RecruitingNCT06939556

High-throughput Serological Testing of Antibodies Platform

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


Sponsor

Istituto Zooprofilattico Sperimentale delle Venezie

Enrollment

152 participants

Start Date

Apr 15, 2025

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 2 YearsMax Age: 65 Years

Inclusion Criteria1

  • 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 Criteria3

  • subjects with an immunocompromised status, such as immunodeficiency disorders or those undergoing immunosuppressant treatments
  • subjects with underlying chronic inflammatory conditions (i.e., autoimmune disorders, chronic gastrointestinal, and rheumatic conditions)
  • subjects who have received immunomodulatory treatment within the past year.

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Locations(2)

Istituto Zooprofilattico Sperimentale delle Venezie

Padova, Italy, Italy

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

Padova, Italy, Italy

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NCT06939556


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