Back to resultsSafety and Immunogenicity of Takeda's Tetravalent Dengue Vaccine (TDV) in Healthy Children
Primary Purpose
Healthy Volunteers
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
TDV
Sponsored by
About this trial
This is an interventional prevention trial for Healthy Volunteers focused on measuring Drug therapy
Eligibility Criteria
Main Inclusion Criteria:
- Is aged 4 to 16 years, inclusive (Latin America) or 4 to 8 years, inclusive (Asia).
- Are in good health at the time of entry into the study as determined by medical history, physical examination (including vital signs), and clinical judgment of the investigator.
Main Exclusion Criteria:
- Febrile illness (body temperature ≥38°C) or moderate or severe acute illness or infection at the time of enrolment.
- History or any illness that, in the opinion of the investigator, might interfere with the results of the study or pose an additional risk to the participant due to participation in the study.
- Receipt of any other vaccines within 14 days (for inactivated vaccines) or 28 days (for live vaccines) prior to Day 1 (Month 0) or planning to receive any vaccines within 28 days after Day 1 (Month 0).
- Previous participation in any clinical study of a dengue candidate vaccine, or previous receipt of any dengue vaccines (investigational or licensed).
Sites / Locations
- CEVAXIN
- Research Institute for Tropical Medicine
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Tetravalent Dengue Vaccine (TDV) 0.5 mL
Arm Description
TDV 0.5 mL, subcutaneous (SC) injection, on Day 1 (Month 0) and Day 90 (Month 3).
Outcomes
Primary Outcome Measures
Percentage of Participants With Cellular Immune Response to 2 Doses of Tetravalent Dengue Vaccine (TDV) at 1 Month Post Second Vaccination
Percentage of participants with cellular immune response were reported. Cellular immune response was defined as an interferon-gamma (IFN-γ) enzyme-linked immunospot (ELISPOT) response that was >3 times higher compared to Baseline (Day 1) and ≥ 5 spots per well. Cellular immune response to any peptide pool was reported. The peptide pool included non-structural protein (NS) for each of the dengue serotype: DENV-1, DENV-2, DENV-3 and DENV-4. Percentage of participants with cellular immune response were reported. Cellular immune response was defined as an interferon-gamma (IFN-γ) enzyme-linked immunospot (ELISPOT) response that was >3 times higher compared to Baseline (Day 1) and ≥ 5 spots per well. Cellular immune response to any peptide pool was reported. The peptide pool included non-structural protein (NS) for each of the dengue serotype: DENV-1, DENV-2, DENV-3 and DENV-4.
Secondary Outcome Measures
Magnitude of Cellular Immune Response Assessed by Number of Spot Forming Cells (SFC)/Million Peripheral Blood Mononuclear Cells (PBMCs) Measured by IFN-γ ELISPOT at 1 Month Post Second Vaccination
The magnitude of cellular immune response was assessed by the number of SFC/million PBMCs for participants with a cellular immune response. Cellular immune response was defined as IFN-γ ELISPOT response that was >3 times higher compared to Baseline (Day 1) and ≥ 5 spots per well. Data (SFC/million PBMC) for participants with a cellular immune response to any peptide pool is reported. The peptide pool included NS for each of the dengue serotype: DENV-1, DENV-2, DENV-3 and DENV-4.
Percentage of Participants With Cellular Immune Response to TDV at 1 Month Post First Vaccination, Pre-second Vaccination, 6 Months Post Second Vaccination
Percentage of participants with cellular immune response were reported. Cellular immune response was defined as an IFN-γ ELISPOT response that was >3 times higher compared to Baseline (Day 1 [M0]) and >=5 spots per well. Cellular immune response to any peptide pool was reported. The peptide pool included NS for each of the dengue serotype: DENV-1, DENV-2, DENV-3 and DENV-4.
Magnitude of Cellular Immune Response Assessed by Number of SFC/Million PBMCs Measured by IFN-γ ELISPOT at 1 Month Post First Vaccination, Pre-second Vaccination, 6 Months Post Second Vaccination
The magnitude of cellular immune response was assessed by the number of SFC/million PBMCs for participants with a cellular immune response. Cellular immune response was defined as IFN-γ ELISPOT response that was >3 times higher compared to Baseline (Day 1) and ≥ 5 spots per well. Data (SFC/million PBMC) for participants with a cellular immune response to any peptide pool is reported. The peptide pool included NS protein for each of the dengue serotype: DENV-1, DENV-2, DENV-3 and DENV-4.
Percentage of Participants With Cellular Immune Responses to TDV at 1 Month Post First Vaccination, Pre-second Vaccination, 1 and 6 Months Post Second Vaccination Assessed by Country
Percentage of participants with cellular immune response by country were reported. Cellular immune response was defined as an IFN-γ ELISPOT response that was >3 times higher compared to Baseline (Day 1 [M0]) and >=5 spots per well. Cellular immune response to any peptide pool was reported. The peptide pool included NS for each of the dengue serotype: DENV-1, DENV-2, DENV-3 and DENV-4. Data is reported as per enrollment by country (Panama and Philippines).
Percentage of Participants With Cellular Immune Responses to TDV:1 Month Post First Vaccination, Pre-second Vaccination, 1 and 6 Months Post Second Vaccination, by Dengue Baseline Seropositivity Status
Percentage of participants with cellular immune response by dengue Baseline seropositivity status were reported. Cellular immune response was defined as an IFN-γ ELISPOT response that was >3 times higher compared to Baseline (Day 1 [M0]) and >=5 spots per well. Seropositive at Baseline was defined as a reciprocal neutralizing titer >=10 for one or more dengue serotypes. Seronegative at Baseline was defined as having a reciprocal neutralizing titer <10 for all dengue serotypes. The 4 dengue virus serotypes were dengue virus (DENV)-1, DENV-2, DENV-3 and DENV-4. Cellular immune response to any peptide pool was reported. The peptide pool included NS for each of the dengue serotype: DENV-1, DENV-2, DENV-3 and DENV-4. Data is reported per Baseline seropositivity status of participants (Seropositive and Seronegative).
Magnitude of Cellular Immune Response Assessed by Number of SFC/Million PBMCs Measured by IFN-γ ELISPOT at 1 Month Post First, Pre- Second Vaccination, 1 and 6 Months Post Second Vaccination, by Country
The magnitude of cellular immune response by country was assessed by the number of SFC/million PBMCs for participants with a cellular immune response. Cellular immune response was defined as IFN-γ ELISPOT response that was >3 times higher compared to Baseline (Day 1) and ≥ 5 spots per well. Data (SFC/million PBMC) for participants with a cellular immune response to any peptide pool is reported. The peptide pool included NS protein for each of the dengue serotype: DENV-1, DENV-2, DENV-3 and DENV-4. Data is reported as per enrollment by country (Panama and Philippines).
Magnitude of Cellular Immune Response Assessed by Number of SFC/Million PBMCs Measured by IFN-γ ELISPOT 1 Month Post First; Pre-second Vaccination; 1 and 6 Months Post Second Vaccination, by Dengue Baseline Seropositivity Status
The magnitude of cellular immune response by dengue Baseline seropositivity status was assessed by the number of SFC/million PBMCs for participants with a cellular immune response. Cellular immune response was defined as IFN-γ ELISPOT response that was >3 times higher compared to Baseline (Day 1) and ≥ 5 spots per well. Seropositive at Baseline was defined as a reciprocal neutralizing titer >=10 for one or more dengue serotypes. Seronegative at Baseline was defined as having a reciprocal neutralizing titer <10 for all dengue serotypes. The 4 dengue virus serotypes were dengue virus (DENV)-1, DENV-2, DENV-3 and DENV-4. Cellular immune response to any peptide pool was reported. The peptide pool included NS for each of the dengue serotype: DENV-1, DENV-2, DENV-3 and DENV-4. Data is reported per Baseline seropositivity status of participants (Seropositive and Seronegative).
