Seasonal Influenza Vaccination
Conditions
Keywords
vaccine, vaccination, seasonal influenza, influenza, immune response, immunokinetics
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.
Interventions
DRUGVaxigrip Tetra 2020/2021
vaccine against seasonal influenza
Sponsors
University Medicine Greifswald
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| mean current anti-influenza antibody production and cumulative antibody titer on the day of the vaccination | 1 day | 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. |
| mean current anti-influenza antibody production 7 days after the vaccination | 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. |
| mean current anti-influenza antibody production 14 days after the vaccination | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| plasma antibody levels against seasonal influenza | 3 weeks | anti-influenza antibodies are quantified using ELISA |
| immune cell phenotyping (B cells, T cells) | 3 weeks | flow cytometry-based analyses |
Countries
Germany
Outcome results
None listed