NCT05921448

Vaccine Pandemic Preparedness Through Airway Immunology Characterization

In-depth Immunological Analysis of Airway Immunity Following Nasal Live Attenuated and Intramuscular Influenza Vaccine

• Status: Active Not Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Copenhagen Respiratory Research · Network
• Sex: All
• Age: 18 Years – 49 Years
• Healthy volunteers: Accepted

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.

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 'intramuscular-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 18-49 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.

Conditions

• Influenza, Human

Interventions

Type	Name	Description
BIOLOGICAL	Vaxigripetra	Tetravalent intramuscular vaccine. Mechanism of action: The vaccine induces an immune reaction involving antibody production.
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).

Timeline

• Start date: 2025-05-19
• Primary completion: 2026-07-27
• Completion: 2026-07-27
• First posted: 2023-06-27
• Last updated: 2026-03-25

Locations

7 sites across 2 countries: Denmark, United Kingdom