About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
Age < 4 years.
Absence of signed informed consent.
Trial population
All pediatric and adult subjects attending the travel clinic of the DITM for the administration of Dengue vaccine will be considered eligible.
Trial design
Cohort
Prospective
Treatments tested in this trial
Qdenga
DrugAdministration of Dengue vaccine and blood sample collection
Treatment groups
Trial outcomes
Primary outcomes
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)
Secondary outcomes
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
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.
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,
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
Sponsors and contacts
Click on the lead sponsor to view all of their trials.