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NCT06939556: DEVHISE

High-throughput Serological Testing of Antibodies Platform

Recruiting now Last updated 8 June 2025
What this trial tests

trial in Diagnostics in 152 participants. Currently enrolling.

Timeline
15 April 2025
Primary endpoint
30 July 2025
31 October 2025

Quick facts

Lead sponsorIstituto Zooprofilattico Sperimentale delle Venezie
StatusRecruiting now
Study typeOBSERVATIONAL
Enrollment152
Start date15 April 2025
Primary completion30 July 2025
Estimated completion31 October 2025
Sites2 locations across Italy

Conditions studied

Sponsor

Istituto Zooprofilattico Sperimentale delle Venezie

Who can join

Adults 2 to 65, any sex, with Diagnostics or Pandemic Response. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Data sources for this page

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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing