Characterisation of Dengue Vaccine-induced Specific Immunity in Vaccinees With and Without Prior Exposure to Flavivirus Infections or Vaccination

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age4+
SponsorIRCCS Sacro Cuore Don Calabria di Negrar

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Qdenga

    Drug

    Administration of Dengue vaccine and blood sample collection

Treatment groups

402 Participants
are divided into 1 treatment group
Group A: Patients1 intervention

Trial outcomes

Primary outcomes

1

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)

Secondary outcomes

1

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)
2

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)
3

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)
4

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)

Other outcomes

Sponsors and contacts

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