Trial Outcomes & Findings for Immune Response to Systemic and Mucosal Antigenic Challenge in the Presence of Vedolizumab (NCT NCT01981616)
NCT ID: NCT01981616
Last Updated: 2014-07-21
Results Overview
Immune response was defined as hepatitis B surface antibody (anti-HBs) ≥ 10 IU/L.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
127 participants
Primary outcome timeframe
Day 74
Results posted on
2014-07-21
Participant Flow
Participants took part in the study at one investigative site in the United Kingdom from 13 September 2011 to 13 July 2012.
Healthy participants were randomized in a 1:1 ratio to receive a single dose of placebo or vedolizumab.
Participant milestones
| Measure |
Vedolizumab 750 mg
Vedolizumab 750 mg solution, intravenous (IV) infusion, once on Day 1. Also 3 doses of a hepatitis B vaccine series on Days 4, 32 and 60, and 2 doses of an oral cholera vaccine on Days 4 and 18.
|
Placebo
Vedolizumab placebo-matching solution, IV infusion, once on Day 1. Also 3 doses of a hepatitis B vaccine series on Days 4, 32 and 60, and 2 doses of an oral cholera vaccine on Days 4 and 18.
|
|---|---|---|
|
Overall Study
STARTED
|
64
|
63
|
|
Overall Study
COMPLETED
|
63
|
62
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
Vedolizumab 750 mg
Vedolizumab 750 mg solution, intravenous (IV) infusion, once on Day 1. Also 3 doses of a hepatitis B vaccine series on Days 4, 32 and 60, and 2 doses of an oral cholera vaccine on Days 4 and 18.
|
Placebo
Vedolizumab placebo-matching solution, IV infusion, once on Day 1. Also 3 doses of a hepatitis B vaccine series on Days 4, 32 and 60, and 2 doses of an oral cholera vaccine on Days 4 and 18.
|
|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
|
Overall Study
Protocol Violation
|
1
|
0
|
Baseline Characteristics
Immune Response to Systemic and Mucosal Antigenic Challenge in the Presence of Vedolizumab
Baseline characteristics by cohort
| Measure |
Vedolizumab 750 mg
n=64 Participants
Vedolizumab 750 mg solution, intravenous (IV) infusion, once on Day 1. Also 3 doses of a hepatitis B vaccine series on Days 4, 32 and 60, and 2 doses of an oral cholera vaccine on Days 4 and 18.
|
Placebo
n=63 Participants
Vedolizumab placebo-matching solution, IV infusion, once on Day 1. Also 3 doses of a hepatitis B vaccine series on Days 4, 32 and 60, and 2 doses of an oral cholera vaccine on Days 4 and 18.
|
Total
n=127 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
27.7 years
STANDARD_DEVIATION 5.64 • n=5 Participants
|
27.3 years
STANDARD_DEVIATION 5.33 • n=7 Participants
|
27.5 years
STANDARD_DEVIATION 5.47 • n=5 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
44 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
87 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
62 participants
n=5 Participants
|
56 participants
n=7 Participants
|
118 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 participants
n=5 Participants
|
2 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 participants
n=5 Participants
|
4 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
64 participants
n=5 Participants
|
62 participants
n=7 Participants
|
126 participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
64 participants
n=5 Participants
|
63 participants
n=7 Participants
|
127 participants
n=5 Participants
|
|
Height
|
173.4 cm
STANDARD_DEVIATION 8.89 • n=5 Participants
|
173.1 cm
STANDARD_DEVIATION 7.94 • n=7 Participants
|
173.3 cm
STANDARD_DEVIATION 8.40 • n=5 Participants
|
|
Weight
|
75.0 kg
STANDARD_DEVIATION 13.48 • n=5 Participants
|
76.2 kg
STANDARD_DEVIATION 11.53 • n=7 Participants
|
75.6 kg
STANDARD_DEVIATION 12.51 • n=5 Participants
|
|
Body Mass Index (BMI)
|
24.8 kg/m^2
STANDARD_DEVIATION 3.34 • n=5 Participants
|
25.4 kg/m^2
STANDARD_DEVIATION 2.71 • n=7 Participants
|
25.1 kg/m^2
STANDARD_DEVIATION 3.04 • n=5 Participants
|
PRIMARY outcome
Timeframe: Day 74Population: The Per Protocol Population consisted of all participants who received any amount of study drug and who met predefined evaluability criteria, including receiving the correct and complete dose of study drug, completed both Baseline and day 72 serology assessments and full schedule of hepatitis B vaccine and immunomodulator or corticosteroid use.
Immune response was defined as hepatitis B surface antibody (anti-HBs) ≥ 10 IU/L.
Outcome measures
| Measure |
Vedolizumab 750 mg
n=61 Participants
Vedolizumab 750 mg solution, intravenous (IV) infusion, once on Day 1. Also 3 doses of a hepatitis B vaccine series on Days 4, 32 and 60, and 2 doses of an oral cholera vaccine on Days 4 and 18.
|
Placebo
n=62 Participants
Vedolizumab placebo-matching solution, IV infusion, once on Day 1. Also 3 doses of a hepatitis B vaccine series on Days 4, 32 and 60, and 2 doses of an oral cholera vaccine on Days 4 and 18.
|
|---|---|---|
|
Percentage of Participants With an Immune Response to Hepatitis B Vaccine at Day 74
|
88.5 percentage of participants
Interval 80.5 to 96.5
|
90.3 percentage of participants
Interval 83.0 to 97.7
|
SECONDARY outcome
Timeframe: Baseline and Day 74Population: The Dukoral Population was defined as all participants who had evaluable samples for assessing immune response to cholera vaccine (Dukoral) vaccine at any visit.
A positive immune response was defined as an increase of greater than 4-fold over the Baseline immunoglobulin M (IgM), IgG, or IgA anticholera antibodies.
Outcome measures
| Measure |
Vedolizumab 750 mg
n=63 Participants
Vedolizumab 750 mg solution, intravenous (IV) infusion, once on Day 1. Also 3 doses of a hepatitis B vaccine series on Days 4, 32 and 60, and 2 doses of an oral cholera vaccine on Days 4 and 18.
|
Placebo
n=62 Participants
Vedolizumab placebo-matching solution, IV infusion, once on Day 1. Also 3 doses of a hepatitis B vaccine series on Days 4, 32 and 60, and 2 doses of an oral cholera vaccine on Days 4 and 18.
|
|---|---|---|
|
Percentage of Participants With an Immune Response to Oral Cholera Vaccine
|
82.5 percentage of participants
Interval 73.2 to 91.9
|
96.8 percentage of participants
Interval 92.4 to 100.0
|
SECONDARY outcome
Timeframe: Baseline and Days 18, 32, 60 and 74Population: Per Protocol Population; "n" indicates the number of participants with available data at each time point.
Outcome measures
| Measure |
Vedolizumab 750 mg
n=61 Participants
Vedolizumab 750 mg solution, intravenous (IV) infusion, once on Day 1. Also 3 doses of a hepatitis B vaccine series on Days 4, 32 and 60, and 2 doses of an oral cholera vaccine on Days 4 and 18.
|
Placebo
n=62 Participants
Vedolizumab placebo-matching solution, IV infusion, once on Day 1. Also 3 doses of a hepatitis B vaccine series on Days 4, 32 and 60, and 2 doses of an oral cholera vaccine on Days 4 and 18.
|
|---|---|---|
|
Anti-Hepatitis B Surface Antibody Over Time
Baseline (n=24, 31)
|
1.2 IU/L
Geometric Coefficient of Variation 51.9
|
1.0 IU/L
Geometric Coefficient of Variation 12.5
|
|
Anti-Hepatitis B Surface Antibody Over Time
Day 18 (n=39, 40)
|
2.5 IU/L
Geometric Coefficient of Variation 501.0
|
1.3 IU/L
Geometric Coefficient of Variation 73.5
|
|
Anti-Hepatitis B Surface Antibody Over Time
Day 32 (n=37, 41)
|
2.3 IU/L
Geometric Coefficient of Variation 472.8
|
1.6 IU/L
Geometric Coefficient of Variation 99.9
|
|
Anti-Hepatitis B Surface Antibody Over Time
Day 60 (n=58, 59)
|
16.3 IU/L
Geometric Coefficient of Variation 501.3
|
15.2 IU/L
Geometric Coefficient of Variation 365.8
|
|
Anti-Hepatitis B Surface Antibody Over Time
Day 74 (n=59, 62)
|
129.6 IU/L
Geometric Coefficient of Variation 359.3
|
114.4 IU/L
Geometric Coefficient of Variation 539.6
|
SECONDARY outcome
Timeframe: From the first dose of study medication through Day 127Population: The Safety Population was defined as all participants who received any amount of study drug (vedolizumab or placebo) based on what they actually received.
An AE was defined as any untoward medical occurrence in a subject administered a pharmaceutical product; the untoward medical occurrence did not necessarily have a causal relationship with this treatment. Serious adverse event (SAE) meant any untoward medical occurrence that at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of an existing hospitalization, resulted in persistent or significant disability or incapacity, was a congenital anomaly/birth defect or was a medically important event. Relationship of each AE to study drug was determined by the Investigator.
Outcome measures
| Measure |
Vedolizumab 750 mg
n=64 Participants
Vedolizumab 750 mg solution, intravenous (IV) infusion, once on Day 1. Also 3 doses of a hepatitis B vaccine series on Days 4, 32 and 60, and 2 doses of an oral cholera vaccine on Days 4 and 18.
|
Placebo
n=63 Participants
Vedolizumab placebo-matching solution, IV infusion, once on Day 1. Also 3 doses of a hepatitis B vaccine series on Days 4, 32 and 60, and 2 doses of an oral cholera vaccine on Days 4 and 18.
|
|---|---|---|
|
Number of Participants With Adverse Events (AEs)
Any adverse event
|
41 participants
|
50 participants
|
|
Number of Participants With Adverse Events (AEs)
Drug-related adverse event
|
22 participants
|
22 participants
|
|
Number of Participants With Adverse Events (AEs)
Adverse event resulting in study discontinuation
|
0 participants
|
1 participants
|
|
Number of Participants With Adverse Events (AEs)
Serious adverse event
|
0 participants
|
1 participants
|
|
Number of Participants With Adverse Events (AEs)
Serious infection adverse events
|
0 participants
|
0 participants
|
|
Number of Participants With Adverse Events (AEs)
Drug-related serious adverse event
|
0 participants
|
0 participants
|
|
Number of Participants With Adverse Events (AEs)
Serious adverse event resulting in discontinuation
|
0 participants
|
0 participants
|
|
Number of Participants With Adverse Events (AEs)
Deaths
|
0 participants
|
0 participants
|
Adverse Events
Vedolizumab 750 mg
Serious events: 0 serious events
Other events: 24 other events
Deaths: 0 deaths
Placebo
Serious events: 1 serious events
Other events: 25 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Vedolizumab 750 mg
n=64 participants at risk
Vedolizumab 750 mg solution, intravenous (IV) infusion, once on Day 1. Also 3 doses of a hepatitis B vaccine series on Days 4, 32 and 60, and 2 doses of an oral cholera vaccine on Days 4 and 18.
|
Placebo
n=63 participants at risk
Vedolizumab placebo-matching solution, IV infusion, once on Day 1. Also 3 doses of a hepatitis B vaccine series on Days 4, 32 and 60, and 2 doses of an oral cholera vaccine on Days 4 and 18.
|
|---|---|---|
|
Pregnancy, puerperium and perinatal conditions
Spontaneous abortion
|
0.00%
0/64 • From the first dose of study medication through Day 127.
|
1.6%
1/63 • From the first dose of study medication through Day 127.
|
Other adverse events
| Measure |
Vedolizumab 750 mg
n=64 participants at risk
Vedolizumab 750 mg solution, intravenous (IV) infusion, once on Day 1. Also 3 doses of a hepatitis B vaccine series on Days 4, 32 and 60, and 2 doses of an oral cholera vaccine on Days 4 and 18.
|
Placebo
n=63 participants at risk
Vedolizumab placebo-matching solution, IV infusion, once on Day 1. Also 3 doses of a hepatitis B vaccine series on Days 4, 32 and 60, and 2 doses of an oral cholera vaccine on Days 4 and 18.
|
|---|---|---|
|
Infections and infestations
Viral upper respiratory tract infection
|
12.5%
8/64 • From the first dose of study medication through Day 127.
|
12.7%
8/63 • From the first dose of study medication through Day 127.
|
|
Infections and infestations
Upper respiratory tract infection
|
6.2%
4/64 • From the first dose of study medication through Day 127.
|
4.8%
3/63 • From the first dose of study medication through Day 127.
|
|
Infections and infestations
Gastroenteritis
|
3.1%
2/64 • From the first dose of study medication through Day 127.
|
7.9%
5/63 • From the first dose of study medication through Day 127.
|
|
Nervous system disorders
Headache
|
18.8%
12/64 • From the first dose of study medication through Day 127.
|
12.7%
8/63 • From the first dose of study medication through Day 127.
|
|
Gastrointestinal disorders
Nausea
|
6.2%
4/64 • From the first dose of study medication through Day 127.
|
0.00%
0/63 • From the first dose of study medication through Day 127.
|
|
General disorders
Fatigue
|
1.6%
1/64 • From the first dose of study medication through Day 127.
|
6.3%
4/63 • From the first dose of study medication through Day 127.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER