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

Sponsor
University of Zurich (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT04979871
Collaborator
(none)
50
Enrollment
1
Location
5.3
Anticipated Duration (Months)
9.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational [Patient Registry]
Actual Enrollment :
50 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Kinetics and Stability of Anti-SARS-CoV-2 Antibodies and Virus Neutralization After COVID-19 Vaccination in a Swiss Cohort
Actual Study Start Date :
Jul 22, 2021
Anticipated Primary Completion Date :
Sep 30, 2021
Anticipated Study Completion Date :
Dec 31, 2021

Outcome Measures

Primary Outcome Measures

  1. Immunity to Covid-19 vaccines [July 2021 through September 2021]

    Analysis SARS-CoV-2 immunity with ELISA anti-S1 IgG and IgA assay and tissue-culture infection dose (TCID) neutralisation assays

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Univeristy Hospital Zurich Zurich Switzerland 8091

Sponsors and Collaborators

  • University of Zurich

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Zurich
ClinicalTrials.gov Identifier:
NCT04979871
Other Study ID Numbers:
  • DER-CoV2-001
  • BASEC Nr
First Posted:
Jul 28, 2021
Last Update Posted:
Sep 2, 2021
Last Verified:
Aug 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Sep 2, 2021