Adaptive Immune Response to Seasonal Influenza Vaccination (AIGI) ((AIGI))

October 2, 2023 updated by: University Medicine Greifswald

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • MV
      • Greifswald, MV, Germany, 17475
        • University Medicine Greifswald

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Employees at the University Medicine Greifswald, Germany, who plan to be vaccinated against seasonal influenza

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Drug: Vaxigrip Tetra 2020/2021
vaccine against seasonal influenza

What is the study measuring?

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
Time Frame: 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.
1 day
mean current anti-influenza antibody production 7 days after the vaccination
Time Frame: 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
Time Frame: 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
Time Frame: 3 weeks
anti-influenza antibodies are quantified using ELISA
3 weeks
immune cell phenotyping (B cells, T cells)
Time Frame: 3 weeks
flow cytometry-based analyses
3 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Medicine Greifswald

Investigators

  • Study Chair: Barbara M. Bröker, Prof. Dr., University Medicine Greifswald, Dept. of Immunology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 10, 2020

Primary Completion (Actual)

March 31, 2021

Study Completion (Estimated)

December 31, 2023

Study Registration Dates

First Submitted

November 10, 2021

First Submitted That Met QC Criteria

November 10, 2021

First Posted (Actual)

November 22, 2021

Study Record Updates

Last Update Posted (Actual)

October 3, 2023

Last Update Submitted That Met QC Criteria

October 2, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AIGI

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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