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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04979871
Acronym
DER-CoV2-001
Enrollment
50
Registered
2021-07-28
Start date
2021-07-22
Completion date
2021-12-31
Last updated
2023-05-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vaccine Reaction

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.

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.

Interventions

PROCEDUREVenous bleeding

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

Sponsors

University of Zurich
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
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

Design outcomes

Primary

MeasureTime frameDescription
Immunity to Covid-19 vaccinesJuly 2021 through September 2021Analysis SARS-CoV-2 immunity with ELISA anti-S1 IgG and IgA assay and tissue-culture infection dose (TCID) neutralisation assays

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026