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
Sex
ALL
Min age
18 Years
Max age
49 Years
Healthy volunteers
Accepted
Inclusion Criteria:
1. Healthy individuals (Charlson´s co-morbidity index :0, and investigator judged as healthy)
2. Age: 18-49 years
3. Total IgG levels in normal range (discretion of investigator according to local lab)
4. Total IgA levels (discretion of investigator according to local lab)
5. Undetectable HAI titres to the H3N2 component of the vaccines\*
6. Normal CD4+ and CD8+ T-cell and normal B-cell counts
7. Reference levels from ISO-15189 accredited T-, B- and NK-cell count routine analyses will be applied.
* If \<20% of the first 100 screened persons apply to this criterion, this will be changed to a specific cut off based on the lowest quartile level of HAI titres to the H3N2 component of these 100 screened persons.
Exclusion Criteria:
1. 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
2. Active smoker
3. BMI \> 35 kg/m2
4. Women of childbearing potential not using safe contraception, or who are pregnant, or breast-feeding
5. Any allergies to components of or contraindication for Vaxigriptetra® or Flumist® incl. previous severe adverse reactions to influenza vaccinations or components of the vaccines
6. Use of immunosuppressive drugs\* within the past 6 months or who are currently using them
7. HIV, HBV, HCV laboratory confirmed active infection at screening visit
8. Have an acute illness, including an oral temperature ≥ 38°C, within 3 days prior to vaccination
9. 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
10. Any known malignant neoplasm within 5 years (except basal carcinoma of the skin).
11. Severe mental illness or linguistic issues which significantly impedes cooperation
12. Inability to provide written informed consent
* defined as: Azathioprin, methotrexate, cyclophosphamide, basiliximab, belimumab, anifrolumab, alemtuzumab, rituximab, mycophenolat, calcineurin inhibitors (ciclosporin, voclosporin and tacrolimus), mTOR inhibitors (everolimus and sirolimus), prednisolone (or any corticosteroid in doses above the equivalent of 5 mg prednisolone), TNF-α inhibitors (such as infliximab), anti-thymocyte globulin.
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.
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