 15 | 0 / 14 | 0 / 15 |
Outcome results
Primary
Change in Cell Mediated Immunity
The primary objective will be the change in cell mediated immunity (CMI) as measured by ELISPOT from pre-immunization to one month after receiving second dose of vaccine.
Time frame: It will be measured from pre-immunization to 1 month after receiving second dose of booster vaccine post-immunization.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Vedolizumab | Change in Cell Mediated Immunity | Pre-Vaccine | 33 cells per million |
| Vedolizumab | Change in Cell Mediated Immunity | One month after series completion of two dose series | 33 cells per million |
| Anti-TNF Monotherapy | Change in Cell Mediated Immunity | Pre-Vaccine | 33 cells per million |
| Anti-TNF Monotherapy | Change in Cell Mediated Immunity | One month after series completion of two dose series | 50 cells per million |
Comparison: one month after series completion of two dose seriesp-value: 0.16Mann-Whitney U test
Secondary
Number of Participants Experiencing a Change in Disease Activity Post Immunization Reported
The Simple Clinical Colitis Activity Index (SCCAI) will be used to measure disease activity. It is a questionnaire with six subscore topics with scores defined by UC signs and symptoms from 0 to 4 for a range of scores from 0 to 17. Total scores are interpreted as: Remission = score of 0 to 4 points, Mild Activity = score of 5 to 7 points, Moderate Activity = Score of 8 to 16 points, and Severe Activity = Score of \> 16 points. Number of participants experiencing a change will be reported.
Time frame: at the baseline visit and one month after receipt of each vaccine
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Vedolizumab | Number of Participants Experiencing a Change in Disease Activity Post Immunization Reported | baseline | 0 Participants |
| Vedolizumab | Number of Participants Experiencing a Change in Disease Activity Post Immunization Reported | 1 month post-dose 1 | 0 Participants |
| Vedolizumab | Number of Participants Experiencing a Change in Disease Activity Post Immunization Reported | 1 month post-dose 2 | 0 Participants |
| Anti-TNF Monotherapy | Number of Participants Experiencing a Change in Disease Activity Post Immunization Reported | 1 month post-dose 2 | 0 Participants |
| Anti-TNF Monotherapy | Number of Participants Experiencing a Change in Disease Activity Post Immunization Reported | baseline | 0 Participants |
| Anti-TNF Monotherapy | Number of Participants Experiencing a Change in Disease Activity Post Immunization Reported | 1 month post-dose 1 | 0 Participants |
Secondary
Number of Participants Who Experienced Vaccine Related Adverse Events After Dose 1
To evaluate for adverse effects following immunization patients will receive phone calls from study personnel to ascertain vaccine-related adverse effects. Dose and Schedule: Two doses (0.5 mL each) administered intramuscularly according to the following schedule: A first dose at Month 0 followed by a second dose administered anytime between 2 and 6 months later.
Time frame: Dose 1 (Month 0)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Vedolizumab | Number of Participants Who Experienced Vaccine Related Adverse Events After Dose 1 | Congestion | 0 Participants |
| Vedolizumab | Number of Participants Who Experienced Vaccine Related Adverse Events After Dose 1 | Erythema | 0 Participants |
| Vedolizumab | Number of Participants Who Experienced Vaccine Related Adverse Events After Dose 1 | Fatigue | 5 Participants |
| Vedolizumab | Number of Participants Who Experienced Vaccine Related Adverse Events After Dose 1 | Lymphadenopathy | 0 Participants |
| Vedolizumab | Number of Participants Who Experienced Vaccine Related Adverse Events After Dose 1 | Pain/Soreness | 9 Participants |
| Vedolizumab | Number of Participants Who Experienced Vaccine Related Adverse Events After Dose 1 | Intermittent fever/chills | 3 Participants |
| Vedolizumab | Number of Participants Who Experienced Vaccine Related Adverse Events After Dose 1 | Any Local Adverse Effect | 8 Participants |
| Vedolizumab | Number of Participants Who Experienced Vaccine Related Adverse Events After Dose 1 | Myalgias/joint pain | 2 Participants |
| Vedolizumab | Number of Participants Who Experienced Vaccine Related Adverse Events After Dose 1 | Warmth | 0 Participants |
| Vedolizumab | Number of Participants Who Experienced Vaccine Related Adverse Events After Dose 1 | Swelling | 3 Participants |
| Vedolizumab | Number of Participants Who Experienced Vaccine Related Adverse Events After Dose 1 | Plugged ear | 1 Participants |
| Vedolizumab | Number of Participants Who Experienced Vaccine Related Adverse Events After Dose 1 | Headaches | 6 Participants |
| Vedolizumab | Number of Participants Who Experienced Vaccine Related Adverse Events After Dose 1 | Any Systemic Adverse Effect | 7 Participants |
| Vedolizumab | Number of Participants Who Experienced Vaccine Related Adverse Events After Dose 1 | Pruritus | 1 Participants |
| Anti-TNF Monotherapy | Number of Participants Who Experienced Vaccine Related Adverse Events After Dose 1 | Erythema | 1 Participants |
| Anti-TNF Monotherapy | Number of Participants Who Experienced Vaccine Related Adverse Events After Dose 1 | Congestion | 0 Participants |
| Anti-TNF Monotherapy | Number of Participants Who Experienced Vaccine Related Adverse Events After Dose 1 | Fatigue | 0 Participants |
| Anti-TNF Monotherapy | Number of Participants Who Experienced Vaccine Related Adverse Events After Dose 1 | Lymphadenopathy | 0 Participants |
| Anti-TNF Monotherapy | Number of Participants Who Experienced Vaccine Related Adverse Events After Dose 1 | Warmth | 1 Participants |
| Anti-TNF Monotherapy | Number of Participants Who Experienced Vaccine Related Adverse Events After Dose 1 | Myalgias/joint pain | 1 Participants |
| Anti-TNF Monotherapy | Number of Participants Who Experienced Vaccine Related Adverse Events After Dose 1 | Pruritus | 0 Participants |
| Anti-TNF Monotherapy | Number of Participants Who Experienced Vaccine Related Adverse Events After Dose 1 | Swelling | 0 Participants |
| Anti-TNF Monotherapy | Number of Participants Who Experienced Vaccine Related Adverse Events After Dose 1 | Intermittent fever/chills | 0 Participants |
| Anti-TNF Monotherapy | Number of Participants Who Experienced Vaccine Related Adverse Events After Dose 1 | Any Systemic Adverse Effect | 1 Participants |
| Anti-TNF Monotherapy | Number of Participants Who Experienced Vaccine Related Adverse Events After Dose 1 | Pain/Soreness | 1 Participants |
| Anti-TNF Monotherapy | Number of Participants Who Experienced Vaccine Related Adverse Events After Dose 1 | Any Local Adverse Effect | 1 Participants |
| Anti-TNF Monotherapy | Number of Participants Who Experienced Vaccine Related Adverse Events After Dose 1 | Headaches | 0 Participants |
| Anti-TNF Monotherapy | Number of Participants Who Experienced Vaccine Related Adverse Events After Dose 1 | Plugged ear | 0 Participants |
| Vedolizumab Dose 1: Grade 3 | Number of Participants Who Experienced Vaccine Related Adverse Events After Dose 1 | Intermittent fever/chills | 0 Participants |
| Vedolizumab Dose 1: Grade 3 | Number of Participants Who Experienced Vaccine Related Adverse Events After Dose 1 | Congestion | 0 Participants |
| Vedolizumab Dose 1: Grade 3 | Number of Participants Who Experienced Vaccine Related Adverse Events After Dose 1 | Any Systemic Adverse Effect | 0 Participants |
| Vedolizumab Dose 1: Grade 3 | Number of Participants Who Experienced Vaccine Related Adverse Events After Dose 1 | Lymphadenopathy | 0 Participants |
| Vedolizumab Dose 1: Grade 3 | Number of Participants Who Experienced Vaccine Related Adverse Events After Dose 1 | Plugged ear | 0 Participants |
| Vedolizumab Dose 1: Grade 3 | Number of Participants Who Experienced Vaccine Related Adverse Events After Dose 1 | Myalgias/joint pain | 0 Participants |
| Vedolizumab Dose 1: Grade 3 | Number of Participants Who Experienced Vaccine Related Adverse Events After Dose 1 | Any Local Adverse Effect | 0 Participants |
| Vedolizumab Dose 1: Grade 3 | Number of Participants Who Experienced Vaccine Related Adverse Events After Dose 1 | Pruritus | 0 Participants |
| Vedolizumab Dose 1: Grade 3 | Number of Participants Who Experienced Vaccine Related Adverse Events After Dose 1 | Fatigue | 0 Participants |
| Vedolizumab Dose 1: Grade 3 | Number of Participants Who Experienced Vaccine Related Adverse Events After Dose 1 | Erythema | 0 Participants |
| Vedolizumab Dose 1: Grade 3 | Number of Participants Who Experienced Vaccine Related Adverse Events After Dose 1 | Pain/Soreness | 0 Participants |
| Vedolizumab Dose 1: Grade 3 | Number of Participants Who Experienced Vaccine Related Adverse Events After Dose 1 | Warmth | 0 Participants |
| Vedolizumab Dose 1: Grade 3 | Number of Participants Who Experienced Vaccine Related Adverse Events After Dose 1 | Headaches | 0 Participants |
| Vedolizumab Dose 1: Grade 3 | Number of Participants Who Experienced Vaccine Related Adverse Events After Dose 1 | Swelling | 0 Participants |
| Vedolizumab Dose 1: Grade 4 | Number of Participants Who Experienced Vaccine Related Adverse Events After Dose 1 | Headaches | 0 Participants |
| Vedolizumab Dose 1: Grade 4 | Number of Participants Who Experienced Vaccine Related Adverse Events After Dose 1 | Myalgias/joint pain | 0 Participants |
| Vedolizumab Dose 1: Grade 4 | Number of Participants Who Experienced Vaccine Related Adverse Events After Dose 1 | Congestion | 0 Participants |
| Vedolizumab Dose 1: Grade 4 | Number of Participants Who Experienced Vaccine Related Adverse Events After Dose 1 | Any Systemic Adverse Effect | 0 Participants |
| Vedolizumab Dose 1: Grade 4 | Number of Participants Who Experienced Vaccine Related Adverse Events After Dose 1 | Warmth | 0 Participants |
| Vedolizumab Dose 1: Grade 4 | Number of Participants Who Experienced Vaccine Related Adverse Events After Dose 1 | Any Local Adverse Effect | 0 Participants |
| Vedolizumab Dose 1: Grade 4 | Number of Participants Who Experienced Vaccine Related Adverse Events After Dose 1 | Lymphadenopathy | 0 Participants |
| Vedolizumab Dose 1: Grade 4 | Number of Participants Who Experienced Vaccine Related Adverse Events After Dose 1 | Swelling | 0 Participants |
| Vedolizumab Dose 1: Grade 4 | Number of Participants Who Experienced Vaccine Related Adverse Events After Dose 1 | Intermittent fever/chills | 0 Participants |
| Vedolizumab Dose 1: Grade 4 | Number of Participants Who Experienced Vaccine Related Adverse Events After Dose 1 | Erythema | 0 Participants |
| Vedolizumab Dose 1: Grade 4 | Number of Participants Who Experienced Vaccine Related Adverse Events After Dose 1 | Plugged ear | 0 Participants |
| Vedolizumab Dose 1: Grade 4 | Number of Participants Who Experienced Vaccine Related Adverse Events After Dose 1 | Pruritus | 0 Participants |
| Vedolizumab Dose 1: Grade 4 | Number of Participants Who Experienced Vaccine Related Adverse Events After Dose 1 | Pain/Soreness | 0 Participants |
| Vedolizumab Dose 1: Grade 4 | Number of Participants Who Experienced Vaccine Related Adverse Events After Dose 1 | Fatigue | 0 Participants |
| Anti-TNF Monotherapy Dose 1: Grade 1 | Number of Participants Who Experienced Vaccine Related Adverse Events After Dose 1 | Pain/Soreness | 12 Participants |
| Anti-TNF Monotherapy Dose 1: Grade 1 | Number of Participants Who Experienced Vaccine Related Adverse Events After Dose 1 | Lymphadenopathy | 1 Participants |
| Anti-TNF Monotherapy Dose 1: Grade 1 | Number of Participants Who Experienced Vaccine Related Adverse Events After Dose 1 | Congestion | 1 Participants |
| Anti-TNF Monotherapy Dose 1: Grade 1 | Number of Participants Who Experienced Vaccine Related Adverse Events After Dose 1 | Fatigue | 2 Participants |
| Anti-TNF Monotherapy Dose 1: Grade 1 | Number of Participants Who Experienced Vaccine Related Adverse Events After Dose 1 | Swelling | 1 Participants |
| Anti-TNF Monotherapy Dose 1: Grade 1 | Number of Participants Who Experienced Vaccine Related Adverse Events After Dose 1 | Any Systemic Adverse Effect | 6 Participants |
| Anti-TNF Monotherapy Dose 1: Grade 1 | Number of Participants Who Experienced Vaccine Related Adverse Events After Dose 1 | Headaches | 3 Participants |
| Anti-TNF Monotherapy Dose 1: Grade 1 | Number of Participants Who Experienced Vaccine Related Adverse Events After Dose 1 | Plugged ear | 0 Participants |
| Anti-TNF Monotherapy Dose 1: Grade 1 | Number of Participants Who Experienced Vaccine Related Adverse Events After Dose 1 | Intermittent fever/chills | 2 Participants |
| Anti-TNF Monotherapy Dose 1: Grade 1 | Number of Participants Who Experienced Vaccine Related Adverse Events After Dose 1 | Myalgias/joint pain | 1 Participants |
| Anti-TNF Monotherapy Dose 1: Grade 1 | Number of Participants Who Experienced Vaccine Related Adverse Events After Dose 1 | Any Local Adverse Effect | 11 Participants |
| Anti-TNF Monotherapy Dose 1: Grade 1 | Number of Participants Who Experienced Vaccine Related Adverse Events After Dose 1 | Pruritus | 0 Participants |
| Anti-TNF Monotherapy Dose 1: Grade 1 | Number of Participants Who Experienced Vaccine Related Adverse Events After Dose 1 | Erythema | 2 Participants |
| Anti-TNF Monotherapy Dose 1: Grade 1 | Number of Participants Who Experienced Vaccine Related Adverse Events After Dose 1 | Warmth | 0 Participants |
| Anti-TNF Monotherapy Dose 1: Grade 2 | Number of Participants Who Experienced Vaccine Related Adverse Events After Dose 1 | Pain/Soreness | 1 Participants |
| Anti-TNF Monotherapy Dose 1: Grade 2 | Number of Participants Who Experienced Vaccine Related Adverse Events After Dose 1 | Plugged ear | 0 Participants |
| Anti-TNF Monotherapy Dose 1: Grade 2 | Number of Participants Who Experienced Vaccine Related Adverse Events After Dose 1 | Erythema | 1 Participants |
| Anti-TNF Monotherapy Dose 1: Grade 2 | Number of Participants Who Experienced Vaccine Related Adverse Events After Dose 1 | Intermittent fever/chills | 0 Participants |
| Anti-TNF Monotherapy Dose 1: Grade 2 | Number of Participants Who Experienced Vaccine Related Adverse Events After Dose 1 | Fatigue | 0 Participants |
| Anti-TNF Monotherapy Dose 1: Grade 2 | Number of Participants Who Experienced Vaccine Related Adverse Events After Dose 1 | Warmth | 0 Participants |
| Anti-TNF Monotherapy Dose 1: Grade 2 | Number of Participants Who Experienced Vaccine Related Adverse Events After Dose 1 | Pruritus | 0 Participants |
| Anti-TNF Monotherapy Dose 1: Grade 2 | Number of Participants Who Experienced Vaccine Related Adverse Events After Dose 1 | Swelling | 0 Participants |
| Anti-TNF Monotherapy Dose 1: Grade 2 | Number of Participants Who Experienced Vaccine Related Adverse Events After Dose 1 | Congestion | 0 Participants |
| Anti-TNF Monotherapy Dose 1: Grade 2 | Number of Participants Who Experienced Vaccine Related Adverse Events After Dose 1 | Any Local Adverse Effect | 2 Participants |
| Anti-TNF Monotherapy Dose 1: Grade 2 | Number of Participants Who Experienced Vaccine Related Adverse Events After Dose 1 | Any Systemic Adverse Effect | 0 Participants |
| Anti-TNF Monotherapy Dose 1: Grade 2 | Number of Participants Who Experienced Vaccine Related Adverse Events After Dose 1 | Myalgias/joint pain | 0 Participants |
| Anti-TNF Monotherapy Dose 1: Grade 2 | Number of Participants Who Experienced Vaccine Related Adverse Events After Dose 1 | Lymphadenopathy | 0 Participants |
| Anti-TNF Monotherapy Dose 1: Grade 2 | Number of Participants Who Experienced Vaccine Related Adverse Events After Dose 1 | Headaches | 0 Participants |
| Anti-TNF Monotherapy Dose 1: Grade 3 | Number of Participants Who Experienced Vaccine Related Adverse Events After Dose 1 | Lymphadenopathy | 0 Participants |
| Anti-TNF Monotherapy Dose 1: Grade 3 | Number of Participants Who Experienced Vaccine Related Adverse Events After Dose 1 | Headaches | 0 Participants |
| Anti-TNF Monotherapy Dose 1: Grade 3 | Number of Participants Who Experienced Vaccine Related Adverse Events After Dose 1 | Myalgias/joint pain | 0 Participants |
| Anti-TNF Monotherapy Dose 1: Grade 3 | Number of Participants Who Experienced Vaccine Related Adverse Events After Dose 1 | Plugged ear | 0 Participants |
| Anti-TNF Monotherapy Dose 1: Grade 3 | Number of Participants Who Experienced Vaccine Related Adverse Events After Dose 1 | Any Systemic Adverse Effect | 0 Participants |
| Anti-TNF Monotherapy Dose 1: Grade 3 | Number of Participants Who Experienced Vaccine Related Adverse Events After Dose 1 | Swelling | 0 Participants |
| Anti-TNF Monotherapy Dose 1: Grade 3 | Number of Participants Who Experienced Vaccine Related Adverse Events After Dose 1 | Pain/Soreness | 0 Participants |
| Anti-TNF Monotherapy Dose 1: Grade 3 | Number of Participants Who Experienced Vaccine Related Adverse Events After Dose 1 | Any Local Adverse Effect | 0 Participants |
| Anti-TNF Monotherapy Dose 1: Grade 3 | Number of Participants Who Experienced Vaccine Related Adverse Events After Dose 1 | Pruritus | 0 Participants |
| Anti-TNF Monotherapy Dose 1: Grade 3 | Number of Participants Who Experienced Vaccine Related Adverse Events After Dose 1 | Warmth | 0 Participants |
| Anti-TNF Monotherapy Dose 1: Grade 3 | Number of Participants Who Experienced Vaccine Related Adverse Events After Dose 1 | Erythema | 0 Participants |
| Anti-TNF Monotherapy Dose 1: Grade 3 | Number of Participants Who Experienced Vaccine Related Adverse Events After Dose 1 | Congestion | 0 Participants |
| Anti-TNF Monotherapy Dose 1: Grade 3 | Number of Participants Who Experienced Vaccine Related Adverse Events After Dose 1 | Fatigue | 0 Participants |
| Anti-TNF Monotherapy Dose 1: Grade 3 | Number of Participants Who Experienced Vaccine Related Adverse Events After Dose 1 | Intermittent fever/chills | 0 Participants |
| Anti-TNF Monotherapy Dose 1: Grade 4 | Number of Participants Who Experienced Vaccine Related Adverse Events After Dose 1 | Any Local Adverse Effect | 0 Participants |
| Anti-TNF Monotherapy Dose 1: Grade 4 | Number of Participants Who Experienced Vaccine Related Adverse Events After Dose 1 | Myalgias/joint pain | 0 Participants |
| Anti-TNF Monotherapy Dose 1: Grade 4 | Number of Participants Who Experienced Vaccine Related Adverse Events After Dose 1 | Erythema | 0 Participants |
| Anti-TNF Monotherapy Dose 1: Grade 4 | Number of Participants Who Experienced Vaccine Related Adverse Events After Dose 1 | Pain/Soreness | 0 Participants |
| Anti-TNF Monotherapy Dose 1: Grade 4 | Number of Participants Who Experienced Vaccine Related Adverse Events After Dose 1 | Warmth | 0 Participants |
| Anti-TNF Monotherapy Dose 1: Grade 4 | Number of Participants Who Experienced Vaccine Related Adverse Events After Dose 1 | Swelling | 0 Participants |
| Anti-TNF Monotherapy Dose 1: Grade 4 | Number of Participants Who Experienced Vaccine Related Adverse Events After Dose 1 | Intermittent fever/chills | 0 Participants |
| Anti-TNF Monotherapy Dose 1: Grade 4 | Number of Participants Who Experienced Vaccine Related Adverse Events After Dose 1 | Any Systemic Adverse Effect | 0 Participants |
| Anti-TNF Monotherapy Dose 1: Grade 4 | Number of Participants Who Experienced Vaccine Related Adverse Events After Dose 1 | Headaches | 0 Participants |
| Anti-TNF Monotherapy Dose 1: Grade 4 | Number of Participants Who Experienced Vaccine Related Adverse Events After Dose 1 | Congestion | 0 Participants |
| Anti-TNF Monotherapy Dose 1: Grade 4 | Number of Participants Who Experienced Vaccine Related Adverse Events After Dose 1 | Pruritus | 0 Participants |
| Anti-TNF Monotherapy Dose 1: Grade 4 | Number of Participants Who Experienced Vaccine Related Adverse Events After Dose 1 | Lymphadenopathy | 0 Participants |
| Anti-TNF Monotherapy Dose 1: Grade 4 | Number of Participants Who Experienced Vaccine Related Adverse Events After Dose 1 | Plugged ear | 0 Participants |
| Anti-TNF Monotherapy Dose 1: Grade 4 | Number of Participants Who Experienced Vaccine Related Adverse Events After Dose 1 | Fatigue | 0 Participants |
Secondary
Number of Participants Who Experienced Vaccine Related Adverse Events After Dose 2
To evaluate for adverse effects following immunization patients will receive phone calls from study personnel to ascertain vaccine-related adverse effects. Dose and Schedule: Two doses (0.5 mL each) administered intramuscularly according to the following schedule: A first dose at Month 0 followed by a second dose administered anytime between 2 and 6 months later.
Time frame: Dose 2 (anytime from Month 2 to Month 6)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Vedolizumab | Number of Participants Who Experienced Vaccine Related Adverse Events After Dose 2 | Congestion | 0 Participants |
| Vedolizumab | Number of Participants Who Experienced Vaccine Related Adverse Events After Dose 2 | Fatigue | 4 Participants |
| Vedolizumab | Number of Participants Who Experienced Vaccine Related Adverse Events After Dose 2 | Any Local Adverse Effect | 10 Participants |
| Vedolizumab | Number of Participants Who Experienced Vaccine Related Adverse Events After Dose 2 | Headaches | 3 Participants |
| Vedolizumab | Number of Participants Who Experienced Vaccine Related Adverse Events After Dose 2 | Warmth | 0 Participants |
| Vedolizumab | Number of Participants Who Experienced Vaccine Related Adverse Events After Dose 2 | Lymphadenopathy | 0 Participants |
| Vedolizumab | Number of Participants Who Experienced Vaccine Related Adverse Events After Dose 2 | Erythema | 4 Participants |
| Vedolizumab | Number of Participants Who Experienced Vaccine Related Adverse Events After Dose 2 | Pain/Soreness | 8 Participants |
| Vedolizumab | Number of Participants Who Experienced Vaccine Related Adverse Events After Dose 2 | Myalgias/joint pain | 6 Participants |
| Vedolizumab | Number of Participants Who Experienced Vaccine Related Adverse Events After Dose 2 | Intermittent fever/chills | 4 Participants |
| Vedolizumab | Number of Participants Who Experienced Vaccine Related Adverse Events After Dose 2 | Swelling | 2 Participants |
| Vedolizumab | Number of Participants Who Experienced Vaccine Related Adverse Events After Dose 2 | Any Systemic Adverse Effect | 5 Participants |
| Vedolizumab | Number of Participants Who Experienced Vaccine Related Adverse Events After Dose 2 | Plugged ear | 0 Participants |
| Vedolizumab | Number of Participants Who Experienced Vaccine Related Adverse Events After Dose 2 | Pruritus | 0 Participants |
| Anti-TNF Monotherapy | Number of Participants Who Experienced Vaccine Related Adverse Events After Dose 2 | Myalgias/joint pain | 0 Participants |
| Anti-TNF Monotherapy | Number of Participants Who Experienced Vaccine Related Adverse Events After Dose 2 | Headaches | 0 Participants |
| Anti-TNF Monotherapy | Number of Participants Who Experienced Vaccine Related Adverse Events After Dose 2 | Erythema | 0 Participants |
| Anti-TNF Monotherapy | Number of Participants Who Experienced Vaccine Related Adverse Events After Dose 2 | Plugged ear | 0 Participants |
| Anti-TNF Monotherapy | Number of Participants Who Experienced Vaccine Related Adverse Events After Dose 2 | Pain/Soreness | 0 Participants |
| Anti-TNF Monotherapy | Number of Participants Who Experienced Vaccine Related Adverse Events After Dose 2 | Fatigue | 1 Participants |
| Anti-TNF Monotherapy | Number of Participants Who Experienced Vaccine Related Adverse Events After Dose 2 | Any Local Adverse Effect | 0 Participants |
| Anti-TNF Monotherapy | Number of Participants Who Experienced Vaccine Related Adverse Events After Dose 2 | Pruritus | 0 Participants |
| Anti-TNF Monotherapy | Number of Participants Who Experienced Vaccine Related Adverse Events After Dose 2 | Congestion | 0 Participants |
| Anti-TNF Monotherapy | Number of Participants Who Experienced Vaccine Related Adverse Events After Dose 2 | Lymphadenopathy | 0 Participants |
| Anti-TNF Monotherapy | Number of Participants Who Experienced Vaccine Related Adverse Events After Dose 2 | Warmth | 0 Participants |
| Anti-TNF Monotherapy | Number of Participants Who Experienced Vaccine Related Adverse Events After Dose 2 | Swelling | 0 Participants |
| Anti-TNF Monotherapy | Number of Participants Who Experienced Vaccine Related Adverse Events After Dose 2 | Any Systemic Adverse Effect | 1 Participants |
| Anti-TNF Monotherapy | Number of Participants Who Experienced Vaccine Related Adverse Events After Dose 2 | Intermittent fever/chills | 0 Participants |
| Vedolizumab Dose 1: Grade 3 | Number of Participants Who Experienced Vaccine Related Adverse Events After Dose 2 | Lymphadenopathy | 0 Participants |
| Vedolizumab Dose 1: Grade 3 | Number of Participants Who Experienced Vaccine Related Adverse Events After Dose 2 | Any Local Adverse Effect | 0 Participants |
| Vedolizumab Dose 1: Grade 3 | Number of Participants Who Experienced Vaccine Related Adverse Events After Dose 2 | Pain/Soreness | 0 Participants |
| Vedolizumab Dose 1: Grade 3 | Number of Participants Who Experienced Vaccine Related Adverse Events After Dose 2 | Fatigue | 0 Participants |
| Vedolizumab Dose 1: Grade 3 | Number of Participants Who Experienced Vaccine Related Adverse Events After Dose 2 | Swelling | 0 Participants |
| Vedolizumab Dose 1: Grade 3 | Number of Participants Who Experienced Vaccine Related Adverse Events After Dose 2 | Any Systemic Adverse Effect | 2 Participants |
| Vedolizumab Dose 1: Grade 3 | Number of Participants Who Experienced Vaccine Related Adverse Events After Dose 2 | Headaches | 0 Participants |
| Vedolizumab Dose 1: Grade 3 | Number of Participants Who Experienced Vaccine Related Adverse Events After Dose 2 | Erythema | 0 Participants |
| Vedolizumab Dose 1: Grade 3 | Number of Participants Who Experienced Vaccine Related Adverse Events After Dose 2 | Plugged ear | 0 Participants |
| Vedolizumab Dose 1: Grade 3 | Number of Participants Who Experienced Vaccine Related Adverse Events After Dose 2 | Intermittent fever/chills | 1 Participants |
| Vedolizumab Dose 1: Grade 3 | Number of Participants Who Experienced Vaccine Related Adverse Events After Dose 2 | Congestion | 0 Participants |
| Vedolizumab Dose 1: Grade 3 | Number of Participants Who Experienced Vaccine Related Adverse Events After Dose 2 | Warmth | 0 Participants |
| Vedolizumab Dose 1: Grade 3 | Number of Participants Who Experienced Vaccine Related Adverse Events After Dose 2 | Pruritus | 0 Participants |
| Vedolizumab Dose 1: Grade 3 | Number of Participants Who Experienced Vaccine Related Adverse Events After Dose 2 | Myalgias/joint pain | 1 Participants |
| Vedolizumab Dose 1: Grade 4 | Number of Participants Who Experienced Vaccine Related Adverse Events After Dose 2 | Any Systemic Adverse Effect | 0 Participants |
| Vedolizumab Dose 1: Grade 4 | Number of Participants Who Experienced Vaccine Related Adverse Events After Dose 2 | Headaches | 0 Participants |
| Vedolizumab Dose 1: Grade 4 | Number of Participants Who Experienced Vaccine Related Adverse Events After Dose 2 | Intermittent fever/chills | 0 Participants |
| Vedolizumab Dose 1: Grade 4 | Number of Participants Who Experienced Vaccine Related Adverse Events After Dose 2 | Swelling | 0 Participants |
| Vedolizumab Dose 1: Grade 4 | Number of Participants Who Experienced Vaccine Related Adverse Events After Dose 2 | Warmth | 0 Participants |
| Vedolizumab Dose 1: Grade 4 | Number of Participants Who Experienced Vaccine Related Adverse Events After Dose 2 | Lymphadenopathy | 0 Participants |
| Vedolizumab Dose 1: Grade 4 | Number of Participants Who Experienced Vaccine Related Adverse Events After Dose 2 | Myalgias/joint pain | 0 Participants |
| Vedolizumab Dose 1: Grade 4 | Number of Participants Who Experienced Vaccine Related Adverse Events After Dose 2 | Any Local Adverse Effect | 0 Participants |
| Vedolizumab Dose 1: Grade 4 | Number of Participants Who Experienced Vaccine Related Adverse Events After Dose 2 | Congestion | 0 Participants |
| Vedolizumab Dose 1: Grade 4 | Number of Participants Who Experienced Vaccine Related Adverse Events After Dose 2 | Pain/Soreness | 0 Participants |
| Vedolizumab Dose 1: Grade 4 | Number of Participants Who Experienced Vaccine Related Adverse Events After Dose 2 | Pruritus | 0 Participants |
| Vedolizumab Dose 1: Grade 4 | Number of Participants Who Experienced Vaccine Related Adverse Events After Dose 2 | Erythema | 0 Participants |
| Vedolizumab Dose 1: Grade 4 | Number of Participants Who Experienced Vaccine Related Adverse Events After Dose 2 | Fatigue | 0 Participants |
| Vedolizumab Dose 1: Grade 4 | Number of Participants Who Experienced Vaccine Related Adverse Events After Dose 2 | Plugged ear | 0 Participants |
| Anti-TNF Monotherapy Dose 1: Grade 1 | Number of Participants Who Experienced Vaccine Related Adverse Events After Dose 2 | Plugged ear | 0 Participants |
| Anti-TNF Monotherapy Dose 1: Grade 1 | Number of Participants Who Experienced Vaccine Related Adverse Events After Dose 2 | Fatigue | 1 Participants |
| Anti-TNF Monotherapy Dose 1: Grade 1 | Number of Participants Who Experienced Vaccine Related Adverse Events After Dose 2 | Erythema | 2 Participants |
| Anti-TNF Monotherapy Dose 1: Grade 1 | Number of Participants Who Experienced Vaccine Related Adverse Events After Dose 2 | Any Local Adverse Effect | 7 Participants |
| Anti-TNF Monotherapy Dose 1: Grade 1 | Number of Participants Who Experienced Vaccine Related Adverse Events After Dose 2 | Congestion | 0 Participants |
| Anti-TNF Monotherapy Dose 1: Grade 1 | Number of Participants Who Experienced Vaccine Related Adverse Events After Dose 2 | Intermittent fever/chills | 1 Participants |
| Anti-TNF Monotherapy Dose 1: Grade 1 | Number of Participants Who Experienced Vaccine Related Adverse Events After Dose 2 | Any Systemic Adverse Effect | 3 Participants |
| Anti-TNF Monotherapy Dose 1: Grade 1 | Number of Participants Who Experienced Vaccine Related Adverse Events After Dose 2 | Lymphadenopathy | 0 Participants |
| Anti-TNF Monotherapy Dose 1: Grade 1 | Number of Participants Who Experienced Vaccine Related Adverse Events After Dose 2 | Pruritus | 0 Participants |
| Anti-TNF Monotherapy Dose 1: Grade 1 | Number of Participants Who Experienced Vaccine Related Adverse Events After Dose 2 | Swelling | 1 Participants |
| Anti-TNF Monotherapy Dose 1: Grade 1 | Number of Participants Who Experienced Vaccine Related Adverse Events After Dose 2 | Myalgias/joint pain | 1 Participants |
| Anti-TNF Monotherapy Dose 1: Grade 1 | Number of Participants Who Experienced Vaccine Related Adverse Events After Dose 2 | Pain/Soreness | 6 Participants |
| Anti-TNF Monotherapy Dose 1: Grade 1 | Number of Participants Who Experienced Vaccine Related Adverse Events After Dose 2 | Headaches | 1 Participants |
| Anti-TNF Monotherapy Dose 1: Grade 1 | Number of Participants Who Experienced Vaccine Related Adverse Events After Dose 2 | Warmth | 0 Participants |
| Anti-TNF Monotherapy Dose 1: Grade 2 | Number of Participants Who Experienced Vaccine Related Adverse Events After Dose 2 | Plugged ear | 0 Participants |
| Anti-TNF Monotherapy Dose 1: Grade 2 | Number of Participants Who Experienced Vaccine Related Adverse Events After Dose 2 | Any Systemic Adverse Effect | 3 Participants |
| Anti-TNF Monotherapy Dose 1: Grade 2 | Number of Participants Who Experienced Vaccine Related Adverse Events After Dose 2 | Lymphadenopathy | 0 Participants |
| Anti-TNF Monotherapy Dose 1: Grade 2 | Number of Participants Who Experienced Vaccine Related Adverse Events After Dose 2 | Fatigue | 1 Participants |
| Anti-TNF Monotherapy Dose 1: Grade 2 | Number of Participants Who Experienced Vaccine Related Adverse Events After Dose 2 | Pain/Soreness | 1 Participants |
| Anti-TNF Monotherapy Dose 1: Grade 2 | Number of Participants Who Experienced Vaccine Related Adverse Events After Dose 2 | Warmth | 0 Participants |
| Anti-TNF Monotherapy Dose 1: Grade 2 | Number of Participants Who Experienced Vaccine Related Adverse Events After Dose 2 | Headaches | 1 Participants |
| Anti-TNF Monotherapy Dose 1: Grade 2 | Number of Participants Who Experienced Vaccine Related Adverse Events After Dose 2 | Intermittent fever/chills | 2 Participants |
| Anti-TNF Monotherapy Dose 1: Grade 2 | Number of Participants Who Experienced Vaccine Related Adverse Events After Dose 2 | Congestion | 0 Participants |
| Anti-TNF Monotherapy Dose 1: Grade 2 | Number of Participants Who Experienced Vaccine Related Adverse Events After Dose 2 | Myalgias/joint pain | 0 Participants |
| Anti-TNF Monotherapy Dose 1: Grade 2 | Number of Participants Who Experienced Vaccine Related Adverse Events After Dose 2 | Any Local Adverse Effect | 1 Participants |
| Anti-TNF Monotherapy Dose 1: Grade 2 | Number of Participants Who Experienced Vaccine Related Adverse Events After Dose 2 | Pruritus | 0 Participants |
| Anti-TNF Monotherapy Dose 1: Grade 2 | Number of Participants Who Experienced Vaccine Related Adverse Events After Dose 2 | Erythema | 0 Participants |
| Anti-TNF Monotherapy Dose 1: Grade 2 | Number of Participants Who Experienced Vaccine Related Adverse Events After Dose 2 | Swelling | 0 Participants |
| Anti-TNF Monotherapy Dose 1: Grade 3 | Number of Participants Who Experienced Vaccine Related Adverse Events After Dose 2 | Intermittent fever/chills | 0 Participants |
| Anti-TNF Monotherapy Dose 1: Grade 3 | Number of Participants Who Experienced Vaccine Related Adverse Events After Dose 2 | Warmth | 0 Participants |
| Anti-TNF Monotherapy Dose 1: Grade 3 | Number of Participants Who Experienced Vaccine Related Adverse Events After Dose 2 | Plugged ear | 0 Participants |
| Anti-TNF Monotherapy Dose 1: Grade 3 | Number of Participants Who Experienced Vaccine Related Adverse Events After Dose 2 | Fatigue | 0 Participants |
| Anti-TNF Monotherapy Dose 1: Grade 3 | Number of Participants Who Experienced Vaccine Related Adverse Events After Dose 2 | Pruritus | 0 Participants |
| Anti-TNF Monotherapy Dose 1: Grade 3 | Number of Participants Who Experienced Vaccine Related Adverse Events After Dose 2 | Headaches | 0 Participants |
| Anti-TNF Monotherapy Dose 1: Grade 3 | Number of Participants Who Experienced Vaccine Related Adverse Events After Dose 2 | Congestion | 0 Participants |
| Anti-TNF Monotherapy Dose 1: Grade 3 | Number of Participants Who Experienced Vaccine Related Adverse Events After Dose 2 | Swelling | 0 Participants |
| Anti-TNF Monotherapy Dose 1: Grade 3 | Number of Participants Who Experienced Vaccine Related Adverse Events After Dose 2 | Pain/Soreness | 0 Participants |
| Anti-TNF Monotherapy Dose 1: Grade 3 | Number of Participants Who Experienced Vaccine Related Adverse Events After Dose 2 | Any Systemic Adverse Effect | 0 Participants |
| Anti-TNF Monotherapy Dose 1: Grade 3 | Number of Participants Who Experienced Vaccine Related Adverse Events After Dose 2 | Lymphadenopathy | 0 Participants |
| Anti-TNF Monotherapy Dose 1: Grade 3 | Number of Participants Who Experienced Vaccine Related Adverse Events After Dose 2 | Erythema | 0 Participants |
| Anti-TNF Monotherapy Dose 1: Grade 3 | Number of Participants Who Experienced Vaccine Related Adverse Events After Dose 2 | Any Local Adverse Effect | 0 Participants |
| Anti-TNF Monotherapy Dose 1: Grade 3 | Number of Participants Who Experienced Vaccine Related Adverse Events After Dose 2 | Myalgias/joint pain | 0 Participants |
| Anti-TNF Monotherapy Dose 1: Grade 4 | Number of Participants Who Experienced Vaccine Related Adverse Events After Dose 2 | Myalgias/joint pain | 0 Participants |
| Anti-TNF Monotherapy Dose 1: Grade 4 | Number of Participants Who Experienced Vaccine Related Adverse Events After Dose 2 | Fatigue | 0 Participants |
| Anti-TNF Monotherapy Dose 1: Grade 4 | Number of Participants Who Experienced Vaccine Related Adverse Events After Dose 2 | Congestion | 0 Participants |
| Anti-TNF Monotherapy Dose 1: Grade 4 | Number of Participants Who Experienced Vaccine Related Adverse Events After Dose 2 | Intermittent fever/chills | 0 Participants |
| Anti-TNF Monotherapy Dose 1: Grade 4 | Number of Participants Who Experienced Vaccine Related Adverse Events After Dose 2 | Plugged ear | 0 Participants |
| Anti-TNF Monotherapy Dose 1: Grade 4 | Number of Participants Who Experienced Vaccine Related Adverse Events After Dose 2 | Headaches | 0 Participants |
| Anti-TNF Monotherapy Dose 1: Grade 4 | Number of Participants Who Experienced Vaccine Related Adverse Events After Dose 2 | Any Systemic Adverse Effect | 0 Participants |
| Anti-TNF Monotherapy Dose 1: Grade 4 | Number of Participants Who Experienced Vaccine Related Adverse Events After Dose 2 | Erythema | 0 Participants |
| Anti-TNF Monotherapy Dose 1: Grade 4 | Number of Participants Who Experienced Vaccine Related Adverse Events After Dose 2 | Swelling | 0 Participants |
| Anti-TNF Monotherapy Dose 1: Grade 4 | Number of Participants Who Experienced Vaccine Related Adverse Events After Dose 2 | Pruritus | 0 Participants |
| Anti-TNF Monotherapy Dose 1: Grade 4 | Number of Participants Who Experienced Vaccine Related Adverse Events After Dose 2 | Pain/Soreness | 0 Participants |
| Anti-TNF Monotherapy Dose 1: Grade 4 | Number of Participants Who Experienced Vaccine Related Adverse Events After Dose 2 | Warmth | 0 Participants |
| Anti-TNF Monotherapy Dose 1: Grade 4 | Number of Participants Who Experienced Vaccine Related Adverse Events After Dose 2 | Lymphadenopathy | 0 Participants |
| Anti-TNF Monotherapy Dose 1: Grade 4 | Number of Participants Who Experienced Vaccine Related Adverse Events After Dose 2 | Any Local Adverse Effect | 0 Participants |
Secondary
Percent of Participants With a Change in Antibody Concentration Post Immunization
A secondary outcome will be the change in varicella zoster virus (VZV) antibody concentration comparing pre-immunization to post immunization antibody concentration.
Time frame: pre-immunization to one month 2nd dose post-immunization
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Vedolizumab | Percent of Participants With a Change in Antibody Concentration Post Immunization | 15 Participants |
| Anti-TNF Monotherapy | Percent of Participants With a Change in Antibody Concentration Post Immunization | 15 Participants |
Secondary
Percent of Participants With a Change in Antibody Concentration That is Sustained at 6 Months
Sustained change in VZV antibody concentration at 6 months after receiving a second dose of booster vaccine post-immunization will be assessed.
Time frame: Baseline to 6 months post-immunization
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Vedolizumab | Percent of Participants With a Change in Antibody Concentration That is Sustained at 6 Months | 15 Participants |
| Anti-TNF Monotherapy | Percent of Participants With a Change in Antibody Concentration That is Sustained at 6 Months | 15 Participants |
Secondary
Percent of Participants With Sustained Cell Mediated Immunity Measured Via ELISPOT After Immunization.
Sustained change in CMI at 6 months will be assessed after receiving a second dose of booster vaccine post-immunization. CMI will be measured via ELISPOT
Time frame: Baseline to 6 months post-immunization 2nd dose of vaccine.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Vedolizumab | Percent of Participants With Sustained Cell Mediated Immunity Measured Via ELISPOT After Immunization. | 15 Participants |
| Anti-TNF Monotherapy | Percent of Participants With Sustained Cell Mediated Immunity Measured Via ELISPOT After Immunization. | 15 Participants |