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 volunteersQualifiers
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
Other
Cross-sectional
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
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.
Sponsors and contacts
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Istituto Zooprofilattico Sperimentale delle Venezie
Lead sponsor
European Union
Collaborator
VERDI Consortium
Collaborator
University of Padova
Collaborator