Understanding immunity from the Dengue vaccine in vaccinated individuals
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
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 |
|---|---|
| Enrollment | 402 (estimated) |
| Ages | 4 Years and up |
| Sex | All |
| Sponsor | IRCCS Sacro Cuore Don Calabria di Negrar Academic / other |
| Locations | 1 site (Negrar, VR) |
| Trial ID | NCT06776692 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include individuals aged 4 years and older who are scheduled to receive the Dengue vaccine.
Not a fit: Patients under 4 years of age or those who do not provide signed informed consent will not benefit from this study.
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 performed: While there have been studies on dengue vaccines, this specific observational approach to characterize immunity is relatively novel.
Eligibility criteria
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 this trial is running
Negrar, VR
- IRCCS Sacro Cuore Don Calabria — Negrar, Vr, Italy (Recruiting)
Study contacts
- Study coordinator: Elvia Malo
- Email: elvia.malo@sacrocuore.it
- Phone: +390456013111
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.