Study to Assess the Effect of Tezepelumab on the Immune Response to Influenza Vaccination in Participants With Asthma
VECTOR
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)
1 other identifier
interventional
70
1 country
15
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Aug 2021
Shorter than P25 for phase_3
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 23, 2021
CompletedStudy Start
First participant enrolled
August 23, 2021
CompletedFirst Posted
Study publicly available on registry
September 30, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 21, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
July 18, 2022
CompletedResults Posted
Study results publicly available
April 21, 2023
CompletedJune 22, 2023
June 1, 2023
7 months
August 23, 2021
March 9, 2023
June 20, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (8)
Post-vaccination Strain-specific Hemagglutination Inhibition (HAI) Antibody Geometric Mean Fold Rises (GMFRs)
Effect of tezepelumab on the humoral immune response following seasonal influenza virus vaccination in adolescent and young adult participants with moderate to severe asthma was assessed. HAI assay was not performed for H3N2 strain due to the known low haemagglutination effect.
From Week 12 to Week 16
Post-vaccination Strain-specific Microneutralization (MN) Antibody GMFRs
Effect of tezepelumab on the humoral immune response following seasonal influenza virus vaccination in adolescent and young adult participants with moderate to severe asthma was assessed.
From Week 12 to Week 16
Post-vaccination Strain-specific Serum HAI Antibody Geometric Mean Titers (GMTs)
Effect of tezepelumab on the humoral immune response following seasonal influenza virus vaccination in adolescent and young adult participants with moderate to severe asthma was assessed. HAI assay was not performed for H3N2 strain due to the known low haemagglutination effect.
Week 16
Post-vaccination Strain-specific Serum MN Antibody GMTs
Effect of tezepelumab on the humoral immune response following seasonal influenza virus vaccination in adolescent and young adult participants with moderate to severe asthma was assessed.
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
Effect of tezepelumab on the humoral immune response following seasonal influenza virus vaccination in adolescent and young adult participants with moderate to severe asthma was assessed. HAI assay was not performed for H3N2 strain due to the known low haemagglutination effect.
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
Effect of tezepelumab on the humoral immune response following seasonal influenza virus vaccination in adolescent and young adult participants with moderate to severe asthma was assessed. Vaccine immunogenicity analysis set consisted of all randomised patients who received the influenza vaccine plus at least 1 dose of tezepelumab or placebo, had pre and post vaccination HAI or MN antibody measurements, had no influenza infection prior to Visit 7 (Week 16), and had no protocol deviation, judged to have the potential to interfere with the generation or interpretation of an antibody response.
Week 16
Percentage of Patients With Post-vaccination Strain-specific HAI Antibody Titer ≥ 40
Effect of tezepelumab on the humoral immune response following seasonal influenza virus vaccination in adolescent and young adult participants with moderate to severe asthma was assessed. HAI assay was not performed for H3N2 strain due to the known low haemagglutination effect.
Week 16
Percentage of Patients With Post-vaccination Strain-specific MN Antibody Titer ≥ 40
Effect of tezepelumab on the humoral immune response following seasonal influenza virus vaccination in adolescent and young adult participants with moderate to severe asthma was assessed.
Week 16
Secondary Outcomes (2)
Serum Tezepelumab Concentrations
Week 0, Week 12, Week 16 and Week 28
Immunogenicity
From Baseline to Week 28
Study Arms (2)
Tezepelumab
EXPERIMENTALParticipants will be randomized to receive tezepelumab 210 mg administered at Weeks 0, 4, 8 and 12. Participants will also receive a single dose of inactivated quadrivalent seasonal influenza vaccine intramuscularly at Week 12, prior to the fourth dose of study intervention.
Placebo to Tezepelumab
PLACEBO COMPARATORParticipants will be randomized to receive placebo SC Q4W, administered at Weeks 0, 4, 8 and 12. Participants will also receive a single dose of inactivated quadrivalent seasonal influenza vaccine intramuscularly at Week 12, prior to the fourth dose of study intervention.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
- Amgencollaborator
Study Sites (15)
Research Site
Bakersfield, California, 93301, United States
Research Site
Huntington Beach, California, 92647, United States
Research Site
Miami, Florida, 33133, United States
Research Site
Columbia, Missouri, 65203, United States
Research Site
Northfield, New Jersey, 08225, United States
Research Site
Dayton, Ohio, 45406, United States
Research Site
Toledo, Ohio, 43617, United States
Research Site
Edmond, Oklahoma, 73034, United States
Research Site
Oklahoma City, Oklahoma, 73120, United States
Research Site
Dallas, Texas, 75225, United States
Research Site
San Antonio, Texas, 78229, United States
Research Site
Tyler, Texas, 75708, United States
Research Site
Waco, Texas, 76712, United States
Research Site
Salt Lake City, Utah, 84107, United States
Research Site
Milwaukee, Wisconsin, 53228, United States
Related Publications (1)
Cole J, Capala-Szczurko I, Roseti S, Chen C, Caveney S, Aksyuk AA, Streicher K, Ponnarambil S, Colice G. 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. Pulm Ther. 2024 Mar;10(1):53-67. doi: 10.1007/s41030-023-00245-9. Epub 2023 Dec 8.
PMID: 38064153DERIVED
Related Links
MeSH Terms
Interventions
Results Point of Contact
- Title
- Global Clinical Head
- Organization
- AstraZeneca Clinical Study Information Center
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Masking Details
- Neither the participant nor any of the investigators or sponsor staff who are involved in the treatment or clinical evaluation and monitoring of the participants will be aware of the treatment received. Since tezepelumab and placebo are not visually distinct, study intervention will be handled by a qualified person (eg, pharmacist or study nurse) at the site.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 23, 2021
First Posted
September 30, 2021
Study Start
August 23, 2021
Primary Completion
March 21, 2022
Study Completion
July 18, 2022
Last Updated
June 22, 2023
Results First Posted
April 21, 2023
Record last verified: 2023-06
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please refer to our disclosure commitment at: https://astrazenecagrouptrials.pharmacm.com /ST/Submission/Disclosure.
- Access Criteria
- When a request has been approved AstraZeneca will provide access to the de-identified individual patient level data in an approved sponsored tool. Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at: https://astrazenecagrouptrials.pharmacm.com /ST/Submission/Disclosure.
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com /ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.