An Early Phase 1 interventional study of Vaccine in Dengue, sponsored by Prince of Songkla University. Completed at 2 sites in Thailand. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-02.
Sponsored by Prince of Songkla University · Early Phase 1, Interventional, and Basic science
Official title: Immunogenicity of an intradermal Qdenga vaccine among healthy volunteers: A pilot study
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.
279 studies on the registry are indexed under Dengue; 45 are open to participants now.
This study's enrollment of 29 is below the median of 123 across 195 interventional studies indexed under Dengue.
Browse Dengue studies →Prince of Songkla University is the lead sponsor of 112 studies on the registry; 13 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
subcutaneous Qdenga for 1st vaccination then intradermal Qdenga for 2nd vaccination
Biological: Vaccine
subcutaneous Qdenga for 1st vaccination then subcutaneous Qdenga for 2nd vaccination
Biological: Vaccine
Subcutaneous route vs Intradermal route
Dengue IgG Level
To measure Antibody level for dengue by ELISA on day 0, day 30 and day 120 after 1st vaccination
Time frame: 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.
Time frame: 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.
Time frame: Day 0 (Baseline), Day 30 (30 days post 1st vaccination) and Day 120 (30 days post 2nd vaccination)
All-Cause Mortality
Death from any cause occurring from the first vaccination until the end of the 120-day follow-up period.
Time frame: 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.
Time frame: at day 7 and 30 post each vaccination
Local Reactions
\- Include any reported pain, swelling, erythema or nodule at the vaccination site
Time frame: at day 7 and 30 post each vaccination
Systemic Reactions
fever, chill, fatique, headache, myalgia
Time frame: 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.
Time frame: 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.
Time frame: 7 day post 1st vaccination
Malaise, 7 Day Post 1st Vaccination
Self-reported malaise during the 7-day period following the first vaccine dose.
Time frame: 7 day post 1st vaccination
Headache, 7 Day Post 1st Vaccination
Self-reported headache during the 7-day period following the first vaccine dose.
Time frame: 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.
Time frame: 7 day post 2nd vaccination
Twenty-nine adult volunteers were assessed for eligibility. Twenty-four eligible participants were randomized in a 1:1 ratio to the SC-SC or SC-ID group (12 participants per group).
| Milestone | SC ID | SC SC |
|---|---|---|
| Started | 12 | 12 |
| Completed | 12 | 12 |
| Not completed | 0 | 0 |
To measure Antibody level for dengue by ELISA on day 0, day 30 and day 120 after 1st vaccination
| RU/ml | SC ID | SC SC |
|---|---|---|
| Baseline | 108.9 (102.2 to 124.8) | 104.0 (104.0 to 113.0) |
| Day 30 | 158.5 (151.1 to 164.5) | 143.2 (129.2 to 150.1) |
| Day 120 | 148.6 (143.3 to 159.4) | 141.3 (127.1 to 152.8) |
To measure T cell responses to dengue antigen by ELISpot on day 0, day 30 and day 120 after 1st vaccination.
| SFCs per 10^6 PBMCs | SC ID | SC SC |
|---|---|---|
| Baseline | 22.0 (17.8 to 81.3) | 15.0 (5.0 to 38.0) |
| Day 30 | 137.5 (60.8 to 178.3) | 103.0 (46.0 to 134.0) |
| Day 120 | 98.5 (21.0 to 163.8) | 94.5 (67.3 to 127.0) |
To measure T cell responses to dengue antigen by ELISpot on day 0, day 30 and day 120 after 1st vaccination.
| SFCs per 10^6 PBMCs | SC ID | SC SC |
|---|---|---|
| Baseline | 5.0 (1.8 to 38.5) | 11.0 (1.0 to 47.0) |
| Day 30 | 62.0 (24.5 to 105.5) | 11.0 (2.5 to 67.0) |
| Day 120 | 6.0 (0.0 to 17.0) | 10.0 (2.5 to 49.5) |
Death from any cause occurring from the first vaccination until the end of the 120-day follow-up period.
| Participants | SC ID | SC SC |
|---|---|---|
| All-Cause mortality | 0 | 0 |
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.
| Participants | SC ID | SC SC |
|---|---|---|
| Serious Adverse Events | 0 | 0 |
\- Include any reported pain, swelling, erythema or nodule at the vaccination site
| Participants | SC ID | SC SC |
|---|---|---|
| Local Reactions | 3 | 1 |
fever, chill, fatique, headache, myalgia
| Participants | SC ID | SC SC |
|---|---|---|
| Systemic Reactions | 0 | 2 |
Injection-site pain reported during the 7-day period following the first vaccine dose.
| Participants | SC ID | SC SC |
|---|---|---|
| Pain at Vaccination Site, 7 Day Post 1st Vaccination | 2 | 1 |
Erythema at vaccination site reported during the 7-day period following the first vaccine dose.
| Participants | SC ID | SC SC |
|---|---|---|
| Erythema at Vaccination Site, 7 Day Post 1st Vaccination | 2 | 0 |
Self-reported malaise during the 7-day period following the first vaccine dose.
| Participants | SC ID | SC SC |
|---|---|---|
| Malaise, 7 Day Post 1st Vaccination | 0 | 1 |
Self-reported headache during the 7-day period following the first vaccine dose.
| Participants | SC ID | SC SC |
|---|---|---|
| Headache, 7 Day Post 1st Vaccination | 0 | 1 |
Erythema at vaccination site reported during the 7-day period following the second vaccine dose.
| Participants | SC ID | SC SC |
|---|---|---|
| Erythema at Vaccination Site, 7 Day Post 2nd Vaccination | 2 | 0 |
Collected over Day 37, 60 (7 and 30 days post 1st vaccination) and Day 97, 120 (7 and 30 days post 2nd vaccination). Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| SC ID | 0/12 (0%) | 0/12 (0%) | 3/12 (25%) |
| SC SC | 0/12 (0%) | 0/12 (0%) | 3/12 (25%) |
| Event | SC ID | SC SC |
|---|---|---|
| Local reactionsSkin and subcutaneous tissue disorders | 3/12 | 1/12 |
| Systemic reactionsImmune system disorders | 0/12 | 2/12 |
| Pain at vaccination site, 7 day post 1st vaccinationSkin and subcutaneous tissue disorders | 2/12 | 1/12 |
| Erythema at vaccination site, 7 day post 1st vaccinationSkin and subcutaneous tissue disorders | 2/12 | 0/12 |
| Erythema at vaccination site, 7 day post 2nd vaccinationSkin and subcutaneous tissue disorders | 2/12 | 0/12 |
| Malaise, 7 day post 1st vaccinationGeneral disorders | 0/12 | 1/12 |
| Headache, 7 day post 1st vaccinationNervous system disorders | 0/12 | 1/12 |
| Age, Continuous(year) | SC ID | SC SC | Total |
|---|---|---|---|
| Median | 32.2 (23.9 to 40.5) | 39 (32 to 46) | 35.6 (27.3 to 43.9) |
| Sex: Female, Male(Participants) | SC ID | SC SC | Total |
|---|---|---|---|
| Female | 10 | 11 | 21 |
| Male | 2 | 1 | 3 |
| Body Mass Index(kg/m^2) | SC ID | SC SC | Total |
|---|---|---|---|
| Median | 21.18 (19.87 to 24.97) | 20.96 (20.34 to 23.34) | 21.05 (20.00 to 24.81) |
| Race and Ethnicity Not Collected(Participants) | SC ID | SC SC | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: No — The data will be anonymized.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Prince of Songkla University