The effects of Perfluoroalkyl substances on SARS-CoV-2 vaccination.

Does PFAS-exposure modify the risk of COVID-19 infection or the immunological response after vaccination against SARS-CoV-2?

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2021-000842-16-SE

Enrollment

500

Registered

2021-02-18

Start date

2021-03-18

Completion date

Unknown

Last updated

2021-03-22

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

Conditions

An observational study in healthy, differently PFAS-exposed subjects to check if PFAS modifies the immunological response to SARS-CoV-2 vaccination. The immunological response is quantified as SARS-CoV-2-specific IgG antibody production and T-cell activity. MedDRA version: 23.0 Level: LLT Classification code 10084462 Term: SARS-CoV-2 vaccination System Organ Class: 100000004865 MedDRA version: 23.1 Level: LLT Classification code 10084465 Term: COVID-19 vaccination System Organ Class: 100000004

Interventions

Pharmaceutical Form: Injection

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Men and women, 20 to 60 years old, who participated in PFAS-studies 2014-2016 with measured serum PFAS-levels, planning to be vaccinated against SARS-CoV-2. 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 500 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Previous vaccination against SARS-CoV-2

Design outcomes

Primary

Measure	Time frame
Main Objective: The overarching aim is to gather knowledge about how Perfluoroalkyl substances (PFAS) affects the immune system. This aim is studied through immunological response after SARS-CoV-2-vaccination in adults. Primary research question: Does PFAS-exposure modify IgG-antibody production after SARS-CoV-2-vaccination? The question will be answered through quantification of IgG-antibodies against SARS-CoV-2 S-protein. Exposure to PFAS is quantified as the molar sum of the 16 PFAS-substances in serum, and stratified into low and high.;Secondary Objective: Secondary research question: Does PFAS-exposure affects the cellular immune response after SARS-CoV-2-vaccination? This question will be answered through analyses of SARS-CoV-2 specific T-cell response. Exposure to PFAS is quantified as the molar sum of the 16 PFAS-substances in serum, and stratified into low and high. ;Primary end point(s): IgG-antibodies against S-protein from SARS-CoV-2;Timepoint(s) of evaluation of this end point: 1, 6 and 24 months after full vaccination.	—

Measure

Time frame

Main Objective: The overarching aim is to gather knowledge about how Perfluoroalkyl substances (PFAS) affects the immune system. This aim is studied through immunological response after SARS-CoV-2-vaccination in adults. Primary research question: Does PFAS-exposure modify IgG-antibody production after SARS-CoV-2-vaccination? The question will be answered through quantification of IgG-antibodies against SARS-CoV-2 S-protein. Exposure to PFAS is quantified as the molar sum of the 16 PFAS-substances in serum, and stratified into low and high.;Secondary Objective: Secondary research question: Does PFAS-exposure affects the cellular immune response after SARS-CoV-2-vaccination? This question will be answered through analyses of SARS-CoV-2 specific T-cell response. Exposure to PFAS is quantified as the molar sum of the 16 PFAS-substances in serum, and stratified into low and high. ;Primary end point(s): IgG-antibodies against S-protein from SARS-CoV-2;Timepoint(s) of evaluation of this end point: 1, 6 and 24 months after full vaccination.

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Secondary

Measure	Time frame
Secondary end point(s): T-cell response against S-protein from SARS-CoV-2;Timepoint(s) of evaluation of this end point: 1, 6 and 24 months after full vaccination.	—

Countries

Sweden

Contacts

Public ContactKristina Jakobsson

University of Gothenburg

Kristina.jakobsson@amm.gu.se+46031786 6256

Outcome results

None listed

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