Immune response to COVID-19 vaccines in the military environment

Immune response to SARS-CoV-2 vaccines and its clinical significance in the Finnish Defence Forces

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2021-003686-36-FI

Enrollment

200

Registered

2021-07-15

Start date

2021-07-19

Completion date

Unknown

Last updated

2025-01-27

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

Conditions

Immune response induced by SARS-CoV-2 vaccination.

Interventions

Pharmaceutical Form: Suspension for injection in multidose container Other descriptive name: COVID-19 vaccine

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Eligible individuals 1. Belong to the Finnish Defence Forces' personnel or are undergoing their military service AND 2. Have not yet received vaccinations against COVID-19, but are planning to receive them in the near future AND 3. Have sufficient skills in Finnish AND 4. Are free from conditions that increase blood draw related risks. 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) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Exclusion criteria: Individuals who 1. Do not fulfill inclusion criteria OR 2. Cannot participate in the study as described in the Study Protocol - Do not understand the study concept - Cannot give their written informed consent - Are not willing to give the required information or blood samples - Have any health related or social situation associated conditions that may worsen if the individual participates in this study.

Design outcomes

Primary

Measure	Time frame
Main Objective: This is an observational study independent of national vaccination program. We will evaluate the dynamics and the clinical protective properties of the antibodies induces by SARS-CoV-2 vaccines.;Secondary Objective: To evaluate the feasibility of the rapid SARS-CoV-2 antibody testing in the context of force health protection.;Primary end point(s): Immune response induced by the SARS-CoV-2 vaccination: 1. Immunoglobulin class M, G and A antibodies (quantitative and qualitative analyses) 2. Neutralizing antibodies (semi-quantitative analyses) 3. Rapid antibody tests vs. conventional serological assessments.;Timepoint(s) of evaluation of this end point: Cross-sectional analyses at 3, 6, 12, and 15 months and longitudinal trends during the whole follow-up time .	—

Measure

Time frame

Main Objective: This is an observational study independent of national vaccination program. We will evaluate the dynamics and the clinical protective properties of the antibodies induces by SARS-CoV-2 vaccines.;Secondary Objective: To evaluate the feasibility of the rapid SARS-CoV-2 antibody testing in the context of force health protection.;Primary end point(s): Immune response induced by the SARS-CoV-2 vaccination: 1. Immunoglobulin class M, G and A antibodies (quantitative and qualitative analyses) 2. Neutralizing antibodies (semi-quantitative analyses) 3. Rapid antibody tests vs. conventional serological assessments.;Timepoint(s) of evaluation of this end point: Cross-sectional analyses at 3, 6, 12, and 15 months and longitudinal trends during the whole follow-up time .

—

Secondary

Measure	Time frame
Secondary end point(s): Feasibility of the rapid antibody tests in the military context. ;Timepoint(s) of evaluation of this end point: At the end of the study; when all samples and data are gathered and available for the analyses.	—

Countries

Finland

Contacts

Public ContactCerter for Military Medicine

Finnish Defence Forces

heli.siljander@mil.fi

Outcome results

None listed

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