VAXXAIR: Vaccine Pandemic Preparedness Through Airway Immunological Characterization
Study Details
Study Description
Brief Summary
The study aims to compare the effectiveness of live attenuated influenza vaccines (LAIV) and injected-inactivated vaccines (IIV) in healthy individuals aged 20-40. It will investigate cellular and humoral responses, identify immunological markers for targeted vaccine improvement, and establish a collaborative platform for accelerated immunological and clinical vaccine research.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Early Phase 1 |
Detailed Description
There are several types of vaccines and the focus on the important role of vaccines in health has increased after the SARS-CoV-2 pandemic. Therefore, it is desired to investigate whether so-called 'live attenuated influenza vaccines' (LAIV) can prove more effective than the most frequently used 'injected-inactivated vaccines' (IIV).
Several studies have previously compared the humoral and cellular response to LAIV and IIV and some of these have shown that LAIV elicits a more robust cellular response than intramuscularly administered vaccines.
In the study, the immunological differences in cellular and humoral response following vaccination either intramuscularly or nasally will be characterized. The patient group will consist of healthy individuals between 20-40 years of age. It is further desired to identify immunological markers that vaccines can be directed against in order to improve the immunological response. Finally, a platform for collaboration on accelerated immunological and clinical vaccine research will be established.
The study is a randomized, double-blind, placebo-controlled study. It is carried out in several locations and is Good Clinical Practice monitored.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Vaxigripetra This arm will receive 1 dose of 0.5 mL Vaxigripetra (intra-muscular injection) and 1 dose of 0.2 mL placebo (nasal, 1 spray in each nostril). |
Biological: Vaxigripetra
Tetravalent intramuscular vaccine. Mechanism of action: The vaccine induces an immune reaction involving antibody production.
|
| Experimental: Flumist This arm will receive 1 dose of 0.5 mL placebo (intra-muscular injection) and 1 dose of 0.2 mL Flumist (nasal, 1 spray in each nostril). |
Biological: Flumist
Tetravalent live attenuated influenza vaccine administered as a nasal spray. Mechanism of action: Not fully understood according to the prescribing information, but may involve influenza-specific T-cells and antibodies (serum and mucosal).
|
Outcome Measures
Primary Outcome Measures
- Antigen activated CD4+ T-lymphocytes [2 years]
Cellular
- HAI-specific IgG [2 years]
Humoral
Eligibility Criteria
Criteria
Inclusion Criteria:
- Participants who have not received any influenza vaccines as per medical history and documented in The Danish Vaccine Registry(DDV)
Exclusion Criteria:
-
Laboratory-confirmed influenza infection during the past year documented by a positive PCR test in the Danish Microbiological database
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Total IgG levels < 6.1 g/L obtaining at screening visit
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HAI IgG in upper quartile (defined in Danish Blood donors in same age group)
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Active smoker
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BMI > 35
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Charlson (score > 0)
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Women of childbearing potential not using safe contraception, or who are pregnant, or breast-feeding
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Any allergies to components of or contraindication for Vaxigriptetra® or Flumist®
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Participants who have experienced severe adverse reactions to previous influenza vaccinations or components of the vaccines, including allergy to egg
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Use of immunosuppressive drugs1 within the past 6 months or who are currently using them
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Known immunodeficiency disorders [any diagnosis that would qualify to an ICD-10 diagnosis in the categories DD80-DD89 (except DD86)
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HIV, HBV, HCV laboratory-confirmed active infection at screening visit
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Subject having an acute illness, including an oral temperature ≥ 38°C, within 3 days prior to vaccination
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Have received any vaccines, including live-attenuated vaccines within 4 weeks before inclusion, or plan receipt of such vaccines within 30 days following the inclusion
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Any known malignant neoplasm within 5 years (except basal carcinoma of the skin).
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Severe mental illness or linguistic issues which significantly impedes cooperation
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Inability to provide written informed consent
-
Previous medical history, evidence of an intercurrent illness or any condition that, in the opinion of the investigator, would interfere with evaluation of the study vaccine products or interpretation of subject safety or that may compromise the safety of the subject in the study.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Department of Medicine, Section of Respiratory Medicine, Herlev and Gentofte Hospital | Gentofte | Copenhagen | Denmark | 2900 |
| 2 | Copenhagen Hospital Biobank Unit, Department of Clinical Immunology, Rigshospitalet, Denmark | Copenhagen | Denmark | 2100 | |
| 3 | CPR-CT, department of cardiology, Herlev-Gentofte Hospital | Copenhagen | Denmark | 2100 | |
| 4 | Diagnostic Immunology, Department of Clinical Immunology, Rigshospitalet, Denmark | Copenhagen | Denmark | 2100 | |
| 5 | Institute for Immunology and Microbiology (ISIM), Panum Institute, University of Copenhagen | Copenhagen | Denmark | 2100 | |
| 6 | Department of Respiratory and Infectious Medicine, North Zealand Hospital | Hillerød | Denmark | 3400 |
Sponsors and Collaborators
- Chronic Obstructive Pulmonary Disease Trial Network, Denmark
- The Novo Nordic Foundation
Investigators
- Principal Investigator: Jens-Ulrik Stæhr Jensen, MD, PhD, Chronic Obstructive Pulmonary Disease Trial Network, Denmark
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- VAXXAIR