Dengue VaccinesVaQDENVNCT06776692
Characterisation of Dengue Vaccine-induced Specific Immunity in Vaccinees With and Without Prior Exposure to Flavivirus Infections or Vaccination
An observational study of Dengue Vaccines, run by IRCCS Sacro Cuore Don Calabria di Negrar at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 4 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dengue Vaccines
- What is being tested?
- Qdenga
- Type of treatment
- Vaccines
- How many people
- 402 participants
- Where
- 1 siteItaly
- Study dates
- 10 Jul 2024to Jan 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: All pediatric and adult subjects attending the travel clinic of the DITM for the administration of Dengue vaccine will be considered eligible.
Who may be able to join
- 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.
Who cannot join
- Age < 4 years.
- Absence of signed informed consent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
IRCCS Sacro Cuore Don Calabria
Negrar, VR, 37024
Concetta Castilletti, concetta.castilletti@sacrocuore.it
Concetta Castilletti
About this study
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
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.
Read the 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.
- Conditions
- Dengue Vaccines
- Being tested
- Qdenga
- Keywords
- Dengue, Vaccine
- Medical subject headings
- Dengue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QdengaDrug
Administration of Dengue vaccine and blood sample collection
| Study group | Role | What they receive |
|---|---|---|
| Patients | All pediatric and adult subjects attending the travel clinic of the DITM for the administration of Dengue vaccine. Receives: Drug: Qdenga |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
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
Measured: 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.
Measured: 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,
Measured: 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
Measured: 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.
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2025
- Study start10 Jul 2024
- Primary completionJan 2028 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dengue VaccinesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 402 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS Sacro Cuore Don Calabria di Negrar
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06776692
- Sponsor's protocol ID
- 2024-L
- Acronym
- VaQDENV
- Status last verified
- May 2025
- First submitted
- 3 Jan 2025
- Last updated
- 18 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06776692
- Acronym / sponsor ID
- VaQDENV / 2024-L
- Conditions
- Dengue Vaccines
- Keywords
- Dengue, Vaccine
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 402 participants (estimated)
- Lead sponsor
- IRCCS Sacro Cuore Don Calabria di NegrarUniversity, hospital or other
- Study start
- 10 Jul 2024 (actual)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 15 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients | – | Drug: QdengaAll pediatric and adult subjects attending the travel clinic of the DITM for the administration of Dengue vaccine. |
Who may qualify
- Ages
- 4 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All pediatric and adult subjects attending the travel clinic of the DITM for the administration of Dengue vaccine will be considered eligible.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- Age < 4 years.
- Absence of signed informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QdengaAdministration of Dengue vaccine and blood sample collection | Drug | Patients |
Primary outcome
Anti-DENV antibodies
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)
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)
5 secondary outcomes
Innate immunity response
Time frame: BEFORE administration of the first dose (T0), after 24-48h after the first dose (Time 1 = T1)
Cellular response
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)
Quantitative and qualitative anti-DENV antibody response
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)
Humoral response
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)
Cell mediated response
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dengue Vaccines, run by IRCCS Sacro Cuore Don Calabria di Negrar at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Elvia Malo (+390456013111, elvia.malo@sacrocuore.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anti-DENV antibodies (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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2025.