Characterisation of Dengue Vaccine-induced Specific Immunity in Vaccinees With and Without Prior Exposure to Flavivirus Infections or Vaccination
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Qdenga.
- Who it may be relevant to
- Registry conditions: Dengue Vaccines. Basic parameters: from 4 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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.
Interventions
- Drug Qdenga
Administration of Dengue vaccine and blood sample collection
Primary outcome measures
- Anti-DENV antibodies [Time frame: 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 outcome measures (5)
- Innate immunity response [Time frame: BEFORE administration of the first dose (T0), after 24-48h after the first dose (Time 1 = T1)]
- Cellular response [Time frame: 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)]
- Quantitative and qualitative anti-DENV antibody response [Time frame: 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)]
- Humoral response [Time frame: 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)]
- Cell mediated response [Time frame: 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)]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
Italy · 1 center
- IRCCS Sacro Cuore Don Calabria — Negrar
Identifiers
NCT: NCT06776692 · 2024-L