SARS-CoV-2 VaccinationAICOVINCT04826770
Adaptive Immune Response to COVID-19 Vaccination
An observational study of SARS-CoV-2 Vaccination, run by University Medicine Greifswald at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- SARS-CoV-2 Vaccination
- What is being tested?
- BNT162b2, AZD 1222 and mRNA-1273
- Type of treatment
- Vaccines
- How many people
- 70 participants
- Where
- 1 siteGermany
- Study dates
- 6 Jan 2021to 31 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Employees at the University Medicine Greifswald, Germany, who plan to be vaccinated against COVID-19
Who may be able to join
- Planned participation in COVID-19 vaccination
- Completion of the 18th year of life
- verbal and written consent given
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Germany1 site
University Medicine Greifswald
Greifswald, Mecklenburg-Vorpommern, 17475
About this study
Official title: Blood Donations From Healthy Probands for the Study of the Adaptive Immune Response to COVID-19 Vaccination (AICOVI)
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.
Read the 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.
- Conditions
- SARS-CoV-2 Vaccination
- Being tested
- BNT162b2, AZD 1222, mRNA-1273
- Keywords
- vaccine, vaccination, SARS-CoV-2, COVID-19, immune response, immunokinetics
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BNT162b2Drug
Also called Comirnaty®, tozinameran
vaccination against COVID-19
AZD 1222Drug
Also called Vaxzevria®, Covishield®, ChadOx1 nCoV-19
vaccination against COVID-19
mRNA-1273Drug
Also called Spikevax®, elasomeran
vaccination against COVID-19
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: BNT162b2 | |
| 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 Receives: Drug: BNT162b2; Drug: AZD 1222 | |
| 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 Receives: Drug: BNT162b2; Drug: AZD 1222 | |
| 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 Receives: Drug: BNT162b2; Drug: AZD 1222; Drug: mRNA-1273 | |
| 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 Receives: Drug: BNT162b2; Drug: AZD 1222; Drug: mRNA-1273 | |
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 14 days after the booster vaccination
Secondary outcomes (5)
plasma antibody levels against SARS-CoV-2
Anti-SARS-CoV-2 antibodies are quantified using ELISA and/or xMAP(R) technology.
Measured: On each day of vaccination as well as 7 and 14 days after each vaccination
immune cell phenotyping (B cells, T cells)
flow cytometry-based analyses
Measured: On each day of vaccination as well as 7 and 14 days after each vaccination
Characterization of antibody proteomics profile changes after vaccination
The antibody profile in plasma is assessed using mass spectrometry.
Measured: On each day of vaccination as well as 7 and 14 days after each vaccination
Characterization of the cytokine profile elicited after vaccination
The cytokine profile elicited after vaccination is assessed using a multiplex immunoassay.
Measured: On each day of vaccination as well as 7 and 14 days after each vaccination
Measurement of neutralizating antibodies after vaccination
Neutralizing antibodies are measured by neutralization tests.
