SARS-CoV-2 Antibodies and Virus Neutralisation in a Cohort Vaccinted Against COVID-19 (DER-CoV2-001)

Kinetics and Stability of Anti-SARS-CoV-2 Antibodies and Virus Neutralization After COVID-19 Vaccination in a Swiss Cohort

Analysis of SARS-CoV-2 antibodies and serum virus neutralisation in vaccinated heath care personnel. Analysis of virus neutralisation as a function of age, gender, and history of COVID-19 infection.

Study Overview

• Status: Completed
• Conditions: Vaccine Reaction
• Intervention / Treatment: Procedure: Venous bleeding

Detailed Description

This study is an observational study with subsequent use of coded biological material. Sera of Universitiy Hospital of Zurich (USZ) personnel vaccinated with BNT162b2 (BioNTech/Pfizer) was analyzed for SARS-CoV-2 specific antibodies and virus neutralization.

Serum was analysed for virus-specific IgG and IgA using ELISA kits from Euroimmun (Kriens, Switzerland) according to the manufacturer's instruction. IgG was determined with the quantitative Anti-SARS-CoV-2 Quantivac kit and IgA was determined with the semi-quantitative Anti-SARS-CoV-2 kit The kits determine antibodies against the spike-1 protein. The sera were not diluted and not heat-inactivated prior to testing. The developed 96-well plates were analysed by reading absorbance at 450 nm using an ELx808 ELISA reader from BioTek Instr. Inc.

In addition, a SARS-CoV-2 neutralization assay was developed at the department. In this Tissue Culture Infection Dose (TCID) assay, Vero cells were infected with live SARS-CoV-2, and sera were added at various dilutions to test the potential to neutralize viral infection. The assay was conducted in a biosafety level 3 lab. Briefly, VERO-E6 cells were grown overnight to ca. 80-90% adherence in flat-bottom 96-well cell culture plates. The SARS-CoV-2 was then mixed in round-bottom 96 well titre plates with 2-fold serial dilutions of serum and incubated. The virus-serum mixture was then added to the VERO-E6 cell, and the cultures were incubated again. After three days, the cultures were fixed by addition of paraformaldehyde and stained with crystal violet for visualisation of cytotoxicity. The highest serum dilution preventing infections of the cells was defined as the neutralization titre.

• Study Type: Observational
• Enrollment (Actual): 50

Contacts and Locations

Study Locations

• Switzerland
  • Zurich, Switzerland, 8091
    • Univeristy Hospital Zürich

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Approximately 250 blood samples from 50 vaccinated persons working in the USZ Department of Dermatology were collected in 2020 and 2021. All individuals recieveid either one or two doses of BNT162b2 (BioNTech/Pfizer) vaccine between January 2021 and June 2021. The persons providing blood samples (study subjects) were recruited by a general email (in English) to all members of the research unit of the Department of Dermatology (cf. Appendix). The sera were frozen and kept at the Dermatology biobank. The samples are labelled with subjects initials and date of sampling.

Description

Inclusion Criteria:

• Employed at the USZ Department of Dermatology
• Vaccinated against Covid-19 at USZ
• Male and female persons of any age
• Serum samples collected in 2020 or until June 11th 2021
• The subject was informed and gave his/her consent to the research project (non-coded samples and data) and to publish data obtained from analysis of own biological samples

Exclusion Criteria:

• Known clinical relevant disease, e.g. immune suppressed by drugs or disease
• Documented objection of subsequent use and publication of biological samples and personal health data

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Immunity to Covid-19 vaccines	Analysis SARS-CoV-2 immunity with ELISA anti-S1 IgG and IgA assay and tissue-culture infection dose (TCID) neutralisation assays	July 2021 through September 2021

Collaborators and Investigators

• Sponsor: University of Zurich
• Investigators: Principal Investigator: Pål Johansen, Prof, University of Zurich, Dept. Dermatology

Publications and helpful links

General Publications

• Sosic L, Paolucci M, Duda A, Hasler F, Walton SM, Kundig TM, Johansen P. Kinetics and persistence of anti-SARS-CoV-2 neutralisation and antibodies after BNT162b2 vaccination in a Swiss cohort. Immun Inflamm Dis. 2022 Mar;10(3):e583. doi: 10.1002/iid3.583. Epub 2021 Dec 29.

Study record dates

Study Major Dates

• Study Start (Actual): July 22, 2021
• Primary Completion (Actual): September 30, 2021
• Study Completion (Actual): December 31, 2021

Study Registration Dates

• First Submitted: July 25, 2021
• First Submitted That Met QC Criteria: July 25, 2021
• First Posted (Actual): July 28, 2021

Study Record Updates

• Last Update Posted (Actual): May 9, 2023
• Last Update Submitted That Met QC Criteria: May 8, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: DER-CoV2-001; BASEC Nr (Other Identifier: 2021-01361)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Study protocol is shared

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No