NCT06939556 High-throughput Serological Testing of Antibodies Platform
| NCT ID | NCT06939556 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Istituto Zooprofilattico Sperimentale delle Venezie |
| Condition | Diagnostics |
| Study Type | OBSERVATIONAL |
| Enrollment | 152 participants |
| Start Date | 2025-04-15 |
| Primary Completion | 2025-07-30 |
Trial Parameters
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
Brief Summary
In the case of large emergency serosurveys, innovation in the sampling techniques is an often neglected, but relevant aspect to facilitate the enrolment of subjects in both adult and paediatric populations. Further, neutralization assays are the first line of response immediately after the emergence of a novel virus in the human population. This study aims at developing at IZSVe 384-format high-throughput neutralization assays for emerging and re-emerging respiratory viruses with pandemic potential to increase the preparedness capacity at both regional and national levels. This diagnostic platform will include the validation of Mitra VAMS devices for gathering blood samples for the diagnostic procedure. The platform will be tested and validated using adult subject-matched serum samples collected by venipuncture and finger-prick with volumetric tip microsampling devices (Mitra VAMS). This comparison will focus on the titration of antibodies against endemic viruses like influenza type A (i.e., seasonal influenza strains, like pdmH1N1 or H3N2) and SARS-CoV-2. The same serological assay will be developed to titrate neutralizing antibodies against emerging pathogens like avian influenza viruses of the H3 and H5 subtypes, Zika virus, and MERS-CoV.
Eligibility Criteria
Inclusion Criteria: Adult Cohort - between 20 and 65 years of age Pediatric Cohort - between 2 and 10 years of age Signed consent form by the subject for adults or by caregivers for children Exclusion Criteria: 1. subjects with an immunocompromised status, such as immunodeficiency disorders or those undergoing immunosuppressant treatments 2. subjects with underlying chronic inflammatory conditions (i.e., autoimmune disorders, chronic gastrointestinal, and rheumatic conditions) 3. subjects who have received immunomodulatory treatment within the past year.