Clinical Trial: Safety and Immunogenicity With Two Different Serotype 2 Potencies of Tetravalent Dengue Vaccine (TDV) in Adults in Singapore

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: A Phase II, Double-Blind, Randomized, Controlled Trial to Assess the Safety and Immunogenicity of a Tetravalent Dengue Vaccine With Two Different Serotype 2 Potencies in a

Brief Summary: The purpose of this study is to assess the post-vaccination neutralizing antibody response against each dengue serotype by treatment arm.

Detailed Summary:

The vaccine being tested in this study is Takeda's Tetravalent Dengue Vaccine Candidate (TDV). TDV is being tested to protect people against dengue fever. This study will look at safety and the amount of antibodies to dengue fever formed in people who are administered a high-dose of TDV (HD-TDV) compared to TDV.

The study will enroll approximately 400 patients. Before being assigned to a treatment group participants will be screened for previous exposure to the dengue virus. Dengue naïve and previously exposed participants will then be randomly assigned (by chance) to one of the two treatment groups—which will remain undisclosed to the patient and study doctor during the study (unless there is an urgent medical need):

  • HD-TDV 0.5 mL subcutaneous injection
  • TDV 0.5 mL subcutaneous injection

All participants will receive a single injection on Day 1. Participants will be asked to record any symptoms that may be related to the vaccine or the injection site in a diary card for 28 days after vaccination.

This multi-center trial will be conducted in Singapore. The overall time to participate in this study is 12 months. Participants will make multiple visits to the clinic, including a final visit 1 year after receiving their dose of TDV.


Sponsor: Takeda

Current Primary Outcome:

  • Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the Four DENV Serotypes [ Time Frame: Up to 12 Months ]
    The four DENV serotypes are DEN-1, DEN-2, DEN-3 and DEN-4.
  • Percentage of Participants Seropositive to Each of the Four DENV Serotypes [ Time Frame: Up to 12 Months ]
    Seropositivity is defined as a reciprocal neutralizing titer ≥ 10. The four DENV serotypes are DEN-1, DEN-2, DEN-3 and DEN-4.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Percentage of Participants with Solicited Local (Injection Site) Adverse Events (AEs) [ Time Frame: Up to Day 7 ]
    Solicited local AEs at injection site are defined as pain, erythema and swelling that occurred within 7 days after vaccination.
  • Percentage of Participants with Solicited Systemic Adverse Events (AEs) [ Time Frame: Up to Day 14 ]
    Solicited systemic AEs are defined as headache, malaise, myalgia, asthenia and fever that occurred within 14 days after vaccination.
  • Percentage of Participants with Any Unsolicited Adverse Events (AEs) [ Time Frame: Up to Day 28 after vaccination ]
    Unsolicited AEs are any AEs that are not solicited local or systemic AEs, as defined by this study.
  • Percentage of Participants with Serious Adverse Events (SAEs) [ Time Frame: Up to 12 Months ]
    A serious adverse event (SAE) is 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.
  • Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the Four DENV Serotypes Assessed by Dengue Baseline Seropositivity (MNT) Status [ Time Frame: Up to 12 Months ]
    Baseline dengue seropositivity is based on the microneutralization test (MNT) result and is defined as a reciprocal neutralizing titer ≥10 for one or more dengue serotype at baseline. The four DENV serotypes are DEN-1, DEN-2, DEN-3 and DEN-4.
  • Percentage of Participants Seropositive to Each of the Four DENV Serotypes Assessed by Dengue Baseline Seropositivity (MNT) Status [ Time Frame: Up to 12 Months ]
    Baseline dengue seropositivity is based on the MNT result and is defined as a reciprocal neutralizing titer ≥10 for one or more dengue serotype at baseline. Seropositive response is defined as a reciprocal neutralizing titer ≥ 10 at any time post-vaccination. The four DENV serotypes are DEN-1, DEN-2, DEN-3 and DEN-4.
  • Percentage of Participants with Vaccine Viremia for each of the Four Dengue Serotypes [ Time Frame: Up to Day 30 ]
    Post-vaccination vaccine viremia will be assessed on blood samples collected Days 5, 7, 9, 11, 15, 17, 21 and 30 (Month 1).
  • Duration of Vaccine Viremia for each of the Four Dengue Serotypes [ Time Frame: Up to Day 30 ]
    Post-vaccination vaccine viremia will be assessed on blood samples collected Days 5, 7, 9, 11, 15, 17, 21 and 30 (Month 1).
  • Level of Vaccine Viremia for each of the Four Dengue Serotypes [ Time Frame: Up to Day 30 ]
    Post-vaccination vaccine viremia will be assessed on blood samples collected Days 5, 7, 9, 11, 15, 17, 21 and 30 (Month 1).


Original Secondary Outcome: Same as current

Information By: Takeda

Dates:
Date Received: April 9, 2015
Date Started: June 3, 2015
Date Completion: August 31, 2017
Last Updated: April 5, 2017
Last Verified: April 2017