Percentage of Participants With Cellular Immune Response to TDV in Participants >10 Years of Age
Percentage of participants with cellular immune response in participants >10 years of age were reported. Cellular immune response was defined as an IFN-γ ELISPOT response that was >3 times higher compared to Baseline (Day 1 [M0]) and >=5 spots per well. Cellular immune response to any peptide pool was reported. The peptide pool included NS for each of the dengue serotype: DENV-1, DENV-2, DENV-3 and DENV-4. SFC/million PBMC for any peptide pool is reported in participants >10 years of age.
Magnitude of Cellular Immune Response Assessed by Number of SFC/Million PBMCs Measured by IFN-γ ELISPOT in Participants >10 Years of Age
The magnitude of cellular immune response was assessed by the number of SFC/million PBMCs for participants with a cellular immune response. Cellular immune response was defined as IFN-γ ELISPOT response that was >3 times higher compared to Baseline (Day 1) and ≥ 5 spots per well. Cellular immune response to any peptide pool was reported. The peptide pool included NS for each of the dengue serotype: DENV-1, DENV-2, DENV-3 and DENV-4. SFC/million PBMC for any peptide pool is reported in participants >10 years of age.
Phenotype Characterization of Cellular Immune Response Assessed by Percentage of Total T Cells of Cellular Response to DENV-2 NS Proteins at 1 Month Post First, Pre-second Vaccination, 1 and 6 Months Post Second Vaccination
The phenotype characterization of cellular immune response was assessed by intracellular cytokine staining (ICS) by the frequency of total cluster of differentiation 4 (CD4)+ and CD8+ T cells and was performed in a subset of participants with IFN- γ ELISPOT responses >500 SFC/million cells and availability of sufficient cells. The peptide pools included NS for the DENV-2 serotype. Data are presented for the different expression profiles of interferon-gamma (IFN-γ), interleukin-2 (IL-2) and tumor necrosis factor-alpha (TNF-α) cytokines for each peptide pool. Data is reported based on the type of T cells present in participants at the time of analysis (CD4+ T cells and CD8+ T cells).
Phenotype Characterization of Cellular Immune Response Assessed by Percentage of Total T Cells of Cellular Response DENV-2 NS Proteins,1 Month Post First, Pre Second Vaccination;1 and 6 Months Post Second Vaccination, by Country
The phenotype characterization of cellular immune response by country was assessed by ICS by the frequency of total CD4+ and CD8+ T cells and was performed in a subset of participants with IFN- γ ELISPOT responses >500 SFC/million cells and availability of sufficient cells. The peptide pools included NS for the DENV-2 serotype. Data are presented for the different expression profiles of IFN-γ, IL-2 and TNF-α cytokines for each peptide pool. Data is reported per country (Panama and Philippines) based on the type of T cells present in participants at the time of analysis (CD4+ T cells and CD8+ T cells).
Phenotype Characterization of Cellular Immune Response by Percentage of Total T Cells DENV-2 NS Proteins at 1 Month Post First, Pre Second Vaccination,1 and 6 Months Post Second Vaccination, by Dengue Baseline Seropositivity Status
The phenotype characterization of cellular immune response by dengue Baseline seropositivity status was assessed by the frequency of total CD4+ and CD8+ T cells and was performed in a subset of participants with IFN- γ ELISPOT responses >500 SFC/million cells and availability of sufficient cells. Seropositive was defined as a reciprocal neutralizing titer (MNT50) >=10 for one or more dengue serotypes. Seronegative was defined as titer value of <10 for all 4 serotypes. The peptide pools included NS for the DENV-2 serotype. Data are presented for the different expression profiles of IFN-γ, IL-2 and TNF-α cytokines for each peptide pool. Data is reported per Baseline seropositivity status (Seropositive and Seronegative) based on the type of T cells present in participants at the time of analysis (CD4+ T cells and CD8+ T cells).
Geometric Mean Titers (GMT) of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at 1 Month Post First Vaccination, Pre Second Vaccination, and 1, 6 Months Post Second Vaccination and Then Annually Up to 3 Years
GMT of neutralizing antibodies was measured by microneutralization test (MTN). The dengue virus serotypes are DENV-1, DENV-2, DENV-3 and DENV-4.
Percentage of Participants Seropositive for Each of the 4 Dengue Serotypes at 1 Month Post First Vaccination, Pre-second Vaccination, and 1, 6 Months Post Second Vaccination and Then Annually up to 3 Years
Seropositive was defined as a reciprocal neutralizing titer ≥10. The dengue virus serotypes are DENV-1, DENV-2, DENV-3 and DENV-4.
Percentage of Participants Seropositive for Multiple Dengue Serotypes at 1 Month Post First Vaccination, Pre Second Vaccination, 1, 6 Months Post Second Vaccination and Annually up to 3 Years
Seropositive was defined as a reciprocal neutralizing titer ≥10. The dengue virus serotypes are DENV-1, DENV-2, DENV-3 and DENV-4. Seropositive for multiple dengue serotypes were summarized in the following categories: tetravalent and at least trivalent.
Percentage of Participants Experiencing Unsolicited Adverse Events (AE)
An AE was defined as any untoward medical occurrence in a clinical investigation participant administered a trial vaccine; it does not necessarily have to have a causal relationship with trial vaccine administration.
Percentage of Participants With Medically Attended AEs (MAAEs)
MAAEs were defined as AEs leading to a medical visit to or by a healthcare professional, including visits to an emergency department, but not fulfilling seriousness criteria.
Percentage of Participants With Serious Adverse Events (SAEs)
A SAE was defined as any untoward medical occurrence or effect that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability / incapacity, is a congenital anomaly / birth defect or is medically important due to other reasons than the above mentioned criteria.
Percentage of Participants With Virologically Confirmed Dengue
Participants with febrile illness defined as fever ≥38°C on any 2 of 3 consecutive days were evaluated for dengue. Virologically confirmed dengue was defined as febrile illness with a positive serotype-specific RT-PCR (i.e. positive dengue detection RT-PCR).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02948829
Brief Title
Safety and Immunogenicity of Takeda's Tetravalent Dengue Vaccine (TDV) in Healthy Children
Official Title
An Open Label, Phase 2 Study to Investigate Cell-mediated Immunity and Safety of a Tetravalent Dengue Vaccine Candidate (TDV) Administered Subcutaneously in Healthy Children Aged 4 to 16 Years
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
April 3, 2017 (Actual)
Primary Completion Date
October 16, 2017 (Actual)
Study Completion Date
December 14, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Takeda
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to assess the cellular immune responses following 2 doses given 3 months apart of tetravalent dengue vaccine candidate (TDV) in 4 to 16 years' healthy participants.
Detailed Description
The vaccine tested in this study was TDV. This study assessed cellular immune responses and safety up to 3 years post second TDV administration to healthy children aged 4 to 16 years and in dengue endemic regions.
The study enrolled 200 participants. Participants received:
• TDV 0.5 mL subcutaneous (SC) injection into the upper arm at Day 1 (Month 0) and at Day 90 (Month 3).
This multi-center trial was conducted in Panama and Philippines. 198 participants received the 2-dose schedule of TDV, and 2 participants received only the first dose of TDV (Day 1). Participants made multiple visits to the clinic and were contacted at least every week for the entire study duration post first injection.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy Volunteers
Keywords
Drug therapy
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
200 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Tetravalent Dengue Vaccine (TDV) 0.5 mL
Arm Type
Experimental
Arm Description
TDV 0.5 mL, subcutaneous (SC) injection, on Day 1 (Month 0) and Day 90 (Month 3).
Intervention Type
Biological
Intervention Name(s)
TDV
Intervention Description
TDV SC injection.
Primary Outcome Measure Information:
Title
Percentage of Participants With Cellular Immune Response to 2 Doses of Tetravalent Dengue Vaccine (TDV) at 1 Month Post Second Vaccination
Description
Percentage of participants with cellular immune response were reported. Cellular immune response was defined as an interferon-gamma (IFN-γ) enzyme-linked immunospot (ELISPOT) response that was >3 times higher compared to Baseline (Day 1) and ≥ 5 spots per well. Cellular immune response to any peptide pool was reported. The peptide pool included non-structural protein (NS) for each of the dengue serotype: DENV-1, DENV-2, DENV-3 and DENV-4. Percentage of participants with cellular immune response were reported. Cellular immune response was defined as an interferon-gamma (IFN-γ) enzyme-linked immunospot (ELISPOT) response that was >3 times higher compared to Baseline (Day 1) and ≥ 5 spots per well. Cellular immune response to any peptide pool was reported. The peptide pool included non-structural protein (NS) for each of the dengue serotype: DENV-1, DENV-2, DENV-3 and DENV-4.
Time Frame
1 month post second vaccination (Day 120)
Secondary Outcome Measure Information:
Title
Magnitude of Cellular Immune Response Assessed by Number of Spot Forming Cells (SFC)/Million Peripheral Blood Mononuclear Cells (PBMCs) Measured by IFN-γ ELISPOT at 1 Month Post Second Vaccination
Description
The magnitude of cellular immune response was assessed by the number of SFC/million PBMCs for participants with a cellular immune response. Cellular immune response was defined as IFN-γ ELISPOT response that was >3 times higher compared to Baseline (Day 1) and ≥ 5 spots per well. Data (SFC/million PBMC) for participants with a cellular immune response to any peptide pool is reported. The peptide pool included NS for each of the dengue serotype: DENV-1, DENV-2, DENV-3 and DENV-4.
Time Frame
1 month post second vaccination (Day 120)
Title
Percentage of Participants With Cellular Immune Response to TDV at 1 Month Post First Vaccination, Pre-second Vaccination, 6 Months Post Second Vaccination
Description
Percentage of participants with cellular immune response were reported. Cellular immune response was defined as an IFN-γ ELISPOT response that was >3 times higher compared to Baseline (Day 1 [M0]) and >=5 spots per well. Cellular immune response to any peptide pool was reported. The peptide pool included NS for each of the dengue serotype: DENV-1, DENV-2, DENV-3 and DENV-4.
Time Frame
1 month post first vaccination (Day 30); 6 month post second vaccination (Day 270)
Title
Magnitude of Cellular Immune Response Assessed by Number of SFC/Million PBMCs Measured by IFN-γ ELISPOT at 1 Month Post First Vaccination, Pre-second Vaccination, 6 Months Post Second Vaccination
Description
The magnitude of cellular immune response was assessed by the number of SFC/million PBMCs for participants with a cellular immune response. Cellular immune response was defined as IFN-γ ELISPOT response that was >3 times higher compared to Baseline (Day 1) and ≥ 5 spots per well. Data (SFC/million PBMC) for participants with a cellular immune response to any peptide pool is reported. The peptide pool included NS protein for each of the dengue serotype: DENV-1, DENV-2, DENV-3 and DENV-4.
Time Frame
1 month post first vaccination (Day 30); 6 month post second vaccination (Day 270)
Title
Percentage of Participants With Cellular Immune Responses to TDV at 1 Month Post First Vaccination, Pre-second Vaccination, 1 and 6 Months Post Second Vaccination Assessed by Country
Description
Percentage of participants with cellular immune response by country were reported. Cellular immune response was defined as an IFN-γ ELISPOT response that was >3 times higher compared to Baseline (Day 1 [M0]) and >=5 spots per well. Cellular immune response to any peptide pool was reported. The peptide pool included NS for each of the dengue serotype: DENV-1, DENV-2, DENV-3 and DENV-4. Data is reported as per enrollment by country (Panama and Philippines).
