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

NCT06776692 | Recruiting

• 1 other identifier: 2024-L
• Study Type: observational
• Target: 402
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Dengue Vaccines

Keywords

Dengue; Vaccine

Outcome Measures

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)

  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 (5)

• Innate immunity response

  BEFORE administration of the first dose (T0), after 24-48h after the first dose (Time 1 = T1)

• 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

  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)

Study Arms (1)

Patients

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

Drug: Qdenga

Interventions

Qdenga DRUG

Administration of Dengue vaccine and blood sample collection

Patients

Eligibility Criteria

• Age: 4 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• Age \< 4 years.
• Absence of signed informed consent.

Sponsors & Collaborators

• IRCCS Sacro Cuore Don Calabria di Negrar: lead

Study Sites (1)

IRCCS Sacro Cuore Don Calabria

Negrar, VR, 37024, Italy

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples

MeSH Terms

Conditions

Dengue

Condition Hierarchy (Ancestors)

Mosquito-Borne Diseases; Vector Borne Diseases; Infections; Arbovirus Infections; Virus Diseases; Flavivirus Infections; Flaviviridae Infections; RNA Virus Infections; Hemorrhagic Fevers, Viral

Central Study Contacts

Elvia Malo

CONTACT

+390456013111; elvia.malo@sacrocuore.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 3, 2025
• First Posted: January 15, 2025
• Study Start: July 10, 2024
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2028
• Last Updated: May 18, 2025

Record last verified: 2025-05

Locations

IT (1)