Clinical trial NCT05062759: Study to Assess the Effect of Tezepelumab on the Immune Response to Influenza Vaccination in Participants With Asthma
Official title: A Multicenter, Randomized, Double-blind, Parallel Group, Placebo-controlled, Phase 3b Study to Evaluate the Potential Effect of Tezepelumab on the Humoral Immune Response to Seasonal Quadrivalent Influenza Vaccination in Adolescent and Young Adult Participants With Moderate to Severe Asthma (VECTOR)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Moderate to Severe Asthma
Keywords: Tezepelumab
Humoral Immune Response
Quadrivalent Influenza Vaccination
Antibody response
Subcutaneous
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
Collaborators: name: Amgen
First posted: 2021-09-30
Enrollment: 70
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: TREATMENT

Brief summary: 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.

Detailed description: Participants with moderate to severe asthma will enter the screening period of a minimum of 2 weeks to allow adequate time for all of the eligibility criteria to be evaluated. They will be randomized 1:1 to receive tezepelumab 210 mg or placebo SC Q4W, administered at Weeks 0, 4, 8 and 12. Randomization will be monitored to ensure at least 50% of the randomized participants are between the ages of 12 to 17 years.

Participants will receive a single dose of inactivated quadrivalent seasonal influenza vaccine intramuscularly at Week 12, prior to the fourth dose of study intervention.

Serum samples for evaluation of antibody response will be drawn at Week 12 (pre-vaccination) and at Week 16 (4 weeks post-vaccination) when humoral response to the vaccination is expected to be fully developed.

The End of Treatment (EOT) Visit will be conducted at Week 16 and a final Follow-up Visit and the End of Study Visit will be conducted at Week 28.

Eligibility 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.

Primary outcomes:
measure: Post-vaccination Strain-specific Hemagglutination Inhibition (HAI) Antibody Geometric Mean Fold Rises (GMFRs)
timeFrame: From Week 12 to Week 16
measure: Post-vaccination Strain-specific Microneutralization (MN) Antibody GMFRs
timeFrame: From Week 12 to Week 16
measure: Post-vaccination Strain-specific Serum HAI Antibody Geometric Mean Titers (GMTs)
timeFrame: Week 16
measure: Post-vaccination Strain-specific Serum MN Antibody GMTs
timeFrame: Week 16
measure: 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
measure: 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
measure: Percentage of Patients With Post-vaccination Strain-specific HAI Antibody Titer ≥ 40
timeFrame: Week 16
measure: Percentage of Patients With Post-vaccination Strain-specific MN Antibody Titer ≥ 40
timeFrame: Week 16
Secondary outcomes:
measure: Serum Tezepelumab Concentrations
timeFrame: Week 0, Week 12, Week 16 and Week 28
measure: Immunogenicity
timeFrame: From Baseline to Week 28
Other outcomes:
Locations:
city: Bakersfield
country: United States
facility: Research Site
state: California
city: Huntington Beach
country: United States
facility: Research Site
state: California
city: Miami
country: United States
facility: Research Site
state: Florida
city: Columbia
country: United States
facility: Research Site
state: Missouri
city: Northfield
country: United States
facility: Research Site
state: New Jersey
city: Dayton
country: United States
facility: Research Site
state: Ohio
city: Toledo
country: United States
facility: Research Site
state: Ohio
city: Edmond
country: United States
facility: Research Site
state: Oklahoma
city: Oklahoma City
country: United States
facility: Research Site
state: Oklahoma
city: Dallas
country: United States
facility: Research Site
state: Texas
city: San Antonio
country: United States
facility: Research Site
state: Texas
city: Tyler
country: United States
facility: Research Site
state: Texas
city: Waco
country: United States
facility: Research Site
state: Texas
city: Salt Lake City
country: United States
facility: Research Site
state: Utah
city: Milwaukee
country: United States
facility: Research Site
state: Wisconsin
Study officials:
References: