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Trial record 59 of 276 for:    Panama

Safety and Immunogenicity of Takeda's TDV in Healthy Children

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ClinicalTrials.gov Identifier: NCT02948829
Recruitment Status : Active, not recruiting
First Posted : October 28, 2016
Last Update Posted : December 24, 2018
Sponsor:
Information provided by (Responsible Party):
Takeda

Brief Summary:
The purpose of this study is to assess the cellular immune responses following 2 doses of tetravalent dengue vaccine candidate (TDV) in 4 to 16 years' healthy participants.

Condition or disease Intervention/treatment Phase
Healthy Volunteers Biological: Tetravalent Dengue Vaccine Candidate Phase 2

Detailed Description:

The vaccine being tested in this study is TDV. This study will look at cellular immune responses following TDV vaccination in dengue endemic regions.

The study will enroll approximately 200 participants. Participants will receive:

• TDV 0.5 mL subcutaneous (SC) injection

All participants will receive 2-dose schedule of TDV by SC injection into the upper arm at Day 1 (Month 0) and at Day 90 (Month 3).

This multi-center trial will be conducted in Panama and the Philippines. The overall time to participate in this study is approximately 3 years 4 months. Participants will make multiple visits to the clinic and will be contacted at least every week for the entire study duration post first injection.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : April 3, 2017
Actual Primary Completion Date : October 16, 2017
Estimated Study Completion Date : August 12, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dengue

Arm Intervention/treatment
Experimental: Tetravalent Dengue Vaccine Candidate
Tetravalent Dengue Vaccine Candidate (TDV) 0.5 mL, subcutaneous injection on Day 1 and Day 90.
Biological: Tetravalent Dengue Vaccine Candidate
TDV subcutaneous injection




Primary Outcome Measures :
  1. Percentage of Participants with Cellular Immune Response to 2 Doses of Tetravalent Dengue Vaccine (TDV) at 1 Month Post Second Vaccination [ Time Frame: Day 120 (Month 4) ]
    Cellular immune response is defined as an interferon-gamma (IFN-γ) enzyme-linked immunospot (ELISPOT) response that is >3 times higher compared to Baseline (Day 1) and ≥ 5 spots per well.


Secondary Outcome Measures :
  1. Magnitude of IFN-γ ELISPOT Responses to 2 Doses of TDV at 1 Month Post Second Vaccination [ Time Frame: Day 120 (Month 4) ]
  2. Percentage of Participants With IFN-γ ELISPOT Response to TDV [ Time Frame: 1 month post first vaccination (Day 30), pre-second vaccination (Day 90]), 6 months post second vaccination (Day 270), and then annually (up to 3 years) ]
  3. Magnitude of IFN-γ ELISPOT Response to TDV [ Time Frame: 1 month post first vaccination (Day 30), pre-second vaccination (Day 90]), 6 months post second vaccination (Day 270), and then annually (up to 3 years) ]
  4. Percentage of Participants With IFN- γ ELISPOT Responses to TDV by Region and Dengue Baseline Seropositivity Status [ Time Frame: 1 month post first vaccination (Day 30), pre-second vaccination (Day 90]), 6 months post second vaccination (Day 270), and then annually (up to 3 years) ]
  5. Magnitude of IFN- γ ELISPOT Responses to TDV by Region and Dengue Baseline Seropositivity Status [ Time Frame: 1 month post first vaccination (Day 30), pre-second vaccination (Day 90]), 6 months post second vaccination (Day 270), and then annually (up to 3 years) ]
  6. Percentage of Participants With IFN- γ ELISPOT Responses to TDV in Participants >10 Years of Age [ Time Frame: Day 14 ]
  7. Magnitude of IFN- γ ELISPOT Responses to TDV in Participants >10 Years of Age [ Time Frame: Day 14 ]
  8. Phenotype Characterization of Cellular Response to TDV Assessed by Intracellular Cytokine Staining (ICS) [ Time Frame: 1 month post first vaccination (Day 30), pre-second vaccination (Day 90]), 6 months post second vaccination (Day 270), and then annually (up to 3 years) ]
    Phenotype characterization of cellular immune Response will be performed in a subset of participants with IFN- γ ELISPOT responses >500 spot forming cells/10^6 cells and availability of sufficient cells. Markers will include cluster of differentiation (CD) 4, CD8, IFN-γ, tumor necrosis factor-alpha (TNF-α) and interleukin-2 (IL-2).

  9. Phenotype Characterization of Cellular Immune Responses to TDV by Region and Dengue Baseline Seropositivity Status [ Time Frame: 1 month post first vaccination (Day 30), pre-second vaccination (Day 90]), 6 months post second vaccination (Day 270), and then annually (up to 3 years) ]
    Phenotype characterization of cellular immune Response will be performed in a subset of participants with IFN- γ ELISPOT responses >500 spot forming cells/10^6 cells and availability of sufficient cells. Markers will include CD4, CD8, IFN-γ, TNF-α and IL-2.

  10. Geometric Mean Titer (GMT) of Neutralizing Antibodies for Each of the 4 Dengue Serotypes [ Time Frame: 1 month post first vaccination (Day 30), pre-second vaccination (Day 90]), 6 months post second vaccination (Day 270), and then annually (up to 3 years) ]
    GMT of neutralizing antibodies will be measured by microneutralization test (MTN). The 4 Wild type dengue virus serotypes are DEN-1, DEN-2, DEN-3 and DEN-4.

  11. Percentage of Participants with Seropositivity for Each of the 4 Dengue Serotypes [ Time Frame: 1 month post first vaccination (Day 30), pre-second vaccination (Day 90]), 6 months post second vaccination (Day 270), and then annually (up to 3 years) ]
    Seropositivity is defined as a reciprocal neutralizing titer ≥10. The 4 Wild type dengue virus serotypes are DEN-1, DEN-2, DEN-3 and DEN-4.

  12. Percentage of Participants with Seropositivity for Multiple (2, 3 or 4) Dengue Serotypes [ Time Frame: 1 month post first vaccination (Day 30), pre-second vaccination (Day 90]), 6 months post second vaccination (Day 270), and then annually (up to 3 years) ]
    Seropositivity is defined as a reciprocal neutralizing titer ≥10.

  13. Percentage of Participants Experiencing Non-serious Unsolicited Adverse Events (AE) [ Time Frame: Up to 28 days (day of vaccination +27 days) after the first (Day 1) and second vaccination (Day 90) ]
  14. Percentage of Participants With Medically Attended AEs (MAAEs) [ Time Frame: First vaccination (Day 1) up to 6 months after second vaccination (Day 90) ]
    MAAEs are 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.

  15. Percentage of Participants With Serious Adverse Events (SAEs) [ Time Frame: Up to 3 years 3 months ]
    A serious adverse event (SAE) is 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.

  16. Percentage of Participants With Virologically Confirmed Febrile Illness with Potential Dengue Etiology [ Time Frame: First vaccination (Day 1) up to 3 years after the second vaccination (Day 90) ]
    Febrile illness is defined as fever ≥38°C on any 2 of 3 consecutive days.



Information from the National Library of Medicine

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Ages Eligible for Study:   4 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Is aged 4 to 16 years, inclusive (Latin America) or 4 to 8 years, inclusive (Asia).
  2. 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.

Exclusion Criteria:

  1. Febrile illness (body temperature ≥38°C) or moderate or severe acute illness or infection at the time of enrolment.
  2. 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.
  3. 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).
  4. Previous participation in any clinical study of a dengue candidate vaccine, or previous receipt of any dengue vaccines (investigational or licensed).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02948829


Locations
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Panama
CEVAXIN
Panama, Panama
Philippines
Research Institute for Tropical Medicine
Muntinlupa, Philippines, 1781
Sponsors and Collaborators
Takeda
Investigators
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Study Director: Medical Director Clinical Science Takeda

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Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT02948829     History of Changes
Other Study ID Numbers: DEN-313
U1111-1184-1893 ( Other Identifier: WHO )
First Posted: October 28, 2016    Key Record Dates
Last Update Posted: December 24, 2018
Last Verified: December 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Takeda:
Drug therapy

Additional relevant MeSH terms:
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Vaccines
Immunologic Factors
Physiological Effects of Drugs