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Arbovirus InfectionsARBOspotNCT07291206

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

An observational study of Arbovirus Infections, run by Fondazione IRCCS Policlinico San Matteo di Pavia at 1 site in Italy.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Arbovirus Infections
What is being tested?
Immunological assays for charactarization of T-cell mediated response and Immunological assays
How many people
500 participants
Where
1 siteItaly
Study dates
17 May 2025to Dec 2027
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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;

Who cannot join

  • Any condition that might compromise safety or interfere with study results.
  • All other conditions not present in the inclusion criteria.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Italy1 site, 1 recruiting
  • Fondazione IRCCS Policlinico San Matteo

    Pavia, Lombardy, 27100

    Fausto Baldanti, f.baldanti@smatteo.pv.it

    Recruiting

Other trials in Italy

About this study

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.

Being tested
Immunological assays for charactarization of T-cell mediated response, Immunological assays
Keywords
ELISpot, immune response, serology
Medical subject headings
Arbovirus Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Immunological assays for charactarization of T-cell mediated responseDiagnostic test

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

  • Immunological assaysDiagnostic test

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

Study groups in NCT07291206
Study groupRoleWhat they receive
Patients with suspected or confirmed arbovirus infectionNot described
Receives: Diagnostic Test: Immunological assays for charactarization of T-cell mediated response; Diagnostic Test: Immunological assays

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: from enrolment to up 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Dec 2025
  2. Study start17 May 2025
  3. Primary completionDec 2026 (estimated)
  4. Study completionDec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
500 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07291206
Sponsor's protocol ID
ARBOspot
Acronym
ARBOspot
Status last verified
Mar 2026
First submitted
5 Dec 2025
Last updated
4 Mar 2026
Results posted
No

Questions about this trial

What is this clinical trial studying?

An observational study of Arbovirus Infections, run by Fondazione IRCCS Policlinico San Matteo di Pavia at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 4 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Baldanti (+390382502420, segreteria.virologia@smatteo.pv.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Performance of T-cell based assays for arboviruses (time frame: from enrolment to up 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2026.

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