Adaptive Immune Response to COVID-19 Vaccination

NCT04826770 | Unknown

• 1 other identifier: BB 001/21f
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

SARS-CoV-2 Vaccination

Keywords

vaccine; vaccination; SARS-CoV-2; COVID-19; immune response; immunokinetics

Outcome Measures

Primary Outcomes (9)

• 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

• 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

Secondary Outcomes (5)

• 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

Study Arms (6)

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

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

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

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

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

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.

Interventions

BNT162b2 DRUG

vaccination against COVID-19

Also known as: Comirnaty®, tozinameran

AZD/AZD/BNT; AZD/BNT/BNT; AZD/BNT/MOD; AZD/MOD/BNT; BNT/BNT/BNT

AZD 1222 DRUG

vaccination against COVID-19

Also known as: Vaxzevria®, Covishield®, ChadOx1 nCoV-19

AZD/AZD/BNT; AZD/BNT/BNT; AZD/BNT/MOD; AZD/MOD/BNT

mRNA-1273 DRUG

vaccination against COVID-19

Also known as: Spikevax®, elasomeran

AZD/BNT/MOD; AZD/MOD/BNT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Employees at the University Medicine Greifswald, Germany, who plan to be vaccinated against COVID-19

You may qualify if:

• Planned participation in COVID-19 vaccination
• Completion of the 18th year of life
• verbal and written consent given

You may not qualify if:

• current infectious diseases
• underweight (BMI\<18,5)
• blood coagulation disorders, anemia or similar diseases
• known congenital or acquired immunodeficiencies
• informed written consent

Sponsors & Collaborators

• University Medicine Greifswald: lead

Study Sites (1)

University Medicine Greifswald

Greifswald, Mecklenburg-Vorpommern, 17475, Germany

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

EDTA plasma, peripheral blood mononuclear cells

MeSH Terms

Conditions

COVID-19

Interventions

BNT162 Vaccine; ChAdOx1 nCoV-19; 2019-nCoV Vaccine mRNA-1273

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

mRNA Vaccines; Nucleic Acid-Based Vaccines; Vaccines, Synthetic; Recombinant Proteins; Proteins; Amino Acids, Peptides, and Proteins; Vaccines; Biological Products; Complex Mixtures; COVID-19 Vaccines; Viral Vaccines; Antigens; Biological Factors; Vaccines, DNA

Study Officials

• Barbara M. Bröker, Prof. Dr.

  University Medicine Greifswald, Dept. of Immunology

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 22, 2021
• First Posted: April 1, 2021
• Study Start: January 6, 2021
• Primary Completion: December 13, 2021
• Study Completion: December 31, 2023
• Last Updated: October 3, 2023

Record last verified: 2023-10

Locations

DE (1)