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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-001874-24 | EudraCT Number | ||
| U1111-1147-3216 | Registry Identifier | WHO |
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The primary purpose of this study is to determine the rates of seroconversion to a hepatitis B vaccine series after a single 750 mg intravenous (IV) dose of vedolizumab or placebo. Secondary objectives are to determine the rates of seroconversion to an oral cholera vaccine series, assess change in anti-hepatitis B surface antibodies and assess the safety and tolerability of a single 750-mg IV dose of vedolizumab.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vedolizumab 750 mg | Experimental | Vedolizumab 750 mg, 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 | Placebo Comparator | Vedolizumab placebo-matching, 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vedolizumab | Drug | Vedolizumab for intravenous infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With an Immune Response to Hepatitis B Vaccine at Day 74 | Immune response was defined as hepatitis B surface antibody (anti-HBs) ≥ 10 IU/L. | Day 74 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With an Immune Response to Oral Cholera Vaccine | 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. | Baseline and Day 74 |
| Anti-Hepatitis B Surface Antibody Over Time |
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Inclusion criteria
Exclusion criteria
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Millennium Pharmaceuticals, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ICON Development Solutions | Manchester | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24763133 | Derived | Wyant T, Leach T, Sankoh S, Wang Y, Paolino J, Pasetti MF, Feagan BG, Parikh A. Vedolizumab affects antibody responses to immunisation selectively in the gastrointestinal tract: randomised controlled trial results. Gut. 2015 Jan;64(1):77-83. doi: 10.1136/gutjnl-2014-307127. Epub 2014 Apr 24. |
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Healthy participants were randomized in a 1:1 ratio to receive a single dose of placebo or vedolizumab.
Participants took part in the study at one investigative site in the United Kingdom from 13 September 2011 to 13 July 2012.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants With an Immune Response to Hepatitis B Vaccine at Day 74 | Immune response was defined as hepatitis B surface antibody (anti-HBs) ≥ 10 IU/L. | 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. | Posted | Number | 95% Confidence Interval | percentage of participants | Day 74 |
|
From the first dose of study medication through Day 127.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Spontaneous abortion | Pregnancy, puerperium and perinatal conditions | MedDRA (15.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Viral upper respiratory tract infection | Infections and infestations | MedDRA (15.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Director | Millennium Pharmaceuticals Inc. | 800-778-2860 | clinicaltrialregistry@tpna.com |
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| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
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| ID | Term |
|---|---|
| C543529 | vedolizumab |
| C438271 | LDP-02 |
| D017325 | Hepatitis B Vaccines |
| D022121 | Cholera Vaccines |
| C586175 | Dukoral |
| ID | Term |
|---|---|
| D014761 | Viral Hepatitis Vaccines |
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
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| Placebo | Drug | Placebo intravenous infusion |
|
| Hepatitis B vaccine | Biological |
|
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| Oral cholera vaccine | Biological |
|
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| Baseline and Days 18, 32, 60 and 74 |
| Number of Participants With Adverse Events (AEs) | 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. | From the first dose of study medication through Day 127 |
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.
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
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| Race/Ethnicity, Customized | Number | participants |
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| Region of Enrollment | Number | participants |
|
| Height | Mean | Standard Deviation | cm |
|
| Weight | Mean | Standard Deviation | kg |
|
| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m^2 |
|
| OG001 |
| 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. |
|
|
|
| Secondary | Percentage of Participants With an Immune Response to Oral Cholera Vaccine | 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. | The Dukoral Population was defined as all participants who had evaluable samples for assessing immune response to cholera vaccine (Dukoral) vaccine at any visit. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline and Day 74 |
|
|
|
|
| Secondary | Anti-Hepatitis B Surface Antibody Over Time | Per Protocol Population; "n" indicates the number of participants with available data at each time point. | Posted | Geometric Mean | Geometric Coefficient of Variation | IU/L | Baseline and Days 18, 32, 60 and 74 |
|
|
|
| Secondary | Number of Participants With Adverse Events (AEs) | 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. | The Safety Population was defined as all participants who received any amount of study drug (vedolizumab or placebo) based on what they actually received. | Posted | Number | participants | From the first dose of study medication through Day 127 |
|
|
|
| 0 |
| 64 |
| 24 |
| 64 |
| EG001 | 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. | 1 | 63 | 25 | 63 |
| Upper respiratory tract infection | Infections and infestations | MedDRA (15.0) | Systematic Assessment |
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| Gastroenteritis | Infections and infestations | MedDRA (15.0) | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA (15.0) | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
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| Fatigue | General disorders | MedDRA (15.0) | Systematic Assessment |
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| D045424 |
| Complex Mixtures |
| D001428 | Bacterial Vaccines |
| Day 32 (n=37, 41) |
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| Day 60 (n=58, 59) |
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| Day 74 (n=59, 62) |
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| Adverse event resulting in study discontinuation |
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| Serious adverse event |
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| Serious infection adverse events |
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| Drug-related serious adverse event |
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| Serious adverse event resulting in discontinuation |
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| Deaths |
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