Trial Outcomes & Findings for Immunogenicity of Herpes Zoster Subunit Vaccine in Inflammatory Bowel Disease Patients Treated With Vedolizumab (NCT NCT03798691)
NCT ID: NCT03798691
Last Updated: 2025-04-02
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
33 participants
Primary outcome timeframe
It will be measured from pre-immunization to 1 month after receiving second dose of booster vaccine post-immunization.
Results posted on
2025-04-02
Participant Flow
Participants were enrolled at UW Health from May 2019 to July 2023
Participant milestones
| Measure |
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.
Shingrix: 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.
|
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.
Shingrix: 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.
|
|---|---|---|
|
Overall Study
STARTED
|
16
|
17
|
|
Overall Study
Received First Dose
|
15
|
17
|
|
Overall Study
Received Second Dose
|
15
|
15
|
|
Overall Study
Completed 90 Day Follow Up
|
15
|
15
|
|
Overall Study
Completed 1 Year Follow Up
|
14
|
15
|
|
Overall Study
Analyzed
|
15
|
15
|
|
Overall Study
COMPLETED
|
14
|
15
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
Reasons for withdrawal
| Measure |
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.
Shingrix: 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.
|
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.
Shingrix: 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.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
2
|
Baseline Characteristics
Immunogenicity of Herpes Zoster Subunit Vaccine in Inflammatory Bowel Disease Patients Treated With Vedolizumab
Baseline characteristics by cohort
| Measure |
Vedolizumab
n=16 Participants
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.
|
Anti-TNF Monotherapy
n=17 Participants
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.
|
Total
n=33 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
55 years
n=99 Participants
|
62 years
n=107 Participants
|
58 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
15 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
32 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
16 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
32 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
16 participants
n=99 Participants
|
17 participants
n=107 Participants
|
33 participants
n=206 Participants
|
|
Smoking Status
Former Smoker
|
4 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
Smoking Status
Current Smoker
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Participants with Crohn's Disease
|
8 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
22 Participants
n=206 Participants
|
|
Current Irritable Bowel Disease (IBD) Medication
Adalimumab
|
0 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Current Irritable Bowel Disease (IBD) Medication
Infliximab
|
0 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Current Irritable Bowel Disease (IBD) Medication
Certolizumab
|
0 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Current Irritable Bowel Disease (IBD) Medication
Vedolizumab
|
16 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
|
Current Irritable Bowel Disease (IBD) Medication
Sulfasalazine
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Previous IBD Medications
Previous anti-TNF
|
13 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
|
Previous IBD Medications
5-ASA
|
12 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
|
Previous IBD Medications
Methotrexate or azathioprine
|
9 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
|
Positive history of herpes zoster
|
2 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Length of disease
|
162 months
n=99 Participants
|
344 months
n=107 Participants
|
243 months
n=206 Participants
|
|
Previous IBD surgery
|
2 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
|
Steroid use in past year
|
6 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Charlson Comorbidity Score
|
1.5 units on a scale
n=99 Participants
|
3 units on a scale
n=107 Participants
|
2.1 units on a scale
n=206 Participants
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Vedolizumab
n=15 Participants
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.
|
Anti-TNF Monotherapy
n=15 Participants
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.
|
Vedolizumab Dose 1: Grade 3
Grade 3 (Severe) Adverse Event
Patients with IBD on vedolizumab monotherapy will be given the shingrix vaccine.
|
Vedolizumab Dose 1: Grade 4
Grade 4 (Life Threatening) Adverse Event
Patients with IBD on vedolizumab monotherapy will be given the shingrix vaccine.
|
Anti-TNF Monotherapy Dose 1: Grade 1
Grade 1 (Mild) Adverse Event
Patients with IBD on Anti-TNF monotherapy will be given the shingrix vaccine.
|
Anti-TNF Monotherapy Dose 1: Grade 2
Grade 2 (Moderate) Adverse Event
Patients with IBD on Anti-TNF monotherapy will be given the shingrix vaccine.
|
Anti-TNF Monotherapy Dose 1: Grade 3
Grade 3 (Severe) Adverse Event
Patients with IBD on Anti-TNF monotherapy will be given the shingrix vaccine.
|
Anti-TNF Monotherapy Dose 1: Grade 4
Grade 4 (Life Threatening) Adverse Event
Patients with IBD on Anti-TNF monotherapy will be given the shingrix vaccine.
|
|---|---|---|---|---|---|---|---|---|
|
Change in Cell Mediated Immunity
Pre-Vaccine
|
33 cells per million
Interval 5.0 to 58.0
|
33 cells per million
Interval 13.0 to 88.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change in Cell Mediated Immunity
One month after series completion of two dose series
|
33 cells per million
Interval 17.0 to 91.0
|
50 cells per million
Interval 36.0 to 193.0
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 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
Outcome measures
| Measure |
Vedolizumab
n=15 Participants
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.
|
Anti-TNF Monotherapy
n=15 Participants
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.
|
Vedolizumab Dose 1: Grade 3
Grade 3 (Severe) Adverse Event
Patients with IBD on vedolizumab monotherapy will be given the shingrix vaccine.
|
Vedolizumab Dose 1: Grade 4
Grade 4 (Life Threatening) Adverse Event
Patients with IBD on vedolizumab monotherapy will be given the shingrix vaccine.
|
Anti-TNF Monotherapy Dose 1: Grade 1
Grade 1 (Mild) Adverse Event
Patients with IBD on Anti-TNF monotherapy will be given the shingrix vaccine.
|
Anti-TNF Monotherapy Dose 1: Grade 2
Grade 2 (Moderate) Adverse Event
Patients with IBD on Anti-TNF monotherapy will be given the shingrix vaccine.
|
Anti-TNF Monotherapy Dose 1: Grade 3
Grade 3 (Severe) Adverse Event
Patients with IBD on Anti-TNF monotherapy will be given the shingrix vaccine.
|
Anti-TNF Monotherapy Dose 1: Grade 4
Grade 4 (Life Threatening) Adverse Event
Patients with IBD on Anti-TNF monotherapy will be given the shingrix vaccine.
|
|---|---|---|---|---|---|---|---|---|
|
Percent of Participants With Sustained Cell Mediated Immunity Measured Via ELISPOT After Immunization.
|
15 Participants
|
15 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: pre-immunization to one month 2nd dose post-immunizationA secondary outcome will be the change in varicella zoster virus (VZV) antibody concentration comparing pre-immunization to post immunization antibody concentration.
Outcome measures
| Measure |
Vedolizumab
n=15 Participants
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.
|
Anti-TNF Monotherapy
n=15 Participants
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.
|
Vedolizumab Dose 1: Grade 3
Grade 3 (Severe) Adverse Event
Patients with IBD on vedolizumab monotherapy will be given the shingrix vaccine.
|
Vedolizumab Dose 1: Grade 4
Grade 4 (Life Threatening) Adverse Event
Patients with IBD on vedolizumab monotherapy will be given the shingrix vaccine.
|
Anti-TNF Monotherapy Dose 1: Grade 1
Grade 1 (Mild) Adverse Event
Patients with IBD on Anti-TNF monotherapy will be given the shingrix vaccine.
|
Anti-TNF Monotherapy Dose 1: Grade 2
Grade 2 (Moderate) Adverse Event
Patients with IBD on Anti-TNF monotherapy will be given the shingrix vaccine.
|
Anti-TNF Monotherapy Dose 1: Grade 3
Grade 3 (Severe) Adverse Event
Patients with IBD on Anti-TNF monotherapy will be given the shingrix vaccine.
|
Anti-TNF Monotherapy Dose 1: Grade 4
Grade 4 (Life Threatening) Adverse Event
Patients with IBD on Anti-TNF monotherapy will be given the shingrix vaccine.
|
|---|---|---|---|---|---|---|---|---|
|
Percent of Participants With a Change in Antibody Concentration Post Immunization
|
15 Participants
|
15 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to 6 months post-immunizationSustained change in VZV antibody concentration at 6 months after receiving a second dose of booster vaccine post-immunization will be assessed.
Outcome measures
| Measure |
Vedolizumab
n=15 Participants
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.
|
Anti-TNF Monotherapy
n=15 Participants
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.
|
Vedolizumab Dose 1: Grade 3
Grade 3 (Severe) Adverse Event
Patients with IBD on vedolizumab monotherapy will be given the shingrix vaccine.
|
Vedolizumab Dose 1: Grade 4
Grade 4 (Life Threatening) Adverse Event
Patients with IBD on vedolizumab monotherapy will be given the shingrix vaccine.
|
Anti-TNF Monotherapy Dose 1: Grade 1
Grade 1 (Mild) Adverse Event
Patients with IBD on Anti-TNF monotherapy will be given the shingrix vaccine.
|
Anti-TNF Monotherapy Dose 1: Grade 2
Grade 2 (Moderate) Adverse Event
Patients with IBD on Anti-TNF monotherapy will be given the shingrix vaccine.
|
Anti-TNF Monotherapy Dose 1: Grade 3
Grade 3 (Severe) Adverse Event
Patients with IBD on Anti-TNF monotherapy will be given the shingrix vaccine.
|
Anti-TNF Monotherapy Dose 1: Grade 4
Grade 4 (Life Threatening) Adverse Event
Patients with IBD on Anti-TNF monotherapy will be given the shingrix vaccine.
|
|---|---|---|---|---|---|---|---|---|
|
Percent of Participants With a Change in Antibody Concentration That is Sustained at 6 Months
|
15 Participants
|
15 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Vedolizumab
n=15 Participants
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.
|
Anti-TNF Monotherapy
n=15 Participants
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.
|
Vedolizumab Dose 1: Grade 3
n=15 Participants
Grade 3 (Severe) Adverse Event
Patients with IBD on vedolizumab monotherapy will be given the shingrix vaccine.
|
Vedolizumab Dose 1: Grade 4
n=15 Participants
Grade 4 (Life Threatening) Adverse Event
Patients with IBD on vedolizumab monotherapy will be given the shingrix vaccine.
|
Anti-TNF Monotherapy Dose 1: Grade 1
n=15 Participants
Grade 1 (Mild) Adverse Event
Patients with IBD on Anti-TNF monotherapy will be given the shingrix vaccine.
|
Anti-TNF Monotherapy Dose 1: Grade 2
n=15 Participants
Grade 2 (Moderate) Adverse Event
Patients with IBD on Anti-TNF monotherapy will be given the shingrix vaccine.
|
Anti-TNF Monotherapy Dose 1: Grade 3
n=15 Participants
Grade 3 (Severe) Adverse Event
Patients with IBD on Anti-TNF monotherapy will be given the shingrix vaccine.
|
Anti-TNF Monotherapy Dose 1: Grade 4
n=15 Participants
Grade 4 (Life Threatening) Adverse Event
Patients with IBD on Anti-TNF monotherapy will be given the shingrix vaccine.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants Who Experienced Vaccine Related Adverse Events After Dose 1
Any Systemic Adverse Effect
|
7 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
6 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Who Experienced Vaccine Related Adverse Events After Dose 1
Headaches
|
6 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Who Experienced Vaccine Related Adverse Events After Dose 1
Plugged ear
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Who Experienced Vaccine Related Adverse Events After Dose 1
Intermittent fever/chills
|
3 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Who Experienced Vaccine Related Adverse Events After Dose 1
Lymphadenopathy
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Who Experienced Vaccine Related Adverse Events After Dose 1
Congestion
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Who Experienced Vaccine Related Adverse Events After Dose 1
Fatigue
|
5 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Who Experienced Vaccine Related Adverse Events After Dose 1
Myalgias/joint pain
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Who Experienced Vaccine Related Adverse Events After Dose 1
Any Local Adverse Effect
|
8 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
11 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Who Experienced Vaccine Related Adverse Events After Dose 1
Pain/Soreness
|
9 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
12 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Who Experienced Vaccine Related Adverse Events After Dose 1
Pruritus
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Who Experienced Vaccine Related Adverse Events After Dose 1
Erythema
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Who Experienced Vaccine Related Adverse Events After Dose 1
Swelling
|
3 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Who Experienced Vaccine Related Adverse Events After Dose 1
Warmth
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Vedolizumab
n=15 Participants
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.
|
Anti-TNF Monotherapy
n=15 Participants
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.
|
Vedolizumab Dose 1: Grade 3
n=15 Participants
Grade 3 (Severe) Adverse Event
Patients with IBD on vedolizumab monotherapy will be given the shingrix vaccine.
|
Vedolizumab Dose 1: Grade 4
n=15 Participants
Grade 4 (Life Threatening) Adverse Event
Patients with IBD on vedolizumab monotherapy will be given the shingrix vaccine.
|
Anti-TNF Monotherapy Dose 1: Grade 1
n=15 Participants
Grade 1 (Mild) Adverse Event
Patients with IBD on Anti-TNF monotherapy will be given the shingrix vaccine.
|
Anti-TNF Monotherapy Dose 1: Grade 2
n=15 Participants
Grade 2 (Moderate) Adverse Event
Patients with IBD on Anti-TNF monotherapy will be given the shingrix vaccine.
|
Anti-TNF Monotherapy Dose 1: Grade 3
n=15 Participants
Grade 3 (Severe) Adverse Event
Patients with IBD on Anti-TNF monotherapy will be given the shingrix vaccine.
|
Anti-TNF Monotherapy Dose 1: Grade 4
n=15 Participants
Grade 4 (Life Threatening) Adverse Event
Patients with IBD on Anti-TNF monotherapy will be given the shingrix vaccine.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants Who Experienced Vaccine Related Adverse Events After Dose 2
Warmth
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Who Experienced Vaccine Related Adverse Events After Dose 2
Erythema
|
4 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Who Experienced Vaccine Related Adverse Events After Dose 2
Swelling
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Who Experienced Vaccine Related Adverse Events After Dose 2
Any Systemic Adverse Effect
|
5 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
3 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Who Experienced Vaccine Related Adverse Events After Dose 2
Headaches
|
3 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Who Experienced Vaccine Related Adverse Events After Dose 2
Plugged ear
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Who Experienced Vaccine Related Adverse Events After Dose 2
Intermittent fever/chills
|
4 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Who Experienced Vaccine Related Adverse Events After Dose 2
Congestion
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Who Experienced Vaccine Related Adverse Events After Dose 2
Fatigue
|
4 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Who Experienced Vaccine Related Adverse Events After Dose 2
Myalgias/joint pain
|
6 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Who Experienced Vaccine Related Adverse Events After Dose 2
Any Local Adverse Effect
|
10 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
7 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Who Experienced Vaccine Related Adverse Events After Dose 2
Pain/Soreness
|
8 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
6 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Who Experienced Vaccine Related Adverse Events After Dose 2
Pruritus
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Who Experienced Vaccine Related Adverse Events After Dose 2
Lymphadenopathy
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: at the baseline visit and one month after receipt of each vaccineThe 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.
Outcome measures
| Measure |
Vedolizumab
n=15 Participants
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.
|
Anti-TNF Monotherapy
n=15 Participants
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.
|
Vedolizumab Dose 1: Grade 3
Grade 3 (Severe) Adverse Event
Patients with IBD on vedolizumab monotherapy will be given the shingrix vaccine.
|
Vedolizumab Dose 1: Grade 4
Grade 4 (Life Threatening) Adverse Event
Patients with IBD on vedolizumab monotherapy will be given the shingrix vaccine.
|
Anti-TNF Monotherapy Dose 1: Grade 1
Grade 1 (Mild) Adverse Event
Patients with IBD on Anti-TNF monotherapy will be given the shingrix vaccine.
|
Anti-TNF Monotherapy Dose 1: Grade 2
Grade 2 (Moderate) Adverse Event
Patients with IBD on Anti-TNF monotherapy will be given the shingrix vaccine.
|
Anti-TNF Monotherapy Dose 1: Grade 3
Grade 3 (Severe) Adverse Event
Patients with IBD on Anti-TNF monotherapy will be given the shingrix vaccine.
|
Anti-TNF Monotherapy Dose 1: Grade 4
Grade 4 (Life Threatening) Adverse Event
Patients with IBD on Anti-TNF monotherapy will be given the shingrix vaccine.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants Experiencing a Change in Disease Activity Post Immunization Reported
baseline
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Experiencing a Change in Disease Activity Post Immunization Reported
1 month post-dose 1
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Experiencing a Change in Disease Activity Post Immunization Reported
1 month post-dose 2
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Vedolizumab: Dose 1
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Anti-TNF Monotherapy: Dose 1
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Vedolizumab: Dose 2
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Anti-TNF Monotherapy: Dose 2
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Vedolizumab: 6 Months Post Follow up
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Anti-TNF Monotherapy: 6 Months Post Follow up
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Vedolizumab: 12 Months Post Follow up
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Anti-TNF Monotherapy: 12 Months Post Follow up
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Vedolizumab: Dose 1
n=15 participants at risk
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.
|
Anti-TNF Monotherapy: Dose 1
n=15 participants at risk
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.
|
Vedolizumab: Dose 2
n=15 participants at risk
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.
|
Anti-TNF Monotherapy: Dose 2
n=15 participants at risk
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.
|
Vedolizumab: 6 Months Post Follow up
n=15 participants at risk
Patients with IBD on vedolizumab monotherapy will be given the shingrix vaccine.
|
Anti-TNF Monotherapy: 6 Months Post Follow up
n=15 participants at risk
Patients with IBD on Anti-TNF monotherapy will be given the shingrix vaccine.
|
Vedolizumab: 12 Months Post Follow up
n=14 participants at risk
Patients with IBD on vedolizumab monotherapy will be given the shingrix vaccine.
|
Anti-TNF Monotherapy: 12 Months Post Follow up
n=15 participants at risk
Patients with IBD on Anti-TNF monotherapy will be given the shingrix vaccine.
|
|---|---|---|---|---|---|---|---|---|
|
General disorders
Headache
|
40.0%
6/15 • up to 12 months post second dose (approximately 425 days on study)
data collected via phone call and follow up visits (follow up phone call at day 12, visit at day 60, phone call at day 72, visit at day 90 (one month post-second-dose), visit at day 240 (6 months post-second-dose), visit at day 425 (12 months post-second-dose)
|
20.0%
3/15 • up to 12 months post second dose (approximately 425 days on study)
data collected via phone call and follow up visits (follow up phone call at day 12, visit at day 60, phone call at day 72, visit at day 90 (one month post-second-dose), visit at day 240 (6 months post-second-dose), visit at day 425 (12 months post-second-dose)
|
20.0%
3/15 • up to 12 months post second dose (approximately 425 days on study)
data collected via phone call and follow up visits (follow up phone call at day 12, visit at day 60, phone call at day 72, visit at day 90 (one month post-second-dose), visit at day 240 (6 months post-second-dose), visit at day 425 (12 months post-second-dose)
|
13.3%
2/15 • up to 12 months post second dose (approximately 425 days on study)
data collected via phone call and follow up visits (follow up phone call at day 12, visit at day 60, phone call at day 72, visit at day 90 (one month post-second-dose), visit at day 240 (6 months post-second-dose), visit at day 425 (12 months post-second-dose)
|
0.00%
0/15 • up to 12 months post second dose (approximately 425 days on study)
data collected via phone call and follow up visits (follow up phone call at day 12, visit at day 60, phone call at day 72, visit at day 90 (one month post-second-dose), visit at day 240 (6 months post-second-dose), visit at day 425 (12 months post-second-dose)
|
0.00%
0/15 • up to 12 months post second dose (approximately 425 days on study)
data collected via phone call and follow up visits (follow up phone call at day 12, visit at day 60, phone call at day 72, visit at day 90 (one month post-second-dose), visit at day 240 (6 months post-second-dose), visit at day 425 (12 months post-second-dose)
|
0.00%
0/14 • up to 12 months post second dose (approximately 425 days on study)
data collected via phone call and follow up visits (follow up phone call at day 12, visit at day 60, phone call at day 72, visit at day 90 (one month post-second-dose), visit at day 240 (6 months post-second-dose), visit at day 425 (12 months post-second-dose)
|
0.00%
0/15 • up to 12 months post second dose (approximately 425 days on study)
data collected via phone call and follow up visits (follow up phone call at day 12, visit at day 60, phone call at day 72, visit at day 90 (one month post-second-dose), visit at day 240 (6 months post-second-dose), visit at day 425 (12 months post-second-dose)
|
|
General disorders
Plugged Ear
|
6.7%
1/15 • up to 12 months post second dose (approximately 425 days on study)
data collected via phone call and follow up visits (follow up phone call at day 12, visit at day 60, phone call at day 72, visit at day 90 (one month post-second-dose), visit at day 240 (6 months post-second-dose), visit at day 425 (12 months post-second-dose)
|
0.00%
0/15 • up to 12 months post second dose (approximately 425 days on study)
data collected via phone call and follow up visits (follow up phone call at day 12, visit at day 60, phone call at day 72, visit at day 90 (one month post-second-dose), visit at day 240 (6 months post-second-dose), visit at day 425 (12 months post-second-dose)
|
0.00%
0/15 • up to 12 months post second dose (approximately 425 days on study)
data collected via phone call and follow up visits (follow up phone call at day 12, visit at day 60, phone call at day 72, visit at day 90 (one month post-second-dose), visit at day 240 (6 months post-second-dose), visit at day 425 (12 months post-second-dose)
|
0.00%
0/15 • up to 12 months post second dose (approximately 425 days on study)
data collected via phone call and follow up visits (follow up phone call at day 12, visit at day 60, phone call at day 72, visit at day 90 (one month post-second-dose), visit at day 240 (6 months post-second-dose), visit at day 425 (12 months post-second-dose)
|
0.00%
0/15 • up to 12 months post second dose (approximately 425 days on study)
data collected via phone call and follow up visits (follow up phone call at day 12, visit at day 60, phone call at day 72, visit at day 90 (one month post-second-dose), visit at day 240 (6 months post-second-dose), visit at day 425 (12 months post-second-dose)
|
0.00%
0/15 • up to 12 months post second dose (approximately 425 days on study)
data collected via phone call and follow up visits (follow up phone call at day 12, visit at day 60, phone call at day 72, visit at day 90 (one month post-second-dose), visit at day 240 (6 months post-second-dose), visit at day 425 (12 months post-second-dose)
|
0.00%
0/14 • up to 12 months post second dose (approximately 425 days on study)
data collected via phone call and follow up visits (follow up phone call at day 12, visit at day 60, phone call at day 72, visit at day 90 (one month post-second-dose), visit at day 240 (6 months post-second-dose), visit at day 425 (12 months post-second-dose)
|
0.00%
0/15 • up to 12 months post second dose (approximately 425 days on study)
data collected via phone call and follow up visits (follow up phone call at day 12, visit at day 60, phone call at day 72, visit at day 90 (one month post-second-dose), visit at day 240 (6 months post-second-dose), visit at day 425 (12 months post-second-dose)
|
|
General disorders
Intermittent Fever or Chills
|
20.0%
3/15 • up to 12 months post second dose (approximately 425 days on study)
data collected via phone call and follow up visits (follow up phone call at day 12, visit at day 60, phone call at day 72, visit at day 90 (one month post-second-dose), visit at day 240 (6 months post-second-dose), visit at day 425 (12 months post-second-dose)
|
13.3%
2/15 • up to 12 months post second dose (approximately 425 days on study)
data collected via phone call and follow up visits (follow up phone call at day 12, visit at day 60, phone call at day 72, visit at day 90 (one month post-second-dose), visit at day 240 (6 months post-second-dose), visit at day 425 (12 months post-second-dose)
|
33.3%
5/15 • up to 12 months post second dose (approximately 425 days on study)
data collected via phone call and follow up visits (follow up phone call at day 12, visit at day 60, phone call at day 72, visit at day 90 (one month post-second-dose), visit at day 240 (6 months post-second-dose), visit at day 425 (12 months post-second-dose)
|
20.0%
3/15 • up to 12 months post second dose (approximately 425 days on study)
