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
Type of treatment: Vaccines, Injection or infusion
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

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.

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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 group	Role	What they receive
SC ID	Active comparator	subcutaneous Qdenga for 1st vaccination then intradermal Qdenga for 2nd vaccination Receives: Biological: Vaccine
SC SC	Active comparator	subcutaneous 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.

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)
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)
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)

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
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
Local Reactions
- Include any reported pain, swelling, erythema or nodule at the vaccination site
Measured: at day 7 and 30 post each vaccination
Systemic Reactions
fever, chill, fatique, headache, myalgia
Measured: at day 7 and 30 post each vaccination
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
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
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
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
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.

19 Apr 202530 Sep 2025

First posted20 Feb 2025
Study start19 Apr 2025
Primary completion30 Aug 2025
Study completion30 Sep 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for DengueStudies 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: 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
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: The data will be anonymized.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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