High-throughput Serological Testing of Antibodies Platform

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age2-65
SponsorIstituto Zooprofilattico Sperimentale delle Venezie

About this trial

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 criteria

This trial accepts healthy volunteers

Qualifiers

None

Disqualifiers

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.

Trial population

Employees of the IZSVe between the ages of 20 and 65 years Children admitted at the Department of Women's and Children's Health, Padova University Hospital

Trial design

Design model

Other

Time perspective

Cross-sectional

Treatments tested in this trial

Not listed

Trial groups

152 Participants
are grouped into 2 trial groups
Group A: Adult Cohort
Group B: Pediatric Cohort

Trial outcomes

Primary outcomes

1

Detection of neutralising antibodies for viral infectious diseases of epidemic nature

Validation of the use in the diagnostic practice of microsampling devices (Mitra VAMS) for the detection of neutralizing antibodies for viral infectious diseases of epidemic nature in a real-world scenario for adult and pediatric populations.

Time frame
From enrollment to detection of the presence or lack thereof of neutralizing antibodies for seasonal influenza virus and/or SARS-CoV-2 (around 2 months).

Secondary outcomes

1

high-throughput serological platform for the detection of potentially pandemic viruses

Development of a high-throughput serological platform for the detection of neutralizing antibodies against avian influenza strains associated with pandemic potential (H5N1, H3N8, H9N2, etc), MERS-CoV and Zika virus.

Time frame
From enrollment to development of a high-throughput serological platform for the detection of neutralizing antibodies against avian influenza strains associated with pandemic potential (H5N1, H3N8, H9N2, etc), MERS-CoV and Zika virus (around 5 months).

Other outcomes

Sponsors and contacts

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Istituto Zooprofilattico Sperimentale delle Venezie

Lead sponsor

European Union

Collaborator

VERDI Consortium

Collaborator

University of Padova

Collaborator