E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Immune response induced by SARS-CoV-2 vaccination. |
|
E.1.1.1 | Medical condition in easily understood language |
Immune response induced by COVID-19 vaccination. |
|
E.1.1.2 | Therapeutic area | Body processes [G] - Immune system processes [G12] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
|
E.2.2 | Secondary objectives of the trial |
To evaluate the feasibility of the rapid SARS-CoV-2 antibody testing in the context of force health protection. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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.
|
|
E.4 | Principal 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. |
|
E.5 End points |
E.5.1 | 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. |
|
E.5.1.1 | 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 . |
|
E.5.2 | Secondary end point(s) |
Feasibility of the rapid antibody tests in the military context.
|
|
E.5.2.1 | 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. |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
Observational prospective cohort study |
|
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 4 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
The last contact via internet questionnaire at 18 months. |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |