Clinical trial NCT04826770: Adaptive Immune Response to COVID-19 Vaccination
Official title: Blood Donations From Healthy Probands for the Study of the Adaptive Immune Response to COVID-19 Vaccination (AICOVI)
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: SARS-CoV-2 Vaccination
Keywords: vaccine
vaccination
SARS-CoV-2
COVID-19
immune response
immunokinetics
Lead sponsor: University Medicine Greifswald
Sponsor class: OTHER
First posted: 2021-04-01
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Employees at the University Medicine Greifswald, Germany, who plan to be vaccinated against COVID-19

Brief summary: AICOVI (Adaptive Immune Response to COVID-19 Vaccination) is a prospective clinical cohort study aiming at studying the kinetics of vaccine-specific antibody production after 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.

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

Primary outcomes:
measure: mean current anti-SARS-CoV-2 antibody production and cumulative antibody titer on the day of the 1st vaccination
timeFrame: 1 day
measure: mean current anti-SARS-CoV-2 antibody production 7 days after the 1st vaccination
timeFrame: 7 days after the 1st vaccination
measure: mean current anti-SARS-CoV-2 antibody production 14 days after the 1st vaccination
timeFrame: 14 days after the 1st vaccination
measure: mean current anti-SARS-CoV-2 antibody production on the day of the 2nd vaccination
timeFrame: day of the 2nd vaccination
measure: mean current anti-SARS-CoV-2 antibody production 7 days after the 2nd vaccination
timeFrame: 7 days after the 2nd vaccination
measure: mean current anti-SARS-CoV-2 antibody production 14 days after the 2nd vaccination
timeFrame: 14 days after the 2nd vaccination
measure: mean current anti-SARS-CoV-2 antibody production and cumulative antibody titer on the day of the booster vaccination
timeFrame: 1 day
measure: mean current anti-SARS-CoV-2 antibody production 7 days after the booster vaccination
timeFrame: 7 days after the booster vaccination
measure: mean current anti-SARS-CoV-2 antibody production 14 days after the booster vaccination
timeFrame: 14 days after the booster vaccination
Secondary outcomes:
measure: plasma antibody levels against SARS-CoV-2
timeFrame: On each day of vaccination as well as 7 and 14 days after each vaccination
measure: immune cell phenotyping (B cells, T cells)
timeFrame: On each day of vaccination as well as 7 and 14 days after each vaccination
measure: Characterization of antibody proteomics profile changes after vaccination
timeFrame: On each day of vaccination as well as 7 and 14 days after each vaccination
measure: Characterization of the cytokine profile elicited after vaccination
timeFrame: On each day of vaccination as well as 7 and 14 days after each vaccination
measure: Measurement of neutralizating antibodies after vaccination
timeFrame: On each day of vaccination as well as 7 and 14 days after each vaccination
Other outcomes:
Locations:
city: Greifswald
country: Germany
facility: University Medicine Greifswald
state: MV
Study officials:
affiliation: University Medicine Greifswald, Dept. of Immunology
name: Barbara M. Bröker, Prof. Dr.
role: STUDY_CHAIR
References: