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RECRUITING
NCT06939556

High-throughput Serological Testing of Antibodies Platform

Sponsor: Istituto Zooprofilattico Sperimentale delle Venezie

View on ClinicalTrials.gov

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.

Official title: Development of a High-throughput Serological Testing Platform for Mass Screening Purposes of Both Pediatric and Adult Cohorts

Key Details

Gender

All

Age Range

2 Years - 65 Years

Study Type

OBSERVATIONAL

Enrollment

152

Start Date

2025-04-15

Completion Date

2025-10-31

Last Updated

2025-06-08

Healthy Volunteers

Yes

Locations (2)

Istituto Zooprofilattico Sperimentale delle Venezie

Padova, Italy, Italy

Padova University Hospital, Department of Women's and Children's Health

Padova, Italy, Italy