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NCT04979871 Clinical Trial

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

Vaccine Reaction Clinical Trial

— DER-CoV2-001  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04979871
Other study ID # DER-CoV2-001
Secondary ID BASEC Nr
Status Completed
Phase
First received
Last updated
Start date July 22, 2021
Est. completion date December 31, 2021

Study information
Verified date May 2023
Source University of Zurich
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 50
Est. completion date December 31, 2021
Est. primary completion date September 30, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Venous bleeding
Blood samples collected 5 times with approx. 2-4 weeks interval

Locations
Country Name City State
Switzerland Univeristy Hospital Zurich Zurich

Sponsors (1)
Lead Sponsor Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
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