Adaptive Immune Response to COVID-19 Vaccination

University Medicine Greifswald70 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

SARS-CoV-2 Vaccination

Interventions

BNT162b2DRUG

vaccination against COVID-19

AZD 1222DRUG

vaccination against COVID-19

mRNA-1273DRUG

vaccination against COVID-19

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

University Medicine Greifswald

Greifswald, Mecklenburg-Vorpommern, Germany

Outcomes

Primary Outcomes

mean current anti-SARS-CoV-2 antibody production and cumulative antibody titer on the day of the 1st 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 1st vaccination.

Time frame: 1 day

mean current anti-SARS-CoV-2 antibody production 7 days after the 1st 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 1st vaccination.

Time frame: 7 days after the 1st vaccination

mean current anti-SARS-CoV-2 antibody production 14 days after the 1st 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 1st vaccination.

Data from ClinicalTrials.gov

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Time frame: 14 days after the 1st vaccination

mean current anti-SARS-CoV-2 antibody production on the day of the 2nd 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 2nd vaccination.

Time frame: day of the 2nd vaccination

mean current anti-SARS-CoV-2 antibody production 7 days after the 2nd 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 2nd vaccination.

Time frame: 7 days after the 2nd vaccination

mean current anti-SARS-CoV-2 antibody production 14 days after the 2nd 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 2nd vaccination.

Time frame: 14 days after the 2nd vaccination

mean current anti-SARS-CoV-2 antibody production and cumulative antibody titer on the day of the booster vaccination

Time frame: 1 day

mean current anti-SARS-CoV-2 antibody production 7 days after the booster 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 booster vaccination.

Time frame: 7 days after the booster vaccination

mean current anti-SARS-CoV-2 antibody production 14 days after the booster 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 booster vaccination.

Time frame: 14 days after the booster vaccination