Clinical trial NCT02814643: 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
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Asthma
Keywords: Male and female adolescent patients
severe asthma
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2016-06-28
Enrollment: 103
Sex: ALL
Minimum age (years): 12
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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

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

Eligibility 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

Primary outcomes:
measure: Postdose Strain-specific Hemagglutination-inhibition (HAI) Antibody Geometric Mean Fold Rise From Week 8 to Week 12
timeFrame: 4 weeks
measure: Postdose Strain-specific Hemagglutination-inhibition Antibody Geometric Mean Titers Obtained at Week 12
timeFrame: 12 weeks
measure: 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
timeFrame: 4 weeks
measure: Proportion of Patients Who Achieved a Strain-specific Postdose Hemagglutination-inhibition Antibody Titer ≥40 at Week 12
timeFrame: 12 weeks
Secondary outcomes:
measure: Proportion of Patients Who Achieved a Strain-specific Postdose Hemagglutination Inhibition Antibody Titre ≥320 at Week 12
timeFrame: 12 weeks
measure: Postdose Strain-specific Microneutralization Antibody Geometric Mean Fold Rise From Week 8 to Week 12
timeFrame: 4 weeks
measure: Postdose Strain-specific Serum Microneutralization Antibody Geometric Mean Titers Obtained at Week 12
timeFrame: 12 weeks
measure: 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
timeFrame: 4 weeks
measure: Change From Baseline in Mean Asthma Control Questionnaire 6 (ACQ-6) Score at Week 12
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Research Site
state: Alabama
city: Mesa
country: United States
facility: Research Site
state: Arizona
city: Huntington Beach
country: United States
facility: Research Site
state: California
city: Newport Beach
country: United States
facility: Research Site
state: California
city: Aurora
country: United States
facility: Research Site
state: Colorado
city: Colorado Springs
country: United States
facility: Research Site
state: Colorado
city: Denver
country: United States
facility: Research Site
state: Colorado
city: Aventura
country: United States
facility: Research Site
state: Florida
city: Miami
country: United States
facility: Research Site
state: Florida
city: Miami
country: United States
facility: Research Site
state: Florida
city: Minneapolis
country: United States
facility: Research Site
state: Minnesota
city: Bellevue
country: United States
facility: Research Site
state: Nebraska
city: Northfield
country: United States
facility: Research Site
state: New Jersey
city: Edmond
country: United States
facility: Research Site
state: Oklahoma
city: Oklahoma City
country: United States
facility: Research Site
state: Oklahoma
city: Medford
country: United States
facility: Research Site
state: Oregon
city: North Charleston
country: United States
facility: Research Site
state: South Carolina
city: Arlington
country: United States
facility: Research Site
state: Texas
city: El Paso
country: United States
facility: Research Site
state: Texas
city: New Braunfels
country: United States
facility: Research Site
state: Texas
city: San Antonio
country: United States
facility: Research Site
state: Texas
city: San Antonio
country: United States
facility: Research Site
state: Texas
city: Waco
country: United States
facility: Research Site
state: Texas
city: Clinton
country: United States
facility: Research Site
state: Utah
Study officials:
affiliation: Johns Hopkins University
name: Pamela L Zeitlin, M.D. Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: