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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Dengue Vaccines
• Intervention / Treatment: Drug: Qdenga

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.

• Study Type: Observational
• Enrollment (Estimated): 402

Contacts and Locations

• Study Contact: Name: Elvia Malo; Phone Number: +390456013111; Email: elvia.malo@sacrocuore.it

Study Locations

• Italy
  • VR
    • Negrar, VR, Italy, 37024
      • Recruiting
      • IRCCS Sacro Cuore Don Calabria
      • Contact: Concetta Castilletti; Email: concetta.castilletti@sacrocuore.it
      • Principal Investigator: Concetta Castilletti

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

All pediatric and adult subjects attending the travel clinic of the DITM for the administration of Dengue vaccine will be considered eligible.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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)

Secondary Outcome Measures

Outcome Measure	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)
Cellular response	immunophenotype asset: results of the flow cytometry profiles (proportions of cells),; 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.	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	anti-DENV antibodies quantities (IgG and IgM, continuous variables unity of measure: Antibody titre dilution) at T0, T2 and T3,; Analysis results of neutralization assays against different DENV serotypes (continuous variables, unity of measure: TCID50/ml) 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)
Humoral response	Analysis results humoral response against different flaviviruses (IgG and IgM, continuous variables unity of measure: Antibody titre dilution) at T0, T2 and T3,; Analysis results of DENV specific avidity assays (unity of measure: Index);; Previous infections with (y/n) or vaccinations against (y/n) other flaviviruses	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)

Collaborators and Investigators

• Sponsor: IRCCS Sacro Cuore Don Calabria di Negrar

Study record dates

Study Major Dates

• Study Start (Actual): July 10, 2024
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2028

Study Registration Dates

• First Submitted: January 3, 2025
• First Submitted That Met QC Criteria: January 14, 2025
• First Posted (Actual): January 15, 2025

Study Record Updates

• Last Update Posted (Actual): May 18, 2025
• Last Update Submitted That Met QC Criteria: May 16, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: Vaccine; Dengue
• Additional Relevant MeSH Terms: Vector Borne Diseases; Mosquito-Borne Diseases; Infections; RNA Virus Infections; Virus Diseases; Arbovirus Infections; Flaviviridae Infections; Hemorrhagic Fevers, Viral; Dengue; Flavivirus Infections
• Other Study ID Numbers: 2024-L

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No