Substudy "Responses to Covid-19 vaccines" in research "Clinical picture, immunology, genetics and pathogenesis of COVID-19 infection"

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2021-004016-26-FI

Enrollment

1000

Registered

2021-09-14

Start date

2021-10-18

Completion date

Unknown

Last updated

2024-12-09

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

Conditions

None

Interventions

Trade Name: Comirnaty Product Name: Comirnaty Pharmaceutical Form: Injection Other descriptive name: COVID-19 mRNA vaccine (nucleoside-modified) Concentration unit: µg microgram(s) Concentration type:

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Written informed consent. 2. >18 years old 3. Receiving Covid-19 vaccination despite of participating to this study. In this study we only investigate the responses and do not vaccinate participants. 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 1000 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: 1. Suspected non-compliance.

Design outcomes

Primary

Measure	Time frame
Main Objective: Response of Covid-19 vaccine;Secondary Objective: Objectives are to find answers to the following questions: -Is there a difference in immune responses to SARS-CoV-2 vaccine between those with a history of a confirmed Covid-19 infection and asymptomatic / PCR-negative controls? Those reporting symptoms consistent with long Covid-19? -How long does the immune response to SARS-CoV-2 vaccine last? -Are there differences in the duration and strength of inflammatory and humoral and cell-mediated immune responses to SARS-CoV-2 vaccine among those with versus without a history of a Covid-19 infection? -Is there a difference in the immune response elicited by Covid-19 infection vs SARS-CoV-2 vaccine? -What kind of changes does the vaccine induce (transcriptomics, antibodies, cell-mediated immune response, markers, cytokines, complement etc.) -Does the vaccine induce antibodies /other markers in secretions (see list below)? -provide sample for scent dog training? ;Primary end point(s): Immune response to Covid-19 vaccines;Timepoint(s) of evaluation of this end point: Before and 3 weeks after primary and secondary dose of the vaccination	—

Measure

Time frame

Main Objective: Response of Covid-19 vaccine;Secondary Objective: Objectives are to find answers to the following questions: -Is there a difference in immune responses to SARS-CoV-2 vaccine between those with a history of a confirmed Covid-19 infection and asymptomatic / PCR-negative controls? Those reporting symptoms consistent with long Covid-19? -How long does the immune response to SARS-CoV-2 vaccine last? -Are there differences in the duration and strength of inflammatory and humoral and cell-mediated immune responses to SARS-CoV-2 vaccine among those with versus without a history of a Covid-19 infection? -Is there a difference in the immune response elicited by Covid-19 infection vs SARS-CoV-2 vaccine? -What kind of changes does the vaccine induce (transcriptomics, antibodies, cell-mediated immune response, markers, cytokines, complement etc.) -Does the vaccine induce antibodies /other markers in secretions (see list below)? -provide sample for scent dog training? ;Primary end point(s): Immune response to Covid-19 vaccines;Timepoint(s) of evaluation of this end point: Before and 3 weeks after primary and secondary dose of the vaccination

—

Secondary

Measure	Time frame
Secondary end point(s): -Vaccine induced gene expression -Explore scent dogs for their ability to identify covid-19 infected person as compared to vaccinated participants ;Timepoint(s) of evaluation of this end point: Multiple time points	—

Countries

Finland

Contacts

Public ContactMeilahti Vaccine Research Center

Meilahti Vaccine Research Center - Helsinki University Hospital

anu.kantele@hus.fi+358504270203

Outcome results

None listed

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