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High-throughput Serological Testing of Antibodies Platform

NCT06939556 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 152

Last updated 2025-06-08

No results posted yet for this study

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.

Conditions

  • Diagnostics
  • Pandemic Response

Sponsors & Collaborators

  • European Union

    collaborator OTHER

  • VERDI Consortium

    collaborator UNKNOWN

  • University of Padova

    collaborator OTHER

  • Istituto Zooprofilattico Sperimentale delle Venezie

    lead OTHER

Eligibility

Min Age
2 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-04-15
Primary Completion
2025-07-30
Completion
2025-10-31

Countries

  • Italy

Study Locations

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Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06939556 on ClinicalTrials.gov