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)

AstraZeneca

Status and phase: Completed; Phase 3

Conditions: Asthma

Treatments: Drug: Benralizumab Placebo; Drug: Seasonal influenza virus vaccine; Drug: Benralizumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT02814643

D3250C00033

Details and patient eligibility

About

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

Full 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

Enrollment: 103 patients

Sex: All

Ages: 12 to 21 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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103 participants in 2 patient groups, including a placebo group

Benralizumab

Experimental group

Description:

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.

Treatment:

Drug: Benralizumab

Drug: Seasonal influenza virus vaccine

Placebo

Placebo Comparator group

Description:

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.

Treatment:

Drug: Benralizumab Placebo

Drug: Seasonal influenza virus vaccine