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DengueEarly Phase 1NCT06837116

Immunogenicity of an Intradermal Qdenga Vaccine Among Healthy Volunteers

A Early Phase 1 study testing Vaccine in people with Dengue, run by Prince of Songkla University at 2 sites in Thailand.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Official title: Immunogenicity of an intradermal Qdenga vaccine among healthy volunteers: A pilot study Read more about this study

Who is it for?
Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for
Dengue
What is being tested?
Vaccine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
29 participants
Where
2 sitesThailand
Study dates
19 Apr 2025to 30 Sep 2025
Phase
Early Phase 1
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 18 to 60 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Thai adult aged 18-60 years, who not previously received dengue vaccine.
  • The subjects are able to and willing to comply with the requirements of the clinical trial program and could complete the 3-month follow-up of the study.
  • Individuals who are in good health condition at the time of entry into the trial as determined by medical history, physical examination and clinical judgment of the investigator and meet the requirements of immunization
  • The subject can provide with informed consent and sign informed consent form

Who cannot join

  • Have a medical history or family history of convulsion, epilepsy, encephalopathy and psychosis.
  • Be allergic to any component of the research vaccines or used to have a history of hypersensitivity or serious reactions to vaccination.
  • Women with positive urine pregnancy test, pregnant or breast-feeding, or have a pregnancy plan within six months.
  • Have acute infectious diseases, including dengue infection
  • Have severe chronic diseases or condition in progress cannot be controlled. For example, poor controlled DM and uncontrolled HT.
  • Have the history of urticaria 1 year before receiving the investigational vaccine.
Show all 12Show fewer
  • Have known underlying diseases of thrombocytopenia or other coagulation disorders (which may cause contraindications for intramuscular injection).
  • Have needle sickness.
  • Have the history of immunosuppressive therapy, cytotoxic therapy or systemic corticosteroids
  • Have received blood products within 4 months before injection of investigational vaccines.
  • Under anti-tuberculosis treatment.
  • Not be able to follow the protocol, or not be able to understand the informed consent according to the researcher's judgment, due to various medical, psychological, social or other conditions.

Trial locations and contacts

2 sites in 1 country.

Thailand2 sites

  • Faculty of Medicine, Prince of Songkla University

    Hat Yai, Changwat Songkhla, 90110

  • Prince of Songkla university

    Hat Yai, Changwat Songkhla, 90110

Other trials in Thailand

About this study

Official title: Immunogenicity of an Intradermal Qdenga Vaccine Among Healthy Volunteers: A Pilot Study

Official title: Immunogenicity of an intradermal Qdenga vaccine among healthy volunteers: A pilot study

Read the detailed description

As in the setting of low- to middle-income countries, to demonstrating that lower doses of vaccine via intradermal route can still elicit robust immune responses, thereby lowering the overall cost of vaccination might be particularly meaningful ,with possible extra benefit of experiencing fewer side effects or risk of allergy. This study goal is to explores the potential of intradermal administration of Qdenga, hypothesizing that a lower dose via this route could achieve adequate immunogenicity compared to the standard subcutaneous administration, thus offering a cost-effective alternative particularly in low-resource settings where dengue is most prevalent.

Conditions
Dengue
Being tested
Vaccine
Keywords
Safety, Immunogenicity, intradermal Qdenga
Medical subject headings
Dengue

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • VaccineBiological

    Subcutaneous route vs Intradermal route

Study groups in NCT06837116
Study groupRoleWhat they receive
SC IDActive comparatorsubcutaneous Qdenga for 1st vaccination then intradermal Qdenga for 2nd vaccination
Receives: Biological: Vaccine
SC SCActive comparatorsubcutaneous Qdenga for 1st vaccination then subcutaneous Qdenga for 2nd vaccination
Receives: Biological: Vaccine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Dengue IgG Level

    To measure Antibody level for dengue by ELISA on day 0, day 30 and day 120 after 1st vaccination

    Measured: Day 0 (Baseline), Day 30 (30 days post 1st vaccination) and Day 120 (30 days post 2nd vaccination)

  2. CD4 T Cell Responses

    To measure T cell responses to dengue antigen by ELISpot on day 0, day 30 and day 120 after 1st vaccination.

    Measured: Day 0 (Baseline), Day 30 (30 days post 1st vaccination) and Day 120 (30 days post 2nd vaccination)

  3. CD8 T Cell Response

    To measure T cell responses to dengue antigen by ELISpot on day 0, day 30 and day 120 after 1st vaccination.

    Measured: Day 0 (Baseline), Day 30 (30 days post 1st vaccination) and Day 120 (30 days post 2nd vaccination)

Secondary outcomes (9)

  1. All-Cause Mortality

    Death from any cause occurring from the first vaccination until the end of the 120-day follow-up period.

    Measured: at day 7 and 30 post each vaccination

  2. Serious Adverse Events

    Any untoward medical occurrence during the study period that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability or incapacity, or is a congenital anomaly/birth defect, regardless of its relationship to the study vaccine.

    Measured: at day 7 and 30 post each vaccination

  3. Local Reactions

    • Include any reported pain, swelling, erythema or nodule at the vaccination site

    Measured: at day 7 and 30 post each vaccination

  4. Systemic Reactions

    fever, chill, fatique, headache, myalgia

    Measured: at day 7 and 30 post each vaccination

  5. Pain at Vaccination Site, 7 Day Post 1st Vaccination

    Injection-site pain reported during the 7-day period following the first vaccine dose.

    Measured: 7 day post 1st vaccination

  6. Erythema at Vaccination Site, 7 Day Post 1st Vaccination

    Erythema at vaccination site reported during the 7-day period following the first vaccine dose.

    Measured: 7 day post 1st vaccination

  7. Malaise, 7 Day Post 1st Vaccination

    Self-reported malaise during the 7-day period following the first vaccine dose.

    Measured: 7 day post 1st vaccination

  8. Headache, 7 Day Post 1st Vaccination

    Self-reported headache during the 7-day period following the first vaccine dose.

    Measured: 7 day post 1st vaccination

  9. Erythema at Vaccination Site, 7 Day Post 2nd Vaccination

    Erythema at vaccination site reported during the 7-day period following the second vaccine dose.

    Measured: 7 day post 2nd vaccination

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Feb 2025
  2. Study start19 Apr 2025
  3. Primary completion30 Aug 2025
  4. Study completion30 Sep 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
29 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06837116
Sponsor's protocol ID
REC.67-475-14-1
Status last verified
Sep 2026
First submitted
14 Feb 2025
Last updated
2 Oct 2026
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: The data will be anonymized.

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Vaccine in people with Dengue, run by Prince of Songkla University at 2 sites in Thailand.

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 4 inclusion and 12 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: finished, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Thailand. 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.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Jan 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dengue IgG Level (time frame: Day 0 (Baseline), Day 30 (30 days post 1st vaccination) and Day 120 (30 days post 2nd vaccination)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06837116.

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 2 Oct 2026.

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