Vaccine Pandemic Preparedness Through Airway Immunology Characterization
Condition(s) studied
Investigational drug(s) / intervention(s)
Vaxigripetra: Tetravalent intramuscular vaccine. Mechanism of action: The vaccine induces an immune reaction involving antibody production.
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).
Study summary
The study aims to compare the effectiveness of live attenuated influenza vaccines (LAIV) and intramuscular-inactivated vaccines (IIV) in healthy individuals aged 18-49. 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.
Eligibility
Primary outcome measure(s)
- Day 28, mucosal immunity in nasopharynx (humoral) — Day -14 (baseline) [+/-5 days] vs. day +28 [+/-5 days]
Time point: Comparison between day -14 (baseline) \[+/-5 days\] vs. day +28 \[+/-5 days\]. Explanation: all individuals who have a ≥-4-fold rise in (A (H3N2) haemagglutinin vaccine-specific IgA in nasopharyngeal secretions will be characterized as outcome 1. All other individuals will be characterized as outcome 0. Material: Nasopharyngeal secretions Explanation: all individuals who have a ≥-4-fold rise in (A (H3N2) haemagglutinin vaccine-specific IgA in nasal secretions will be characterized as outcome 1. All other individuals will be characterized as outcome 0. Material: nasopharyngeal secretion.
Trial sites (7)
| Facility | City | Region | Status |
|---|---|---|---|
| Copenhagen Hospital Biobank Unit, Department of Clinical Immunology, Rigshospitalet, Denmark | Copenhagen | Copenhagen | |
| Diagnostic Immunology, Department of Clinical Immunology, Rigshospitalet, Denmark | Copenhagen | Copenhagen | |
| Institute for Immunology and Microbiology (ISIM), Panum Institute, University of Copenhagen | Copenhagen | Copenhagen | |
| Department of Medicine, Section of Respiratory Medicine, Herlev and Gentofte Hospital | Gentofte Municipality | Copenhagen | |
| National Influenza Center for WHO at Statens Serum Institut (SSI) | Copenhagen | Denmark | |
| Technical University of Denmark (DTU) | Kongens Lyngby | Denmark | |
| Imperial College | London | United Kingdom |
More Copenhagen Respiratory Research trials in Denmark
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05921448 on ClinicalTrials.gov ↗ ← All trials in Denmark