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Study to Evaluate the Potential Effect of Benralizumab on the Humoral Immune Response to the Seasonal Influenza Vaccination in Adolescent and Young Adult Patients With Severe Asthma (ALIZE)

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ClinicalTrials.gov Identifier: NCT02814643
Recruitment Status : Completed
First Posted : June 28, 2016
Results First Posted : March 1, 2018
Last Update Posted : October 24, 2018
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Brief Summary:
This is a randomized, double-blind, parallel group, placebo-controlled study designed to investigate the potential effect of a fixed dose of benralizumab administered subcutaneously (SC) on antibody responses following seasonal influenza virus vaccination

Condition or disease Intervention/treatment Phase
Asthma Drug: Benralizumab Drug: Benralizumab Placebo Drug: Seasonal influenza virus vaccine Phase 3

Detailed Description:
This study is designed to investigate the potential effect of benralizumab on the antibody response to the seasonal influenza virus vaccine in patients 12-21 years of age with asthma. Benralizumab will be given subcutaneously (SC) at Weeks 0, 4, and 8 weeks, at which time benralizumab levels will reach steady state. Patients will then receive 1 dose of intramuscular (IM) seasonal influenza virus vaccine at Week 8 and samples drawn at Week 8 and Week 12 to measure the antibody response to the influenza virus

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 103 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: A Multicenter, Randomized, Double-blind, Parallel Group, Placebo-controlled, Phase 3b Study to Evaluate the Potential Effect of Benralizumab on the Humoral Immune Response to the Seasonal Influenza Vaccination in Adolescent and Young Adult Patients With Severe Asthma.
Actual Study Start Date : July 1, 2016
Actual Primary Completion Date : January 24, 2017
Actual Study Completion Date : January 24, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma Flu Flu Shot

Arm Intervention/treatment
Experimental: Benralizumab
1 mL fill volume administered every 4 weeks for 3 doses (Weeks 0, 4, and 8). Patients will receive 1 dose of seasonal influenza virus vaccine Intramuscular (IM) at Week 8.
Drug: Benralizumab
Benralizumab SC administered every 4 weeks for 3 doses (Weeks 0, 4, and 8).

Drug: Seasonal influenza virus vaccine
Patients will receive 1 dose of seasonal influenza virus vaccine Intramuscular (IM) at Week 8.

Placebo Comparator: Placebo
1 mL fill volume administered every 4 weeks for 3 doses (Weeks 0, 4, and 8). Patients will receive 1 dose of seasonal influenza virus vaccine Intramuscular (IM) at Week 8.
Drug: Benralizumab Placebo
Placebo administered every 4 weeks for 3 doses (Weeks 0, 4, and 8).

Drug: Seasonal influenza virus vaccine
Patients will receive 1 dose of seasonal influenza virus vaccine Intramuscular (IM) at Week 8.




Primary Outcome Measures :
  1. Postdose Strain-specific Hemagglutination-inhibition (HAI) Antibody Geometric Mean Fold Rise From Week 8 to Week 12 [ Time Frame: 4 weeks ]
    To compare the geometric mean fold rises in influenza strain-specific hemagglutination-inhibition responses from Week 8 to Week 12 between patients receiving benralizumab 30mg and patients receiving placebo. Geometric mean fold rise was defined as antilog(z) (mean [log(z) x]), where "x" is the postdose HAI antibody titer fold rise from Week 8 and "z" is the natural logarithm.

  2. Postdose Strain-specific Hemagglutination-inhibition Antibody Geometric Mean Titers Obtained at Week 12 [ Time Frame: 12 weeks ]
    To compare the geometric mean titers of hemagglutination-inhibition antibody as a measure of influenza strain-specific response at Week 12 between patients receiving benralizumab 30mg and patients receiving placebo.

  3. Proportion of Patients Who Experienced a Strain-specific Postdose Antibody Response at Week 12 With Antibody Response Defined as a ≥4-fold Rise in Hemagglutination-inhibition Antibody Titer From Week 8 to Week 12 [ Time Frame: 4 weeks ]
    To compare the proportions of patients experiencing influenza strain-specific responses as measured by ≥4-fold rises in hemagglutination-inhibition antibody titer from Week 8 to Week 12 between patients receiving benralizumab 30mg and patients receiving placebo.

  4. Proportion of Patients Who Achieved a Strain-specific Postdose Hemagglutination-inhibition Antibody Titer ≥40 at Week 12 [ Time Frame: 12 weeks ]
    To compare the proportions of patients experiencing influenza strain-specific responses as measured by ≥40-fold rises in hemagglutination-inhibition antibody titer at Week 12 between patients receiving benralizumab 30mg and patients receiving placebo.


Secondary Outcome Measures :
  1. Proportion of Patients Who Achieved a Strain-specific Postdose Hemagglutination Inhibition Antibody Titre ≥320 at Week 12 [ Time Frame: 12 weeks ]
    To compare the proportions of patients experiencing influenza strain-specific responses as measured by ≥320-fold rises in hemagglutination-inhibition antibody titer at Week 12 between patients receiving benralizumab 30mg and patients receiving placebo.

  2. Postdose Strain-specific Microneutralization Antibody Geometric Mean Fold Rise From Week 8 to Week 12 [ Time Frame: 4 weeks ]
    To compare the geometric mean fold rises in influenza strain-specific microneutralization antibody responses from Week 8 to Week 12 between patients receiving benralizumab 30mg and patients receiving placebo. Geometric mean fold rise was defined as antilog(z) (mean [log(z) x]), where "x" is the postdose microneutralization antibody titer fold rise from Week 8 and "z" is the natural logarithm.

