Vaccine Pandemic Preparedness Through Airway Immunology Characterization
Denmark, United Kingdom60 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 range
18 Years – 49 Years
Sex
ALL
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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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Day 28, mucosal immunity in nasopharynx (humoral)
Timeframe: Day -14 (baseline) [+/-5 days] vs. day +28 [+/-5 days]
. 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
. Use of immunosuppressive drugs\* within the past 6 months or who are currently using them
. HIV, HBV, HCV laboratory confirmed active infection at screening visit
. Have an acute illness, including an oral temperature ≥ 38°C, within 3 days prior to vaccination