Phase 3
Completed N=70
Study to Assess the Effect of Tezepelumab on the Immune Response to Influenza Vaccination in Participants With Asthma
Source: ClinicalTrials.gov NCT05062759 ↗Enrolled (actual)
70
Serious AEs
1.4%
Results posted
Apr 2023
Primary outcomePrimary: Post-vaccination Strain-specific Hemagglutination Inhibition (HAI) Antibody Geometric Mean Fold Rises (GMFRs) — 7.34; 4.75; 1.76; 1.46 Fold change
◆ Published Evidence
Emerging
3citations · ~2 / year
Effect of Tezepelumab on the Humoral Immune Response to Seasonal Quadrivalent Influenza Vaccination in Patients with Moderate to Severe Asthma: The Phase 3b VECTOR Study.
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.
Linked Publications
-
Effect of Tezepelumab on the Humoral Immune Response to Seasonal Quadrivalent Influenza Vaccination in Patients with Moderate to Severe Asthma: The Phase 3b VECTOR Study.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Post-vaccination Strain-specific Hemagglutination Inhibition (HAI) Antibody Geometric Mean Fold Rises (GMFRs) |
7.34; 4.75; 1.76; 1.46; 2.94; 2.90 | — |
| PRIMARY Post-vaccination Strain-specific Microneutralization (MN) Antibody GMFRs |
14.56; 10.62; 4.73; 5.90; 4.00; 3.56 | — |
| PRIMARY Post-vaccination Strain-specific Serum HAI Antibody Geometric Mean Titers (GMTs) |
809.23; 596.76; 167.46; 161.56; 194.68; 200.55 | — |
| PRIMARY Post-vaccination Strain-specific Serum MN Antibody GMTs |
382.55; 303.63; 600.92; 457.33; 355.44; 366.81 | — |
| PRIMARY 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 |
78.8; 51.5; 15.2; 15.2; 30.3; 39.4 | — |
| PRIMARY 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 |
81.8; 75.8; 60.6; 51.5; 51.5; 36.4 | — |
| PRIMARY Percentage of Patients With Post-vaccination Strain-specific HAI Antibody Titer ≥ 40 |
100; 100; 97; 100; 100; 97.0 | — |
| PRIMARY Percentage of Patients With Post-vaccination Strain-specific MN Antibody Titer ≥ 40 |
100; 93.9; 93.9; 97; 97; 100 | — |
| SECONDARY Serum Tezepelumab Concentrations |
NA; 27.00; 20.76; 2.79 | — |
| SECONDARY Immunogenicity |
0; 4; 0; 0; 0; 0 | — |
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.
Data sourced from ClinicalTrials.gov (NCT05062759) and the linked publication. 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.