Understanding immunity from the Dengue vaccine in vaccinated individuals
Official title: 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
Run by IRCCS Sacro Cuore Don Calabria di Negrar · NCT06776692 · Data updated 2026-11-12
This study is testing how well the Qdenga® vaccine helps people aged 4 and older build immunity against dengue after getting vaccinated for travel.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 4 Years and up |
| Sex | All |
| Enrollment | 402 (estimated) |
| Sponsor | IRCCS Sacro Cuore Don Calabria di Negrar Academic / other |
| Locations | 1 site (Negrar, VR) |
| Status | Recruiting |
| Started | July 10, 2024 |
| Main results expected | January 2028 |
| Study ends | January 2028 |
| Registry record updated | May 18, 2025 |
| Trial ID | NCT06776692 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include individuals aged 4 years and older who are scheduled to receive the Dengue vaccine.
✕Probably not a fit
Patients under 4 years of age or those who do not provide signed informed consent will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to characterize the immune response induced by the Qdenga® vaccine in individuals receiving it for travel purposes. Participants, aged 4 years and older, will provide blood samples at various time points: before the first dose, shortly after the first dose, before the second dose, and one to two months after the second dose. The study will analyze these samples to assess both humoral and cellular immunity related to the vaccine. The research is being conducted at a single center, focusing on individuals with and without prior exposure to flavivirus infections.
Why it matters
Potential benefit: If successful, this study could enhance our understanding of vaccine-induced immunity, potentially leading to improved dengue vaccination strategies.
How similar studies have gone: While there have been studies on dengue vaccines, this specific observational approach to characterize immunity is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
-
IRCCS Sacro Cuore Don Calabria
Negrar, Vr, Italy Recruiting
Study contacts
- Study coordinator: Elvia Malo
- Email: elvia.malo@sacrocuore.it
- Phone: +390456013111
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.