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

NCT ID: NCT07291206

Last Updated: 2025-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-05-17

Study Completion Date

2027-12-31

Brief Summary

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Arboviruses (arthropod-borne viruses), are a group of RNA viruses that are transmitted to vertebrate hosts by hematophagous arthropods like mosquitos, ticks, and sandflies \[1\]. 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 \[2\]. 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 \[3\]. 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 \[4\]. 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.

Detailed Description

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Conditions

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Arbovirus Infections

Keywords

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ELISpot immune response serology

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with suspected or confirmed arbovirus infection

Immunological assays for charactarization of T-cell mediated response

Intervention Type DIAGNOSTIC_TEST

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

Immunological assays

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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Immunological assays for charactarization of T-cell mediated response

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

Intervention Type DIAGNOSTIC_TEST

Immunological assays

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* 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;

Exclusion Criteria

* Any condition that might compromise safety or interfere with study results.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fondazione IRCCS Policlinico San Matteo di Pavia

OTHER

Sponsor Role lead

Responsible Party

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Fausto Baldanti

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Fondazione IRCCS Policlinico San Matteo

Pavia, Lombardy, Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Baldanti

Role: CONTACT

Phone: +390382502420

Email: [email protected]

Facility Contacts

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Fausto Baldanti

Role: primary

Other Identifiers

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ARBOspot

Identifier Type: -

Identifier Source: org_study_id