Trial Outcomes & Findings for Immunogenicity of an Intradermal Qdenga Vaccine Among Healthy Volunteers (NCT NCT06837116)
NCT ID: NCT06837116
Last Updated: 2026-01-16
Results Overview
To measure Antibody level for dengue by ELISA on day 0, day 30 and day 120 after 1st vaccination
Recruitment status
COMPLETED
Study phase
EARLY_PHASE1
Target enrollment
29 participants
Primary outcome timeframe
Day 0 (Baseline), Day 30 (30 days post 1st vaccination) and Day 120 (30 days post 2nd vaccination)
Results posted on
2026-01-16
Participant Flow
29 adult volunteers were assessed for eligibility; 24 eligible participants were randomized into 2 groups (n = 12 per group).
5 were excluded (4 have negative baseline dengue IgG, 1 withdraw from the study after randomization because of acute febrile illness prior to first dose vaccination).
Participant milestones
| Measure |
SC ID
subcutaneous Qdenga for 1st vaccination then intradermal Qdenga for 2nd vaccination
|
SC SC
subcutaneous Qdenga for 1st vaccination then subcutaneous Qdenga for 2nd vaccination
|
|---|---|---|
|
Overall Study
STARTED
|
12
|
12
|
|
Overall Study
COMPLETED
|
12
|
12
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
SC ID
n=12 Participants
subcutaneous Qdenga for 1st vaccination then intradermal Qdenga for 2nd vaccination
|
SC SC
n=12 Participants
subcutaneous Qdenga for 1st vaccination then subcutaneous Qdenga for 2nd vaccination
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
32.2 year
n=12 Participants
|
39 year
n=12 Participants
|
35.6 year
n=24 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=12 Participants
|
11 Participants
n=12 Participants
|
21 Participants
n=24 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=12 Participants
|
1 Participants
n=12 Participants
|
3 Participants
n=24 Participants
|
|
Body Mass Index
|
21.18 kg/m^2
n=12 Participants
|
20.96 kg/m^2
n=12 Participants
|
21.05 kg/m^2
n=24 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
PRIMARY outcome
Timeframe: Day 0 (Baseline), Day 30 (30 days post 1st vaccination) and Day 120 (30 days post 2nd vaccination)To measure Antibody level for dengue by ELISA on day 0, day 30 and day 120 after 1st vaccination
Outcome measures
| Measure |
SC ID
n=12 Participants
subcutaneous Qdenga for 1st vaccination then intradermal Qdenga for 2nd vaccination
|
SC SC
n=12 Participants
subcutaneous Qdenga for 1st vaccination then subcutaneous Qdenga for 2nd vaccination
|
|---|---|---|
|
Dengue IgG Level
Baseline
|
108.9 RU/ml
Interval 102.2 to 124.8
|
104.0 RU/ml
Interval 104.0 to 113.0
|
|
Dengue IgG Level
Day 30
|
158.5 RU/ml
Interval 151.1 to 164.5
|
143.2 RU/ml
Interval 129.2 to 150.1
|
|
Dengue IgG Level
Day 120
|
148.6 RU/ml
Interval 143.3 to 159.4
|
141.3 RU/ml
Interval 127.1 to 152.8
|
PRIMARY outcome
Timeframe: Day 0 (Baseline), Day 30 (30 days post 1st vaccination) and Day 120 (30 days post 2nd vaccination)To measure T cell responses to dengue antigen by ELISpot on day 0, day 30 and day 120 after 1st vaccination.
Outcome measures
| Measure |
SC ID
n=12 Participants
subcutaneous Qdenga for 1st vaccination then intradermal Qdenga for 2nd vaccination
|
SC SC
n=12 Participants
subcutaneous Qdenga for 1st vaccination then subcutaneous Qdenga for 2nd vaccination
|
|---|---|---|
|
CD4 T Cell Responses
Baseline
|
22.0 SFCs per 10^6 PBMCs
Interval 17.8 to 81.3
|
15.0 SFCs per 10^6 PBMCs
Interval 5.0 to 38.0
|
|
CD4 T Cell Responses
Day 30
|
137.5 SFCs per 10^6 PBMCs
Interval 60.8 to 178.3
|
103.0 SFCs per 10^6 PBMCs
Interval 46.0 to 134.0
|
|
CD4 T Cell Responses
Day 120
|
98.5 SFCs per 10^6 PBMCs
Interval 21.0 to 163.8
|
94.5 SFCs per 10^6 PBMCs
Interval 67.3 to 127.0
|
PRIMARY outcome
Timeframe: Day 0 (Baseline), Day 30 (30 days post 1st vaccination) and Day 120 (30 days post 2nd vaccination)To measure T cell responses to dengue antigen by ELISpot on day 0, day 30 and day 120 after 1st vaccination.
Outcome measures
| Measure |
SC ID
n=12 Participants
subcutaneous Qdenga for 1st vaccination then intradermal Qdenga for 2nd vaccination
|
SC SC
n=12 Participants
subcutaneous Qdenga for 1st vaccination then subcutaneous Qdenga for 2nd vaccination
|
|---|---|---|
|
CD8 T Cell Response
Day 30
|
62.0 SFCs per 10^6 PBMCs
Interval 24.5 to 105.5
|
11.0 SFCs per 10^6 PBMCs
Interval 2.5 to 67.0
|
|
CD8 T Cell Response
Day 120
|
6.0 SFCs per 10^6 PBMCs
Interval 0.0 to 17.0
|
10.0 SFCs per 10^6 PBMCs
Interval 2.5 to 49.5
|
|
CD8 T Cell Response
Baseline
|
5.0 SFCs per 10^6 PBMCs
Interval 1.8 to 38.5
|
11.0 SFCs per 10^6 PBMCs
Interval 1.0 to 47.0
|
SECONDARY outcome
Timeframe: at day 7 and 30 post each vaccinationDeath from any cause occurring from the first vaccination until the end of the 120-day follow-up period.
Outcome measures
| Measure |
SC ID
n=12 Participants
subcutaneous Qdenga for 1st vaccination then intradermal Qdenga for 2nd vaccination
|
SC SC
n=12 Participants
subcutaneous Qdenga for 1st vaccination then subcutaneous Qdenga for 2nd vaccination
|
|---|---|---|
|
All-Cause Mortality
All-Cause mortality
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: at day 7 and 30 post each vaccinationAny 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.
Outcome measures
| Measure |
SC ID
n=12 Participants
subcutaneous Qdenga for 1st vaccination then intradermal Qdenga for 2nd vaccination
|
SC SC
n=12 Participants
subcutaneous Qdenga for 1st vaccination then subcutaneous Qdenga for 2nd vaccination
|
|---|---|---|
|
Serious Adverse Events
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: at day 7 and 30 post each vaccination\- Include any reported pain, swelling, erythema or nodule at the vaccination site
Outcome measures
| Measure |
SC ID
n=12 Participants
subcutaneous Qdenga for 1st vaccination then intradermal Qdenga for 2nd vaccination
|
SC SC
n=12 Participants
subcutaneous Qdenga for 1st vaccination then subcutaneous Qdenga for 2nd vaccination
|
|---|---|---|
|
Local Reactions
|
3 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: at day 7 and 30 post each vaccinationfever, chill, fatique, headache, myalgia
Outcome measures
| Measure |
SC ID
n=12 Participants
subcutaneous Qdenga for 1st vaccination then intradermal Qdenga for 2nd vaccination
|
SC SC
n=12 Participants
subcutaneous Qdenga for 1st vaccination then subcutaneous Qdenga for 2nd vaccination
|
|---|---|---|
|
Systemic Reactions
|
0 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: 7 day post 1st vaccinationInjection-site pain reported during the 7-day period following the first vaccine dose.
Outcome measures
| Measure |
SC ID
n=12 Participants
subcutaneous Qdenga for 1st vaccination then intradermal Qdenga for 2nd vaccination
|
SC SC
n=12 Participants
subcutaneous Qdenga for 1st vaccination then subcutaneous Qdenga for 2nd vaccination
|
|---|---|---|
|
Pain at Vaccination Site, 7 Day Post 1st Vaccination
|
2 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 7 day post 1st vaccinationErythema at vaccination site reported during the 7-day period following the first vaccine dose.
Outcome measures
| Measure |
SC ID
n=12 Participants
subcutaneous Qdenga for 1st vaccination then intradermal Qdenga for 2nd vaccination
|
SC SC
n=12 Participants
subcutaneous Qdenga for 1st vaccination then subcutaneous Qdenga for 2nd vaccination
|
|---|---|---|
|
Erythema at Vaccination Site, 7 Day Post 1st Vaccination
|
2 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 7 day post 1st vaccinationSelf-reported malaise during the 7-day period following the first vaccine dose.
Outcome measures
| Measure |
SC ID
n=12 Participants
subcutaneous Qdenga for 1st vaccination then intradermal Qdenga for 2nd vaccination
|
SC SC
n=12 Participants
subcutaneous Qdenga for 1st vaccination then subcutaneous Qdenga for 2nd vaccination
|
|---|---|---|
|
Malaise, 7 Day Post 1st Vaccination
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 7 day post 1st vaccinationSelf-reported headache during the 7-day period following the first vaccine dose.
Outcome measures
| Measure |
SC ID
n=12 Participants
subcutaneous Qdenga for 1st vaccination then intradermal Qdenga for 2nd vaccination
|
SC SC
n=12 Participants
subcutaneous Qdenga for 1st vaccination then subcutaneous Qdenga for 2nd vaccination
|
|---|---|---|
|
Headache, 7 Day Post 1st Vaccination
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 7 day post 2nd vaccinationErythema at vaccination site reported during the 7-day period following the second vaccine dose.
Outcome measures
| Measure |
SC ID
n=12 Participants
subcutaneous Qdenga for 1st vaccination then intradermal Qdenga for 2nd vaccination
|
SC SC
n=12 Participants
subcutaneous Qdenga for 1st vaccination then subcutaneous Qdenga for 2nd vaccination
|
|---|---|---|
|
Erythema at Vaccination Site, 7 Day Post 2nd Vaccination
|
2 Participants
|
0 Participants
|
Adverse Events
SC ID
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
SC SC
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
SC ID
n=12 participants at risk
subcutaneous Qdenga for 1st vaccination then intradermal Qdenga for 2nd vaccination
|
SC SC
n=12 participants at risk
subcutaneous Qdenga for 1st vaccination then subcutaneous Qdenga for 2nd vaccination
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Pain at vaccination site, 7 day post 1st vaccination
|
16.7%
2/12 • Day 37, 60 (7 and 30 days post 1st vaccination) and Day 97, 120 (7 and 30 days post 2nd vaccination)
|
8.3%
1/12 • Day 37, 60 (7 and 30 days post 1st vaccination) and Day 97, 120 (7 and 30 days post 2nd vaccination)
|
|
Skin and subcutaneous tissue disorders
Local reactions
|
25.0%
3/12 • Day 37, 60 (7 and 30 days post 1st vaccination) and Day 97, 120 (7 and 30 days post 2nd vaccination)
|
8.3%
1/12 • Day 37, 60 (7 and 30 days post 1st vaccination) and Day 97, 120 (7 and 30 days post 2nd vaccination)
|
|
Immune system disorders
Systemic reactions
|
0.00%
0/12 • Day 37, 60 (7 and 30 days post 1st vaccination) and Day 97, 120 (7 and 30 days post 2nd vaccination)
|
16.7%
2/12 • Day 37, 60 (7 and 30 days post 1st vaccination) and Day 97, 120 (7 and 30 days post 2nd vaccination)
|
|
Skin and subcutaneous tissue disorders
Erythema at vaccination site, 7 day post 1st vaccination
|
16.7%
2/12 • Day 37, 60 (7 and 30 days post 1st vaccination) and Day 97, 120 (7 and 30 days post 2nd vaccination)
|
0.00%
0/12 • Day 37, 60 (7 and 30 days post 1st vaccination) and Day 97, 120 (7 and 30 days post 2nd vaccination)
|
|
General disorders
Malaise, 7 day post 1st vaccination
|
0.00%
0/12 • Day 37, 60 (7 and 30 days post 1st vaccination) and Day 97, 120 (7 and 30 days post 2nd vaccination)
|
8.3%
1/12 • Day 37, 60 (7 and 30 days post 1st vaccination) and Day 97, 120 (7 and 30 days post 2nd vaccination)
|
|
Nervous system disorders
Headache, 7 day post 1st vaccination
|
0.00%
0/12 • Day 37, 60 (7 and 30 days post 1st vaccination) and Day 97, 120 (7 and 30 days post 2nd vaccination)
|
8.3%
1/12 • Day 37, 60 (7 and 30 days post 1st vaccination) and Day 97, 120 (7 and 30 days post 2nd vaccination)
|
|
Skin and subcutaneous tissue disorders
Erythema at vaccination site, 7 day post 2nd vaccination
|
16.7%
2/12 • Day 37, 60 (7 and 30 days post 1st vaccination) and Day 97, 120 (7 and 30 days post 2nd vaccination)
|
0.00%
0/12 • Day 37, 60 (7 and 30 days post 1st vaccination) and Day 97, 120 (7 and 30 days post 2nd vaccination)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place