Time Frame
1 month post first vaccination (Day 30); 1 and 6 months post second vaccination (Days 120 Days 270)
Title
Percentage of Participants With Cellular Immune Responses to TDV:1 Month Post First Vaccination, Pre-second Vaccination, 1 and 6 Months Post Second Vaccination, by Dengue Baseline Seropositivity Status
Description
Percentage of participants with cellular immune response by dengue Baseline seropositivity status were reported. Cellular immune response was defined as an IFN-γ ELISPOT response that was >3 times higher compared to Baseline (Day 1 [M0]) and >=5 spots per well. Seropositive at Baseline was defined as a reciprocal neutralizing titer >=10 for one or more dengue serotypes. Seronegative at Baseline was defined as having a reciprocal neutralizing titer <10 for all dengue serotypes. The 4 dengue virus serotypes were dengue virus (DENV)-1, DENV-2, DENV-3 and DENV-4. Cellular immune response to any peptide pool was reported. The peptide pool included NS for each of the dengue serotype: DENV-1, DENV-2, DENV-3 and DENV-4. Data is reported per Baseline seropositivity status of participants (Seropositive and Seronegative).
Time Frame
1 month post first vaccination (Day 30); 1and 6 months post second vaccination (Days 120 Days 270)
Title
Magnitude of Cellular Immune Response Assessed by Number of SFC/Million PBMCs Measured by IFN-γ ELISPOT at 1 Month Post First, Pre- Second Vaccination, 1 and 6 Months Post Second Vaccination, by Country
Description
The magnitude of cellular immune response by country was assessed by the number of SFC/million PBMCs for participants with a cellular immune response. Cellular immune response was defined as IFN-γ ELISPOT response that was >3 times higher compared to Baseline (Day 1) and ≥ 5 spots per well. Data (SFC/million PBMC) for participants with a cellular immune response to any peptide pool is reported. The peptide pool included NS protein for each of the dengue serotype: DENV-1, DENV-2, DENV-3 and DENV-4. Data is reported as per enrollment by country (Panama and Philippines).
Time Frame
1 month post first vaccination (Day 30); 1and 6 months post second vaccination (Days 120 Days 270)
Title
Magnitude of Cellular Immune Response Assessed by Number of SFC/Million PBMCs Measured by IFN-γ ELISPOT 1 Month Post First; Pre-second Vaccination; 1 and 6 Months Post Second Vaccination, by Dengue Baseline Seropositivity Status
Description
The magnitude of cellular immune response by dengue Baseline seropositivity status was assessed by the number of SFC/million PBMCs for participants with a cellular immune response. Cellular immune response was defined as IFN-γ ELISPOT response that was >3 times higher compared to Baseline (Day 1) and ≥ 5 spots per well. Seropositive at Baseline was defined as a reciprocal neutralizing titer >=10 for one or more dengue serotypes. Seronegative at Baseline was defined as having a reciprocal neutralizing titer <10 for all dengue serotypes. The 4 dengue virus serotypes were dengue virus (DENV)-1, DENV-2, DENV-3 and DENV-4. Cellular immune response to any peptide pool was reported. The peptide pool included NS for each of the dengue serotype: DENV-1, DENV-2, DENV-3 and DENV-4. Data is reported per Baseline seropositivity status of participants (Seropositive and Seronegative).
Time Frame
1 month post first vaccination (Day 30); 1and 6 months post second vaccination (Days 120 Days 270)
Title
Percentage of Participants With Cellular Immune Response to TDV in Participants >10 Years of Age
Description
Percentage of participants with cellular immune response in participants >10 years of age were reported. Cellular immune response was defined as an IFN-γ ELISPOT response that was >3 times higher compared to Baseline (Day 1 [M0]) and >=5 spots per well. Cellular immune response to any peptide pool was reported. The peptide pool included NS for each of the dengue serotype: DENV-1, DENV-2, DENV-3 and DENV-4. SFC/million PBMC for any peptide pool is reported in participants >10 years of age.
Time Frame
Day 14
Title
Magnitude of Cellular Immune Response Assessed by Number of SFC/Million PBMCs Measured by IFN-γ ELISPOT in Participants >10 Years of Age
Description
The magnitude of cellular immune response was assessed by the number of SFC/million PBMCs for participants with a cellular immune response. Cellular immune response was defined as IFN-γ ELISPOT response that was >3 times higher compared to Baseline (Day 1) and ≥ 5 spots per well. Cellular immune response to any peptide pool was reported. The peptide pool included NS for each of the dengue serotype: DENV-1, DENV-2, DENV-3 and DENV-4. SFC/million PBMC for any peptide pool is reported in participants >10 years of age.
