High-throughput Serological Testing of Antibodies Platform

NCT06939556 | Recruiting

• 1 other identifier: Nr. CE_IZSVE 10/2024
• Study Type: observational
• Target: 152
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Diagnostics; Pandemic Response

Keywords

pandemic preparedness; serology; high-throughput; emergent infectious diseases

Outcome Measures

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.

  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

  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).

Study Arms (2)

Adult Cohort

20-65 years of age

Pediatric Cohort

2-10 years of age

Eligibility Criteria

• Age: 2 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Istituto Zooprofilattico Sperimentale delle Venezie: lead
• European Union: collaborator
• VERDI Consortium: collaborator
• University of Padova: collaborator

Study Sites (2)

Istituto Zooprofilattico Sperimentale delle Venezie

Padua, Italy, 35020, Italy

RECRUITING

Padova University Hospital, Department of Women's and Children's Health

Padua, Italy, 35128, Italy

RECRUITING

Related Publications (10)

• Whitcombe AL, McGregor R, Craigie A, James A, Charlewood R, Lorenz N, Dickson JM, Sheen CR, Koch B, Fox-Lewis S, McAuliffe G, Roberts SA, Morpeth SC, Taylor S, Webb RH, Jack S, Upton A, Ussher JE, Moreland NJ. Comprehensive analysis of SARS-CoV-2 antibody dynamics in New Zealand. Clin Transl Immunology. 2021 Mar 14;10(3):e1261. doi: 10.1002/cti2.1261. eCollection 2021.

  PMID: 33747511 BACKGROUND

• Wang Y, Sun J, Li X, Zhu A, Guan W, Sun DQ, Gan M, Niu X, Dai J, Zhang L, Zhang Z, Shi Y, Huang S, Mok CKP, Yang Z, Wang Z, Tan W, Li Y, Chen L, Chen R, Peiris M, Zhong N, Zhao J, Huang J, Zhao J. Increased Pathogenicity and Virulence of Middle East Respiratory Syndrome Coronavirus Clade B In Vitro and In Vivo. J Virol. 2020 Jul 16;94(15):e00861-20. doi: 10.1128/JVI.00861-20. Print 2020 Jul 16.

  PMID: 32434886 BACKGROUND

• Thangavelu MU, Wouters B, Kindt A, Reiss IKM, Hankemeier T. Blood microsampling technologies: Innovations and applications in 2022. Anal Sci Adv. 2023 May 18;4(5-6):154-180. doi: 10.1002/ansa.202300011. eCollection 2023 Jul.

  PMID: 38716066 BACKGROUND

• Terstappen J, Delemarre EM, Versnel A, White JT, Derrien-Colemyn A, Ruckwardt TJ, Bont LJ, Mazur NI. RSV Neutralizing Antibodies in Dried Blood. J Infect Dis. 2024 Jul 25;230(1):e93-e101. doi: 10.1093/infdis/jiad543.

  PMID: 39052716 BACKGROUND

• Sancilio AE, D'Aquila RT, McNally EM, Velez MP, Ison MG, Demonbreun AR, McDade TW. A surrogate virus neutralization test to quantify antibody-mediated inhibition of SARS-CoV-2 in finger stick dried blood spot samples. Sci Rep. 2021 Jul 28;11(1):15321. doi: 10.1038/s41598-021-94653-z.

  PMID: 34321523 BACKGROUND

• Roper KJ, Thomas J, Albalawi W, Maddocks E, Dobson S, Alshehri A, Barone FG, Baltazar M, Semple MG, Ho A, Turtle L; ISARIC4C Consortium; Paxton WA, Pollakis G. Quantifying neutralising antibody responses against SARS-CoV-2 in dried blood spots (DBS) and paired sera. Sci Rep. 2023 Sep 11;13(1):15014. doi: 10.1038/s41598-023-41928-2.

  PMID: 37697014 BACKGROUND

• Kok MGM, Fillet M. Volumetric absorptive microsampling: Current advances and applications. J Pharm Biomed Anal. 2018 Jan 5;147:288-296. doi: 10.1016/j.jpba.2017.07.029. Epub 2017 Jul 27.

  PMID: 28803682 BACKGROUND

• Klumpp-Thomas C, Kalish H, Drew M, Hunsberger S, Snead K, Fay MP, Mehalko J, Shunmugavel A, Wall V, Frank P, Denson JP, Hong M, Gulten G, Messing S, Hicks J, Michael S, Gillette W, Hall MD, Memoli MJ, Esposito D, Sadtler K. Standardization of ELISA protocols for serosurveys of the SARS-CoV-2 pandemic using clinical and at-home blood sampling. Nat Commun. 2021 Jan 4;12(1):113. doi: 10.1038/s41467-020-20383-x.

  PMID: 33397956 BACKGROUND

• Johnson, Joseph M., Syrena C. Fernandes, Danica L. Wuelfing, Aaron R. Baillargeon, Evan L. MacLure, Soyoon Hwang, Andrew J. Ball, et al. 2022. "Quantifying Post-Vaccination Protective Anti-SARS-CoV-2 IgG Antibodies in Blood and Saliva with a Fully Automated, High Throughput Digital Immunoassay". Preprint. Infectious Diseases (except HIV/AIDS). https://doi.org/10.1101/2022.01.21.22269165

  BACKGROUND

• Bossi E, Limo E, Pagani L, Monza N, Serrao S, Denti V, Astarita G, Paglia G. Revolutionizing Blood Collection: Innovations, Applications, and the Potential of Microsampling Technologies for Monitoring Metabolites and Lipids. Metabolites. 2024 Jan 11;14(1):46. doi: 10.3390/metabo14010046.

  PMID: 38248849 BACKGROUND

Related Links

• This is the website of the umbrella project.

Central Study Contacts

Head of the Laboratory of Experimental Animal Models IZSVe

CONTACT

+39 049 8084101-102; fbonfante@izsvenezie.it

Olga S Munoz Pogoreltseva, DVM, MSc, PhD in Public Health

CONTACT

+39 049 8084101-102; omunoz@izsvenezie.it

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of the Laboratory of Experimental Animal Models at the SCS6 - Experimental Virology, Istituto Zooprofilattico Sperimentale delle Venezie (IZSVe)

Study Record Dates

• First Submitted: March 25, 2025
• First Posted: April 23, 2025
• Study Start: April 15, 2025
• Primary Completion: July 30, 2025
• Study Completion: October 31, 2025
• Last Updated: June 8, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

IT (2)