NCT04826770|Unknown
Adaptive Immune Response to COVID-19 Vaccination
AICOVI
Blood Donations From Healthy Probands for the Study of the Adaptive Immune Response to COVID-19 Vaccination (AICOVI)
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AICOVI
Blood Donations From Healthy Probands for the Study of the Adaptive Immune Response to COVID-19 Vaccination (AICOVI)
Sponsor study identifier
observational
70
1 country
1
Study Start
January 6, 2021
Actual (reported)Primary Completion
December 13, 2021
Actual (reported)Study Completion
December 31, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 31, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 6, 2021
Actual (reported)March 22, 2021
Actual (reported)April 1, 2021
Actual (reported)December 13, 2021
Actual (reported)December 31, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
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.
7 days after the 1st vaccination
plasma antibody levels against SARS-CoV-2
On each day of vaccination as well as 7 and 14 days after each vaccination
immune cell phenotyping (B cells, T cells)
On each day of vaccination as well as 7 and 14 days after each vaccination
Characterization of antibody proteomics profile changes after vaccination
On each day of vaccination as well as 7 and 14 days after each vaccination
Characterization of the cytokine profile elicited after vaccination
On each day of vaccination as well as 7 and 14 days after each vaccination
Measurement of neutralizating antibodies after vaccination
On each day of vaccination as well as 7 and 14 days after each vaccination
Subjects receiving two doses of BNT162b2 (Comirnaty®, tozinameran (INN), BioNTech/Pfizer) as homologous basic immunization and one dose of BNT162b2 as booster vaccination
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
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
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
Employees at the University Medicine Greifswald, Germany, who plan to be vaccinated against COVID-19
University Medicine Greifswald
Greifswald, Mecklenburg-Vorpommern, 17475, Germany
EDTA plasma, peripheral blood mononuclear cells
Barbara M. Bröker, Prof. Dr.
University Medicine Greifswald, Dept. of Immunology
70 participants (actual enrollment reported by the registry).
First Submitted
March 22, 2021
First Posted
April 1, 2021
Study Start
January 6, 2021
Actual (reported)COVID-19 Fourth Dose Study in Australia
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.
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.
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.
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.
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
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 booster vaccination.
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.
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.
14 days after the booster vaccination
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
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.
vaccination against COVID-19
Contact the study team to confirm eligibility.
Primary Completion
December 13, 2021
Actual (reported)Study Completion
December 31, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
October 3, 2023
Record last verified: 2023-10
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Source: ClinicalTrials.gov.
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