Adaptive Immune Response to COVID-19 Vaccination (AICOVI)

University Medicine Greifswald

Status: Active, not recruiting

Conditions: SARS-CoV-2 Vaccination

Treatments: Drug: AZD 1222; Drug: BNT162b2; Drug: mRNA-1273

Study type: Observational

Funder types: Other

Identifiers

NCT04826770

BB 001/21f

Details and patient eligibility

About

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.

Full 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.

Enrollment: 70 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

70 participants in 6 patient groups

BNT/BNT/BNT

Description:

Subjects receiving two doses of BNT162b2 (Comirnaty®, tozinameran (INN), BioNTech/Pfizer) as homologous basic immunization and one dose of BNT162b2 as booster vaccination

Treatment:

Drug: BNT162b2

AZD/BNT/BNT

Description:

Subjects receiving one dose of AZD 1222 (Vaxzevria®, Covishield®, ChadOx1 nCoV-19, Oxford University/Astra-Zeneca) followed by one dose of BNT162b2 (Comirnaty®, tozinameran (INN), BioNTech/Pfizer) as heterologous basic immunization and one dose of BNT162b2 (Comirnaty®, tozinameran (INN), BioNTech/Pfizer) as booster vaccination

Treatment:

Drug: BNT162b2

Drug: AZD 1222

AZD/AZD/BNT

Description:

Subjects receiving two doses of AZD 1222 (Vaxzevria®, Covishield®, ChadOx1 nCoV-19, Oxford University/Astra-Zeneca) as homologous basic immunization and one dose of BNT162b2 (Comirnaty®, tozinameran (INN), BioNTech/Pfizer) as booster vaccination

Treatment:

Drug: BNT162b2

Drug: AZD 1222

AZD/MOD/BNT

Description:

Subject receiving one dose of AZD 1222 (Vaxzevria®, Covishield®, ChadOx1 nCoV-19, Oxford University/Astra-Zeneca) followed by one dose of mRNA-1273 (Spikevax®, elasomeran (INN), Moderna) as heterologous basic immunization and one dose of BNT162b2 (Comirnaty®, tozinameran (INN), BioNTech/Pfizer) as booster vaccination

Treatment:

Drug: mRNA-1273

Drug: BNT162b2

Drug: AZD 1222

AZD/BNT/MOD

Description:

Subject receiving one dose of AZD 1222 (Vaxzevria®, Covishield®, ChadOx1 nCoV-19, Oxford University/Astra-Zeneca) followed by one dose of BNT162b2 (Comirnaty®, tozinameran (INN), BioNTech/Pfizer) as heterologous basic immunization and one dose of mRNA-1273 (Spikevax®, elasomeran (INN), Moderna) as booster vaccination

Treatment:

Drug: mRNA-1273

Drug: BNT162b2

Drug: AZD 1222

Control/validation group

Description:

Control samples for the validation of the used methods from the pre-SARS-CoV-2 era were transferred from the study "Blood Donations from Healthy Blood Donors to Investigate Circannual Variations in Tryptophan Metabolism and Adaptive Immune Response to Bacterial Infectious Agents" (in short TRP study). Subjects had not received any SARS-CoV-2 vaccination at that time. Remaining plasma samples were transferred to the AICOVI study.