Adaptive Immune Response to Seasonal Influenza Vaccination (AIGI)

Seasonal Influenza Vaccination Clinical Trial

— (AIGI)  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05129436
• Other study ID #: AIGI
• Status: Active, not recruiting
• Start date: October 10, 2020
• Est. completion date: December 31, 2023

Study information

• Verified date: October 2023
• Source: University Medicine Greifswald
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. completion date: December 31, 2023
• Est. primary completion date: March 31, 2021
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Influenza, Human
• Seasonal Influenza Vaccination

Intervention

Drug:
• Vaxigrip Tetra 2020/2021
vaccine against seasonal influenza

Locations

Country	Name	City	State
Germany	University Medicine Greifswald	Greifswald	MV

Sponsors (1)

Lead Sponsor	Collaborator
University Medicine Greifswald

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	plasma antibody levels against seasonal influenza	anti-influenza antibodies are quantified using ELISA	3 weeks
Secondary	immune cell phenotyping (B cells, T cells)	flow cytometry-based analyses	3 weeks