Time Frame
Day 14
Title
Phenotype Characterization of Cellular Immune Response Assessed by Percentage of Total T Cells of Cellular Response to DENV-2 NS Proteins at 1 Month Post First, Pre-second Vaccination, 1 and 6 Months Post Second Vaccination
Description
The phenotype characterization of cellular immune response was assessed by intracellular cytokine staining (ICS) by the frequency of total cluster of differentiation 4 (CD4)+ and CD8+ T cells and was performed in a subset of participants with IFN- γ ELISPOT responses >500 SFC/million cells and availability of sufficient cells. The peptide pools included NS for the DENV-2 serotype. Data are presented for the different expression profiles of interferon-gamma (IFN-γ), interleukin-2 (IL-2) and tumor necrosis factor-alpha (TNF-α) cytokines for each peptide pool. Data is reported based on the type of T cells present in participants at the time of analysis (CD4+ T cells and CD8+ T cells).
Time Frame
1 month post first vaccination (Day 30); 1and 6 months post second vaccination (Days 120 Days 270)
Title
Phenotype Characterization of Cellular Immune Response Assessed by Percentage of Total T Cells of Cellular Response DENV-2 NS Proteins,1 Month Post First, Pre Second Vaccination;1 and 6 Months Post Second Vaccination, by Country
Description
The phenotype characterization of cellular immune response by country was assessed by ICS by the frequency of total CD4+ and CD8+ T cells and was performed in a subset of participants with IFN- γ ELISPOT responses >500 SFC/million cells and availability of sufficient cells. The peptide pools included NS for the DENV-2 serotype. Data are presented for the different expression profiles of IFN-γ, IL-2 and TNF-α cytokines for each peptide pool. Data is reported per country (Panama and Philippines) based on the type of T cells present in participants at the time of analysis (CD4+ T cells and CD8+ T cells).
Time Frame
1 month post first vaccination (Day 30); 1and 6 months post second vaccination (Days 120 Days 270)
Title
Phenotype Characterization of Cellular Immune Response by Percentage of Total T Cells DENV-2 NS Proteins at 1 Month Post First, Pre Second Vaccination,1 and 6 Months Post Second Vaccination, by Dengue Baseline Seropositivity Status
Description
The phenotype characterization of cellular immune response by dengue Baseline seropositivity status was assessed by the frequency of total CD4+ and CD8+ T cells and was performed in a subset of participants with IFN- γ ELISPOT responses >500 SFC/million cells and availability of sufficient cells. Seropositive was defined as a reciprocal neutralizing titer (MNT50) >=10 for one or more dengue serotypes. Seronegative was defined as titer value of <10 for all 4 serotypes. The peptide pools included NS for the DENV-2 serotype. Data are presented for the different expression profiles of IFN-γ, IL-2 and TNF-α cytokines for each peptide pool. Data is reported per Baseline seropositivity status (Seropositive and Seronegative) based on the type of T cells present in participants at the time of analysis (CD4+ T cells and CD8+ T cells).
Time Frame
1 month post first vaccination (Day 30); 1and 6 months post second vaccination (Days 120 Days 270)
Title
Geometric Mean Titers (GMT) of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at 1 Month Post First Vaccination, Pre Second Vaccination, and 1, 6 Months Post Second Vaccination and Then Annually Up to 3 Years
Description
GMT of neutralizing antibodies was measured by microneutralization test (MTN). The dengue virus serotypes are DENV-1, DENV-2, DENV-3 and DENV-4.
Time Frame
1 month post first vaccination (Day 30); pre second vaccination (Day 90); 1 and 6 months post second vaccination (Days 120 and 270); annually up to 3 years (Years 1, 2 and 3)
Title
Percentage of Participants Seropositive for Each of the 4 Dengue Serotypes at 1 Month Post First Vaccination, Pre-second Vaccination, and 1, 6 Months Post Second Vaccination and Then Annually up to 3 Years
Description
Seropositive was defined as a reciprocal neutralizing titer ≥10. The dengue virus serotypes are DENV-1, DENV-2, DENV-3 and DENV-4.
