Trial Outcomes & Findings for Safety and Immunogenicity of the Dengue Virus Vaccine TV005 (TetraVax-DV TV005) in Healthy Adults, Adolescents, and Children in Dhaka, Bangladesh (NCT NCT02678455)
NCT ID: NCT02678455
Last Updated: 2025-01-17
Results Overview
Collected through daily home visits up to day 14, clinic visits for physical exam and hematological and blood chemistry labs, and weekly phone surveillance after day 14. Study staff record temperatures and AEs on the surveillance source document.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
192 participants
Primary outcome timeframe
Vaccine/placebo administration (study day 0) up to 28 days post vaccine/placebo administration
Results posted on
2025-01-17
Participant Flow
Participant milestones
| Measure |
TV005 Vaccine
Participants will receive one dose of TV005 vaccine at study entry (Day 0).
TV005 vaccine: Delivered by subcutaneous injection; contains 10\^3 PFU of rDEN1Δ30, 10\^4 PFU of rDEN2/4Δ30(ME), 10\^3 PFU of rDEN3Δ30/31, and 10\^3 PFU of rDEN4Δ30.
|
Placebo
Participants will receive one dose of placebo at study entry (Day 0).
Placebo: Delivered by subcutaneous injection
|
|---|---|---|
|
Overall Study
STARTED
|
144
|
48
|
|
Overall Study
COMPLETED
|
135
|
46
|
|
Overall Study
NOT COMPLETED
|
9
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Row population differs from overall because they are subgroups of the overall population. For each of the four subgroups (Adult, Adolescent, Children, and Young children), there are 36 study participants in the TV005 vaccine arm and 12 study participants in the Placebo arm, with a total of 144 in the TV005 vaccine arm and 48 in the Placebo arm.
Baseline characteristics by cohort
| Measure |
TV005 Vaccine
n=144 Participants
Participants will receive one dose of TV005 vaccine at study entry (Day 0).
TV005 vaccine: Delivered by subcutaneous injection; contains 10\^3 PFU of rDEN1Δ30, 10\^4 PFU of rDEN2/4Δ30(ME), 10\^3 PFU of rDEN3Δ30/31, and 10\^3 PFU of rDEN4Δ30.
|
Placebo
n=48 Participants
Participants will receive one dose of placebo at study entry (Day 0).
Placebo: Delivered by subcutaneous injection
|
Total
n=192 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
Adult
|
32.17 Years
STANDARD_DEVIATION 8.26 • n=36 Participants • Row population differs from overall because they are subgroups of the overall population. For each of the four subgroups (Adult, Adolescent, Children, and Young children), there are 36 study participants in the TV005 vaccine arm and 12 study participants in the Placebo arm, with a total of 144 in the TV005 vaccine arm and 48 in the Placebo arm.
|
29.25 Years
STANDARD_DEVIATION 5.10 • n=12 Participants • Row population differs from overall because they are subgroups of the overall population. For each of the four subgroups (Adult, Adolescent, Children, and Young children), there are 36 study participants in the TV005 vaccine arm and 12 study participants in the Placebo arm, with a total of 144 in the TV005 vaccine arm and 48 in the Placebo arm.
|
31.44 Years
STANDARD_DEVIATION 8.24 • n=48 Participants • Row population differs from overall because they are subgroups of the overall population. For each of the four subgroups (Adult, Adolescent, Children, and Young children), there are 36 study participants in the TV005 vaccine arm and 12 study participants in the Placebo arm, with a total of 144 in the TV005 vaccine arm and 48 in the Placebo arm.
|
|
Age, Customized
Adolescent
|
12.58 Years
STANDARD_DEVIATION 1.81 • n=36 Participants • Row population differs from overall because they are subgroups of the overall population. For each of the four subgroups (Adult, Adolescent, Children, and Young children), there are 36 study participants in the TV005 vaccine arm and 12 study participants in the Placebo arm, with a total of 144 in the TV005 vaccine arm and 48 in the Placebo arm.
|
12.83 Years
STANDARD_DEVIATION 1.64 • n=12 Participants • Row population differs from overall because they are subgroups of the overall population. For each of the four subgroups (Adult, Adolescent, Children, and Young children), there are 36 study participants in the TV005 vaccine arm and 12 study participants in the Placebo arm, with a total of 144 in the TV005 vaccine arm and 48 in the Placebo arm.
|
12.65 Years
STANDARD_DEVIATION 1.75 • n=48 Participants • Row population differs from overall because they are subgroups of the overall population. For each of the four subgroups (Adult, Adolescent, Children, and Young children), there are 36 study participants in the TV005 vaccine arm and 12 study participants in the Placebo arm, with a total of 144 in the TV005 vaccine arm and 48 in the Placebo arm.
|
|
Age, Customized
Children
|
8.14 Years
STANDARD_DEVIATION 1.46 • n=36 Participants • Row population differs from overall because they are subgroups of the overall population. For each of the four subgroups (Adult, Adolescent, Children, and Young children), there are 36 study participants in the TV005 vaccine arm and 12 study participants in the Placebo arm, with a total of 144 in the TV005 vaccine arm and 48 in the Placebo arm.
|
7.83 Years
STANDARD_DEVIATION 1.34 • n=12 Participants • Row population differs from overall because they are subgroups of the overall population. For each of the four subgroups (Adult, Adolescent, Children, and Young children), there are 36 study participants in the TV005 vaccine arm and 12 study participants in the Placebo arm, with a total of 144 in the TV005 vaccine arm and 48 in the Placebo arm.
|
8.06 Years
STANDARD_DEVIATION 1.42 • n=48 Participants • Row population differs from overall because they are subgroups of the overall population. For each of the four subgroups (Adult, Adolescent, Children, and Young children), there are 36 study participants in the TV005 vaccine arm and 12 study participants in the Placebo arm, with a total of 144 in the TV005 vaccine arm and 48 in the Placebo arm.
|
|
Age, Customized
Young Children
|
3.25 Years
STANDARD_DEVIATION 0.81 • n=36 Participants • Row population differs from overall because they are subgroups of the overall population. For each of the four subgroups (Adult, Adolescent, Children, and Young children), there are 36 study participants in the TV005 vaccine arm and 12 study participants in the Placebo arm, with a total of 144 in the TV005 vaccine arm and 48 in the Placebo arm.
|
3.42 Years
STANDARD_DEVIATION 0.52 • n=12 Participants • Row population differs from overall because they are subgroups of the overall population. For each of the four subgroups (Adult, Adolescent, Children, and Young children), there are 36 study participants in the TV005 vaccine arm and 12 study participants in the Placebo arm, with a total of 144 in the TV005 vaccine arm and 48 in the Placebo arm.
|
3.29 Years
STANDARD_DEVIATION 0.74 • n=48 Participants • Row population differs from overall because they are subgroups of the overall population. For each of the four subgroups (Adult, Adolescent, Children, and Young children), there are 36 study participants in the TV005 vaccine arm and 12 study participants in the Placebo arm, with a total of 144 in the TV005 vaccine arm and 48 in the Placebo arm.
|
|
Sex/Gender, Customized
Adult Female
|
23 Participants
n=144 Participants
|
5 Participants
n=48 Participants
|
28 Participants
n=192 Participants
|
|
Sex/Gender, Customized
Adult Male
|
13 Participants
n=144 Participants
|
7 Participants
n=48 Participants
|
20 Participants
n=192 Participants
|
|
Sex/Gender, Customized
Adolescent Female
|
17 Participants
n=144 Participants
|
4 Participants
n=48 Participants
|
21 Participants
n=192 Participants
|
|
Sex/Gender, Customized
Adolescent Male
|
19 Participants
n=144 Participants
|
8 Participants
n=48 Participants
|
27 Participants
n=192 Participants
|
|
Sex/Gender, Customized
Child Female
|
26 Participants
n=144 Participants
|
7 Participants
n=48 Participants
|
33 Participants
n=192 Participants
|
|
Sex/Gender, Customized
Child Male
|
10 Participants
n=144 Participants
|
5 Participants
n=48 Participants
|
15 Participants
n=192 Participants
|
|
Sex/Gender, Customized
Young Child Female
|
14 Participants
n=144 Participants
|
5 Participants
n=48 Participants
|
19 Participants
n=192 Participants
|
|
Sex/Gender, Customized
Young Child Male
|
22 Participants
n=144 Participants
|
7 Participants
n=48 Participants
|
29 Participants
n=192 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=144 Participants
|
0 Participants
n=48 Participants
|
0 Participants
n=192 Participants
|
|
Race (NIH/OMB)
Asian
|
144 Participants
n=144 Participants
|
48 Participants
n=48 Participants
|
192 Participants
n=192 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=144 Participants
|
0 Participants
n=48 Participants
|
0 Participants
n=192 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=144 Participants
|
0 Participants
n=48 Participants
|
0 Participants
n=192 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=144 Participants
|
0 Participants
n=48 Participants
|
0 Participants
n=192 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=144 Participants
|
0 Participants
n=48 Participants
|
0 Participants
n=192 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=144 Participants
|
0 Participants
n=48 Participants
|
0 Participants
n=192 Participants
|
|
Region of Enrollment
Bangladesh
|
144 participants
n=144 Participants
|
48 participants
n=48 Participants
|
192 participants
n=192 Participants
|
|
Dengue Serostatus
Dengue Naive
|
81 Participants
n=144 Participants
|
22 Participants
n=48 Participants
|
103 Participants
n=192 Participants
|
|
Dengue Serostatus
Dengue Experienced
|
63 Participants
n=144 Participants
|
26 Participants
n=48 Participants
|
89 Participants
n=192 Participants
|
|
Age Cohort
Adult group (18-50 years)
|
36 Participants
n=144 Participants
|
12 Participants
n=48 Participants
|
48 Participants
n=192 Participants
|
|
Age Cohort
Adolescent group (11-17 years)
|
36 Participants
n=144 Participants
|
12 Participants
n=48 Participants
|
48 Participants
n=192 Participants
|
|
Age Cohort
Children group (5-10 years)
|
36 Participants
n=144 Participants
|
12 Participants
n=48 Participants
|
48 Participants
n=192 Participants
|
|
Age Cohort
Young children group (1-4 years)
|
36 Participants
n=144 Participants
|
12 Participants
n=48 Participants
|
48 Participants
n=192 Participants
|
PRIMARY outcome
Timeframe: Vaccine/placebo administration (study day 0) up to 28 days post vaccine/placebo administrationPopulation: Per Protocol: all participants who received study vaccine/placebo according to random assignment according to dose are in analysis.
Collected through daily home visits up to day 14, clinic visits for physical exam and hematological and blood chemistry labs, and weekly phone surveillance after day 14. Study staff record temperatures and AEs on the surveillance source document.
Outcome measures
| Measure |
TV005 Vaccine
n=144 Participants
Participants will receive one dose of TV005 vaccine at study entry (Day 0).
TV005 vaccine: Delivered by subcutaneous injection; contains 10\^3 PFU of rDEN1Δ30, 10\^4 PFU of rDEN2/4Δ30(ME), 10\^3 PFU of rDEN3Δ30/31, and 10\^3 PFU of rDEN4Δ30.
|
Placebo
n=48 Participants
Participants will receive one dose of placebo at study entry (Day 0).
Placebo: Delivered by subcutaneous injection
|
|---|---|---|
|
Percentage of Study Participants With Each Solicited, Related Adverse Event Types of Any Severity.
Erythema
|
1 Participants
|
0 Participants
|
|
Percentage of Study Participants With Each Solicited, Related Adverse Event Types of Any Severity.
Swelling
|
1 Participants
|
0 Participants
|
|
Percentage of Study Participants With Each Solicited, Related Adverse Event Types of Any Severity.
ALT Increased
|
5 Participants
|
2 Participants
|
|
Percentage of Study Participants With Each Solicited, Related Adverse Event Types of Any Severity.
Hemoglobin Decreased
|
5 Participants
|
2 Participants
|
|
Percentage of Study Participants With Each Solicited, Related Adverse Event Types of Any Severity.
Leukocytosis
|
2 Participants
|
1 Participants
|
|
Percentage of Study Participants With Each Solicited, Related Adverse Event Types of Any Severity.
PTT Prolonged
|
4 Participants
|
2 Participants
|
|
Percentage of Study Participants With Each Solicited, Related Adverse Event Types of Any Severity.
Thrombocytopenia
|
4 Participants
|
0 Participants
|
|
Percentage of Study Participants With Each Solicited, Related Adverse Event Types of Any Severity.
Fever
|
7 Participants
|
0 Participants
|
|
Percentage of Study Participants With Each Solicited, Related Adverse Event Types of Any Severity.
Headache
|
17 Participants
|
7 Participants
|
|
Percentage of Study Participants With Each Solicited, Related Adverse Event Types of Any Severity.
Rash
|
37 Participants
|
6 Participants
|
|
Percentage of Study Participants With Each Solicited, Related Adverse Event Types of Any Severity.
Arthralgia
|
7 Participants
|
0 Participants
|
|
Percentage of Study Participants With Each Solicited, Related Adverse Event Types of Any Severity.
Fatigue
|
7 Participants
|
2 Participants
|
|
Percentage of Study Participants With Each Solicited, Related Adverse Event Types of Any Severity.
Myalgia
|
7 Participants
|
1 Participants
|
|
Percentage of Study Participants With Each Solicited, Related Adverse Event Types of Any Severity.
Nausea
|
6 Participants
|
2 Participants
|
|
Percentage of Study Participants With Each Solicited, Related Adverse Event Types of Any Severity.
Photophobia
|
1 Participants
|
0 Participants
|
|
Percentage of Study Participants With Each Solicited, Related Adverse Event Types of Any Severity.
Retro-orbital Pain
|
3 Participants
|
1 Participants
|
|
Percentage of Study Participants With Each Solicited, Related Adverse Event Types of Any Severity.
Decrease in Activity
|
1 Participants
|
0 Participants
|
|
Percentage of Study Participants With Each Solicited, Related Adverse Event Types of Any Severity.
Loss of Appetite
|
1 Participants
|
0 Participants
|
|
Percentage of Study Participants With Each Solicited, Related Adverse Event Types of Any Severity.
Vomiting
|
3 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Study day 14 through study day 180Population: Only TV005 Vaccine arm included in analysis as per protocol to determine percentage of participants in TV005 vaccine arm who are seropositive after vaccination. Data is analyzed for each sub-group. Two participants (one each in Adult and Adolescent vaccine group) were eliminated from this analysis. There are 35 participants in Adult and Adolescent vaccine Arm groups; 36 in Children, and Young Children vaccine Arm groups with a total of 142 included in this analysis.
Measured by serum plaque reduction neutralization titer, 50% (PRNT50) to DENV-1, DENV-2, DENV-3, and DENV-4 viruses at study day 14, 28, 58, and 180 post vaccination. Seropositivity to each serotype as defined as PRNT50\>=10. Per protocol analysis includes participants meeting eligibility criteria, complying with defined visits and protocols, no elimination criteria, and immunogenicity data endpoints measures available.
Outcome measures
| Measure |
TV005 Vaccine
n=142 Participants
Participants will receive one dose of TV005 vaccine at study entry (Day 0).
TV005 vaccine: Delivered by subcutaneous injection; contains 10\^3 PFU of rDEN1Δ30, 10\^4 PFU of rDEN2/4Δ30(ME), 10\^3 PFU of rDEN3Δ30/31, and 10\^3 PFU of rDEN4Δ30.
|
Placebo
Participants will receive one dose of placebo at study entry (Day 0).
Placebo: Delivered by subcutaneous injection
|
|---|---|---|
|
Percentage of Study Participants Who Are Seropositive Following Vaccination
All study participants seropositive to DENV-1 post TV005 Vaccination
|
83 Percentage of participants
Interval 76.0 to 88.0
|
—
|
|
Percentage of Study Participants Who Are Seropositive Following Vaccination
All study participants seropositive to DENV-2 post TV005 Vaccination
|
99 Percentage of participants
Interval 96.0 to 100.0
|
—
|
|
Percentage of Study Participants Who Are Seropositive Following Vaccination
All study participants seropositive to DENV-3 post TV005 Vaccination
|
96 Percentage of participants
Interval 92.0 to 98.0
|
—
|
|
Percentage of Study Participants Who Are Seropositive Following Vaccination
All study participants seropositive to DENV-4 post TV005 Vaccination
|
87 Percentage of participants
Interval 81.0 to 92.0
|
—
|
|
Percentage of Study Participants Who Are Seropositive Following Vaccination
Adult study participants seropositive to DENV-1 post TV005 vaccination
|
86 Percentage of participants
Interval 71.0 to 94.0
|
—
|
|
Percentage of Study Participants Who Are Seropositive Following Vaccination
Adult study participants seropositive to DENV-2 post TV005 vaccination
|
97 Percentage of participants
Interval 85.0 to 99.0
|
—
|
|
Percentage of Study Participants Who Are Seropositive Following Vaccination
Adult study participants seropositive to DENV-3 post TV005 vaccination
|
97 Percentage of participants
Interval 85.0 to 99.0
|
—
|
|
Percentage of Study Participants Who Are Seropositive Following Vaccination
Adult study participants seropositive to DENV-4 post TV005 vaccination
|
91 Percentage of participants
Interval 78.0 to 97.0
|
—
|
|
Percentage of Study Participants Who Are Seropositive Following Vaccination
Adolescent study participants seropositive to DENV-1 post TV005 vaccination
|
83 Percentage of participants
Interval 67.0 to 92.0
|
—
|
|
Percentage of Study Participants Who Are Seropositive Following Vaccination
Adolescent study participants seropositive to DENV-2 post TV005 vaccination
|
100 Percentage of participants
Interval 90.0 to 100.0
|
—
|
|
Percentage of Study Participants Who Are Seropositive Following Vaccination
Adolescent study participants seropositive to DENV-3 post TV005 vaccination
|
97 Percentage of participants
Interval 85.0 to 99.0
|
—
|
|
Percentage of Study Participants Who Are Seropositive Following Vaccination
Adolescent study participants seropositive to DENV-4 post TV005 vaccination
|
86 Percentage of participants
Interval 71.0 to 94.0
|
—
|
|
Percentage of Study Participants Who Are Seropositive Following Vaccination
Children study participants seropositive to DENV-1 post TV005 vaccination
|
81 Percentage of participants
Interval 65.0 to 90.0
|
—
|
|
Percentage of Study Participants Who Are Seropositive Following Vaccination
Children study participants seropositive to DENV-2 post TV005 vaccination
|
100 Percentage of participants
Interval 90.0 to 100.0
|
—
|
|
Percentage of Study Participants Who Are Seropositive Following Vaccination
Children study participants seropositive to DENV-3 post TV005 vaccination
|
100 Percentage of participants
Interval 90.0 to 100.0
|
—
|
|
Percentage of Study Participants Who Are Seropositive Following Vaccination
Children study participants seropositive to DENV-4 post TV005 vaccination
|
78 Percentage of participants
Interval 62.0 to 88.0
|
—
|
|
Percentage of Study Participants Who Are Seropositive Following Vaccination
Young children study participants seropositive to DENV-1 post TV005 vaccination
|
83 Percentage of participants
Interval 68.0 to 92.0
|
—
|
|
Percentage of Study Participants Who Are Seropositive Following Vaccination
Young children study participants seropositive to DENV-2 post TV005 vaccination
|
100 Percentage of participants
Interval 90.0 to 100.0
|
—
|
|
Percentage of Study Participants Who Are Seropositive Following Vaccination
Young children study participants seropositive to DENV-3 post TV005 vaccination
|
92 Percentage of participants
Interval 78.0 to 97.0
|
—
|
|
Percentage of Study Participants Who Are Seropositive Following Vaccination
Young children study participants seropositive to DENV-4 post TV005 vaccination
|
94 Percentage of participants
Interval 82.0 to 98.0
|
—
|
SECONDARY outcome
Timeframe: Vaccine administration (study day 0) up to 14 days post vaccine administrationPopulation: Per protocol analysis includes all study participants meeting all eligibility criteria and with viremia data endpoints measures available.
Viremia in serum was determined both by amplification and direct titration using Vero cell monolayers. Each specific serotype was identified using monoclonal antibodies.
Outcome measures
| Measure |
TV005 Vaccine
n=142 Participants
Participants will receive one dose of TV005 vaccine at study entry (Day 0).
TV005 vaccine: Delivered by subcutaneous injection; contains 10\^3 PFU of rDEN1Δ30, 10\^4 PFU of rDEN2/4Δ30(ME), 10\^3 PFU of rDEN3Δ30/31, and 10\^3 PFU of rDEN4Δ30.
|
Placebo
n=48 Participants
Participants will receive one dose of placebo at study entry (Day 0).
Placebo: Delivered by subcutaneous injection
|
|---|---|---|
|
Proportion of Study Participants With Vaccine Virus Recovered Following Vaccination
DENV-1 recovered
|
4 Participants
|
0 Participants
|
|
Proportion of Study Participants With Vaccine Virus Recovered Following Vaccination
DENV-2 recovered
|
1 Participants
|
0 Participants
|
|
Proportion of Study Participants With Vaccine Virus Recovered Following Vaccination
DENV-3 recovered
|
1 Participants
|
0 Participants
|
|
Proportion of Study Participants With Vaccine Virus Recovered Following Vaccination
DENV-4 recovered
|
0 Participants
|
0 Participants
|
|
Proportion of Study Participants With Vaccine Virus Recovered Following Vaccination
Total Viremia recovered
|
6 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Study day 14 through study day 180Population: Only TV005 Vaccine arm included in analysis as per protocol to determine percentage of participants in TV005 vaccine arm who are seropositive after vaccination. Data is analyzed by sub-groups based on previous exposure to Dengue at baseline (experienced, and naïve). Two participants from the experienced at baseline group were eliminated from this analysis. There are 61 participants in the experienced at baseline group; 81 in the naïve at baseline group; total of 142 included in this analysis.
Measured by serum plaque reduction neutralization titer, 50% (PRNT50) to DENV-1, DENV-2, DENV-3, and DENV-4 viruses at study day 14, 28, 56, and 180 post vaccination. Seropositivity to each serotype is defined as PRNT50 ≥ 10.
Outcome measures
| Measure |
TV005 Vaccine
n=142 Participants
Participants will receive one dose of TV005 vaccine at study entry (Day 0).
TV005 vaccine: Delivered by subcutaneous injection; contains 10\^3 PFU of rDEN1Δ30, 10\^4 PFU of rDEN2/4Δ30(ME), 10\^3 PFU of rDEN3Δ30/31, and 10\^3 PFU of rDEN4Δ30.
|
Placebo
Participants will receive one dose of placebo at study entry (Day 0).
Placebo: Delivered by subcutaneous injection
|
|---|---|---|
|
Percentage of Seropositive Study Participants Among Dengue Experienced and Dengue Naive Vaccinees.
Experienced at baseline serpositive to DENV-1 post TV005 vaccination
|
100 Percentage of participants
Interval 94.0 to 100.0
|
—
|
|
Percentage of Seropositive Study Participants Among Dengue Experienced and Dengue Naive Vaccinees.
Experienced at baseline seropositive to DENV-2 post TV005 vaccination
|
100 Percentage of participants
Interval 94.0 to 100.0
|
—
|
|
Percentage of Seropositive Study Participants Among Dengue Experienced and Dengue Naive Vaccinees.
Experienced at baseline seropositive to DENV-3 post TV005 vaccination
|
100 Percentage of participants
Interval 94.0 to 100.0
|
—
|
|
Percentage of Seropositive Study Participants Among Dengue Experienced and Dengue Naive Vaccinees.
Experienced at baseline seropoisitive to DENV-4 post TV005 vaccination
|
87 Percentage of participants
Interval 76.0 to 93.0
|
—
|
|
Percentage of Seropositive Study Participants Among Dengue Experienced and Dengue Naive Vaccinees.
Naive at baseline seropositive to DENV-1 post TV005 vaccination
|
70 Percentage of participants
Interval 60.0 to 79.0
|
—
|
|
Percentage of Seropositive Study Participants Among Dengue Experienced and Dengue Naive Vaccinees.
Naive at baseline seropositive to DENV-2 post TV005 vaccination
|
99 Percentage of participants
Interval 93.0 to 100.0
|
—
|
|
Percentage of Seropositive Study Participants Among Dengue Experienced and Dengue Naive Vaccinees.
Naive at baseline seropositive to DENV-3 post TV005 vaccination
|
94 Percentage of participants
Interval 86.0 to 97.0
|
—
|
|
Percentage of Seropositive Study Participants Among Dengue Experienced and Dengue Naive Vaccinees.
Naive at baseline seropositive to DENV-4 post TV005 vaccination
|
88 Percentage of participants
Interval 79.0 to 93.0
|
—
|
SECONDARY outcome
Timeframe: Vaccine/placebo administration (study day 0) up to three years post vaccine/placebo administration (study day 1080).Population: Only TV005 Vaccine arm included in analysis as per protocol to determine percentage of participants in TV005 vaccine arm who are seropositive after vaccination. Data is analyzed for each sub-group. Two participants (one each in Adult and Adolescent vaccine group) were eliminated from this analysis. There are 35 participants in Adult and Adolescent vaccine Arm groups; 36 in Children, and Young Children vaccine Arm groups with a total of 142 included in this analysis.
Estimated percent seropositive, over 3 years by age group and serotype. Measured by serum plaque reduction neutralization titer, 50% (PRNT50) to DENV-1, DENV-2, DENV-3, and DENV-4 viruses at study day 14, 28, 56, 180, 360, 720, and 1080 post vaccination. Seropositivity to each serotype is defined as PRNT50 ≥ 10.
Outcome measures
| Measure |
TV005 Vaccine
n=142 Participants
Participants will receive one dose of TV005 vaccine at study entry (Day 0).
TV005 vaccine: Delivered by subcutaneous injection; contains 10\^3 PFU of rDEN1Δ30, 10\^4 PFU of rDEN2/4Δ30(ME), 10\^3 PFU of rDEN3Δ30/31, and 10\^3 PFU of rDEN4Δ30.
|
Placebo
Participants will receive one dose of placebo at study entry (Day 0).
Placebo: Delivered by subcutaneous injection
|
|---|---|---|
|
Durability of Seropositivity Post TV005 Vaccination
Adult cohort: percent seropositive to DENV-1 at study day 0
|
66 percentage of participants
Interval 49.0 to 79.0
|
—
|
|
Durability of Seropositivity Post TV005 Vaccination
Adult cohort: percent seropositive to DENV-1 at study day 28
|
83 percentage of participants
Interval 67.0 to 92.0
|
—
|
|
Durability of Seropositivity Post TV005 Vaccination
Adult cohort: percent seropositive to DENV-1 at study day 56
|
80 percentage of participants
Interval 64.0 to 90.0
|
—
|
|
Durability of Seropositivity Post TV005 Vaccination
Adult cohort: percent seropositive to DENV-1 at study day 180
|
80 percentage of participants
Interval 64.0 to 90.0
|
—
|
|
Durability of Seropositivity Post TV005 Vaccination
Adult cohort: percent seropositive to DENV-1 at study day 360
|
80 percentage of participants
Interval 64.0 to 90.0
|
—
|
|
Durability of Seropositivity Post TV005 Vaccination
Adult cohort: percent seropositive to DENV-1 at study day 720
|
66 percentage of participants
Interval 49.0 to 79.0
|
—
|
|
Durability of Seropositivity Post TV005 Vaccination
Adult cohort: percent seropositive to DENV-1 at study day 1080
|
66 percentage of participants
Interval 49.0 to 79.0
|
—
|
|
Durability of Seropositivity Post TV005 Vaccination
Adult cohort: percent seropositive to DENV-2 at study day 0
|
69 percentage of participants
Interval 52.0 to 81.0
|
—
|
|
Durability of Seropositivity Post TV005 Vaccination
Adult cohort: percent seropositive to DENV-2 at study day 28
|
94 percentage of participants
Interval 81.0 to 98.0
|
—
|
|
Durability of Seropositivity Post TV005 Vaccination
Adult cohort: percent seropositive to DENV-2 at study day 56
|
97 percentage of participants
Interval 85.0 to 99.0
|
—
|
|
Durability of Seropositivity Post TV005 Vaccination
Adult cohort: percent seropositive to DENV-2 at study day 180
|
89 percentage of participants
Interval 74.0 to 95.0
|
—
|
|
Durability of Seropositivity Post TV005 Vaccination
Adult cohort: percent seropositive to DENV-2 at study day 360
|
89 percentage of participants
Interval 74.0 to 95.0
|
—
|
|
Durability of Seropositivity Post TV005 Vaccination
Adult cohort: percent seropositive to DENV-2 at study day 720
|
91 percentage of participants
Interval 78.0 to 97.0
|
—
|
|
Durability of Seropositivity Post TV005 Vaccination
Adult cohort: percent seropositive to DENV-2 at study day 1080
|
86 percentage of participants
Interval 71.0 to 94.0
|
—
|
|
Durability of Seropositivity Post TV005 Vaccination
Adult cohort: percent seropositive to DENV-3 at study day 0
|
71 percentage of participants
Interval 55.0 to 84.0
|
—
|
|
Durability of Seropositivity Post TV005 Vaccination
Adult cohort: percent seropositive to DENV-3 at study day 28
|
94 percentage of participants
Interval 81.0 to 98.0
|
—
|
|
Durability of Seropositivity Post TV005 Vaccination
Adult cohort: percent seropositive to DENV-3 at study day 56
|
91 percentage of participants
Interval 78.0 to 97.0
|
—
|
|
Durability of Seropositivity Post TV005 Vaccination
Adult cohort: percent seropositive to DENV-3 at study day 180
|
89 percentage of participants
Interval 74.0 to 95.0
|
—
|
|
Durability of Seropositivity Post TV005 Vaccination
Adult cohort: percent seropositive to DENV-3 at study day 360
|
86 percentage of participants
Interval 71.0 to 94.0
|
—
|
|
Durability of Seropositivity Post TV005 Vaccination
Adult cohort: percent seropositive to DENV-3 at study day 720
|
89 percentage of participants
Interval 74.0 to 95.0
|
—
|
|
Durability of Seropositivity Post TV005 Vaccination
Adult cohort: percent seropositive to DENV-3 at study day 1080
|
80 percentage of participants
Interval 64.0 to 90.0
|
—
|
|
Durability of Seropositivity Post TV005 Vaccination
Adult cohort: percent seropositive to DENV-4 at study day 0
|
20 percentage of participants
Interval 10.0 to 36.0
|
—
|
|
Durability of Seropositivity Post TV005 Vaccination
Adult cohort: percent seropositive to DENV-4 at study day 28
|
77 percentage of participants
Interval 61.0 to 88.0
|
—
|
|
Durability of Seropositivity Post TV005 Vaccination
Adult cohort: percent seropositive to DENV-4 at study day 56
|
80 percentage of participants
Interval 64.0 to 90.0
|
—
|
|
Durability of Seropositivity Post TV005 Vaccination
Adult cohort: percent seropositive to DENV-4 at study day 180
|
74 percentage of participants
Interval 58.0 to 86.0
|
—
|
|
Durability of Seropositivity Post TV005 Vaccination
Adult cohort: percent seropositive to DENV-4 at study day 360
|
66 percentage of participants
Interval 49.0 to 79.0
|
—
|
|
Durability of Seropositivity Post TV005 Vaccination
Adult cohort: percent seropositive to DENV-4 at study day 720
|
60 percentage of participants
Interval 44.0 to 74.0
|
—
|
|
Durability of Seropositivity Post TV005 Vaccination
Adult cohort: percent seropositive to DENV-4 at study day 1080
|
63 percentage of participants
Interval 46.0 to 77.0
|
—
|
|
Durability of Seropositivity Post TV005 Vaccination
Adolescent cohort: percent seropositive to DENV-1 at study day 0
|
26 percentage of participants
Interval 14.0 to 42.0
|
—
|
|
Durability of Seropositivity Post TV005 Vaccination
Adolescent cohort: percent seropositive to DENV-1 at study day 28
|
74 percentage of participants
Interval 58.0 to 86.0
|
—
|
|
Durability of Seropositivity Post TV005 Vaccination
Adolescent cohort: percent seropositive to DENV-1 at study day 56
|
71 percentage of participants
Interval 55.0 to 84.0
|
—
|
|
Durability of Seropositivity Post TV005 Vaccination
Adolescent cohort: percent seropositive to DENV-1 at study day 180
|
71 percentage of participants
Interval 55.0 to 84.0
|
—
|
|
Durability of Seropositivity Post TV005 Vaccination
Adolescent cohort: percent seropositive to DENV-1 at study day 360
|
69 percentage of participants
Interval 52.0 to 81.0
|
—
|
|
Durability of Seropositivity Post TV005 Vaccination
