Observation of antibody response in vacinated empoleyes after COVID-19 vaccine.

DYNAMICS OF POSTVACCINATION ANTI- SARS-COV-2 ANTIBODY RESPONSE IN EMPLOYES OF THE NATIONAL INSTITUTE OF PUBLIC HEALTH AND VOLUNTARIES 1-2021

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2021-000633-14-CZ

Enrollment

300

Registered

2021-02-18

Start date

2021-03-30

Completion date

Unknown

Last updated

2024-06-24

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

Conditions

antibody response following vaccine application MedDRA version: 20.1 Level: PT Classification code 10060979 Term: Antibody test System Organ Class: 10022891 - Investigations

Interventions

Trade Name: Comirnaty Product Name: Comirnaty Pharmaceutical Form: Powder for suspension for injection

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: those who were vaccinated in the vaccination centre of Státní zdravotní ústav and singed informed consent with participation in the study Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 200 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 50

Exclusion criteria

Exclusion criteria: contraindications of vaccine application according to Summary of product characteristics application of the first dose of the vaccine after the 1st of February 2021

Design outcomes

Primary

Measure	Time frame
Main Objective: To determine the proportion of vaccinees who seroconverted at least 28 days after the administration of the 2nd dose of the vaccine according to the approved application schedule, quantitative determination of the level of anti-SARS-CoV-2 antibodies To determine the proportion of vaccinated in whom anti-SARS-CoV-2 antibodies are detectable 6 months after the administration of the 2nd dose of the vaccine according to the approved application schedule, quantitative determination of the level of anti-SARS-CoV-2 antibodies Determine the proportion of vaccinees in whom failed the vaccine within 6 months of the 2nd dose of the vaccine according to the approved dosing schedule;Secondary Objective: To determine the proportion of vaccinees who seroconverted in an interval close to 21 days after the administration of the 1st dose of the vaccine, which will precede the administration of the 2nd dose, quantitative determination of the level of anti SARS-CoV-2 antibodies If vaccination fails and SARS-CoV-2 RNA is captured in the nasopharyngeal swab or other relevant biological material of the vaccinated, whole genome sequencing (WGS) sequencing will be performed if there is sufficient nucleic acid in the primary sample.;Primary end point(s): Discontinuation of the treatment for adverse events individual decision not to continue in the study anytime ;Timepoint(s) of evaluation of this end point: Discontinuation of the treatment for adverse events	—

Measure

Time frame

Main Objective: To determine the proportion of vaccinees who seroconverted at least 28 days after the administration of the 2nd dose of the vaccine according to the approved application schedule, quantitative determination of the level of anti-SARS-CoV-2 antibodies To determine the proportion of vaccinated in whom anti-SARS-CoV-2 antibodies are detectable 6 months after the administration of the 2nd dose of the vaccine according to the approved application schedule, quantitative determination of the level of anti-SARS-CoV-2 antibodies Determine the proportion of vaccinees in whom failed the vaccine within 6 months of the 2nd dose of the vaccine according to the approved dosing schedule;Secondary Objective: To determine the proportion of vaccinees who seroconverted in an interval close to 21 days after the administration of the 1st dose of the vaccine, which will precede the administration of the 2nd dose, quantitative determination of the level of anti SARS-CoV-2 antibodies If vaccination fails and SARS-CoV-2 RNA is captured in the nasopharyngeal swab or other relevant biological material of the vaccinated, whole genome sequencing (WGS) sequencing will be performed if there is sufficient nucleic acid in the primary sample.;Primary end point(s): Discontinuation of the treatment for adverse events individual decision not to continue in the study anytime ;Timepoint(s) of evaluation of this end point: Discontinuation of the treatment for adverse events

—

Secondary

Measure	Time frame
Secondary end point(s): not applicable for design of this study;Timepoint(s) of evaluation of this end point: not applicable for design of this study	—

Countries

Czech Republic

Contacts

Public ContactRadomíra Limberková

Státní zdravotní ústav

radomira.limberkova@szu.cz420267082412

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026