Phase 3
Completed N=103
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
Source: ClinicalTrials.gov NCT02814643 ↗Enrolled (actual)
103
Serious AEs
1.9%
Results posted
Mar 2018
Primary outcomePrimary: Postdose Strain-specific Hemagglutination-inhibition (HAI) Antibody Geometric Mean Fold Rise From Week 8 to Week 12 — 3.60; 3.13; 3.25; 3.85 Fold change
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Postdose Strain-specific Hemagglutination-inhibition (HAI) Antibody Geometric Mean Fold Rise From Week 8 to Week 12 |
3.60; 3.13; 3.25; 3.85; 3.42; 3.17 | — |
| PRIMARY Postdose Strain-specific Hemagglutination-inhibition Antibody Geometric Mean Titers Obtained at Week 12 |
521.06; 518.60; 170.73; 219.35; 61.47; 63.15 | — |
| PRIMARY 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 |
0.440; 0.306; 0.500; 0.490; 0.480; 0.490 | — |
| PRIMARY Proportion of Patients Who Achieved a Strain-specific Postdose Hemagglutination-inhibition Antibody Titer ≥40 at Week 12 |
1.00; 1.00; 0.980; 0.980; 0.860; 0.796 | — |
| SECONDARY Proportion of Patients Who Achieved a Strain-specific Postdose Hemagglutination Inhibition Antibody Titre ≥320 at Week 12 |
0.840; 0.857; 0.500; 0.612; 0.020; 0.020 | — |
| SECONDARY Postdose Strain-specific Microneutralization Antibody Geometric Mean Fold Rise From Week 8 to Week 12 |
5.1; 4.4; 3.2; 3.6; 2.8; 3.2 | — |
| SECONDARY Postdose Strain-specific Serum Microneutralization Antibody Geometric Mean Titers Obtained at Week 12 |
3774.1; 3969.1; 4307.5; 4351.3; 350.2; 336.2 | — |
| SECONDARY 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 |
0.420; 0.408; 0.440; 0.429; 0.280; 0.388 | — |
| SECONDARY Change From Baseline in Mean Asthma Control Questionnaire 6 (ACQ-6) Score at Week 12 |
-0.50; -0.42 | — |
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
Data sourced from ClinicalTrials.gov (NCT02814643). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.