Adolescent cohort: percent seropositive to DENV-1 at study day 720
|
43 percentage of participants
Interval 28.0 to 59.0
|
—
|
|
Durability of Seropositivity Post TV005 Vaccination
Adolescent cohort: percent seropositive to DENV-1 at study day 1080
|
46 percentage of participants
Interval 30.0 to 62.0
|
—
|
|
Durability of Seropositivity Post TV005 Vaccination
Adolescent cohort: percent seropositive to DENV-2 at study day 0
|
34 percentage of participants
Interval 21.0 to 51.0
|
—
|
|
Durability of Seropositivity Post TV005 Vaccination
Adolescent cohort: percent seropositive to DENV-2 at study day 28
|
100 percentage of participants
Interval 90.0 to 100.0
|
—
|
|
Durability of Seropositivity Post TV005 Vaccination
Adolescent cohort: percent seropositive to DENV-2 at study day 56
|
97 percentage of participants
Interval 85.0 to 99.0
|
—
|
|
Durability of Seropositivity Post TV005 Vaccination
Adolescent cohort: percent seropositive to DENV-2 at study day 180
|
97 percentage of participants
Interval 85.0 to 99.0
|
—
|
|
Durability of Seropositivity Post TV005 Vaccination
Adolescent cohort: percent seropositive to DENV-2 at study day 360
|
85 percentage of participants
Interval 71.0 to 94.0
|
—
|
|
Durability of Seropositivity Post TV005 Vaccination
Adolescent cohort: percent seropositive to DENV-2 at study day 720
|
74 percentage of participants
Interval 58.0 to 86.0
|
—
|
|
Durability of Seropositivity Post TV005 Vaccination
Adolescent cohort: percent seropositive to DENV-2 at study day 1080
|
69 percentage of participants
Interval 52.0 to 81.0
|
—
|
|
Durability of Seropositivity Post TV005 Vaccination
Adolescent cohort: percent seropositive to DENV-3 at study day 0
|
37 percentage of participants
Interval 23.0 to 54.0
|
—
|
|
Durability of Seropositivity Post TV005 Vaccination
Adolescent cohort: percent seropositive to DENV-3 at study day 28
|
89 percentage of participants
Interval 74.0 to 95.0
|
—
|
|
Durability of Seropositivity Post TV005 Vaccination
Adolescent cohort: percent seropositive to DENV-3 at study day 56
|
94 percentage of participants
Interval 81.0 to 98.0
|
—
|
|
Durability of Seropositivity Post TV005 Vaccination
Adolescent cohort: percent seropositive to DENV-3 at study day 180
|
97 percentage of participants
Interval 85.0 to 99.0
|
—
|
|
Durability of Seropositivity Post TV005 Vaccination
Adolescent cohort: percent seropositive to DENV-3 at study day 360
|
89 percentage of participants
Interval 74.0 to 95.0
|
—
|
|
Durability of Seropositivity Post TV005 Vaccination
Adolescent cohort: percent seropositive to DENV-3 at study day 720
|
57 percentage of participants
Interval 41.0 to 72.0
|
—
|
|
Durability of Seropositivity Post TV005 Vaccination
Adolescent cohort: percent seropositive to DENV-3 at study day 1080
|
57 percentage of participants
Interval 41.0 to 72.0
|
—
|
|
Durability of Seropositivity Post TV005 Vaccination
Adolescent cohort: percent seropositive to DENV-4 at study day 0
|
0 percentage of participants
Interval 0.0 to 10.0
|
—
|
|
Durability of Seropositivity Post TV005 Vaccination
Adolescent cohort: percent seropositive to DENV-4 at study day 28
|
83 percentage of participants
Interval 67.0 to 92.0
|
—
|
|
Durability of Seropositivity Post TV005 Vaccination
Adolescent cohort: percent seropositive to DENV-4 at study day 56
|
77 percentage of participants
Interval 61.0 to 88.0
|
—
|
|
Durability of Seropositivity Post TV005 Vaccination
Adolescent cohort: percent seropositive to DENV-4 at study day 180
|
71 percentage of participants
Interval 55.0 to 84.0
|
—
|
|
Durability of Seropositivity Post TV005 Vaccination
Adolescent cohort: percent seropositive to DENV-4 at study day 360
|
66 percentage of participants
Interval 49.0 to 79.0
|
—
|
|
Durability of Seropositivity Post TV005 Vaccination
Adolescent cohort: percent seropositive to DENV-4 at study day 720
|
60 percentage of participants
Interval 44.0 to 74.0
|
—
|
|
Durability of Seropositivity Post TV005 Vaccination
Adolescent cohort: percent seropositive to DENV-4 at study day 1080
|
43 percentage of participants
Interval 28.0 to 59.0
|
—
|
|
Durability of Seropositivity Post TV005 Vaccination
Children cohort: percent seropositive to DENV-1 at study day 0
|
31 percentage of participants
Interval 18.0 to 47.0
|
—
|
|
Durability of Seropositivity Post TV005 Vaccination
Children cohort: percent seropositive to DENV-1 at study day 28
|
69 percentage of participants
Interval 53.0 to 82.0
|
—
|
|
Durability of Seropositivity Post TV005 Vaccination
Children cohort: percent seropositive to DENV-1 at study day 56
|
61 percentage of participants
Interval 45.0 to 75.0
|
—
|
|
Durability of Seropositivity Post TV005 Vaccination
Children cohort: percent seropositive to DENV-1 at study day 180
|
56 percentage of participants
Interval 40.0 to 70.0
|
—
|
|
Durability of Seropositivity Post TV005 Vaccination
Children cohort: percent seropositive to DENV-1 at study day 360
|
42 percentage of participants
Interval 27.0 to 58.0
|
—
|
|
Durability of Seropositivity Post TV005 Vaccination
Children cohort: percent seropositive to DENV-1 at study day 720
|
42 percentage of participants
Interval 27.0 to 58.0
|
—
|
|
Durability of Seropositivity Post TV005 Vaccination
Children cohort: percent seropositive to DENV-1 at study day 1080
|
36 percentage of participants
Interval 22.0 to 54.0
|
—
|
|
Durability of Seropositivity Post TV005 Vaccination
Children cohort: percent seropositive to DENV-2 at study day 0
|
33 percentage of participants
Interval 20.0 to 50.0
|
—
|
|
Durability of Seropositivity Post TV005 Vaccination
Children cohort: percent seropositive to DENV-2 at study day 28
|
92 percentage of participants
Interval 78.0 to 97.0
|
—
|
|
Durability of Seropositivity Post TV005 Vaccination
Children cohort: percent seropositive to DENV-2 at study day 56
|
89 percentage of participants
Interval 75.0 to 96.0
|
—
|
|
Durability of Seropositivity Post TV005 Vaccination
Children cohort: percent seropositive to DENV-2 at study day 180
|
92 percentage of participants
Interval 78.0 to 97.0
|
—
|
|
Durability of Seropositivity Post TV005 Vaccination
Children cohort: percent seropositive to DENV-2 at study day 360
|
78 percentage of participants
Interval 62.0 to 88.0
|
—
|
|
Durability of Seropositivity Post TV005 Vaccination
Children cohort: percent seropositive to DENV-2 at study day 720
|
67 percentage of participants
Interval 50.0 to 80.0
|
—
|
|
Durability of Seropositivity Post TV005 Vaccination
Children cohort: percent seropositive to DENV-2 at study day 1080
|
58 percentage of participants
Interval 42.0 to 73.0
|
—
|
|
Durability of Seropositivity Post TV005 Vaccination
Children cohort: percent seropositive to DENV-3 at study day 0
|
36 percentage of participants
Interval 22.0 to 52.0
|
—
|
|
Durability of Seropositivity Post TV005 Vaccination
Children cohort: percent seropositive to DENV-3 at study day 28
|
92 percentage of participants
Interval 78.0 to 97.0
|
—
|
|
Durability of Seropositivity Post TV005 Vaccination
Children cohort: percent seropositive to DENV-3 at study day 56
|
92 percentage of participants
Interval 78.0 to 97.0
|
—
|
|
Durability of Seropositivity Post TV005 Vaccination
Children cohort: percent seropositive to DENV-3 at study day 180
|
97 percentage of participants
Interval 86.0 to 100.0
|
—
|
|
Durability of Seropositivity Post TV005 Vaccination
Children cohort: percent seropositive to DENV-3 at study day 360
|
72 percentage of participants
Interval 56.0 to 84.0
|
—
|
|
Durability of Seropositivity Post TV005 Vaccination
Children cohort: percent seropositive to DENV-3 at study day 720
|
72 percentage of participants
Interval 56.0 to 84.0
|
—
|
|
Durability of Seropositivity Post TV005 Vaccination
Children cohort: percent seropositive to DENV-3 at study day 1080
|
67 percentage of participants
Interval 50.0 to 80.0
|
—
|
|
Durability of Seropositivity Post TV005 Vaccination
Children cohort: percent seropositive to DENV-4 at study day 0
|
11 percentage of participants
Interval 4.0 to 25.0
|
—
|
|
Durability of Seropositivity Post TV005 Vaccination
Children cohort: percent seropositive to DENV-4 at study day 28
|
72 percentage of participants
Interval 56.0 to 84.0
|
—
|
|
Durability of Seropositivity Post TV005 Vaccination
Children cohort: percent seropositive to DENV-4 at study day 56
|
56 percentage of participants
Interval 40.0 to 70.0
|
—
|
|
Durability of Seropositivity Post TV005 Vaccination
Children cohort: percent seropositive to DENV-4 at study day 180
|
44 percentage of participants
Interval 30.0 to 60.0
|
—
|
|
Durability of Seropositivity Post TV005 Vaccination
Children cohort: percent seropositive to DENV-4 at study day 360
|
28 percentage of participants
Interval 16.0 to 44.0
|
—
|
|
Durability of Seropositivity Post TV005 Vaccination
Children cohort: percent seropositive to DENV-4 at study day 720
|
25 percentage of participants
Interval 14.0 to 41.0
|
—
|
|
Durability of Seropositivity Post TV005 Vaccination
Children cohort: percent seropositive to DENV-4 at study day 1080
|
19 percentage of participants
Interval 10.0 to 35.0
|
—
|
|
Durability of Seropositivity Post TV005 Vaccination
Young Children cohort: percent seropositive to DENV-1 at study day 0
|
11 percentage of participants
Interval 4.0 to 25.0
|
—
|
|
Durability of Seropositivity Post TV005 Vaccination
Young Children cohort: percent seropositive to DENV-1 at study day 28
|
78 percentage of participants
Interval 62.0 to 88.0
|
—
|
|
Durability of Seropositivity Post TV005 Vaccination
Young Children cohort: percent seropositive to DENV-1 at study day 56
|
42 percentage of participants
Interval 27.0 to 58.0
|
—
|
|
Durability of Seropositivity Post TV005 Vaccination
Young Children cohort: percent seropositive to DENV-1 at study day 180
|
53 percentage of participants
Interval 37.0 to 68.0
|
—
|
|
Durability of Seropositivity Post TV005 Vaccination
Young Children cohort: percent seropositive to DENV-1 at study day 360
|
28 percentage of participants
Interval 16.0 to 44.0
|
—
|
|
Durability of Seropositivity Post TV005 Vaccination
Young Children cohort: percent seropositive to DENV-1 at study day 720
|
28 percentage of participants
Interval 16.0 to 44.0
|
—
|
|
Durability of Seropositivity Post TV005 Vaccination
Young Children cohort: percent seropositive to DENV-1 at study day 1080
|
28 percentage of participants
Interval 16.0 to 44.0
|
—
|
|
Durability of Seropositivity Post TV005 Vaccination
Young Children cohort: percent seropositive to DENV-2 at study day 0
|
11 percentage of participants
Interval 4.0 to 25.0
|
—
|
|
Durability of Seropositivity Post TV005 Vaccination
Young Children cohort: percent seropositive to DENV-2 at study day 28
|
97 percentage of participants
Interval 86.0 to 100.0
|
—
|
|
Durability of Seropositivity Post TV005 Vaccination
Young Children cohort: percent seropositive to DENV-2 at study day 56
|
86 percentage of participants
Interval 71.0 to 94.0
|
—
|
|
Durability of Seropositivity Post TV005 Vaccination
Young Children cohort: percent seropositive to DENV-2 at study day 180
|
81 percentage of participants
Interval 65.0 to 90.0
|
—
|
|
Durability of Seropositivity Post TV005 Vaccination
Young Children cohort: percent seropositive to DENV-2 at study day 360
|
83 percentage of participants
Interval 68.0 to 92.0
|
—
|
|
Durability of Seropositivity Post TV005 Vaccination
Young Children cohort: percent seropositive to DENV-2 at study day 720
|
72 percentage of participants
Interval 56.0 to 84.0
|
—
|
|
Durability of Seropositivity Post TV005 Vaccination
Young Children cohort: percent seropositive to DENV-2 at study day 1080
|
69 percentage of participants
Interval 53.0 to 82.0
|
—
|
|
Durability of Seropositivity Post TV005 Vaccination
Young Children cohort: percent seropositive to DENV-3 at study day 0
|
8 percentage of participants
Interval 3.0 to 22.0
|
—
|
|
Durability of Seropositivity Post TV005 Vaccination
Young Children cohort: percent seropositive to DENV-3 at study day 28
|
86 percentage of participants
Interval 71.0 to 94.0
|
—
|
|
Durability of Seropositivity Post TV005 Vaccination
Young Children cohort: percent seropositive to DENV-3 at study day 56
|
67 percentage of participants
Interval 50.0 to 80.0
|
—
|
|
Durability of Seropositivity Post TV005 Vaccination
Young Children cohort: percent seropositive to DENV-3 at study day 180
|
50 percentage of participants
Interval 34.0 to 66.0
|
—
|
|
Durability of Seropositivity Post TV005 Vaccination
Young Children cohort: percent seropositive to DENV-3 at study day 360
|
25 percentage of participants
Interval 14.0 to 41.0
|
—
|
|
Durability of Seropositivity Post TV005 Vaccination
Young Children cohort: percent seropositive to DENV-3 at study day 720
|
31 percentage of participants
Interval 18.0 to 47.0
|
—
|
|
Durability of Seropositivity Post TV005 Vaccination
Young Children cohort: percent seropositive to DENV-3 at study day 1080
|
25 percentage of participants
Interval 14.0 to 41.0
|
—
|
|
Durability of Seropositivity Post TV005 Vaccination
Young Children cohort: percent seropositive to DENV-4 at study day 0
|
3 percentage of participants
Interval 0.0 to 14.0
|
—
|
|
Durability of Seropositivity Post TV005 Vaccination
Young Children cohort: percent seropositive to DENV-4 at study day 28
|
89 percentage of participants
Interval 75.0 to 96.0
|
—
|
|
Durability of Seropositivity Post TV005 Vaccination
Young Children cohort: percent seropositive to DENV-4 at study day 56
|
72 percentage of participants
Interval 56.0 to 96.0
|
—
|
|
Durability of Seropositivity Post TV005 Vaccination
Young Children cohort: percent seropositive to DENV-4 at study day 180
|
47 percentage of participants
Interval 32.0 to 63.0
|
—
|
|
Durability of Seropositivity Post TV005 Vaccination
Young Children cohort: percent seropositive to DENV-4 at study day 360
|
28 percentage of participants
Interval 16.0 to 44.0
|
—
|
|
Durability of Seropositivity Post TV005 Vaccination
Young Children cohort: percent seropositive to DENV-4 at study day 720
|
28 percentage of participants
Interval 16.0 to 44.0
|
—
|
|
Durability of Seropositivity Post TV005 Vaccination
Young Children cohort: percent seropositive to DENV-4 at study day 1080
|
22 percentage of participants
Interval 12.0 to 38.0
|
—
|
Adverse Events
TV005 Vaccine
Serious events: 6 serious events
Other events: 95 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 25 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
TV005 Vaccine
n=144 participants at risk
Participants will receive one dose of TV005 vaccine at study entry (Day 0).
TV005 vaccine: Delivered by subcutaneous injection; contains 10\^3 PFU of rDEN1Δ30, 10\^4 PFU of rDEN2/4Δ30(ME), 10\^3 PFU of rDEN3Δ30/31, and 10\^3 PFU of rDEN4Δ30.
|
Placebo
n=48 participants at risk
Participants will receive one dose of placebo at study entry (Day 0).
Placebo: Delivered by subcutaneous injection
|
|---|---|---|
|
Cardiac disorders
Angina Unstable
|
0.69%
1/144 • Number of events 1 • All-cause mortality and SAEs were assessed through three years post-vaccination; solicited and all other adverse events were assessed through 28 days post vaccination
Time frame for solicited adverse events is up to 28 days post vaccination; time frame for SAE and all-cause mortality is three years post vaccination
|
0.00%
0/48 • All-cause mortality and SAEs were assessed through three years post-vaccination; solicited and all other adverse events were assessed through 28 days post vaccination
Time frame for solicited adverse events is up to 28 days post vaccination; time frame for SAE and all-cause mortality is three years post vaccination
|
|
Gastrointestinal disorders
Appendicitis
|
0.69%
1/144 • Number of events 1 • All-cause mortality and SAEs were assessed through three years post-vaccination; solicited and all other adverse events were assessed through 28 days post vaccination
Time frame for solicited adverse events is up to 28 days post vaccination; time frame for SAE and all-cause mortality is three years post vaccination
|
0.00%
0/48 • All-cause mortality and SAEs were assessed through three years post-vaccination; solicited and all other adverse events were assessed through 28 days post vaccination
Time frame for solicited adverse events is up to 28 days post vaccination; time frame for SAE and all-cause mortality is three years post vaccination
|
|
Hepatobiliary disorders
ALT Increase
|
0.69%
1/144 • Number of events 1 • All-cause mortality and SAEs were assessed through three years post-vaccination; solicited and all other adverse events were assessed through 28 days post vaccination
Time frame for solicited adverse events is up to 28 days post vaccination; time frame for SAE and all-cause mortality is three years post vaccination
|
0.00%
0/48 • All-cause mortality and SAEs were assessed through three years post-vaccination; solicited and all other adverse events were assessed through 28 days post vaccination
Time frame for solicited adverse events is up to 28 days post vaccination; time frame for SAE and all-cause mortality is three years post vaccination
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.69%
1/144 • Number of events 1 • All-cause mortality and SAEs were assessed through three years post-vaccination; solicited and all other adverse events were assessed through 28 days post vaccination
Time frame for solicited adverse events is up to 28 days post vaccination; time frame for SAE and all-cause mortality is three years post vaccination
|
0.00%
0/48 • All-cause mortality and SAEs were assessed through three years post-vaccination; solicited and all other adverse events were assessed through 28 days post vaccination
Time frame for solicited adverse events is up to 28 days post vaccination; time frame for SAE and all-cause mortality is three years post vaccination
|
|
Cardiac disorders
Endocarditis Infective
|
0.69%
1/144 • Number of events 1 • All-cause mortality and SAEs were assessed through three years post-vaccination; solicited and all other adverse events were assessed through 28 days post vaccination
Time frame for solicited adverse events is up to 28 days post vaccination; time frame for SAE and all-cause mortality is three years post vaccination
|
0.00%
0/48 • All-cause mortality and SAEs were assessed through three years post-vaccination; solicited and all other adverse events were assessed through 28 days post vaccination
Time frame for solicited adverse events is up to 28 days post vaccination; time frame for SAE and all-cause mortality is three years post vaccination
|
|
Infections and infestations
Typhoid Fever
|
0.69%
1/144 • Number of events 1 • All-cause mortality and SAEs were assessed through three years post-vaccination; solicited and all other adverse events were assessed through 28 days post vaccination
Time frame for solicited adverse events is up to 28 days post vaccination; time frame for SAE and all-cause mortality is three years post vaccination
|
0.00%
0/48 • All-cause mortality and SAEs were assessed through three years post-vaccination; solicited and all other adverse events were assessed through 28 days post vaccination
Time frame for solicited adverse events is up to 28 days post vaccination; time frame for SAE and all-cause mortality is three years post vaccination
|
Other adverse events
| Measure |
TV005 Vaccine
n=144 participants at risk
Participants will receive one dose of TV005 vaccine at study entry (Day 0).
TV005 vaccine: Delivered by subcutaneous injection; contains 10\^3 PFU of rDEN1Δ30, 10\^4 PFU of rDEN2/4Δ30(ME), 10\^3 PFU of rDEN3Δ30/31, and 10\^3 PFU of rDEN4Δ30.
|
Placebo
n=48 participants at risk
Participants will receive one dose of placebo at study entry (Day 0).
Placebo: Delivered by subcutaneous injection
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Injection site erythema
|
0.69%
1/144 • Number of events 1 • All-cause mortality and SAEs were assessed through three years post-vaccination; solicited and all other adverse events were assessed through 28 days post vaccination
Time frame for solicited adverse events is up to 28 days post vaccination; time frame for SAE and all-cause mortality is three years post vaccination
|
0.00%
0/48 • All-cause mortality and SAEs were assessed through three years post-vaccination; solicited and all other adverse events were assessed through 28 days post vaccination
Time frame for solicited adverse events is up to 28 days post vaccination; time frame for SAE and all-cause mortality is three years post vaccination
|
|
General disorders
Injection site pain
|
6.2%
9/144 • Number of events 9 • All-cause mortality and SAEs were assessed through three years post-vaccination; solicited and all other adverse events were assessed through 28 days post vaccination
Time frame for solicited adverse events is up to 28 days post vaccination; time frame for SAE and all-cause mortality is three years post vaccination
|
8.3%
4/48 • Number of events 4 • All-cause mortality and SAEs were assessed through three years post-vaccination; solicited and all other adverse events were assessed through 28 days post vaccination
Time frame for solicited adverse events is up to 28 days post vaccination; time frame for SAE and all-cause mortality is three years post vaccination
|
|
General disorders
Injection site swelling
|
0.69%
1/144 • Number of events 1 • All-cause mortality and SAEs were assessed through three years post-vaccination; solicited and all other adverse events were assessed through 28 days post vaccination
Time frame for solicited adverse events is up to 28 days post vaccination; time frame for SAE and all-cause mortality is three years post vaccination
|
0.00%
0/48 • All-cause mortality and SAEs were assessed through three years post-vaccination; solicited and all other adverse events were assessed through 28 days post vaccination
Time frame for solicited adverse events is up to 28 days post vaccination; time frame for SAE and all-cause mortality is three years post vaccination
|
|
General disorders
Fever
|
7.6%
11/144 • Number of events 11 • All-cause mortality and SAEs were assessed through three years post-vaccination; solicited and all other adverse events were assessed through 28 days post vaccination
Time frame for solicited adverse events is up to 28 days post vaccination; time frame for SAE and all-cause mortality is three years post vaccination
|
2.1%
1/48 • Number of events 1 • All-cause mortality and SAEs were assessed through three years post-vaccination; solicited and all other adverse events were assessed through 28 days post vaccination
Time frame for solicited adverse events is up to 28 days post vaccination; time frame for SAE and all-cause mortality is three years post vaccination
|
|
General disorders
Headache
|
13.2%
19/144 • Number of events 19 • All-cause mortality and SAEs were assessed through three years post-vaccination; solicited and all other adverse events were assessed through 28 days post vaccination
Time frame for solicited adverse events is up to 28 days post vaccination; time frame for SAE and all-cause mortality is three years post vaccination
|
16.7%
8/48 • Number of events 8 • All-cause mortality and SAEs were assessed through three years post-vaccination; solicited and all other adverse events were assessed through 28 days post vaccination
Time frame for solicited adverse events is up to 28 days post vaccination; time frame for SAE and all-cause mortality is three years post vaccination
|
|
Skin and subcutaneous tissue disorders
Rash
|
25.7%
37/144 • Number of events 37 • All-cause mortality and SAEs were assessed through three years post-vaccination; solicited and all other adverse events were assessed through 28 days post vaccination
Time frame for solicited adverse events is up to 28 days post vaccination; time frame for SAE and all-cause mortality is three years post vaccination
|
12.5%
6/48 • Number of events 6 • All-cause mortality and SAEs were assessed through three years post-vaccination; solicited and all other adverse events were assessed through 28 days post vaccination
Time frame for solicited adverse events is up to 28 days post vaccination; time frame for SAE and all-cause mortality is three years post vaccination
|
|
Gastrointestinal disorders
Nausea
|
5.6%
8/144 • Number of events 8 • All-cause mortality and SAEs were assessed through three years post-vaccination; solicited and all other adverse events were assessed through 28 days post vaccination
Time frame for solicited adverse events is up to 28 days post vaccination; time frame for SAE and all-cause mortality is three years post vaccination
|
4.2%
2/48 • Number of events 2 • All-cause mortality and SAEs were assessed through three years post-vaccination; solicited and all other adverse events were assessed through 28 days post vaccination
Time frame for solicited adverse events is up to 28 days post vaccination; time frame for SAE and all-cause mortality is three years post vaccination
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.69%
1/144 • Number of events 1 • All-cause mortality and SAEs were assessed through three years post-vaccination; solicited and all other adverse events were assessed through 28 days post vaccination
Time frame for solicited adverse events is up to 28 days post vaccination; time frame for SAE and all-cause mortality is three years post vaccination
|
0.00%
0/48 • All-cause mortality and SAEs were assessed through three years post-vaccination; solicited and all other adverse events were assessed through 28 days post vaccination
Time frame for solicited adverse events is up to 28 days post vaccination; time frame for SAE and all-cause mortality is three years post vaccination
|
|
Hepatobiliary disorders
ALT Elevated
|
3.5%
5/144 • Number of events 5 • All-cause mortality and SAEs were assessed through three years post-vaccination; solicited and all other adverse events were assessed through 28 days post vaccination
Time frame for solicited adverse events is up to 28 days post vaccination; time frame for SAE and all-cause mortality is three years post vaccination
|
4.2%
2/48 • Number of events 2 • All-cause mortality and SAEs were assessed through three years post-vaccination; solicited and all other adverse events were assessed through 28 days post vaccination
Time frame for solicited adverse events is up to 28 days post vaccination; time frame for SAE and all-cause mortality is three years post vaccination
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
4.9%
7/144 • Number of events 7 • All-cause mortality and SAEs were assessed through three years post-vaccination; solicited and all other adverse events were assessed through 28 days post vaccination
Time frame for solicited adverse events is up to 28 days post vaccination; time frame for SAE and all-cause mortality is three years post vaccination
|
2.1%
1/48 • Number of events 1 • All-cause mortality and SAEs were assessed through three years post-vaccination; solicited and all other adverse events were assessed through 28 days post vaccination
Time frame for solicited adverse events is up to 28 days post vaccination; time frame for SAE and all-cause mortality is three years post vaccination
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
4.9%
7/144 • Number of events 7 • All-cause mortality and SAEs were assessed through three years post-vaccination; solicited and all other adverse events were assessed through 28 days post vaccination
Time frame for solicited adverse events is up to 28 days post vaccination; time frame for SAE and all-cause mortality is three years post vaccination
|
0.00%
0/48 • All-cause mortality and SAEs were assessed through three years post-vaccination; solicited and all other adverse events were assessed through 28 days post vaccination
Time frame for solicited adverse events is up to 28 days post vaccination; time frame for SAE and all-cause mortality is three years post vaccination
|
|
Eye disorders
Retro-orbital pain
|
2.1%
3/144 • Number of events 3 • All-cause mortality and SAEs were assessed through three years post-vaccination; solicited and all other adverse events were assessed through 28 days post vaccination
Time frame for solicited adverse events is up to 28 days post vaccination; time frame for SAE and all-cause mortality is three years post vaccination
|
2.1%
1/48 • Number of events 1 • All-cause mortality and SAEs were assessed through three years post-vaccination; solicited and all other adverse events were assessed through 28 days post vaccination
Time frame for solicited adverse events is up to 28 days post vaccination; time frame for SAE and all-cause mortality is three years post vaccination
|
|
General disorders
Fatigue
|
5.6%
8/144 • Number of events 8 • All-cause mortality and SAEs were assessed through three years post-vaccination; solicited and all other adverse events were assessed through 28 days post vaccination
Time frame for solicited adverse events is up to 28 days post vaccination; time frame for SAE and all-cause mortality is three years post vaccination
|
4.2%
2/48 • Number of events 2 • All-cause mortality and SAEs were assessed through three years post-vaccination; solicited and all other adverse events were assessed through 28 days post vaccination
Time frame for solicited adverse events is up to 28 days post vaccination; time frame for SAE and all-cause mortality is three years post vaccination
|
|
General disorders
Photophobia
|
0.69%
1/144 • Number of events 1 • All-cause mortality and SAEs were assessed through three years post-vaccination; solicited and all other adverse events were assessed through 28 days post vaccination
Time frame for solicited adverse events is up to 28 days post vaccination; time frame for SAE and all-cause mortality is three years post vaccination
|
0.00%
0/48 • All-cause mortality and SAEs were assessed through three years post-vaccination; solicited and all other adverse events were assessed through 28 days post vaccination
Time frame for solicited adverse events is up to 28 days post vaccination; time frame for SAE and all-cause mortality is three years post vaccination
|
|
Blood and lymphatic system disorders
Hemoglobin decreasaed
|
13.9%
20/144 • Number of events 20 • All-cause mortality and SAEs were assessed through three years post-vaccination; solicited and all other adverse events were assessed through 28 days post vaccination
Time frame for solicited adverse events is up to 28 days post vaccination; time frame for SAE and all-cause mortality is three years post vaccination
|
18.8%
9/48 • Number of events 9 • All-cause mortality and SAEs were assessed through three years post-vaccination; solicited and all other adverse events were assessed through 28 days post vaccination
Time frame for solicited adverse events is up to 28 days post vaccination; time frame for SAE and all-cause mortality is three years post vaccination
|
|
Blood and lymphatic system disorders
Leukocytosis
|
2.1%
3/144 • Number of events 3 • All-cause mortality and SAEs were assessed through three years post-vaccination; solicited and all other adverse events were assessed through 28 days post vaccination
Time frame for solicited adverse events is up to 28 days post vaccination; time frame for SAE and all-cause mortality is three years post vaccination
|
2.1%
1/48 • Number of events 1 • All-cause mortality and SAEs were assessed through three years post-vaccination; solicited and all other adverse events were assessed through 28 days post vaccination
Time frame for solicited adverse events is up to 28 days post vaccination; time frame for SAE and all-cause mortality is three years post vaccination
|
|
Blood and lymphatic system disorders
PT Prolonged
|
0.69%
1/144 • Number of events 1 • All-cause mortality and SAEs were assessed through three years post-vaccination; solicited and all other adverse events were assessed through 28 days post vaccination
Time frame for solicited adverse events is up to 28 days post vaccination; time frame for SAE and all-cause mortality is three years post vaccination
|
0.00%
0/48 • All-cause mortality and SAEs were assessed through three years post-vaccination; solicited and all other adverse events were assessed through 28 days post vaccination
Time frame for solicited adverse events is up to 28 days post vaccination; time frame for SAE and all-cause mortality is three years post vaccination
|
|
Blood and lymphatic system disorders
PTT prolonged
|
2.8%
4/144 • Number of events 4 • All-cause mortality and SAEs were assessed through three years post-vaccination; solicited and all other adverse events were assessed through 28 days post vaccination
Time frame for solicited adverse events is up to 28 days post vaccination; time frame for SAE and all-cause mortality is three years post vaccination
|
4.2%
2/48 • Number of events 2 • All-cause mortality and SAEs were assessed through three years post-vaccination; solicited and all other adverse events were assessed through 28 days post vaccination
Time frame for solicited adverse events is up to 28 days post vaccination; time frame for SAE and all-cause mortality is three years post vaccination
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
3.5%
5/144 • Number of events 5 • All-cause mortality and SAEs were assessed through three years post-vaccination; solicited and all other adverse events were assessed through 28 days post vaccination
Time frame for solicited adverse events is up to 28 days post vaccination; time frame for SAE and all-cause mortality is three years post vaccination
|
0.00%
0/48 • All-cause mortality and SAEs were assessed through three years post-vaccination; solicited and all other adverse events were assessed through 28 days post vaccination
Time frame for solicited adverse events is up to 28 days post vaccination; time frame for SAE and all-cause mortality is three years post vaccination
|
|
General disorders
Decreased appetite
|
0.69%
1/144 • Number of events 1 • All-cause mortality and SAEs were assessed through three years post-vaccination; solicited and all other adverse events were assessed through 28 days post vaccination
Time frame for solicited adverse events is up to 28 days post vaccination; time frame for SAE and all-cause mortality is three years post vaccination
|
0.00%
0/48 • All-cause mortality and SAEs were assessed through three years post-vaccination; solicited and all other adverse events were assessed through 28 days post vaccination
Time frame for solicited adverse events is up to 28 days post vaccination; time frame for SAE and all-cause mortality is three years post vaccination
|
|
Gastrointestinal disorders
Vomiting
|
2.1%
3/144 • Number of events 3 • All-cause mortality and SAEs were assessed through three years post-vaccination; solicited and all other adverse events were assessed through 28 days post vaccination
Time frame for solicited adverse events is up to 28 days post vaccination; time frame for SAE and all-cause mortality is three years post vaccination
|
0.00%
0/48 • All-cause mortality and SAEs were assessed through three years post-vaccination; solicited and all other adverse events were assessed through 28 days post vaccination
Time frame for solicited adverse events is up to 28 days post vaccination; time frame for SAE and all-cause mortality is three years post vaccination
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place