data collected via phone call and follow up visits (follow up phone call at day 12, visit at day 60, phone call at day 72, visit at day 90 (one month post-second-dose), visit at day 240 (6 months post-second-dose), visit at day 425 (12 months post-second-dose)
|
0.00%
0/15 • up to 12 months post second dose (approximately 425 days on study)
data collected via phone call and follow up visits (follow up phone call at day 12, visit at day 60, phone call at day 72, visit at day 90 (one month post-second-dose), visit at day 240 (6 months post-second-dose), visit at day 425 (12 months post-second-dose)
|
0.00%
0/15 • up to 12 months post second dose (approximately 425 days on study)
data collected via phone call and follow up visits (follow up phone call at day 12, visit at day 60, phone call at day 72, visit at day 90 (one month post-second-dose), visit at day 240 (6 months post-second-dose), visit at day 425 (12 months post-second-dose)
|
0.00%
0/14 • up to 12 months post second dose (approximately 425 days on study)
data collected via phone call and follow up visits (follow up phone call at day 12, visit at day 60, phone call at day 72, visit at day 90 (one month post-second-dose), visit at day 240 (6 months post-second-dose), visit at day 425 (12 months post-second-dose)
|
0.00%
0/15 • up to 12 months post second dose (approximately 425 days on study)
data collected via phone call and follow up visits (follow up phone call at day 12, visit at day 60, phone call at day 72, visit at day 90 (one month post-second-dose), visit at day 240 (6 months post-second-dose), visit at day 425 (12 months post-second-dose)
|
|
General disorders
Lymphadenopathy
|
0.00%
0/15 • up to 12 months post second dose (approximately 425 days on study)
data collected via phone call and follow up visits (follow up phone call at day 12, visit at day 60, phone call at day 72, visit at day 90 (one month post-second-dose), visit at day 240 (6 months post-second-dose), visit at day 425 (12 months post-second-dose)
|
6.7%
1/15 • up to 12 months post second dose (approximately 425 days on study)
data collected via phone call and follow up visits (follow up phone call at day 12, visit at day 60, phone call at day 72, visit at day 90 (one month post-second-dose), visit at day 240 (6 months post-second-dose), visit at day 425 (12 months post-second-dose)
|
0.00%
0/15 • up to 12 months post second dose (approximately 425 days on study)
data collected via phone call and follow up visits (follow up phone call at day 12, visit at day 60, phone call at day 72, visit at day 90 (one month post-second-dose), visit at day 240 (6 months post-second-dose), visit at day 425 (12 months post-second-dose)
|
0.00%
0/15 • up to 12 months post second dose (approximately 425 days on study)
data collected via phone call and follow up visits (follow up phone call at day 12, visit at day 60, phone call at day 72, visit at day 90 (one month post-second-dose), visit at day 240 (6 months post-second-dose), visit at day 425 (12 months post-second-dose)
|
0.00%
0/15 • up to 12 months post second dose (approximately 425 days on study)
data collected via phone call and follow up visits (follow up phone call at day 12, visit at day 60, phone call at day 72, visit at day 90 (one month post-second-dose), visit at day 240 (6 months post-second-dose), visit at day 425 (12 months post-second-dose)
|
0.00%
0/15 • up to 12 months post second dose (approximately 425 days on study)
data collected via phone call and follow up visits (follow up phone call at day 12, visit at day 60, phone call at day 72, visit at day 90 (one month post-second-dose), visit at day 240 (6 months post-second-dose), visit at day 425 (12 months post-second-dose)
|
0.00%
0/14 • up to 12 months post second dose (approximately 425 days on study)
data collected via phone call and follow up visits (follow up phone call at day 12, visit at day 60, phone call at day 72, visit at day 90 (one month post-second-dose), visit at day 240 (6 months post-second-dose), visit at day 425 (12 months post-second-dose)
|
0.00%
0/15 • up to 12 months post second dose (approximately 425 days on study)
data collected via phone call and follow up visits (follow up phone call at day 12, visit at day 60, phone call at day 72, visit at day 90 (one month post-second-dose), visit at day 240 (6 months post-second-dose), visit at day 425 (12 months post-second-dose)
|
|
General disorders
Congestion
|
0.00%
0/15 • up to 12 months post second dose (approximately 425 days on study)
data collected via phone call and follow up visits (follow up phone call at day 12, visit at day 60, phone call at day 72, visit at day 90 (one month post-second-dose), visit at day 240 (6 months post-second-dose), visit at day 425 (12 months post-second-dose)
|
6.7%
1/15 • up to 12 months post second dose (approximately 425 days on study)
data collected via phone call and follow up visits (follow up phone call at day 12, visit at day 60, phone call at day 72, visit at day 90 (one month post-second-dose), visit at day 240 (6 months post-second-dose), visit at day 425 (12 months post-second-dose)
|
0.00%
0/15 • up to 12 months post second dose (approximately 425 days on study)
data collected via phone call and follow up visits (follow up phone call at day 12, visit at day 60, phone call at day 72, visit at day 90 (one month post-second-dose), visit at day 240 (6 months post-second-dose), visit at day 425 (12 months post-second-dose)
|
0.00%
0/15 • up to 12 months post second dose (approximately 425 days on study)
data collected via phone call and follow up visits (follow up phone call at day 12, visit at day 60, phone call at day 72, visit at day 90 (one month post-second-dose), visit at day 240 (6 months post-second-dose), visit at day 425 (12 months post-second-dose)
|
0.00%
0/15 • up to 12 months post second dose (approximately 425 days on study)
data collected via phone call and follow up visits (follow up phone call at day 12, visit at day 60, phone call at day 72, visit at day 90 (one month post-second-dose), visit at day 240 (6 months post-second-dose), visit at day 425 (12 months post-second-dose)
|
0.00%
0/15 • up to 12 months post second dose (approximately 425 days on study)
data collected via phone call and follow up visits (follow up phone call at day 12, visit at day 60, phone call at day 72, visit at day 90 (one month post-second-dose), visit at day 240 (6 months post-second-dose), visit at day 425 (12 months post-second-dose)
|
0.00%
0/14 • up to 12 months post second dose (approximately 425 days on study)
data collected via phone call and follow up visits (follow up phone call at day 12, visit at day 60, phone call at day 72, visit at day 90 (one month post-second-dose), visit at day 240 (6 months post-second-dose), visit at day 425 (12 months post-second-dose)
|
0.00%
0/15 • up to 12 months post second dose (approximately 425 days on study)
data collected via phone call and follow up visits (follow up phone call at day 12, visit at day 60, phone call at day 72, visit at day 90 (one month post-second-dose), visit at day 240 (6 months post-second-dose), visit at day 425 (12 months post-second-dose)
|
|
General disorders
Fatigue
|
33.3%
5/15 • up to 12 months post second dose (approximately 425 days on study)
data collected via phone call and follow up visits (follow up phone call at day 12, visit at day 60, phone call at day 72, visit at day 90 (one month post-second-dose), visit at day 240 (6 months post-second-dose), visit at day 425 (12 months post-second-dose)
|
13.3%
2/15 • up to 12 months post second dose (approximately 425 days on study)
data collected via phone call and follow up visits (follow up phone call at day 12, visit at day 60, phone call at day 72, visit at day 90 (one month post-second-dose), visit at day 240 (6 months post-second-dose), visit at day 425 (12 months post-second-dose)
|
33.3%
5/15 • up to 12 months post second dose (approximately 425 days on study)
data collected via phone call and follow up visits (follow up phone call at day 12, visit at day 60, phone call at day 72, visit at day 90 (one month post-second-dose), visit at day 240 (6 months post-second-dose), visit at day 425 (12 months post-second-dose)
|
13.3%
2/15 • up to 12 months post second dose (approximately 425 days on study)
data collected via phone call and follow up visits (follow up phone call at day 12, visit at day 60, phone call at day 72, visit at day 90 (one month post-second-dose), visit at day 240 (6 months post-second-dose), visit at day 425 (12 months post-second-dose)
|
0.00%
0/15 • up to 12 months post second dose (approximately 425 days on study)
data collected via phone call and follow up visits (follow up phone call at day 12, visit at day 60, phone call at day 72, visit at day 90 (one month post-second-dose), visit at day 240 (6 months post-second-dose), visit at day 425 (12 months post-second-dose)
|
0.00%
0/15 • up to 12 months post second dose (approximately 425 days on study)
data collected via phone call and follow up visits (follow up phone call at day 12, visit at day 60, phone call at day 72, visit at day 90 (one month post-second-dose), visit at day 240 (6 months post-second-dose), visit at day 425 (12 months post-second-dose)
|
0.00%
0/14 • up to 12 months post second dose (approximately 425 days on study)
data collected via phone call and follow up visits (follow up phone call at day 12, visit at day 60, phone call at day 72, visit at day 90 (one month post-second-dose), visit at day 240 (6 months post-second-dose), visit at day 425 (12 months post-second-dose)
|
0.00%
0/15 • up to 12 months post second dose (approximately 425 days on study)
data collected via phone call and follow up visits (follow up phone call at day 12, visit at day 60, phone call at day 72, visit at day 90 (one month post-second-dose), visit at day 240 (6 months post-second-dose), visit at day 425 (12 months post-second-dose)
|
|
Musculoskeletal and connective tissue disorders
Myalgias or Joint Pain
|
20.0%
3/15 • up to 12 months post second dose (approximately 425 days on study)
data collected via phone call and follow up visits (follow up phone call at day 12, visit at day 60, phone call at day 72, visit at day 90 (one month post-second-dose), visit at day 240 (6 months post-second-dose), visit at day 425 (12 months post-second-dose)
|
6.7%
1/15 • up to 12 months post second dose (approximately 425 days on study)
data collected via phone call and follow up visits (follow up phone call at day 12, visit at day 60, phone call at day 72, visit at day 90 (one month post-second-dose), visit at day 240 (6 months post-second-dose), visit at day 425 (12 months post-second-dose)
|
46.7%
7/15 • up to 12 months post second dose (approximately 425 days on study)
data collected via phone call and follow up visits (follow up phone call at day 12, visit at day 60, phone call at day 72, visit at day 90 (one month post-second-dose), visit at day 240 (6 months post-second-dose), visit at day 425 (12 months post-second-dose)
|
6.7%
1/15 • up to 12 months post second dose (approximately 425 days on study)
data collected via phone call and follow up visits (follow up phone call at day 12, visit at day 60, phone call at day 72, visit at day 90 (one month post-second-dose), visit at day 240 (6 months post-second-dose), visit at day 425 (12 months post-second-dose)
|
0.00%
0/15 • up to 12 months post second dose (approximately 425 days on study)
data collected via phone call and follow up visits (follow up phone call at day 12, visit at day 60, phone call at day 72, visit at day 90 (one month post-second-dose), visit at day 240 (6 months post-second-dose), visit at day 425 (12 months post-second-dose)
|
0.00%
0/15 • up to 12 months post second dose (approximately 425 days on study)
data collected via phone call and follow up visits (follow up phone call at day 12, visit at day 60, phone call at day 72, visit at day 90 (one month post-second-dose), visit at day 240 (6 months post-second-dose), visit at day 425 (12 months post-second-dose)
|
0.00%
0/14 • up to 12 months post second dose (approximately 425 days on study)
data collected via phone call and follow up visits (follow up phone call at day 12, visit at day 60, phone call at day 72, visit at day 90 (one month post-second-dose), visit at day 240 (6 months post-second-dose), visit at day 425 (12 months post-second-dose)
|
0.00%
0/15 • up to 12 months post second dose (approximately 425 days on study)
data collected via phone call and follow up visits (follow up phone call at day 12, visit at day 60, phone call at day 72, visit at day 90 (one month post-second-dose), visit at day 240 (6 months post-second-dose), visit at day 425 (12 months post-second-dose)
|
|
Skin and subcutaneous tissue disorders
Pain or Soreness
|
66.7%
10/15 • up to 12 months post second dose (approximately 425 days on study)
data collected via phone call and follow up visits (follow up phone call at day 12, visit at day 60, phone call at day 72, visit at day 90 (one month post-second-dose), visit at day 240 (6 months post-second-dose), visit at day 425 (12 months post-second-dose)
|
86.7%
13/15 • up to 12 months post second dose (approximately 425 days on study)
data collected via phone call and follow up visits (follow up phone call at day 12, visit at day 60, phone call at day 72, visit at day 90 (one month post-second-dose), visit at day 240 (6 months post-second-dose), visit at day 425 (12 months post-second-dose)
|
53.3%
8/15 • up to 12 months post second dose (approximately 425 days on study)
data collected via phone call and follow up visits (follow up phone call at day 12, visit at day 60, phone call at day 72, visit at day 90 (one month post-second-dose), visit at day 240 (6 months post-second-dose), visit at day 425 (12 months post-second-dose)
|
46.7%
7/15 • up to 12 months post second dose (approximately 425 days on study)
data collected via phone call and follow up visits (follow up phone call at day 12, visit at day 60, phone call at day 72, visit at day 90 (one month post-second-dose), visit at day 240 (6 months post-second-dose), visit at day 425 (12 months post-second-dose)
|
0.00%
0/15 • up to 12 months post second dose (approximately 425 days on study)
data collected via phone call and follow up visits (follow up phone call at day 12, visit at day 60, phone call at day 72, visit at day 90 (one month post-second-dose), visit at day 240 (6 months post-second-dose), visit at day 425 (12 months post-second-dose)
|
0.00%
0/15 • up to 12 months post second dose (approximately 425 days on study)
data collected via phone call and follow up visits (follow up phone call at day 12, visit at day 60, phone call at day 72, visit at day 90 (one month post-second-dose), visit at day 240 (6 months post-second-dose), visit at day 425 (12 months post-second-dose)
|
0.00%
0/14 • up to 12 months post second dose (approximately 425 days on study)
data collected via phone call and follow up visits (follow up phone call at day 12, visit at day 60, phone call at day 72, visit at day 90 (one month post-second-dose), visit at day 240 (6 months post-second-dose), visit at day 425 (12 months post-second-dose)
|
0.00%
0/15 • up to 12 months post second dose (approximately 425 days on study)
data collected via phone call and follow up visits (follow up phone call at day 12, visit at day 60, phone call at day 72, visit at day 90 (one month post-second-dose), visit at day 240 (6 months post-second-dose), visit at day 425 (12 months post-second-dose)
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
6.7%
1/15 • up to 12 months post second dose (approximately 425 days on study)
data collected via phone call and follow up visits (follow up phone call at day 12, visit at day 60, phone call at day 72, visit at day 90 (one month post-second-dose), visit at day 240 (6 months post-second-dose), visit at day 425 (12 months post-second-dose)
|
0.00%
0/15 • up to 12 months post second dose (approximately 425 days on study)
data collected via phone call and follow up visits (follow up phone call at day 12, visit at day 60, phone call at day 72, visit at day 90 (one month post-second-dose), visit at day 240 (6 months post-second-dose), visit at day 425 (12 months post-second-dose)
|
0.00%
0/15 • up to 12 months post second dose (approximately 425 days on study)
data collected via phone call and follow up visits (follow up phone call at day 12, visit at day 60, phone call at day 72, visit at day 90 (one month post-second-dose), visit at day 240 (6 months post-second-dose), visit at day 425 (12 months post-second-dose)
|
0.00%
0/15 • up to 12 months post second dose (approximately 425 days on study)
data collected via phone call and follow up visits (follow up phone call at day 12, visit at day 60, phone call at day 72, visit at day 90 (one month post-second-dose), visit at day 240 (6 months post-second-dose), visit at day 425 (12 months post-second-dose)
|
0.00%
0/15 • up to 12 months post second dose (approximately 425 days on study)
data collected via phone call and follow up visits (follow up phone call at day 12, visit at day 60, phone call at day 72, visit at day 90 (one month post-second-dose), visit at day 240 (6 months post-second-dose), visit at day 425 (12 months post-second-dose)
|
0.00%
0/15 • up to 12 months post second dose (approximately 425 days on study)
data collected via phone call and follow up visits (follow up phone call at day 12, visit at day 60, phone call at day 72, visit at day 90 (one month post-second-dose), visit at day 240 (6 months post-second-dose), visit at day 425 (12 months post-second-dose)
|
0.00%
0/14 • up to 12 months post second dose (approximately 425 days on study)
data collected via phone call and follow up visits (follow up phone call at day 12, visit at day 60, phone call at day 72, visit at day 90 (one month post-second-dose), visit at day 240 (6 months post-second-dose), visit at day 425 (12 months post-second-dose)
|
0.00%
0/15 • up to 12 months post second dose (approximately 425 days on study)
data collected via phone call and follow up visits (follow up phone call at day 12, visit at day 60, phone call at day 72, visit at day 90 (one month post-second-dose), visit at day 240 (6 months post-second-dose), visit at day 425 (12 months post-second-dose)
|
|
Skin and subcutaneous tissue disorders
Erythema
|
6.7%
1/15 • up to 12 months post second dose (approximately 425 days on study)
data collected via phone call and follow up visits (follow up phone call at day 12, visit at day 60, phone call at day 72, visit at day 90 (one month post-second-dose), visit at day 240 (6 months post-second-dose), visit at day 425 (12 months post-second-dose)
|
20.0%
3/15 • up to 12 months post second dose (approximately 425 days on study)
data collected via phone call and follow up visits (follow up phone call at day 12, visit at day 60, phone call at day 72, visit at day 90 (one month post-second-dose), visit at day 240 (6 months post-second-dose), visit at day 425 (12 months post-second-dose)
|
26.7%
4/15 • up to 12 months post second dose (approximately 425 days on study)
data collected via phone call and follow up visits (follow up phone call at day 12, visit at day 60, phone call at day 72, visit at day 90 (one month post-second-dose), visit at day 240 (6 months post-second-dose), visit at day 425 (12 months post-second-dose)
|
13.3%
2/15 • up to 12 months post second dose (approximately 425 days on study)
data collected via phone call and follow up visits (follow up phone call at day 12, visit at day 60, phone call at day 72, visit at day 90 (one month post-second-dose), visit at day 240 (6 months post-second-dose), visit at day 425 (12 months post-second-dose)
|
0.00%
0/15 • up to 12 months post second dose (approximately 425 days on study)
data collected via phone call and follow up visits (follow up phone call at day 12, visit at day 60, phone call at day 72, visit at day 90 (one month post-second-dose), visit at day 240 (6 months post-second-dose), visit at day 425 (12 months post-second-dose)
|
0.00%
0/15 • up to 12 months post second dose (approximately 425 days on study)
data collected via phone call and follow up visits (follow up phone call at day 12, visit at day 60, phone call at day 72, visit at day 90 (one month post-second-dose), visit at day 240 (6 months post-second-dose), visit at day 425 (12 months post-second-dose)
|
0.00%
0/14 • up to 12 months post second dose (approximately 425 days on study)
data collected via phone call and follow up visits (follow up phone call at day 12, visit at day 60, phone call at day 72, visit at day 90 (one month post-second-dose), visit at day 240 (6 months post-second-dose), visit at day 425 (12 months post-second-dose)
|
0.00%
0/15 • up to 12 months post second dose (approximately 425 days on study)
data collected via phone call and follow up visits (follow up phone call at day 12, visit at day 60, phone call at day 72, visit at day 90 (one month post-second-dose), visit at day 240 (6 months post-second-dose), visit at day 425 (12 months post-second-dose)
|
|
Skin and subcutaneous tissue disorders
Swelling
|
20.0%
3/15 • up to 12 months post second dose (approximately 425 days on study)
data collected via phone call and follow up visits (follow up phone call at day 12, visit at day 60, phone call at day 72, visit at day 90 (one month post-second-dose), visit at day 240 (6 months post-second-dose), visit at day 425 (12 months post-second-dose)
|
6.7%
1/15 • up to 12 months post second dose (approximately 425 days on study)
data collected via phone call and follow up visits (follow up phone call at day 12, visit at day 60, phone call at day 72, visit at day 90 (one month post-second-dose), visit at day 240 (6 months post-second-dose), visit at day 425 (12 months post-second-dose)
|
13.3%
2/15 • up to 12 months post second dose (approximately 425 days on study)
data collected via phone call and follow up visits (follow up phone call at day 12, visit at day 60, phone call at day 72, visit at day 90 (one month post-second-dose), visit at day 240 (6 months post-second-dose), visit at day 425 (12 months post-second-dose)
|
6.7%
1/15 • up to 12 months post second dose (approximately 425 days on study)
data collected via phone call and follow up visits (follow up phone call at day 12, visit at day 60, phone call at day 72, visit at day 90 (one month post-second-dose), visit at day 240 (6 months post-second-dose), visit at day 425 (12 months post-second-dose)
|
0.00%
0/15 • up to 12 months post second dose (approximately 425 days on study)
data collected via phone call and follow up visits (follow up phone call at day 12, visit at day 60, phone call at day 72, visit at day 90 (one month post-second-dose), visit at day 240 (6 months post-second-dose), visit at day 425 (12 months post-second-dose)
|
0.00%
0/15 • up to 12 months post second dose (approximately 425 days on study)
data collected via phone call and follow up visits (follow up phone call at day 12, visit at day 60, phone call at day 72, visit at day 90 (one month post-second-dose), visit at day 240 (6 months post-second-dose), visit at day 425 (12 months post-second-dose)
|
0.00%
0/14 • up to 12 months post second dose (approximately 425 days on study)
data collected via phone call and follow up visits (follow up phone call at day 12, visit at day 60, phone call at day 72, visit at day 90 (one month post-second-dose), visit at day 240 (6 months post-second-dose), visit at day 425 (12 months post-second-dose)
|
0.00%
0/15 • up to 12 months post second dose (approximately 425 days on study)
data collected via phone call and follow up visits (follow up phone call at day 12, visit at day 60, phone call at day 72, visit at day 90 (one month post-second-dose), visit at day 240 (6 months post-second-dose), visit at day 425 (12 months post-second-dose)
|
|
Skin and subcutaneous tissue disorders
Warmth
|
6.7%
1/15 • up to 12 months post second dose (approximately 425 days on study)
data collected via phone call and follow up visits (follow up phone call at day 12, visit at day 60, phone call at day 72, visit at day 90 (one month post-second-dose), visit at day 240 (6 months post-second-dose), visit at day 425 (12 months post-second-dose)
|
0.00%
0/15 • up to 12 months post second dose (approximately 425 days on study)
data collected via phone call and follow up visits (follow up phone call at day 12, visit at day 60, phone call at day 72, visit at day 90 (one month post-second-dose), visit at day 240 (6 months post-second-dose), visit at day 425 (12 months post-second-dose)
|
0.00%
0/15 • up to 12 months post second dose (approximately 425 days on study)
data collected via phone call and follow up visits (follow up phone call at day 12, visit at day 60, phone call at day 72, visit at day 90 (one month post-second-dose), visit at day 240 (6 months post-second-dose), visit at day 425 (12 months post-second-dose)
|
0.00%
0/15 • up to 12 months post second dose (approximately 425 days on study)
data collected via phone call and follow up visits (follow up phone call at day 12, visit at day 60, phone call at day 72, visit at day 90 (one month post-second-dose), visit at day 240 (6 months post-second-dose), visit at day 425 (12 months post-second-dose)
|
0.00%
0/15 • up to 12 months post second dose (approximately 425 days on study)
data collected via phone call and follow up visits (follow up phone call at day 12, visit at day 60, phone call at day 72, visit at day 90 (one month post-second-dose), visit at day 240 (6 months post-second-dose), visit at day 425 (12 months post-second-dose)
|
0.00%
0/15 • up to 12 months post second dose (approximately 425 days on study)
data collected via phone call and follow up visits (follow up phone call at day 12, visit at day 60, phone call at day 72, visit at day 90 (one month post-second-dose), visit at day 240 (6 months post-second-dose), visit at day 425 (12 months post-second-dose)
|
0.00%
0/14 • up to 12 months post second dose (approximately 425 days on study)
data collected via phone call and follow up visits (follow up phone call at day 12, visit at day 60, phone call at day 72, visit at day 90 (one month post-second-dose), visit at day 240 (6 months post-second-dose), visit at day 425 (12 months post-second-dose)
|
0.00%
0/15 • up to 12 months post second dose (approximately 425 days on study)
data collected via phone call and follow up visits (follow up phone call at day 12, visit at day 60, phone call at day 72, visit at day 90 (one month post-second-dose), visit at day 240 (6 months post-second-dose), visit at day 425 (12 months post-second-dose)
|
Additional Information
Freddy Caldera, DO
UW School of Medicine and Public Health
Phone: 608-628-8201
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place