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Study Complete
Sponsor ID
D5180C00031

Study to Assess the Effect of Tezepelumab on the Immune Response to Influenza Vaccination in Participants With AsthmaVECTOR

Sponsor ID
D5180C00031
Clinicaltrials.gov ID
NCT05062759
EUCTIS ID
N/A
EudraCT ID
N/A
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Study Details

This is a Phase 3b, multicenter, randomized, double-blind, parallel group, placebo-controlled study designed to investigate the potential effect of tezepelumab (210 mg subcutaneous \[SC\] every 4 weeks \[Q4W\]) on antibody responses following seasonal quadrivalent influenza virus vaccination in the fall/winter 2021-2022 in the USA.

Additional Study Details

Phase
Phase 3
Product
N/A
Type
Interventional
Masking
N/A
Enrollment
70
Additional Study Details

Protocol Summary

Primary Outcome Measures

Post-vaccination Strain-specific Hemagglutination Inhibition (HAI) Antibody Geometric Mean Fold Rises (GMFRs)

Timeframe: From Week 12 to Week 16

Post-vaccination Strain-specific Microneutralization (MN) Antibody GMFRs

Timeframe: From Week 12 to Week 16

Post-vaccination Strain-specific Serum HAI Antibody Geometric Mean Titers (GMTs)

Timeframe: Week 16

Post-vaccination Strain-specific Serum MN Antibody GMTs

Timeframe: Week 16

Percentage of Patients With Post-vaccination Strain-specific Antibody Response at Week 16 With Antibody Response Defined as a ≥ 4-fold Rise in HAI Antibody Titer

Timeframe: Week 16

Percentage of Patients With Post-vaccination Strain-specific Antibody Response at Week 16 With Antibody Response Defined as a ≥ 4-fold Rise in MN Antibody Titer

Timeframe: Week 16

Percentage of Patients With Post-vaccination Strain-specific HAI Antibody Titer ≥ 40

Timeframe: Week 16

Percentage of Patients With Post-vaccination Strain-specific MN Antibody Titer ≥ 40

Timeframe: Week 16

Secondary Outcome Measures

Serum Tezepelumab Concentrations

Timeframe: Week 0, Week 12, Week 16 and Week 28

Immunogenicity

Timeframe: From Baseline to Week 28

Study Documents

Protocol
Available Language(s): English
Download Document(s)
Statistical Analysis Plan
Available Language(s): English
Download Document(s)

Locations

Location
Status
Contact Us
Location
Research Site
Bakersfield, California, United States, 93301
Status
N/A
Location
Research Site
Huntington Beach, California, United States, 92647
Status
N/A
Location
Research Site
Miami, Florida, United States, 33133
Status
N/A
Location
Research Site
Columbia, Missouri, United States, 65203
Status
N/A
Location
Research Site
Northfield, New Jersey, United States, 08225
Status
N/A
Location
Research Site
Dayton, Ohio, United States, 45406
Status
N/A
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Study Info
Age
12 - 21 Years
Condition
  • Asthma
    • Sex
    All
    Trial Dates
    Aug 2021 - Mar 2022
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    * Documented physician-diagnosed asthma for at least 12 months prior to Visit 1. * Morning pre-bronchodilator FEV1 (Forced expiratory volume) of \> 50% predicted normal value at Visit 1 or Visit 2. * Body weight ≥ 40 kg. * For women of childbearing potential, a negative urine pregnancy test is required prior to administration of study intervention at Visit 3. * Must have 'not well-controlled' asthma.
    Exclusion Criteria:
    * Clinically important pulmonary disease other than asthma. * Any disorder, including, but not limited to, cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, hematological, psychiatric, or major physical impairment. * Life-threatening asthma * History of cancer. * Allergy to eggs, if egg based influenza vaccine will be administered. * History of anaphylaxis to any biologic therapy. * Current smokers or participants with smoking history ≥ 10 pack-years and participants using vaping products, including electronic cigarettes. Former smokers with a smoking history of \< 10 pack-years and users of vaping or e-cigarette products must have stopped for at least 6 months prior to Visit 1 to be eligible. * History of alcohol or drug abuse within 12 months prior to the date of informed consent. * Major surgery within 8 weeks prior to Visit 1 or planned surgical procedures during the conduct of the study.