Time Frame
1 month post first vaccination (Day 30); pre second vaccination (Day 90); 1 and 6 months post second vaccination (Days 120 and 270); annually up to 3 years (Years 1, 2 and 3)
Title
Percentage of Participants Seropositive for Multiple Dengue Serotypes at 1 Month Post First Vaccination, Pre Second Vaccination, 1, 6 Months Post Second Vaccination and Annually up to 3 Years
Description
Seropositive was defined as a reciprocal neutralizing titer ≥10. The dengue virus serotypes are DENV-1, DENV-2, DENV-3 and DENV-4. Seropositive for multiple dengue serotypes were summarized in the following categories: tetravalent and at least trivalent.
Time Frame
1 month post first vaccination (Day 30); pre second vaccination (Day 90); 1 and 6 months post second vaccination (Days 120 and 270); annually up to 3 years (Years 1, 2 and 3)
Title
Percentage of Participants Experiencing Unsolicited Adverse Events (AE)
Description
An AE was defined as any untoward medical occurrence in a clinical investigation participant administered a trial vaccine; it does not necessarily have to have a causal relationship with trial vaccine administration.
Time Frame
Up to 28 days (day of vaccination + 27 days) after administration of each vaccine dose on Day 1 [Month 0] and Day 90 [Month 3]
Title
Percentage of Participants With Medically Attended AEs (MAAEs)
Description
MAAEs were defined as AEs leading to a medical visit to or by a healthcare professional, including visits to an emergency department, but not fulfilling seriousness criteria.
Time Frame
From first vaccination (Day 1) up to 6 months post second vaccination (Day 270)
Title
Percentage of Participants With Serious Adverse Events (SAEs)
Description
A SAE was defined as any untoward medical occurrence or effect that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability / incapacity, is a congenital anomaly / birth defect or is medically important due to other reasons than the above mentioned criteria.
Time Frame
From first vaccination (Day 1) up to end of study (Approximately 3 years)
Title
Percentage of Participants With Virologically Confirmed Dengue
Description
Participants with febrile illness defined as fever ≥38°C on any 2 of 3 consecutive days were evaluated for dengue. Virologically confirmed dengue was defined as febrile illness with a positive serotype-specific RT-PCR (i.e. positive dengue detection RT-PCR).
Time Frame
From first vaccination (Day 1) up to 6 months post second vaccination (Day 270)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Main Inclusion Criteria:
Is aged 4 to 16 years, inclusive (Latin America) or 4 to 8 years, inclusive (Asia).
Are in good health at the time of entry into the study as determined by medical history, physical examination (including vital signs), and clinical judgment of the investigator.
Main Exclusion Criteria:
Febrile illness (body temperature ≥38°C) or moderate or severe acute illness or infection at the time of enrolment.
History or any illness that, in the opinion of the investigator, might interfere with the results of the study or pose an additional risk to the participant due to participation in the study.
Receipt of any other vaccines within 14 days (for inactivated vaccines) or 28 days (for live vaccines) prior to Day 1 (Month 0) or planning to receive any vaccines within 28 days after Day 1 (Month 0).
Previous participation in any clinical study of a dengue candidate vaccine, or previous receipt of any dengue vaccines (investigational or licensed).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director Clinical Science
Organizational Affiliation
Takeda
Official's Role
Study Director
Facility Information:
Facility Name
CEVAXIN
City
Panama
Country
Panama
Facility Name
Research Institute for Tropical Medicine
City
Muntinlupa
ZIP/Postal Code
1781
Country
Philippines
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
IPD Sharing Access Criteria
IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
IPD Sharing URL
https://vivli.org/ourmember/takeda/
Learn more about this trial
Safety and Immunogenicity of Takeda's Tetravalent Dengue Vaccine (TDV) in Healthy Children
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