Official Title
Blood Donations From Healthy Probands for the Study of the Adaptive Immune Response to COVID-19 Vaccination (AICOVI)
Brief Summary

AICOVI (Adaptive Immune Response to COVID-19 Vaccination) is a prospective clinicalcohort study aiming at studying the kinetics of vaccine-specific antibody productionafter COVID-19 vaccination in health care workers.

Detailed Description

AICOVI (Adaptive Immune Response to COVID-19 Vaccination) is a prospective clinical
cohort study aiming at elucidating the kinetics of vaccine-specific antibody production
after COVID-19 vaccination in health care workers at the Greifswald University hospital.

Participants were recruited before their intended vaccination. Participants received the
basic immunization with either two i. m. doses of BNT162b2 (Comirnaty®, tozinameran
(INN), BioNTech/Pfizer) with a time interval of 21 days or two i. m. dose of AZD 1222
(Vaxzevria®, Covishield®, ChadOx1 nCoV-19, Oxford University/Astra-Zeneca) with a time
interval of 12 weeks (homologous vaccination), or one i. m. dose of AZD 1222 as the first
vaccination and one i. m. dose of BNT162b2 or mRNA-1273 (Spikevax®, elasomeran (INN),
Moderna) as the second vaccination with a time interval of at least 4 weeks (heterologous
vaccination). Approximately 6 months later, participants received a booster vaccination
with BNT162b2.

Within the study, volunteers donate peripheral blood by venipuncture on each day of
vaccination as well as 7 and 14 days after each 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, COVID-19
vaccination, previous SARS-CoV-2 infection as well as current infections, medication,
immune relevant diseases and side effects of the vaccination.

Active, not recruiting
SARS-CoV-2 Vaccination

Drug: BNT162b2

vaccination against COVID-19
Other Name: Comirnaty®,tozinameran

Drug: AZD 1222

vaccination against COVID-19
Other Name: Vaxzevria®,Covishield®,ChadOx1 nCoV-19

Drug: mRNA-1273

vaccination against COVID-19
Other Name: Spikevax®,elasomeran

Eligibility Criteria

Inclusion Criteria:

- Planned participation in COVID-19 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

Inclusion criteria for control/validation group of TRP participants:

- informed written consent

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
Germany
Locations

University Medicine Greifswald
Greifswald, MV, Germany

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

University Medicine Greifswald
NCT Number
Keywords
Vaccine
Vaccination
SARS-CoV-2
Covid-19
immune response
immunokinetics
MeSH Terms
COVID-19