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

AstraZeneca103 enrolled

Overview

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

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

TRIPLE

Enrollment

103

Conditions

Asthma

Interventions

BenralizumabDRUG

Benralizumab SC administered every 4 weeks for 3 doses (Weeks 0, 4, and 8).

Benralizumab PlaceboDRUG

Placebo administered every 4 weeks for 3 doses (Weeks 0, 4, and 8).

Seasonal influenza virus vaccineDRUG

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

Eligibility

Sex: ALLMin age: 12 YearsMax age: 21 Years

Medical Language ↔ Plain English

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

Locations (24)

Research Site

Birmingham, Alabama, United States

Outcomes

Primary Outcomes

Postdose Strain-specific Hemagglutination-inhibition (HAI) Antibody Geometric Mean Fold Rise From Week 8 to Week 12

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.

Time frame: 4 weeks

Postdose Strain-specific Hemagglutination-inhibition Antibody Geometric Mean Titers Obtained at Week 12

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.

Time frame: 12 weeks

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

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.

Time frame: 4 weeks

Proportion of Patients Who Achieved a Strain-specific Postdose Hemagglutination-inhibition Antibody Titer ≥40 at Week 12

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.

Time frame: 12 weeks

Secondary Outcomes

Proportion of Patients Who Achieved a Strain-specific Postdose Hemagglutination Inhibition Antibody Titre ≥320 at Week 12

Data from ClinicalTrials.gov

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