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

NCT04979871 | Completed DMC

• 2 other identifiers: DER-CoV2-001BASEC Nr
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Vaccine Reaction

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

Venous bleeding PROCEDURE

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

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Zurich: lead

Study Sites (1)

Univeristy Hospital Zurich

Zurich, 8091, Switzerland

Location

Related Publications (1)

• 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.

  PMID: 34965032 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum

Study Officials

• Pål Johansen, Prof

  University of Zurich, Dept. Dermatology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Dr. sc.

Study Record Dates

• First Submitted: July 25, 2021
• First Posted: July 28, 2021
• Study Start: July 22, 2021
• Primary Completion: September 30, 2021
• Study Completion: December 31, 2021
• Last Updated: May 9, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)