NCT06776692

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

Characterisation of Dengue Vaccine (Qdenga®, TAK-003)-Induced Humoral and Cellular Specific Immunity in Vaccinees With and Without Prior Exposure to Flavivirus Infections or Vaccination

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 402 (estimated)
• Sponsor: IRCCS Sacro Cuore Don Calabria di Negrar · Academic / Other
• Sex: All
• Age: 4 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
DRUG	Qdenga	Administration of Dengue vaccine and blood sample collection

Timeline

• Start date: 2024-07-10
• Primary completion: 2028-01-01
• Completion: 2028-01-01
• First posted: 2025-01-15
• Last updated: 2025-05-18

Locations

1 site across 1 country: Italy