Vaccine Pandemic Preparedness Through Airway Immunology Characterization
Denmark60 participantsStarted 2025-05-19
Plain-language 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.
Who can participate
Age range18 Years – 49 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Healthy individuals (Charlson´s co-morbidity index :0, and investigator judged as healthy)
✓. Age: 18-49 years
✓. Total IgG levels in normal range (discretion of investigator according to local lab)
✓. Total IgA levels (discretion of investigator according to local lab)
✓. Undetectable HAI titres to the H3N2 component of the vaccines\*
✓. Normal CD4+ and CD8+ T-cell and normal B-cell counts
✓. Reference levels from ISO-15189 accredited T-, B- and NK-cell count routine analyses will be applied.
Exclusion criteria
✕. Laboratory-confirmed influenza infection during the past year documented by a positive PCR test in the Danish Microbiological database or anamnestic reported influenza infection in the same period
✕. Active smoker
✕. BMI \> 35 kg/m2
✕. Women of childbearing potential not using safe contraception, or who are pregnant, or breast-feeding
✕. Any allergies to components of or contraindication for Vaxigriptetra® or Flumist® incl. previous severe adverse reactions to influenza vaccinations or components of the vaccines
✕
What they're measuring
1
Day 28, mucosal immunity in nasopharynx (humoral)
Timeframe: Day -14 (baseline) [+/-5 days] vs. day +28 [+/-5 days]