  3. Postdose Strain-specific Serum Microneutralization Antibody Geometric Mean Titers Obtained at Week 12 [ Time Frame: 12 weeks ]
    To compare the geometric mean titers of microneutralization antibody as a measure of influenza strain-specific response at Week 12 between patients receiving benralizumab 30mg and patients receiving placebo.

  4. Proportion of Patients Who Experience a Strain-specific Postdose Antibody Response at Week 12 With Antibody Response Defined as a ≥4-fold Rise in Microneutralization Antibody Titer From Week 8 to Week 12 [ Time Frame: 4 weeks ]
    To compare the proportions of patients experiencing influenza strain-specific responses as measured by ≥4-fold rises in microneutralization antibody titer from Week 8 to Week 12 between patients receiving benralizumab 30mg and patients receiving placebo.

  5. Change From Baseline in Mean Asthma Control Questionnaire 6 (ACQ-6) Score at Week 12 [ Time Frame: 12 weeks ]
    To compare the change from baseline at Week 12 in mean ACQ-6 score between patients receiving benralizumab 30mg and patients receiving placebo. The ACQ-6 assesses asthma symptoms (nighttime waking, symptoms on waking, activity limitation, shortness of breath, wheezing, and short-acting β2 agonist use). Questions are weighted equally and scored from 0 (totally controlled) to 6 (severely uncontrolled). The mean ACQ-6 score is the mean of the responses to each question. Mean scores of ≤0.75 indicate well-controlled asthma, scores between 0.75 and ≤1.5 indicate partly controlled asthma, and a score >1.5 indicates not well controlled asthma



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Ages Eligible for Study:   12 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Female and male patients aged 12 to 21 years, inclusive, at the time of Visit 1
  • Weight of ≥40 kg
  • Documented history of current treatment with Inhaled corticosteroids (ICS) and long-acting β2 agonists (LABA)
  • Morning pre-bronchodilator forced expiratory volume in 1 second (FEV1) of >50% predicted at Visit 1 or Visit 2.
  • Airway reversibility (FEV1 >12% and 200 ml) demonstrated at Visit 1 or Visit 2 using the Maximum Post-bronchodilator Procedure OR
  • Airway reversibility documented in the previous 12 months prior to Visit 1
  • An exacerbation, 1 or more, that required oral corticosteroids in the previous year OR
  • Any condition assessed by patient recall over the previous 2-4 weeks

Exclusion Criteria:

  • Clinically important pulmonary disease other than asthma
  • Known history of allergy or reaction to the Investigational Product formulation or influenza vaccine
  • Receipt of an influenza vaccine within 90 days prior to randomization
  • Poorly controlled asthma during the screening period that requires treatment with oral corticosteroids or a hospitalization/emergency room visit for the treatment of asthma
  • Acute illness or evidence of significant active infection or known influenza infection during the current flu season

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02814643


Locations
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United States, Alabama
Research Site
Birmingham, Alabama, United States, 35209
United States, Arizona
Research Site
Mesa, Arizona, United States, 85206
United States, California
Research Site
Huntington Beach, California, United States, 92647
Research Site
Newport Beach, California, United States, 92663
United States, Colorado
Research Site
Aurora, Colorado, United States, 80012-4016
Research Site
Colorado Springs, Colorado, United States, 80907
Research Site
Denver, Colorado, United States, 80230
United States, Florida
Research Site
Aventura, Florida, United States, 33180
Research Site
Miami, Florida, United States, 33135
Research Site
Miami, Florida, United States, 33173
United States, Minnesota
Research Site
Minneapolis, Minnesota, United States, 55402
United States, Nebraska
Research Site
Bellevue, Nebraska, United States, 68123
United States, New Jersey
Research Site
Northfield, New Jersey, United States, 08225
United States, Oklahoma
Research Site
Edmond, Oklahoma, United States, 73034
Research Site
Oklahoma City, Oklahoma, United States, 73103
United States, Oregon
Research Site
Medford, Oregon, United States, 97504
United States, South Carolina
Research Site
North Charleston, South Carolina, United States, 29420
United States, Texas
Research Site
Arlington, Texas, United States, 76018
Research Site
El Paso, Texas, United States, 79903
Research Site
New Braunfels, Texas, United States, 78130
Research Site
San Antonio, Texas, United States, 78221
Research Site
San Antonio, Texas, United States, 78251
Research Site
Waco, Texas, United States, 76712
United States, Utah
Research Site
Clinton, Utah, United States, 84015
Sponsors and Collaborators
AstraZeneca
Investigators
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Principal Investigator: Pamela L Zeitlin, M.D. Ph.D. Johns Hopkins University
  Study Documents (Full-Text)

Documents provided by AstraZeneca:
Study Protocol  [PDF] December 14, 2015
Statistical Analysis Plan  [PDF] March 6, 2017


Additional Information:
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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT02814643     History of Changes
Other Study ID Numbers: D3250C00033
First Posted: June 28, 2016    Key Record Dates
Results First Posted: March 1, 2018
Last Update Posted: October 24, 2018
Last Verified: October 2018
Keywords provided by AstraZeneca:
Male and female adolescent patients
severe asthma
Additional relevant MeSH terms:
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Benralizumab
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents