Trial Outcomes & Findings for A Phase I/II Trial of a Tetravalent Live Attenuated DEN Vaccine in Flavivirus Antibody Naive Children (NCT NCT01843621)
NCT ID: NCT01843621
Last Updated: 2018-11-26
Results Overview
Neutralizing antibodies as measured by plaque reduction neutralization test (seropositivity rates to each dengue virus serotype at Prebooster Year 1, 30 Days Post Booster, Year 2, and Year 3 time points.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
7 participants
Primary outcome timeframe
Prebooster Year 1, 30 Days Post Booster, Year 2, and Year 3
Results posted on
2018-11-26
Participant Flow
Seven Thai children from the Dengue-03 study will be invited to participate
Participant milestones
| Measure |
Total Vaccinated
The total vaccinated cohort included all enrolled subjects who received the DEN vaccine F17 for whom data were available. These subjects were Thai children previously enrolled and vaccinated in study Dengue-003
DEN vaccine F17: The dengue booster vaccine was administered subcutaneously in the non-dominant arm (deltoid). The tetravalent, live attenuated DEN F17 vaccine was administered in this study. This pre-transfection formulation contained dengue virus types 1, 2, 3 and 4 (DEN-1, -2, -3 and -4).
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|---|---|
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Overall Study
STARTED
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7
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Overall Study
COMPLETED
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7
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Phase I/II Trial of a Tetravalent Live Attenuated DEN Vaccine in Flavivirus Antibody Naive Children
Baseline characteristics by cohort
| Measure |
Total Vaccinated
n=7 Participants
The total vaccinated cohort included all enrolled subjects who received the DEN vaccine F17 for whom data were available. These subjects were Thai children previously enrolled and vaccinated in study Dengue-003
DEN vaccine F17: The dengue booster vaccine was administered subcutaneously in the non-dominant arm (deltoid). The tetravalent, live attenuated DEN F17 vaccine was administered in this study. This pre-transfection formulation contained dengue virus types 1, 2, 3 and 4 (DEN-1, -2, -3 and -4).
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|---|---|
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Age, Continuous
|
8.3 years
STANDARD_DEVIATION 0.49 • n=5 Participants
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Sex: Female, Male
Female
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5 Participants
n=5 Participants
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Sex: Female, Male
Male
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2 Participants
n=5 Participants
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Region of Enrollment
Thailand
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7 participants
n=5 Participants
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PRIMARY outcome
Timeframe: Prebooster Year 1, 30 Days Post Booster, Year 2, and Year 3Population: Immunogenicity data for one subject was not included in the ATP analysis due to an asymptomatic, sub-clinical, wild-type DEN-2 virus infection prior to DEN vaccine dose 1
Neutralizing antibodies as measured by plaque reduction neutralization test (seropositivity rates to each dengue virus serotype at Prebooster Year 1, 30 Days Post Booster, Year 2, and Year 3 time points.
Outcome measures
| Measure |
> 10 ED50
n=6 Participants
Seropositivity rates (% of subjects)
|
AST Level
Normal Range = 0-40
|
PLA Level
Normal Range = 150000-350000
|
HC Level
Normal Range = 35-45
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NEU Level
Normal Range = 1500-8000
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|---|---|---|---|---|---|
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Percentage of Subjects With Seropositivity Rates for Antibodies to DEN-1 - DEN-4 (ATP Cohort for Immunogenicity)
N lg to DEN-1: Prebooster Year 1
|
16.7 % of subjects
Interval 0.4 to 64.1
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—
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—
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—
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—
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Percentage of Subjects With Seropositivity Rates for Antibodies to DEN-1 - DEN-4 (ATP Cohort for Immunogenicity)
N lg to DEN-1: 30 Days Post Booster
|
83.3 % of subjects
Interval 35.9 to 99.6
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—
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—
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—
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—
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Percentage of Subjects With Seropositivity Rates for Antibodies to DEN-1 - DEN-4 (ATP Cohort for Immunogenicity)
N lg to DEN-1: Year 2
|
16.7 % of subjects
Interval 0.4 to 64.1
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—
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—
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—
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—
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Percentage of Subjects With Seropositivity Rates for Antibodies to DEN-1 - DEN-4 (ATP Cohort for Immunogenicity)
N lg to DEN-1: Year 3
|
66.7 % of subjects
Interval 22.3 to 95.7
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—
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—
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—
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—
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Percentage of Subjects With Seropositivity Rates for Antibodies to DEN-1 - DEN-4 (ATP Cohort for Immunogenicity)
N lg to DEN-2: Prebooster Year 1
|
50.0 % of subjects
Interval 11.8 to 88.2
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—
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—
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—
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—
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Percentage of Subjects With Seropositivity Rates for Antibodies to DEN-1 - DEN-4 (ATP Cohort for Immunogenicity)
N lg to DEN-2: 30 Days Post Booster
|
100 % of subjects
Interval 54.1 to 100.0
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—
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—
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—
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—
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Percentage of Subjects With Seropositivity Rates for Antibodies to DEN-1 - DEN-4 (ATP Cohort for Immunogenicity)
N lg to DEN-2: Year 2
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66.7 % of subjects
Interval 22.3 to 95.7
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—
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—
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—
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—
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Percentage of Subjects With Seropositivity Rates for Antibodies to DEN-1 - DEN-4 (ATP Cohort for Immunogenicity)
N lg to DEN-2: Year 3
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83.3 % of subjects
Interval 35.9 to 99.6
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—
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—
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—
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—
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Percentage of Subjects With Seropositivity Rates for Antibodies to DEN-1 - DEN-4 (ATP Cohort for Immunogenicity)
N lg to DEN-3: Prebooster Year 1
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33.3 % of subjects
Interval 4.3 to 77.7
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—
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—
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—
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—
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Percentage of Subjects With Seropositivity Rates for Antibodies to DEN-1 - DEN-4 (ATP Cohort for Immunogenicity)
N lg to DEN-3: 30 Days Post Booster
|
100 % of subjects
Interval 54.1 to 100.0
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—
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—
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—
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—
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Percentage of Subjects With Seropositivity Rates for Antibodies to DEN-1 - DEN-4 (ATP Cohort for Immunogenicity)
N lg to DEN-3: Year 2
|
33.3 % of subjects
Interval 4.3 to 77.7
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—
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—
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—
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—
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Percentage of Subjects With Seropositivity Rates for Antibodies to DEN-1 - DEN-4 (ATP Cohort for Immunogenicity)
N lg to DEN-3: Year 3
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50.0 % of subjects
Interval 11.8 to 88.2
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—
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—
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—
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—
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Percentage of Subjects With Seropositivity Rates for Antibodies to DEN-1 - DEN-4 (ATP Cohort for Immunogenicity)
N lg to DEN-4: Prebooster Year 1
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50.0 % of subjects
Interval 11.8 to 88.2
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—
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—
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—
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—
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Percentage of Subjects With Seropositivity Rates for Antibodies to DEN-1 - DEN-4 (ATP Cohort for Immunogenicity)
N lg to DEN-4: 30 days Post Booster
|
100 % of subjects
Interval 54.1 to 100.0
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—
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—
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—
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—
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Percentage of Subjects With Seropositivity Rates for Antibodies to DEN-1 - DEN-4 (ATP Cohort for Immunogenicity)
N lg to DEN-4: Year 2
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50.0 % of subjects
Interval 11.8 to 88.2
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—
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—
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—
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—
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Percentage of Subjects With Seropositivity Rates for Antibodies to DEN-1 - DEN-4 (ATP Cohort for Immunogenicity)
N lg to DEN-4: Year 3
|
100 % of subjects
Interval 54.1 to 100.0
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—
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—
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—
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—
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PRIMARY outcome
Timeframe: Prebooster Year 1, 30 Days Post Booster, Year 2, and Year 3Neutralizing antibodies as measured by plaque reduction neutralization test (geometric mean titers \[GMTs\]) to each dengue virus serotype at Prebooster Year 1, 30 Days Post Booster, Year 2, and Year 3 time points.
Outcome measures
| Measure |
> 10 ED50
n=6 Participants
Seropositivity rates (% of subjects)
|
AST Level
Normal Range = 0-40
|
PLA Level
Normal Range = 150000-350000
|
HC Level
Normal Range = 35-45
|
NEU Level
Normal Range = 1500-8000
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|---|---|---|---|---|---|
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Geometric Mean Titers (GMTs) on All Subjects for Antibodies to DEN-1 - DEN-4 (ATP Cohort for Immunogenicity)
N lg to DEN-1: Pre-booster Year 1
|
6.0 GMTs
Interval 3.8 to 9.6
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—
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—
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—
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—
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Geometric Mean Titers (GMTs) on All Subjects for Antibodies to DEN-1 - DEN-4 (ATP Cohort for Immunogenicity)
N lg to DEN-1: 30 Days Post-booster
|
28.2 GMTs
Interval 6.6 to 121.3
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—
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—
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—
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—
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Geometric Mean Titers (GMTs) on All Subjects for Antibodies to DEN-1 - DEN-4 (ATP Cohort for Immunogenicity)
N lg to DEN-1: Year 2
|
6.8 GMTs
Interval 3.1 to 15.1
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—
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—
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—
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—
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Geometric Mean Titers (GMTs) on All Subjects for Antibodies to DEN-1 - DEN-4 (ATP Cohort for Immunogenicity)
N lg to DEN-1: Year 3
|
18.0 GMTs
Interval 5.2 to 63.0
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—
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—
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—
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—
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Geometric Mean Titers (GMTs) on All Subjects for Antibodies to DEN-1 - DEN-4 (ATP Cohort for Immunogenicity)
N lg to DEN-2: Pre-booster Year 1
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16.8 GMTs
Interval 3.4 to 82.5
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—
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—
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—
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—
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Geometric Mean Titers (GMTs) on All Subjects for Antibodies to DEN-1 - DEN-4 (ATP Cohort for Immunogenicity)
N lg to DEN-2: 30 Day Post-booster
|
94.4 GMTs
Interval 24.0 to 370.3
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—
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—
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—
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—
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Geometric Mean Titers (GMTs) on All Subjects for Antibodies to DEN-1 - DEN-4 (ATP Cohort for Immunogenicity)
N lg to DEN-2: Year 2
|
20.8 GMTs
Interval 4.6 to 92.9
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—
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—
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—
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—
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Geometric Mean Titers (GMTs) on All Subjects for Antibodies to DEN-1 - DEN-4 (ATP Cohort for Immunogenicity)
N lg to DEN-2: Year 3
|
36.3 GMTs
Interval 7.0 to 186.8
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—
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—
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—
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—
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Geometric Mean Titers (GMTs) on All Subjects for Antibodies to DEN-1 - DEN-4 (ATP Cohort for Immunogenicity)
N lg to DEN-3: Pre-booster Year 1
|
12.8 GMTs
Interval 2.1 to 77.5
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—
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—
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—
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—
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Geometric Mean Titers (GMTs) on All Subjects for Antibodies to DEN-1 - DEN-4 (ATP Cohort for Immunogenicity)
N lg to DEN-3: 30 Days post-booster
|
67.2 GMTs
Interval 9.3 to 487.2
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—
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—
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—
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—
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Geometric Mean Titers (GMTs) on All Subjects for Antibodies to DEN-1 - DEN-4 (ATP Cohort for Immunogenicity)
N lg to DEN-3: Year 2
|
9.4 GMTs
Interval 2.8 to 31.7
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—
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—
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—
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—
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Geometric Mean Titers (GMTs) on All Subjects for Antibodies to DEN-1 - DEN-4 (ATP Cohort for Immunogenicity)
N lg to DEN-3: Year 3
|
12.9 GMTs
Interval 4.1 to 41.3
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—
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—
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—
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—
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Geometric Mean Titers (GMTs) on All Subjects for Antibodies to DEN-1 - DEN-4 (ATP Cohort for Immunogenicity)
N lg to DEN-4: Pre-booster Year 1
|
27.0 GMTs
Interval 3.6 to 200.7
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—
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—
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—
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—
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Geometric Mean Titers (GMTs) on All Subjects for Antibodies to DEN-1 - DEN-4 (ATP Cohort for Immunogenicity)
N lg to DEN-4: 30 Days Post-booster
|
112.0 GMTs
Interval 26.5 to 473.1
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—
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—
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—
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—
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Geometric Mean Titers (GMTs) on All Subjects for Antibodies to DEN-1 - DEN-4 (ATP Cohort for Immunogenicity)
N lg to DEN-4: Year 2
|
25.4 GMTs
Interval 3.5 to 182.1
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—
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—
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—
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—
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Geometric Mean Titers (GMTs) on All Subjects for Antibodies to DEN-1 - DEN-4 (ATP Cohort for Immunogenicity)
N lg to DEN-4: Year 3
|
70.4 GMTs
Interval 23.9 to 207.4
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—
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—
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—
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—
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SECONDARY outcome
Timeframe: 21 daysPopulation: Incidence of solicited local symptoms reported during the 21-day post-vaccination (total vaccination cohort).
Incidence of solicited local symptoms reported during the 21-day post-vaccination (total vaccination cohort).
Outcome measures
| Measure |
> 10 ED50
n=7 Participants
Seropositivity rates (% of subjects)
|
AST Level
Normal Range = 0-40
|
PLA Level
Normal Range = 150000-350000
|
HC Level
Normal Range = 35-45
|
NEU Level
Normal Range = 1500-8000
|
|---|---|---|---|---|---|
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Solicited Local Adverse Events (AEs) Within 21 Day Follow-up
Pain: All
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3 Adverse events
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—
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—
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—
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—
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Solicited Local Adverse Events (AEs) Within 21 Day Follow-up
Pain: Grade 3
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0 Adverse events
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—
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—
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—
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—
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Solicited Local Adverse Events (AEs) Within 21 Day Follow-up
Redness: All
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3 Adverse events
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—
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—
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—
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—
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Solicited Local Adverse Events (AEs) Within 21 Day Follow-up
Redness: Grade 3
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0 Adverse events
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—
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—
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—
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—
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Solicited Local Adverse Events (AEs) Within 21 Day Follow-up
Swelling: All
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4 Adverse events
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—
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—
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—
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—
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Solicited Local Adverse Events (AEs) Within 21 Day Follow-up
Swelling: Grade 3
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1 Adverse events
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—
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—
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—
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—
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SECONDARY outcome
Timeframe: 31 daysPopulation: Percentage of subjects reporting unsolicited AEs within 31 days (Day 0-30) after the DEN vaccine dose (total vaccinated cohort)
Percentage of subjects reporting unsolicited AEs within 31 days (Day 0-30) after the DEN vaccine dose (total vaccinated cohort)
Outcome measures
| Measure |
> 10 ED50
n=7 Participants
Seropositivity rates (% of subjects)
|
AST Level
Normal Range = 0-40
|
PLA Level
Normal Range = 150000-350000
|
HC Level
Normal Range = 35-45
|
NEU Level
Normal Range = 1500-8000
|
|---|---|---|---|---|---|
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Unsolicited Adverse Events (AEs) Within 31 Days Post Vaccination
At Least One Symptom
|
85.7 Percentage of subjects
Interval 42.1 to 99.6
|
—
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—
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—
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—
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Unsolicited Adverse Events (AEs) Within 31 Days Post Vaccination
Infections and Infestations
|
14.3 Percentage of subjects
Interval 0.4 to 57.9
|
—
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—
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—
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—
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Unsolicited Adverse Events (AEs) Within 31 Days Post Vaccination
Injury, Poisoning and Procedural Complications
|
14.3 Percentage of subjects
Interval 0.4 to 57.9
|
—
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—
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—
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—
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Unsolicited Adverse Events (AEs) Within 31 Days Post Vaccination
Nervous System Disorders
|
42.9 Percentage of subjects
Interval 9.9 to 81.6
|
—
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—
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—
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—
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Unsolicited Adverse Events (AEs) Within 31 Days Post Vaccination
Renal and Urinary Disorders
|
14.3 Percentage of subjects
Interval 0.4 to 57.9
|
—
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—
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—
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—
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Unsolicited Adverse Events (AEs) Within 31 Days Post Vaccination
Respiratory, Thoracic and Mediastinal Disorders
|
28.6 Percentage of subjects
Interval 3.7 to 71.0
|
—
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—
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—
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—
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SECONDARY outcome
Timeframe: 31 daysPopulation: Occurrence of SAEs within 31 days (Day 0-30) after vaccination
Occurrence of SAEs within 31 days (Day 0-30) after vaccination
Outcome measures
| Measure |
> 10 ED50
n=7 Participants
Seropositivity rates (% of subjects)
|
AST Level
Normal Range = 0-40
|
PLA Level
Normal Range = 150000-350000
|
HC Level
Normal Range = 35-45
|
NEU Level
Normal Range = 1500-8000
|
|---|---|---|---|---|---|
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Serious Adverse Events (SAE) Within 31 Days Post Vaccination
|
0 Participants
|
—
|
—
|
—
|
—
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SECONDARY outcome
Timeframe: 31 daysPopulation: Incidence of dengue physical examination findings reported during the 31-day post-vaccination period (total vaccinated cohort)
Incidence of dengue physical examination findings reported during the 31-day post-vaccination period (total vaccinated cohort)
Outcome measures
| Measure |
> 10 ED50
n=7 Participants
Seropositivity rates (% of subjects)
|
AST Level
Normal Range = 0-40
|
PLA Level
Normal Range = 150000-350000
|
HC Level
Normal Range = 35-45
|
NEU Level
Normal Range = 1500-8000
|
|---|---|---|---|---|---|
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Abnormal Findings Reported During Physical Exam 31-Days Post Vaccination
|
42.9 Percentage of subjects
Interval 9.9 to 86.6
|
—
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—
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—
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—
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SECONDARY outcome
Timeframe: Prebooster year 1, 30 Days Post Booster, Year 2, Year 3Population: Monovalent, Bivalent, Trivalent and Tetravalent response for DEN neut. antibodies 30 days post booster dose vaccine (ATP cohort for immunogenicity). Immunogenicity data for one subject was not included in the ATP analysis due to an asymptomatic, sub-clinical, wild-type DEN-2 virus infection prior to DEN vaccine dose 1
Monovalent, Bivalent, Trivalent and Tetravalent response for DEN neut. antibodies 30 days post booster dose vaccine (ATP cohort for immunogenicity)
Outcome measures
| Measure |
> 10 ED50
n=6 Participants
Seropositivity rates (% of subjects)
|
AST Level
Normal Range = 0-40
|
PLA Level
Normal Range = 150000-350000
|
HC Level
Normal Range = 35-45
|
NEU Level
Normal Range = 1500-8000
|
|---|---|---|---|---|---|
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Monovalent, Bivalent, Trivalent and Tetravalent Response for Neutralizing Antibodies 30 Days Post Booster
Year 2: Monovalent
|
33.33 percentage of subjects
Interval 4.33 to 77.72
|
—
|
—
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—
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—
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Monovalent, Bivalent, Trivalent and Tetravalent Response for Neutralizing Antibodies 30 Days Post Booster
Pre-Booster Year 1: Monovalent
|
16.67 percentage of subjects
Interval 0.42 to 64.12
|
—
|
—
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—
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—
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|
Monovalent, Bivalent, Trivalent and Tetravalent Response for Neutralizing Antibodies 30 Days Post Booster
Pre-Booster Year 1: Bivalent
|
33.33 percentage of subjects
Interval 4.33 to 77.72
|
—
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—
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—
|
—
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|
Monovalent, Bivalent, Trivalent and Tetravalent Response for Neutralizing Antibodies 30 Days Post Booster
Pre-Booster Year 1: Trivalent
|
0.00 percentage of subjects
Interval 0.0 to 45.93
|
—
|
—
|
—
|
—
|
|
Monovalent, Bivalent, Trivalent and Tetravalent Response for Neutralizing Antibodies 30 Days Post Booster
Pre-Booster Year 1: Tetravalent
|
16.67 percentage of subjects
Interval 0.42 to 64.12
|
—
|
—
|
—
|
—
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|
Monovalent, Bivalent, Trivalent and Tetravalent Response for Neutralizing Antibodies 30 Days Post Booster
30 Days Post Booster: Monovalent
|
0.00 percentage of subjects
Interval 0.0 to 45.93
|
—
|
—
|
—
|
—
|
|
Monovalent, Bivalent, Trivalent and Tetravalent Response for Neutralizing Antibodies 30 Days Post Booster
30 Days Post Booster: Bivalent
|
0.00 percentage of subjects
Interval 0.0 to 45.93
|
—
|
—
|
—
|
—
|
|
Monovalent, Bivalent, Trivalent and Tetravalent Response for Neutralizing Antibodies 30 Days Post Booster
30 Days post Booster: Trivalent
|
16.67 percentage of subjects
Interval 0.42 to 64.12
|
—
|
—
|
—
|
—
|
|
Monovalent, Bivalent, Trivalent and Tetravalent Response for Neutralizing Antibodies 30 Days Post Booster
30 Days Post Booster: Tetravalent
|
83.33 percentage of subjects
Interval 35.88 to 99.58
|
—
|
—
|
—
|
—
|
|
Monovalent, Bivalent, Trivalent and Tetravalent Response for Neutralizing Antibodies 30 Days Post Booster
Year 2: Bivalent
|
33.33 percentage of subjects
Interval 4.33 to 77.72
|
—
|
—
|
—
|
—
|
|
Monovalent, Bivalent, Trivalent and Tetravalent Response for Neutralizing Antibodies 30 Days Post Booster
Year 2: Trivalent
|
0.00 percentage of subjects
Interval 0.0 to 45.93
|
—
|
—
|
—
|
—
|
|
Monovalent, Bivalent, Trivalent and Tetravalent Response for Neutralizing Antibodies 30 Days Post Booster
Year 2: Tetravalent
|
16.67 percentage of subjects
Interval 0.42 to 64.12
|
—
|
—
|
—
|
—
|
|
Monovalent, Bivalent, Trivalent and Tetravalent Response for Neutralizing Antibodies 30 Days Post Booster
Year 3: Monovalent
|
0.00 percentage of subjects
Interval 0.0 to 45.93
|
—
|
—
|
—
|
—
|
|
Monovalent, Bivalent, Trivalent and Tetravalent Response for Neutralizing Antibodies 30 Days Post Booster
Year 3: Bivalent
|
33.33 percentage of subjects
Interval 4.33 to 77.72
|
—
|
—
|
—
|
—
|
|
Monovalent, Bivalent, Trivalent and Tetravalent Response for Neutralizing Antibodies 30 Days Post Booster
Year 3: Trivalent
|
33.33 percentage of subjects
Interval 4.33 to 77.72
|
—
|
—
|
—
|
—
|
|
Monovalent, Bivalent, Trivalent and Tetravalent Response for Neutralizing Antibodies 30 Days Post Booster
Year 3: Tetravalent
|
33.33 percentage of subjects
Interval 4.33 to 77.72
|
—
|
—
|
—
|
—
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SECONDARY outcome
Timeframe: 10 daysPopulation: Nested PCR for DEN was conducted on day 10 after DEN booster vaccination to evaluate the presence of Dengue viremia 10 days after vaccination
Nested Polymerase Chain Reaction (PCR) for DEN was conducted on day 10 after DEN booster vaccination to evaluate the presence of Dengue viremia 10 days after vaccination
Outcome measures
| Measure |
> 10 ED50
n=7 Participants
Seropositivity rates (% of subjects)
|
AST Level
Normal Range = 0-40
|
PLA Level
Normal Range = 150000-350000
|
HC Level
Normal Range = 35-45
|
NEU Level
Normal Range = 1500-8000
|
|---|---|---|---|---|---|
|
Presence of Dengue Viremia 10 Days After the Dengue Vaccine Dose
|
1 Participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 1 year, 30 Days Post Booster, 2 yearsThe ratio of DEN Immunoglobulin type M and G (IgM:IgG) measured at the time of booster vaccination and 30 days following was used to assess intercurrent flavivirus infection. Flavivirus infection in terms of dengue IgM and IgG and Japanese encephalitis virus (JEV) IgM and IgG is summarized. Flavivirus immunity= ratio IgM on IgG \<1.8 with either IgM or IgM \>1:40 If the antibody response is detectable by isotype capture enzyme immunoassay (either the IgM or IgG component ≥40 U), its anamnestic character can be inferred from detection of a DEN IgM to IgG ratio of \<1.8.
Outcome measures
| Measure |
> 10 ED50
n=6 Participants
Seropositivity rates (% of subjects)
|
AST Level
Normal Range = 0-40
|
PLA Level
Normal Range = 150000-350000
|
HC Level
Normal Range = 35-45
|
NEU Level
Normal Range = 1500-8000
|
|---|---|---|---|---|---|
|
Flavivirus Infection in Terms of Dengue Immunoglobulin M and Immunoglobulin G Per Subject (ATP Cohort for Immunogenicity)
JEV Subject 6: Year 2 Ratio
|
0 Flavivirus immunity ratio
|
—
|
—
|
—
|
—
|
|
Flavivirus Infection in Terms of Dengue Immunoglobulin M and Immunoglobulin G Per Subject (ATP Cohort for Immunogenicity)
DEN Subject 2: 1 Year Ratio
|
0 Flavivirus immunity ratio
|
—
|
—
|
—
|
—
|
|
Flavivirus Infection in Terms of Dengue Immunoglobulin M and Immunoglobulin G Per Subject (ATP Cohort for Immunogenicity)
DEN Subject 2: 30 Days Post Booster Ratio
|
0.3 Flavivirus immunity ratio
|
—
|
—
|
—
|
—
|
|
Flavivirus Infection in Terms of Dengue Immunoglobulin M and Immunoglobulin G Per Subject (ATP Cohort for Immunogenicity)
DEN Subject 2: Year 2 Ratio
|
0 Flavivirus immunity ratio
|
—
|
—
|
—
|
—
|
|
Flavivirus Infection in Terms of Dengue Immunoglobulin M and Immunoglobulin G Per Subject (ATP Cohort for Immunogenicity)
JEV Subject 2: Year 1 Ratio
|
0 Flavivirus immunity ratio
|
—
|
—
|
—
|
—
|
|
Flavivirus Infection in Terms of Dengue Immunoglobulin M and Immunoglobulin G Per Subject (ATP Cohort for Immunogenicity)
JEV Subject 2: 30 Days Post Booster Ratio
|
0.4 Flavivirus immunity ratio
|
—
|
—
|
—
|
—
|
|
Flavivirus Infection in Terms of Dengue Immunoglobulin M and Immunoglobulin G Per Subject (ATP Cohort for Immunogenicity)
JEV Subject 2: Year 2 Ratio
|
0 Flavivirus immunity ratio
|
—
|
—
|
—
|
—
|
|
Flavivirus Infection in Terms of Dengue Immunoglobulin M and Immunoglobulin G Per Subject (ATP Cohort for Immunogenicity)
DEN Subject 3: Year 1 Ratio
|
0 Flavivirus immunity ratio
|
—
|
—
|
—
|
—
|
|
Flavivirus Infection in Terms of Dengue Immunoglobulin M and Immunoglobulin G Per Subject (ATP Cohort for Immunogenicity)
DEN Subject 3: 30 Days Post Booster Ratio
|
0 Flavivirus immunity ratio
|
—
|
—
|
—
|
—
|
|
Flavivirus Infection in Terms of Dengue Immunoglobulin M and Immunoglobulin G Per Subject (ATP Cohort for Immunogenicity)
DEN Subject 3: Year 2 Ratio
|
0 Flavivirus immunity ratio
|
—
|
—
|
—
|
—
|
|
Flavivirus Infection in Terms of Dengue Immunoglobulin M and Immunoglobulin G Per Subject (ATP Cohort for Immunogenicity)
JEV Subject 3: Year 1 Ratio
|
0 Flavivirus immunity ratio
|
—
|
—
|
—
|
—
|
|
Flavivirus Infection in Terms of Dengue Immunoglobulin M and Immunoglobulin G Per Subject (ATP Cohort for Immunogenicity)
JEV Subject 3: 30 Days Post Booster Ratio
|
0 Flavivirus immunity ratio
|
—
|
—
|
—
|
—
|
|
Flavivirus Infection in Terms of Dengue Immunoglobulin M and Immunoglobulin G Per Subject (ATP Cohort for Immunogenicity)
JEV Subject 3: Year 2 Ratio
|
0 Flavivirus immunity ratio
|
—
|
—
|
—
|
—
|
|
Flavivirus Infection in Terms of Dengue Immunoglobulin M and Immunoglobulin G Per Subject (ATP Cohort for Immunogenicity)
DEN Subject 4: Year 1 Ratio
|
0 Flavivirus immunity ratio
|
—
|
—
|
—
|
—
|
|
Flavivirus Infection in Terms of Dengue Immunoglobulin M and Immunoglobulin G Per Subject (ATP Cohort for Immunogenicity)
DEN Subject 4: 30 Days Post Booster Ratio
|
0 Flavivirus immunity ratio
|
—
|
—
|
—
|
—
|
|
Flavivirus Infection in Terms of Dengue Immunoglobulin M and Immunoglobulin G Per Subject (ATP Cohort for Immunogenicity)
DEN Subject 4: Year 2 Ratio
|
0 Flavivirus immunity ratio
|
—
|
—
|
—
|
—
|
|
Flavivirus Infection in Terms of Dengue Immunoglobulin M and Immunoglobulin G Per Subject (ATP Cohort for Immunogenicity)
JEV Subject 4: Year 1 Ratio
|
0 Flavivirus immunity ratio
|
—
|
—
|
—
|
—
|
|
Flavivirus Infection in Terms of Dengue Immunoglobulin M and Immunoglobulin G Per Subject (ATP Cohort for Immunogenicity)
JEV Subject 4: Year 2 Ratio
|
0 Flavivirus immunity ratio
|
—
|
—
|
—
|
—
|
|
Flavivirus Infection in Terms of Dengue Immunoglobulin M and Immunoglobulin G Per Subject (ATP Cohort for Immunogenicity)
DEN Subject 5: Year 1 Ratio
|
0 Flavivirus immunity ratio
|
—
|
—
|
—
|
—
|
|
Flavivirus Infection in Terms of Dengue Immunoglobulin M and Immunoglobulin G Per Subject (ATP Cohort for Immunogenicity)
DEN Subject 5: 30 Days Post Booster Ratio
|
0 Flavivirus immunity ratio
|
—
|
—
|
—
|
—
|
|
Flavivirus Infection in Terms of Dengue Immunoglobulin M and Immunoglobulin G Per Subject (ATP Cohort for Immunogenicity)
DEN Subject 5: Year 2 Ratio
|
0 Flavivirus immunity ratio
|
—
|
—
|
—
|
—
|
|
Flavivirus Infection in Terms of Dengue Immunoglobulin M and Immunoglobulin G Per Subject (ATP Cohort for Immunogenicity)
JEV Subject 5: Year 1 Ratio
|
0 Flavivirus immunity ratio
|
—
|
—
|
—
|
—
|
|
Flavivirus Infection in Terms of Dengue Immunoglobulin M and Immunoglobulin G Per Subject (ATP Cohort for Immunogenicity)
JEV Subject 5: 30 Days Post Booster Ratio
|
0 Flavivirus immunity ratio
|
—
|
—
|
—
|
—
|
|
Flavivirus Infection in Terms of Dengue Immunoglobulin M and Immunoglobulin G Per Subject (ATP Cohort for Immunogenicity)
JEV Subject 5: Year 2 Ratio
|
0 Flavivirus immunity ratio
|
—
|
—
|
—
|
—
|
|
Flavivirus Infection in Terms of Dengue Immunoglobulin M and Immunoglobulin G Per Subject (ATP Cohort for Immunogenicity)
DEN Subject 6: Year 1 Ratio
|
0 Flavivirus immunity ratio
|
—
|
—
|
—
|
—
|
|
Flavivirus Infection in Terms of Dengue Immunoglobulin M and Immunoglobulin G Per Subject (ATP Cohort for Immunogenicity)
DEN Subject 6: 30 Days Post Booster Ratio
|
0 Flavivirus immunity ratio
|
—
|
—
|
—
|
—
|
|
Flavivirus Infection in Terms of Dengue Immunoglobulin M and Immunoglobulin G Per Subject (ATP Cohort for Immunogenicity)
DEN Subject 6: Year 2 Ratio
|
0 Flavivirus immunity ratio
|
—
|
—
|
—
|
—
|
|
Flavivirus Infection in Terms of Dengue Immunoglobulin M and Immunoglobulin G Per Subject (ATP Cohort for Immunogenicity)
JEV Subject 6: Year 1 Ratio
|
0 Flavivirus immunity ratio
|
—
|
—
|
—
|
—
|
|
Flavivirus Infection in Terms of Dengue Immunoglobulin M and Immunoglobulin G Per Subject (ATP Cohort for Immunogenicity)
JEV Subject 6: 30 Days Post Booster Ratio
|
0 Flavivirus immunity ratio
|
—
|
—
|
—
|
—
|
|
Flavivirus Infection in Terms of Dengue Immunoglobulin M and Immunoglobulin G Per Subject (ATP Cohort for Immunogenicity)
DEN Subject 7: Year 1 Ratio
|
0 Flavivirus immunity ratio
|
—
|
—
|
—
|
—
|
|
Flavivirus Infection in Terms of Dengue Immunoglobulin M and Immunoglobulin G Per Subject (ATP Cohort for Immunogenicity)
DEN Subject 7: 30 Days Post Booster Ratio
|
0 Flavivirus immunity ratio
|
—
|
—
|
—
|
—
|
|
Flavivirus Infection in Terms of Dengue Immunoglobulin M and Immunoglobulin G Per Subject (ATP Cohort for Immunogenicity)
DEN Subject 7: Year 2 Ratio
|
0 Flavivirus immunity ratio
|
—
|
—
|
—
|
—
|
|
Flavivirus Infection in Terms of Dengue Immunoglobulin M and Immunoglobulin G Per Subject (ATP Cohort for Immunogenicity)
JEV Subject 7: Year 1 Ratio
|
0 Flavivirus immunity ratio
|
—
|
—
|
—
|
—
|
|
Flavivirus Infection in Terms of Dengue Immunoglobulin M and Immunoglobulin G Per Subject (ATP Cohort for Immunogenicity)
JEV Subject 7: 30 Days Post Ratio
|
0 Flavivirus immunity ratio
|
—
|
—
|
—
|
—
|
|
Flavivirus Infection in Terms of Dengue Immunoglobulin M and Immunoglobulin G Per Subject (ATP Cohort for Immunogenicity)
JEV Subject 7: Year 2 Ratio
|
0 Flavivirus immunity ratio
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Year 1 (day 0); Year 1 (day 30); Year 2Population: Tests were performed by Laser scattering using Cell Dyn 3500 and Serum chemistry conducted by Kinetic method using Hitachi 717. Tests included ALT, AST, PLA, HC, and NEU levels.
Clinical safety laboratory test were monitored for alert levels. Tests were performed by Laser scattering using Cell Dyn 3500 and Serum chemistry conducted by Kinetic method using Hitachi 717. Normal Ranges: Alanine Aminotransferases (ALT): LNL=0 and UNL=30 Aspartate Aminotransferases (AST): LNL=0 and UNL=40 Platelet (PLA): LNL=150000 and UNL=350000 Hematocrit (HC): LNL=35 and UNL=45 Neutrophil (NEU): LNL=1500 and UNL=8000
Outcome measures
| Measure |
> 10 ED50
n=7 Participants
Seropositivity rates (% of subjects)
|
AST Level
n=7 Participants
Normal Range = 0-40
|
PLA Level
n=7 Participants
Normal Range = 150000-350000
|
HC Level
n=7 Participants
Normal Range = 35-45
|
NEU Level
n=7 Participants
Normal Range = 1500-8000
|
|---|---|---|---|---|---|
|
Subject Biochemistry and Hematology Parameters Monitored for Alert Levels
Subject 2: Year 1, Day 10
|
13 U/L
|
30 U/L
|
248000 U/L
|
36.9 U/L
|
2770 U/L
|
|
Subject Biochemistry and Hematology Parameters Monitored for Alert Levels
Subject 3: Year 2
|
46 U/L
|
33 U/L
|
306000 U/L
|
40.4 U/L
|
5170 U/L
|
|
Subject Biochemistry and Hematology Parameters Monitored for Alert Levels
Subject 4: Year 1, Day 0
|
11 U/L
|
24 U/L
|
280000 U/L
|
38.8 U/L
|
3320 U/L
|
|
Subject Biochemistry and Hematology Parameters Monitored for Alert Levels
Subject 4: Year 1, Day 30
|
13 U/L
|
34 U/L
|
297000 U/L
|
41.8 U/L
|
3320 U/L
|
|
Subject Biochemistry and Hematology Parameters Monitored for Alert Levels
Subject 4: Year 2
|
16 U/L
|
34 U/L
|
231000 U/L
|
43.1 U/L
|
3900 U/L
|
|
Subject Biochemistry and Hematology Parameters Monitored for Alert Levels
Subject 5: Year 1, Day 0
|
49 U/L
|
45 U/L
|
403000 U/L
|
39 U/L
|
3950 U/L
|
|
Subject Biochemistry and Hematology Parameters Monitored for Alert Levels
Subject 5: Year 1, Day 30
|
41 U/L
|
49 U/L
|
329000 U/L
|
38.8 U/L
|
2970 U/L
|
|
Subject Biochemistry and Hematology Parameters Monitored for Alert Levels
Subject 6, Year 1, Day 10
|
13 U/L
|
28 U/L
|
434000 U/L
|
38 U/L
|
3390 U/L
|
|
Subject Biochemistry and Hematology Parameters Monitored for Alert Levels
Subject 6, Year 1, Day 30
|
12 U/L
|
28 U/L
|
417000 U/L
|
35.4 U/L
|
2690 U/L
|
|
Subject Biochemistry and Hematology Parameters Monitored for Alert Levels
Subject 6, Year 2
|
16 U/L
|
35 U/L
|
461000 U/L
|
39.7 U/L
|
3840 U/L
|
|
Subject Biochemistry and Hematology Parameters Monitored for Alert Levels
Subject 7: Year 1, Day 0
|
11 U/L
|
27 U/L
|
244000 U/L
|
38.6 U/L
|
3460 U/L
|
|
Subject Biochemistry and Hematology Parameters Monitored for Alert Levels
Subject 7: Year 1, Day 10
|
12 U/L
|
26 U/L
|
238000 U/L
|
37.1 U/L
|
3050 U/L
|
|
Subject Biochemistry and Hematology Parameters Monitored for Alert Levels
Subject 7, Year 2
|
13 U/L
|
27 U/L
|
311000 U/L
|
41.4 U/L
|
4240 U/L
|
|
Subject Biochemistry and Hematology Parameters Monitored for Alert Levels
Subject 4: Year 1, Day 10
|
12 U/L
|
23 U/L
|
253000 U/L
|
39.9 U/L
|
3460 U/L
|
|
Subject Biochemistry and Hematology Parameters Monitored for Alert Levels
Subject 1: Year 1, Day 0
|
15 U/L
|
28 U/L
|
494000 U/L
|
37 U/L
|
2820 U/L
|
|
Subject Biochemistry and Hematology Parameters Monitored for Alert Levels
Subject 1: Year 1, Day 10
|
15 U/L
|
34 U/L
|
369000 U/L
|
37.1 U/L
|
3020 U/L
|
|
Subject Biochemistry and Hematology Parameters Monitored for Alert Levels
Subject 1: Year 1, Day 30
|
12 U/L
|
32 U/L
|
411000 U/L
|
39.3 U/L
|
3000 U/L
|
|
Subject Biochemistry and Hematology Parameters Monitored for Alert Levels
Subject 1: Year 2
|
12 U/L
|
23 U/L
|
502000 U/L
|
38.9 U/L
|
4790 U/L
|
|
Subject Biochemistry and Hematology Parameters Monitored for Alert Levels
Subject 2: Year 1, Day 0
|
10 U/L
|
29 U/L
|
293000 U/L
|
36.1 U/L
|
3210 U/L
|
|
Subject Biochemistry and Hematology Parameters Monitored for Alert Levels
Subject 2: Year 1, Day 30
|
12 U/L
|
31 U/L
|
296000 U/L
|
35.9 U/L
|
3070 U/L
|
|
Subject Biochemistry and Hematology Parameters Monitored for Alert Levels
Subject 2: Year 2
|
11 U/L
|
28 U/L
|
323000 U/L
|
38.4 U/L
|
2400 U/L
|
|
Subject Biochemistry and Hematology Parameters Monitored for Alert Levels
Subject 3: Year 1, Day 0
|
51 U/L
|
28 U/L
|
270000 U/L
|
39.3 U/L
|
2580 U/L
|
|
Subject Biochemistry and Hematology Parameters Monitored for Alert Levels
Subject 3: Year 1, Day 10
|
68 U/L
|
44 U/L
|
272000 U/L
|
41.8 U/L
|
3750 U/L
|
|
Subject Biochemistry and Hematology Parameters Monitored for Alert Levels
Subject 3: Year 1, Day 30
|
68 U/L
|
36 U/L
|
303000 U/L
|
42.3 U/L
|
4380 U/L
|
|
Subject Biochemistry and Hematology Parameters Monitored for Alert Levels
Subject 5: Year 1, Day 10
|
28 U/L
|
36 U/L
|
415000 U/L
|
40.2 U/L
|
4580 U/L
|
|
Subject Biochemistry and Hematology Parameters Monitored for Alert Levels
Subject 5: Year 2
|
26 U/L
|
29 U/L
|
346000 U/L
|
36.6 U/L
|
5920 U/L
|
|
Subject Biochemistry and Hematology Parameters Monitored for Alert Levels
Subject 6: Year 1, Day 0
|
10 U/L
|
27 U/L
|
440000 U/L
|
36.6 U/L
|
3020 U/L
|
|
Subject Biochemistry and Hematology Parameters Monitored for Alert Levels
Subject 7: Year 1, Day 30
|
10 U/L
|
29 U/L
|
270000 U/L
|
38.4 U/L
|
2940 U/L
|
Adverse Events
Total Vaccinated
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Total Vaccinated
n=7 participants at risk
The total vaccinated cohort included all enrolled subjects who received the DEN vaccine F17 for whom data were available. These subjects were Thai children previously enrolled and vaccinated in study Dengue-003
DEN vaccine F17: The dengue booster vaccine was administered subcutaneously in the non-dominant arm (deltoid). The tetravalent, live attenuated DEN F17 vaccine was administered in this study. This pre-transfection formulation contained dengue virus types 1, 2, 3 and 4 (DEN-1, -2, -3 and -4).
|
|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
14.3%
1/7 • Number of events 1 • 21 days post vaccination period following each dose
|
|
Gastrointestinal disorders
Abdominial Pain
|
0.00%
0/7 • 21 days post vaccination period following each dose
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
14.3%
1/7 • Number of events 1 • 21 days post vaccination period following each dose
|
|
General disorders
Fatigue
|
0.00%
0/7 • 21 days post vaccination period following each dose
|
|
General disorders
Fever (Axillary)
|
0.00%
0/7 • 21 days post vaccination period following each dose
|
|
Nervous system disorders
Headache
|
14.3%
1/7 • Number of events 1 • 21 days post vaccination period following each dose
|
|
Musculoskeletal and connective tissue disorders
Muscle aches
|
14.3%
1/7 • Number of events 1 • 21 days post vaccination period following each dose
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/7 • 21 days post vaccination period following each dose
|
|
Eye disorders
Pain behind eyes
|
14.3%
1/7 • Number of events 1 • 21 days post vaccination period following each dose
|
|
Eye disorders
Photophobia
|
14.3%
1/7 • Number of events 1 • 21 days post vaccination period following each dose
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/7 • 21 days post vaccination period following each dose
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/7 • 21 days post vaccination period following each dose
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/7 • 21 days post vaccination period following each dose
|
Additional Information
Sriluck Simasathien, MD
Dept of Pediatrics, Pharmongkutklao Hospital, Bankok, Thailand
Phone: 66-2-644-8971
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place