High-throughput Serological Testing of Antibodies Platform
Recruiting
Observational Study
DiagnosticsPandemic Response
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
2 – 65
Sex
Any
Study type
Observational
Participants needed
152 (estimated)
Sponsor
Istituto Zooprofilattico Sperimentale delle Venezie · Other
Who this trial is looking for
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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-th…
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.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
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 Criteria:
1. subjects with an immunocompromised status, such as immunodeficiency disorders or th…
Inclusion Criteria:
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 Criteria:
1. subjects with an immunocompromised status, such as immunodeficiency disorders or those undergoing immunosuppressant treatments
2. subjects with underlying chronic inflammatory conditions (i.e., autoimmune disorders, chronic gastrointestinal, and rheumatic conditions)
3. subjects who have received immunomodulatory treatment within the past year.
Contacts
Head of the Laboratory of Experimental Animal Models IZSVe
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