SARS-CoV-2 Antibodies and Virus Neutralisation in a Cohort Vaccinted Against COVID-19

NCT ID: NCT04979871

Last Updated: 2023-05-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-07-22

Study Completion Date

2021-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Vaccine Reaction

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Venous bleeding

Blood samples collected 5 times with approx. 2-4 weeks interval

Intervention Type PROCEDURE

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Zurich

OTHER

Sponsor Role lead

Responsible Party

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Pal Johansen

Professor Dr. sc.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Pål Johansen, Prof

Role: PRINCIPAL_INVESTIGATOR

University of Zurich, Dept. Dermatology

Locations

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Univeristy Hospital Zurich

Zurich, , Switzerland

Site Status

Countries

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Switzerland

References

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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.

Reference Type DERIVED
PMID: 34965032 (View on PubMed)

Other Identifiers

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BASEC Nr

Identifier Type: OTHER

Identifier Source: secondary_id

DER-CoV2-001

Identifier Type: -

Identifier Source: org_study_id

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