Clinical trial NCT05129436: Adaptive Immune Response to Seasonal Influenza Vaccination (AIGI)
Official title: Blood Donations From Healthy Volunteers for the Study of the Adaptive Immune Response to Seasonal Influenza Vaccination (AIGI)
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Seasonal Influenza Vaccination
Keywords: vaccine
vaccination
seasonal influenza
influenza
immune response
immunokinetics
Lead sponsor: University Medicine Greifswald
Sponsor class: OTHER
First posted: 2021-11-22
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Employees at the University Medicine Greifswald, Germany, who plan to be vaccinated against seasonal influenza

Brief summary: AIGI (Adaptive Immune Response to Seasonal Influenza Vaccination) is a prospective clinical study aiming at studying the kinetics of vaccine-specific antibody production after seasonal influenza vaccination in health care workers.

Detailed description: AIGI (Adaptive Immune Response to Seasonal Influenza Vaccination) is a prospective clinical study aiming at elucidating the kinetics of vaccine-specific antibody production after seasonal Influenza vaccination in health care workers at the Greifswald University hospital. Participants were recruited before their intended vaccination.

Participants received the influenza vaccine Vaxigrip Tetra 2020/2021 by Sanofi Pasteur Europe.

Within the study, volunteers donate peripheral blood by venipuncture on the day of vaccination as well as 7 and 14 days after vaccination. EDTA plasma and peripheral mononuclear cells (PBMCs) are prepared and stored at -20 °C.

Volunteers are also asked to complete a standardized questionnaire on each day of blood sampling. Questionnaires collect data about physical characteristics, seasonal influenza vaccinations, current infections, medication, immune relevant diseases and side effects of the vaccination.

Eligibility criteria: Inclusion Criteria:

* Planned participation in seasonal influenza vaccination
* Completion of the 18th year of life
* verbal and written consent given

Exclusion Criteria:

* current infectious diseases
* underweight (BMI\<18,5)
* blood coagulation disorders, anemia or similar diseases
* known congenital or acquired immunodeficiencies

Primary outcomes:
measure: mean current anti-influenza antibody production and cumulative antibody titer on the day of the vaccination
timeFrame: 1 day
measure: mean current anti-influenza antibody production 7 days after the vaccination
timeFrame: 7 days after the vaccination
measure: mean current anti-influenza antibody production 14 days after the vaccination
timeFrame: 14 days after the vaccination
Secondary outcomes:
measure: plasma antibody levels against seasonal influenza
timeFrame: 3 weeks
measure: immune cell phenotyping (B cells, T cells)
timeFrame: 3 weeks
Other outcomes:
Locations:
city: Greifswald
country: Germany
facility: University Medicine Greifswald
state: MV
Study officials:
affiliation: University Medicine Greifswald, Dept. of Immunology
name: Barbara M. Bröker, Prof. Dr.
role: STUDY_CHAIR
References: