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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients | All pediatric and adult subjects attending the travel clinic of the DITM for the administration of Dengue vaccine. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Qdenga | Drug | Administration of Dengue vaccine and blood sample collection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Anti-DENV antibodies | Anti-DENV antibodies quantities (IgG and IgM, continuous variables unity of measure: Antibody titre dilution) BEFORE administration of the first dose (T0), immediately BEFORE the second dose (T2) of vaccine, and one to two months after the second dose (T3) | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Innate immunity response | Type I and II IFN and IFN-inducible genes, specific cytokines and chemokines induced by Qdenga® vaccine (continuous variables: deltaCt mRNA expression and Optical Density (OD)) at T0 and T1 | BEFORE administration of the first dose (T0), after 24-48h after the first dose (Time 1 = T1) |
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Inclusion Criteria:
Exclusion Criteria:
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All pediatric and adult subjects attending the travel clinic of the DITM for the administration of Dengue vaccine will be considered eligible.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Elvia Malo | Contact | +390456013111 | elvia.malo@sacrocuore.it |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IRCCS Sacro Cuore Don Calabria | Recruiting | Negrar | VR | 37024 | Italy |
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| ID | Term |
|---|---|
| D003715 | Dengue |
| ID | Term |
|---|---|
| D000096724 | Mosquito-Borne Diseases |
| D000079426 | Vector Borne Diseases |
| D007239 | Infections |
| D001102 | Arbovirus Infections |
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Blood samples
| Cellular response |
|
| 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 |
| 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 |
| 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 | Analysis results cell mediated response against different flaviviruses (continuous variables, unity of measure: Optical Density (OD)) at T0, T2 and T3. | 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) |
| D014777 |
| Virus Diseases |
| D018177 | Flavivirus Infections |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006482 | Hemorrhagic Fevers, Viral |