Adaptive Immune Response to Seasonal Influenza Vaccination (AIGI)

NCT ID: NCT05129436

Last Updated: 2023-10-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-10-10

Study Completion Date

2023-12-31

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.

Conditions

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Seasonal Influenza Vaccination

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Establishment of method

healthy volunteers who are asked to donate peripheral blood for the establishment of the method

No interventions assigned to this group

Influenza vaccination

Subjects receiving the influenza vaccine Vaxigrip Tetra 2020/2021 by Sanofi Pasteur Europe.

Vaxigrip Tetra 2020/2021

Intervention Type DRUG

vaccine against seasonal influenza

Interventions

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Vaxigrip Tetra 2020/2021

vaccine against seasonal influenza

Intervention Type DRUG

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Medicine Greifswald

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Barbara M. Bröker, Prof. Dr.

Role: STUDY_CHAIR

University Medicine Greifswald, Dept. of Immunology

Locations

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University Medicine Greifswald

Greifswald, Mecklenburg-Vorpommern, Germany

Site Status

Countries

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Germany

Other Identifiers

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AIGI

Identifier Type: -

Identifier Source: org_study_id

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