Clinical trial NCT06776692: Characterisation of Dengue Vaccine-induced Specific Immunity in Vaccinees With and Without Prior Exposure to Flavivirus Infections or Vaccination
Official title: 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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Dengue Vaccines
Keywords: Dengue
Vaccine
Lead sponsor: IRCCS Sacro Cuore Don Calabria di Negrar
Sponsor class: OTHER
First posted: 2025-01-15
Enrollment: 402
Sex: ALL
Minimum age (years): 4
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All pediatric and adult subjects attending the travel clinic of the DITM for the administration of Dengue vaccine will be considered eligible.

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.

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.

Primary outcomes:
measure: Anti-DENV antibodies
timeFrame: BEFORE administration of the first dose (Time 0 = T0), immediately BEFORE the second dose (Time 2 = T2) of vaccine, and one to two months after the second dose (Time 3 = T3)
Secondary outcomes:
measure: Innate immunity response
timeFrame: BEFORE administration of the first dose (T0), after 24-48h after the first dose (Time 1 = T1)
measure: Cellular response
timeFrame: At the moment of the administration of the first dose (T0), immediately before the second dose (T2), and one to two months after the second dose (T3)
measure: Quantitative and qualitative anti-DENV antibody response
timeFrame: At the moment of the administration of the first dose (T0), immediately before the second dose (T2), and one to two months after the second dose (T3)
measure: Humoral response
timeFrame: At the moment of the administration of the first dose (T0), immediately before the second dose (T2), and one to two months after the second dose (T3)
measure: Cell mediated response
timeFrame: At the moment of the administration of the first dose (T0), immediately before the second dose (T2), and one to two months after the second dose (T3)
Other outcomes:
Locations:
city: Negrar
country: Italy
facility: IRCCS Sacro Cuore Don Calabria
state: VR
Study officials:
References: