Development of a High-throughput Serological Testing Platform for Mass Screening Purposes of Both Pediatric and Adult Cohorts

Status: Recruiting
Location: See all (2) locations...
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 2
Maximum Age: 65
Healthy Volunteers: t
View:

• 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

Locations
Other Locations
Italy
Istituto Zooprofilattico Sperimentale delle Venezie
RECRUITING
Padua
Padova University Hospital, Department of Women's and Children's Health
RECRUITING
Padua
Contact Information
Primary
Head of the Laboratory of Experimental Animal Models IZSVe
fbonfante@izsvenezie.it
+39 049 8084101-102
Backup
Olga S Munoz Pogoreltseva, DVM, MSc, PhD in Public Health
omunoz@izsvenezie.it
+39 049 8084101-102
Time Frame
Start Date: 2025-04-15
Estimated Completion Date: 2025-10-31
Participants
Target number of participants: 152
Treatments
Adult Cohort
20-65 years of age
Pediatric Cohort
2-10 years of age
Related Therapeutic Areas
Sponsors
Collaborators: VERDI Consortium, University of Padova, European Union
Leads: Istituto Zooprofilattico Sperimentale delle Venezie

This content was sourced from clinicaltrials.gov