ARBOspot: Characterization of Arbovirus Specific T Cell Response in Patients by Using Enzyme Linked Immunospot (ELISpot) Assays

NCT07291206 | Recruiting

• 1 other identifier: ARBOspot
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

Arboviruses (arthropod-borne viruses), are a group of RNA viruses that are transmitted to vertebrate hosts by hematophagous arthropods like mosquitos, ticks, and sandflies. In Italy, arboviruses pose a considerable public health concern because of their potential to infect humans and cause severe emergent or re-emergent diseases. Over the past few decades, arboviruses have already been responsible for epidemic outbreaks in Italy, and travels increase the risk of introducing new species previously confined to tropical and sub-tropical regions. Some arboviral infections, like West Nile Virus (WNV), Toscana Virus (TOSV), Sandfly Fever Sicily Virus (SFSV), Sandfly Fever Naples Virus (SFNV), Usutu Virus (USUV), and tick-borne encephalitis virus (TBEV), are considered endemic in Italy. Others, such as Chikungunya Virus (CHIKV), Dengue Virus (DENV), Zika Virus (ZIKV), Yellow Fever Virus (YFV) and Japanese encephalitis Virus (JEV) are under surveillance since imported infections could lead to local outbreaks and subsequent endemic circulation in Italy. Moreover, the increased global travel and unpredictable climate changes could facilitate the spread of arboviral infections. Adequate diagnostic tests play a crucial role in disease surveillance, identifying potential associations between previous infections and chronic diseases and controlling outbreaks by breaking transmission chains. Furthermore, immunological tests can help predict disease severity in healthy and immunocompromised subjects and identify patients at risk for severe disease during secondary infections. In parallel with direct molecular diagnosis tests, the development of an immunological test capable of determining specific arbovirus T cell response may be useful for diagnostic as well as for epidemiological and investigative purposes. Furthermore, its development provides a set of initial knowledge on which to base the construction of other immunological tests for future emerging viruses, providing tools to counter new epidemic outbreaks. At the same time, the evaluation of immune response is necessary in order to control and contain the spread of these viruses. In conclusion, the present study aims to investigate immunological responses in patients infected with endemic arboviruses circulating in Italy those that could potentially emerging in the future. Molecular tests have a reduced detectability window in biological samples, which is why often they are not useful for making a diagnosis. Serological tests can give cross-reactivity phenomena between some arboviruses, making differential diagnosis difficult and often inconclusive. Objective is to assess sensitivity of immunological assays for arboviruses-specific T Cell Response (ARBOspot) in order to use them in combination with conventional diagnostic methods.

Conditions

Arbovirus Infections

Keywords

ELISpot; immune response; serology

Outcome Measures

Primary Outcomes (1)

• Performance of T-cell based assays for arboviruses

  Primary endpoint is to evaluate sensitivity of immunological arboviruses Specific T Cell Response assays (ARBOspot) of patients with confirmed arbovirus infection.

  from enrolment to up 1 year

Study Arms (1)

Patients with suspected or confirmed arbovirus infection

Diagnostic Test: Immunological assays for charactarization of T-cell mediated response; Diagnostic Test: Immunological assays

Interventions

Immunological assays DIAGNOSTIC_TEST

Immunological assays for characterization of T-cell mediated respone against arboviruses will be performed in follow-up

Patients with suspected or confirmed arbovirus infection

Immunological assays for charactarization of T-cell mediated response DIAGNOSTIC_TEST

ELISpot assay will be performed for monitoring of T-cell mediated response against arboviruses

Patients with suspected or confirmed arbovirus infection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects with suspected arbovirus infection will be included in the study. All the subjects will be enrolled after signature of informed consent. Follow-up will be performed in case of confirmed arbovirus infection.

You may qualify if:

• Adults 18 years- old and over; all sexes will be eligible for the study;
• Suspected arbovirus infection
• Written informed consent and any required authorization obtained from the participant prior to performing any protocol-related procedures;

You may not qualify if:

• Any condition that might compromise safety or interfere with study results.

Sponsors & Collaborators

• Fondazione IRCCS Policlinico San Matteo di Pavia: lead

Study Sites (1)

Fondazione IRCCS Policlinico San Matteo

Pavia, Lombardy, 27100, Italy

RECRUITING

MeSH Terms

Conditions

Arbovirus Infections

Condition Hierarchy (Ancestors)

Vector Borne Diseases; Infections; Virus Diseases

Central Study Contacts

Baldanti

CONTACT

+390382502420; segreteria.virologia@smatteo.pv.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Director, Microbiology and Virology Unit, Clinical Professor of University of Pavia

Study Record Dates

• First Submitted: December 5, 2025
• First Posted: December 18, 2025
• Study Start: May 17, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: March 4, 2026

Record last verified: 2026-03

Locations

IT (1)