Measured: On each day of vaccination as well as 7 and 14 days after each vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2021
- Study start6 Jan 2021
- Primary completion13 Dec 2021
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SARS-CoV-2 VaccinationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medicine Greifswald
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Barbara M. Bröker, Prof. Dr., Study chair, University Medicine Greifswald, Dept. of Immunology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04826770
- Sponsor's protocol ID
- BB 001/21f
- Acronym
- AICOVI
- Status last verified
- Oct 2023
- First submitted
- 22 Mar 2021
- Last updated
- 3 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blood Donations From Healthy Probands for the Study of the Adaptive Immune Response to COVID-19 Vaccination (AICOVI)
- ClinicalTrials.gov ID
- NCT04826770
- Acronym / sponsor ID
- AICOVI / BB 001/21f
- Conditions
- SARS-CoV-2 Vaccination
- Keywords
- vaccine, vaccination, SARS-CoV-2, COVID-19, immune response, immunokinetics
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (actual)
- Lead sponsor
- University Medicine GreifswaldUniversity, hospital or other
- Study start
- 6 Jan 2021 (actual)
- Primary completion
- 13 Dec 2021 (actual)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 1 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| BNT/BNT/BNT | – | Drug: BNT162b2Subjects receiving two doses of BNT162b2 (Comirnaty®, tozinameran (INN), BioNTech/Pfizer) as homologous basic immunization and one dose of BNT162b2 as booster vaccination |
| AZD/BNT/BNT | – | Drug: BNT162b2, Drug: AZD 1222Subjects 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 |
| AZD/AZD/BNT | – | Drug: BNT162b2, Drug: AZD 1222Subjects 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 |
| AZD/MOD/BNT | – | Drug: BNT162b2, Drug: AZD 1222, Drug: mRNA-1273Subject 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 |
| AZD/BNT/MOD | – | Drug: BNT162b2, Drug: AZD 1222, Drug: mRNA-1273Subject 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/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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Employees at the University Medicine Greifswald, Germany, who plan to be vaccinated against COVID-19
Key inclusion criteria (3 listed)
- Planned participation in COVID-19 vaccination
- Completion of the 18th year of life
- verbal and written consent given
Key exclusion criteria (6 listed)
- current infectious diseases
- underweight (BMI<18,5)
- blood coagulation disorders, anemia or similar diseases
- known congenital or acquired immunodeficiencies
- informed written consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BNT162b2Also: Comirnaty®, tozinameranvaccination against COVID-19 | Drug | AZD/AZD/BNT, AZD/BNT/BNT, AZD/BNT/MOD, AZD/MOD/BNT, BNT/BNT/BNT |
| AZD 1222Also: Vaxzevria®, Covishield®, ChadOx1 nCoV-19vaccination against COVID-19 | Drug | AZD/AZD/BNT, AZD/BNT/BNT, AZD/BNT/MOD, AZD/MOD/BNT |
| mRNA-1273Also: Spikevax®, elasomeranvaccination against COVID-19 | Drug | AZD/BNT/MOD, AZD/MOD/BNT |
Primary outcome
mean current anti-SARS-CoV-2 antibody production and cumulative antibody titer on the day of the 1st vaccination
Time frame: 1 day
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.
mean current anti-SARS-CoV-2 antibody production 7 days after the 1st vaccination
Time frame: 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.
mean current anti-SARS-CoV-2 antibody production 14 days after the 1st vaccination
Time frame: 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.
mean current anti-SARS-CoV-2 antibody production on the day of the 2nd vaccination
Time frame: 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.
mean current anti-SARS-CoV-2 antibody production 7 days after the 2nd vaccination
Time frame: 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.
mean current anti-SARS-CoV-2 antibody production 14 days after the 2nd vaccination
Time frame: 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.
mean current anti-SARS-CoV-2 antibody production and cumulative antibody titer on the day of the booster vaccination
Time frame: 1 day
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.
mean current anti-SARS-CoV-2 antibody production 7 days after the booster vaccination
Time frame: 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.
mean current anti-SARS-CoV-2 antibody production 14 days after the booster vaccination
Time frame: 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.
5 secondary outcomes
plasma antibody levels against SARS-CoV-2
Time frame: On each day of vaccination as well as 7 and 14 days after each vaccination
immune cell phenotyping (B cells, T cells)
Time frame: On each day of vaccination as well as 7 and 14 days after each vaccination
Characterization of antibody proteomics profile changes after vaccination
Time frame: On each day of vaccination as well as 7 and 14 days after each vaccination
Characterization of the cytokine profile elicited after vaccination
Time frame: On each day of vaccination as well as 7 and 14 days after each vaccination
Measurement of neutralizating antibodies after vaccination
Time frame: On each day of vaccination as well as 7 and 14 days after each vaccination
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Barbara M. Bröker, Prof. Dr. study chair
University Medicine Greifswald, Dept. of Immunology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of SARS-CoV-2 Vaccination, run by University Medicine Greifswald at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mean current anti-SARS-CoV-2 antibody production and cumulative antibody titer on the day of the 1st vaccination (time frame: 1 day). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2023.