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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Establishment of method | healthy volunteers who are asked to donate peripheral blood for the establishment of the method | ||
| Influenza vaccination | Subjects receiving the influenza vaccine Vaxigrip Tetra 2020/2021 by Sanofi Pasteur Europe. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vaxigrip Tetra 2020/2021 | Drug | vaccine against seasonal influenza |
|
| 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. |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Employees at the University Medicine Greifswald, Germany, who plan to be vaccinated against seasonal influenza
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| Name | Affiliation | Role |
|---|---|---|
| Barbara M. Bröker, Prof. Dr. | University Medicine Greifswald, Dept. of Immunology | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Medicine Greifswald | Greifswald | Mecklenburg-Vorpommern | 17475 | Germany |
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| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
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EDTA plasma, peripheral blood mononuclear cells
| 14 days after the vaccination |
| 3 weeks |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |