Trial Outcomes & Findings for Shingrix Vaccine in Patients With Moderate to Severe Ulcerative Colitis on Tofacitinib (NCT NCT03591770)

Last Updated: 2025-02-21

Results Overview

Immunogenicity will be assessed by the change in cell mediated immunity (CMI) as measured by ELISPOT from pre-immunization to 1 month after receiving second dose of booster vaccine post-immunization. ELISPOT is an enzyme-linked assay for detecting and enumerating cytokine-producing lymphocytes. A colored spot indicates a cell producing IFNγ. Each well will be inspected and cytokine-producing cells will be counted using AID® imaging system. Any well with more than 300 spots will be considered too numerous to count and reported as \>300 cells/well. It will be measured from pre-immunization to 1 month after receiving second dose of booster vaccine post-immunization.

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

15 participants

Primary outcome timeframe

Baseline and approximately 90 days

Results posted on

2025-02-21

Participant Flow

The study was terminated before any participants were assigned to the arm on anti-TNF and thiopurine.

Participant milestones

Participant milestones
Measure	UC Patients on Tofacitinib Monotherapy Ulcerative Colitis patients on Tofacitinib monotherapy, all patients will be treated with the standard Tofacitinib and will receive Shingrix vaccine.	UC Patients on Anti-TNF Monotherapy Ulcerative Colitis patients on anti-TNF monotherapy, all patients will be treated with the standard anti-TNF monotherapy and will receive Shingrix vaccine.	UC Pts. on Aminosalicylates or Off Immunomodulatory Therapy Ulcerative Colitis patients on non-immunosuppressive therapy or 5-aminosalicylates, all patients will be treated with the standard non-immunosuppressive therapy or 5-aminosalicylates and will receive Shingrix vaccine.
Overall Study STARTED	3	8	4
Overall Study COMPLETED	1	0	0
Overall Study NOT COMPLETED	2	8	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Shingrix Vaccine in Patients With Moderate to Severe Ulcerative Colitis on Tofacitinib

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	UC Patients on Tofacitinib Monotherapy n=3 Participants Ulcerative Colitis patients on Tofacitinib monotherapy, all patients will be treated with the standard Tofacitinib and will receive Shingrix vaccine.	UC Patients on Anti-TNF Monotherapy n=8 Participants Ulcerative Colitis patients on anti-TNF monotherapy, all patients will be treated with the standard anti-TNF monotherapy and will receive Shingrix vaccine.	UC Patients on Anti-TNF and a Thiopurine Ulcerative Colitis patients on anti-TNF and a thiopurine, all patients will be treated with the standard anti-TNF monotherapy and thiopurine (6-mercaptopurine, azathioprine) and will receive Shingrix vaccine.	UC Pts. on Aminosalicylates or Off Immunomodulatory Therapy n=4 Participants Ulcerative Colitis patients on non-immunosuppressive therapy or 5-aminosalicylates, all patients will be treated with the standard non-immunosuppressive therapy or 5-aminosalicylates and will receive Shingrix vaccine.	Total n=15 Participants Total of all reporting groups
Age, Continuous	33 years STANDARD_DEVIATION 7 • n=5 Participants	54 years STANDARD_DEVIATION 10 • n=7 Participants	—	58 years STANDARD_DEVIATION 6 • n=4 Participants	51 years STANDARD_DEVIATION 12 • n=21 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	6 Participants n=7 Participants	—	3 Participants n=4 Participants	9 Participants n=21 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	2 Participants n=7 Participants	—	1 Participants n=4 Participants	6 Participants n=21 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	4 Participants n=7 Participants	—	1 Participants n=4 Participants	6 Participants n=21 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	2 Participants n=5 Participants	4 Participants n=7 Participants	—	3 Participants n=4 Participants	9 Participants n=21 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	—	0 Participants n=4 Participants	0 Participants n=21 Participants
Race/Ethnicity, Customized Black or Af Am	0 Participants n=5 Participants	2 Participants n=7 Participants	—	1 Participants n=4 Participants	3 Participants n=21 Participants
Race/Ethnicity, Customized White	2 Participants n=5 Participants	2 Participants n=7 Participants	—	2 Participants n=4 Participants	6 Participants n=21 Participants
Race/Ethnicity, Customized Unk or Not reported	1 Participants n=5 Participants	4 Participants n=7 Participants	—	1 Participants n=4 Participants	6 Participants n=21 Participants
Region of Enrollment United States	3 participants n=5 Participants	8 participants n=7 Participants	—	4 participants n=4 Participants	15 participants n=21 Participants

PRIMARY outcome

Timeframe: Baseline and approximately 90 days

Population: The study was terminated before any participants were assigned to the arm on anti-TNF and thiopurine so there are no participants enrolled in this arm. For the other three arms there were not enough participants enrolled to test the samples for this outcome measure as the minimum number needed for this test is 25. Therefore, there are no data for this outcome measure.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 1 month

Population: The study was terminated before any participants were assigned to the arm on anti-TNF and thiopurine so there are no participants enrolled in this arm.

Vaccine adverse effects will be documented following immunization by evaluating participants at each clinic visit and from a phone call by study personnel.

Outcome measures

Outcome measures
Measure	UC Patients on Tofacitinib Monotherapy n=3 Participants Ulcerative Colitis patients on Tofacitinib monotherapy, all patients will be treated with the standard Tofacitinib and will receive Shingrix vaccine.	UC Patients on Anti-TNF Monotherapy n=8 Participants Ulcerative Colitis patients on anti-TNF monotherapy, all patients will be treated with the standard anti-TNF monotherapy and will receive Shingrix vaccine.	UC Patients on Anti-TNF and a Thiopurine Ulcerative Colitis patients on anti-TNF and a thiopurine, all patients will be treated with the standard anti-TNF monotherapy and thiopurine (6-mercaptopurine, azathioprine) and will receive Shingrix vaccine.	UC Pts. on Aminosalicylates or Off Immunomodulatory Therapy n=4 Participants Ulcerative Colitis patients on non-immunosuppressive therapy or 5-aminosalicylates, all patients will be treated with the standard non-immunosuppressive therapy or 5-aminosalicylates and will receive Shingrix vaccine.
The Number of Participants With Vaccine Adverse Effects at 1 Month	0 Participants	0 Participants	—	0 Participants

SECONDARY outcome

Timeframe: 8 months (6 months post-immunization)

Population: The study was terminated before any participants were assigned to the arm on anti-TNF and thiopurine so there are no participants enrolled in this arm. At 8 months, all participants in the other 3 arms, except for one in the UC patients on tofacitinib monotherapy, were lost to follow-up so there are no data for the UC patients on anti-TNF monotherapy and the UC pts. on aminosalicylates or off immunomodulatory therapy arms.

Vaccine adverse effects will be documented following immunization by evaluating participants at each clinic visit and from a phone call by study personnel.

Outcome measures

Outcome measures
Measure	UC Patients on Tofacitinib Monotherapy n=1 Participants Ulcerative Colitis patients on Tofacitinib monotherapy, all patients will be treated with the standard Tofacitinib and will receive Shingrix vaccine.	UC Patients on Anti-TNF Monotherapy Ulcerative Colitis patients on anti-TNF monotherapy, all patients will be treated with the standard anti-TNF monotherapy and will receive Shingrix vaccine.	UC Patients on Anti-TNF and a Thiopurine Ulcerative Colitis patients on anti-TNF and a thiopurine, all patients will be treated with the standard anti-TNF monotherapy and thiopurine (6-mercaptopurine, azathioprine) and will receive Shingrix vaccine.	UC Pts. on Aminosalicylates or Off Immunomodulatory Therapy Ulcerative Colitis patients on non-immunosuppressive therapy or 5-aminosalicylates, all patients will be treated with the standard non-immunosuppressive therapy or 5-aminosalicylates and will receive Shingrix vaccine.
Number of Participants With Vaccine Adverse Effects at 8 Months (6 Months Post-immunization)	0 Participants	—	—	—

SECONDARY outcome

Timeframe: Baseline, 2 months, and 8 months (6 months post-immunization)

Population: 1. The study was terminated before any participants were assigned to the arm on anti-TNF and thiopurine so there are no participants enrolled in this arm. 2. None of the participants in the arm on UC pts. on aminosalicylates or off immunomodulatory therapy completed any of the questionnaires for any of the time frames, so there are no data for this arm.

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.

Outcome measures

Outcome measures
Measure	UC Patients on Tofacitinib Monotherapy n=3 Participants Ulcerative Colitis patients on Tofacitinib monotherapy, all patients will be treated with the standard Tofacitinib and will receive Shingrix vaccine.	UC Patients on Anti-TNF Monotherapy n=3 Participants Ulcerative Colitis patients on anti-TNF monotherapy, all patients will be treated with the standard anti-TNF monotherapy and will receive Shingrix vaccine.	UC Patients on Anti-TNF and a Thiopurine Ulcerative Colitis patients on anti-TNF and a thiopurine, all patients will be treated with the standard anti-TNF monotherapy and thiopurine (6-mercaptopurine, azathioprine) and will receive Shingrix vaccine.	UC Pts. on Aminosalicylates or Off Immunomodulatory Therapy Ulcerative Colitis patients on non-immunosuppressive therapy or 5-aminosalicylates, all patients will be treated with the standard non-immunosuppressive therapy or 5-aminosalicylates and will receive Shingrix vaccine.
Number of Participants Classified by Disease Activity 2 months · Mild Activity	0 Participants	0 Participants	—	—
Number of Participants Classified by Disease Activity Baseline · Remission	2 Participants	1 Participants	—	—
Number of Participants Classified by Disease Activity Baseline · Mild Activity	1 Participants	1 Participants	—	—
Number of Participants Classified by Disease Activity Baseline · ModerateActivity	0 Participants	1 Participants	—	—
Number of Participants Classified by Disease Activity Baseline · Severe Activity	0 Participants	0 Participants	—	—
Number of Participants Classified by Disease Activity 2 months · Remission	2 Participants	2 Participants	—	—
Number of Participants Classified by Disease Activity 2 months · ModerateActivity	0 Participants	1 Participants	—	—
Number of Participants Classified by Disease Activity 2 months · Severe Activity	0 Participants	0 Participants	—	—
Number of Participants Classified by Disease Activity 8 months · Remission	1 Participants	—	—	—
Number of Participants Classified by Disease Activity 8 months · Mild Activity	0 Participants	—	—	—
Number of Participants Classified by Disease Activity 8 months · ModerateActivity	0 Participants	—	—	—
Number of Participants Classified by Disease Activity 8 months · Severe Activity	0 Participants	—	—	—

Adverse Events

UC Patients on Tofacitinib Monotherapy

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

UC Patients on Anti-TNF Monotherapy

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

UC Patients on Anti-TNF and a Thiopurine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

UC Pts. on Aminosalicylates or Off Immunomodulatory Therapy

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Sharmeel K. Wasan, MD

Boston Medical Center

Phone: (617) 638-6116

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place