High-throughput Serological Testing of Antibodies Platform

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.

NCT Number	NCT06939556
Lead Sponsor	Istituto Zooprofilattico Sperimentale delle Venezie Collaborators: European Union, VERDI Consortium, University of Padova
Conditions	Diagnostics, Pandemic Response
Enrollment	152 participants
Start Date	2025-04-15
Primary Completion	2025-07-30 (estimated)
Study Completion	2025-10-31 (estimated)
Updated on ClinicalTrials.gov	2025-06-08