Characterisation of Dengue Vaccine-induced Specific Immunity in Vaccinees With and Without Prior Exposure to Flavivirus Infections or Vaccination

NCT ID: NCT06776692

Last Updated: 2025-05-18

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 402 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-07-10
• Study Completion Date: 2028-01-31

Brief Summary

The goal of this observational study is to learn about the immunity induced by the Qdenga® vaccine in vaccinees.

Participants that will receive the Dengue vaccine as part of their routine before a travel will be asked to undergo a blood sample at the time of administration of the first dose (T0), 24-48 hours after the first dose (T1) of the vaccine, immediately before the second dose (T2 ) and one to two months after the second dose (T3). Possibly a further sample will be collected within 2 years.

Detailed Description

This is a non-profit, single-center, drug-based observational study whose primary objective is to characterize dengue-specific humoral and cellular immunity induced by the Qdenga® vaccine in vaccinees.

The study involves the enrollment of all pediatric subjects (age ≥ 4 years) and adults who present themselves at the DITM travel clinic for the administration of the Dengue vaccine; 402 patients are expected to be enrolled and will be asked to undergo a blood sample at the time of administration of the first dose (T0), 24-48 hours after the first dose (T1) of the vaccine, immediately before the second dose (T2 ) and one to two months after the second dose (T3). Possibly a further sample will be collected within 2 years (T4). The samples thus collected will be analyzed for the characterization of innate immunity, the characterization of cellular immunity and the characterization of the humoral response.

Conditions

Dengue Vaccines

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Patients

All pediatric and adult subjects attending the travel clinic of the DITM for the administration of Dengue vaccine.

Qdenga

Intervention Type: DRUG

Administration of Dengue vaccine and blood sample collection

Interventions

Qdenga

Administration of Dengue vaccine and blood sample collection

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Subjects of both sexes presenting to the DITM to receive the anti-DENV vaccine whether or not they have had a history of prior DENV or other flaviviruses infection or a history of prior vaccination against other flaviviruses. These data will be recorded in the study CRF.
• Age >= 4 years.
• Signed informed consent.

Exclusion Criteria

• Age < 4 years.
• Absence of signed informed consent.

• Minimum Eligible Age: 4 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

IRCCS Sacro Cuore Don Calabria di Negrar

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

IRCCS Sacro Cuore Don Calabria

Negrar, VR, Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Elvia Malo

Role: CONTACT

elvia.malo@sacrocuore.it

+390456013111

Facility Contacts

Concetta Castilletti

Role: primary

concetta.castilletti@sacrocuore.it

Other Identifiers

2024-L

Identifier Type: -

Identifier Source: org_study_id