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

IRCCS Sacro Cuore Don Calabria di Negrar

Status: Enrolling

Conditions: Dengue Vaccines

Treatments: Drug: Qdenga

Study type: Observational

Funder types: Other

Identifiers

NCT06776692

2024-L

Details and patient eligibility

About

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.

Full 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.

Enrollment: 402 estimated patients

Sex: All

Ages: 4+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

402 participants in 1 patient group

Patients

Description:

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

Treatment:

Drug: Qdenga