Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
70 participants
OBSERVATIONAL
2021-01-06
2023-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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BNT/BNT/BNT
Subjects receiving two doses of BNT162b2 (Comirnaty®, tozinameran (INN), BioNTech/Pfizer) as homologous basic immunization and one dose of BNT162b2 as booster vaccination
BNT162b2
vaccination against COVID-19
AZD/BNT/BNT
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
BNT162b2
vaccination against COVID-19
AZD 1222
vaccination against COVID-19
AZD/AZD/BNT
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
BNT162b2
vaccination against COVID-19
AZD 1222
vaccination against COVID-19
AZD/MOD/BNT
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
BNT162b2
vaccination against COVID-19
AZD 1222
vaccination against COVID-19
mRNA-1273
vaccination against COVID-19
AZD/BNT/MOD
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
BNT162b2
vaccination against COVID-19
AZD 1222
vaccination against COVID-19
mRNA-1273
vaccination against COVID-19
Control/validation group
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.
No interventions assigned to this group
Interventions
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BNT162b2
vaccination against COVID-19
AZD 1222
vaccination against COVID-19
mRNA-1273
vaccination against COVID-19
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Completion of the 18th year of life
* verbal and written consent given
* informed written consent
Exclusion Criteria
* underweight (BMI\<18,5)
* blood coagulation disorders, anemia or similar diseases
* known congenital or acquired immunodeficiencies
18 Years
ALL
Yes
Sponsors
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University Medicine Greifswald
OTHER
Responsible Party
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Principal Investigators
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Barbara M. Bröker, Prof. Dr.
Role: STUDY_CHAIR
University Medicine Greifswald, Dept. of Immunology
Locations
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University Medicine Greifswald
Greifswald, Mecklenburg-Vorpommern, Germany
Countries
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Other Identifiers
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BB 001/21f
Identifier Type: -
Identifier Source: org_study_id
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