Adaptive Immune Response to Seasonal Influenza Vaccination (AIGI)

Study Overview
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Brief Summary
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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
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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.

Official Title
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Blood Donations From Healthy Volunteers for the Study of the Adaptive Immune Response to Seasonal Influenza Vaccination (AIGI)

Conditions
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Seasonal Influenza Vaccination

Intervention / Treatment
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* Drug: Vaxigrip Tetra 2020/2021


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Establishment of method<br>healthy volunteers who are asked to donate peripheral blood for the establishment of the method | |
| Influenza vaccination<br>Subjects receiving the influenza vaccine Vaxigrip Tetra 2020/2021 by Sanofi Pasteur Europe. | Drug: Vaxigrip Tetra 2020/2021<br>* vaccine against seasonal influenza<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mean current anti-influenza antibody production and cumulative antibody titer on the day of the vaccination | Serum antibody titers represent a cumulative measure of any preceded or recent immune responses. The current antibody production can be quantified using MENSA (medium enriched for newly synthesized antibodies), an approach that measures antibodies released from recently stimulated circulating antibody-secreting plasmablasts. For this purpose PBMCs are collected from the subject's whole blood sample, washed to remove serum antibodies, and then cultured for 7 days. Antibodies released ex vivo from the antibody-secreting plasmablasts can now be detected in the culture supernatant. These newly synthesized antibodies are a measure of the instantaneous antibody response. Sampling is conducted on the day of the vaccination. | 1 day | 
| mean current anti-influenza antibody production 7 days after the vaccination | Serum antibody titers represent a cumulative measure of any preceded or recent immune responses. The current antibody production can be quantified using MENSA (medium enriched for newly synthesized antibodies), an approach that measures antibodies released from recently stimulated circulating antibody-secreting plasmablasts. For this purpose, PBMCs are collected from the subject's whole blood sample, washed to remove serum antibodies, and then cultured for 7 days. Antibodies released ex vivo from the antibody-secreting plasmablasts can now be detected in the culture supernatant. These newly synthesized antibodies are a measure of the instantaneous antibody response. Sampling is conducted 7 days after the vaccination. | 7 days after the vaccination | 
| mean current anti-influenza antibody production 14 days after the vaccination | Serum antibody titers represent a cumulative measure of any preceded or recent immune responses. The current antibody production can be quantified using MENSA (medium enriched for newly synthesized antibodies), an approach that measures antibodies released from recently stimulated circulating antibody-secreting plasmablasts. For this purpose, PBMCs are collected from the subject's whole blood sample, washed to remove serum antibodies, and then cultured for 7 days. Antibodies released ex vivo from the antibody-secreting plasmablasts can now be detected in the culture supernatant. These newly synthesized antibodies are a measure of the instantaneous antibody response. Sampling is conducted 14 days after the vaccination. | 14 days after the vaccination | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| plasma antibody levels against seasonal influenza | anti-influenza antibodies are quantified using ELISA | 3 weeks | 
| immune cell phenotyping (B cells, T cells) | flow cytometry-based analyses | 3 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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vaccine, vaccination, seasonal influenza, influenza, immune response, immunokinetics