An observational study in Dengue Vaccines, sponsored by IRCCS Sacro Cuore Don Calabria di Negrar. Recruiting at 1 site in Italy. Open to participants aged 4 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-05-18.
Sponsored by IRCCS Sacro Cuore Don Calabria di Negrar · Observational
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.
283 studies on the registry are indexed under Dengue; 44 are open to participants now.
This study's planned enrollment of 402 is below the median of 595 across 80 observational studies indexed under Dengue.
Browse Dengue studies →IRCCS Sacro Cuore Don Calabria di Negrar is the lead sponsor of 38 studies on the registry; 22 are open to participants now.
Counted across the registry records on this site, refreshed daily.
All pediatric and adult subjects attending the travel clinic of the DITM for the administration of Dengue vaccine will be considered eligible.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
All pediatric and adult subjects attending the travel clinic of the DITM for the administration of Dengue vaccine.
Drug: Qdenga
Administration of Dengue vaccine and blood sample collection
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)
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)
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
Time frame: BEFORE administration of the first dose (T0), after 24-48h after the first dose (Time 1 = T1)
Cellular response
1. immunophenotype asset: results of the flow cytometry profiles (proportions of cells), 2. specific T- and B-cells response to viral peptides: analysis results of T- and B-cells stimulation with DENV specific peptides (continuous variables, unity of measure: Optical Density (OD)) at T0, T2 and T3.
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
1. anti-DENV antibodies quantities (IgG and IgM, continuous variables unity of measure: Antibody titre dilution) at T0, T2 and T3, 2. Analysis results of neutralization assays against different DENV serotypes (continuous variables, unity of measure: TCID50/ml) at T0, T2 and T3,
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
1. Analysis results humoral response against different flaviviruses (IgG and IgM, continuous variables unity of measure: Antibody titre dilution) at T0, T2 and T3, 2. Analysis results of DENV specific avidity assays (unity of measure: Index); 3. Previous infections with (y/n) or vaccinations against (y/n) other flaviviruses
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
Analysis results cell mediated response against different flaviviruses (continuous variables, unity of measure: Optical Density (OD)) at T0, T2 and T3.
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)
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IRCCS Sacro Cuore Don Calabria di Negrar