Clinical Trial Info

Efficacy, Safety and Immunogenicity of Takeda's Tetravalent Dengue Vaccine (TDV) in Healthy Children (TIDES)

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Staff

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 and to look at long-term safety results. This study will look at the success rate of TDV in preventing dengue fever (vaccine efficacy) and the long-term side effects of the vaccine.

The study will be conducted in 5 parts. Part 1 will evaluate vaccine efficacy (VE) and will last a minimum of 15 months.

Part 2 will be for an additional 6 months to evaluate VE. Part 3 will evaluate long-term safety by following participants for side effects and will last an additional 3 years.

Part 4 will evaluate safety for 13 months post-booster vaccination.

Part 5 will be the long-term safety follow-up for 1 year after completion of Part 4.

Approximately 20,100 participants will be enrolled in the study and randomly assigned (by chance) to one of the two treatment groups-which will remain undisclosed to the participants and study doctors during the study (unless there is an urgent medical need).

This multi-center trial will be conducted worldwide. The overall time to participate in this study is approximately 7 years. Participants will make multiple visits to the clinic and will be contacted at least every week for the entire study duration.

Results

UPDATE: Takeda announced on June 9, 2022, that the TAK-003 vaccine candidate prevented 84% of hospitalized dengue cases and 61% of symptomatic dengue cases through 54 months after vaccination.

While the long-term follow-up for the primary two-dose series has been completed, the TIDES trial remains ongoing to evaluate the safety and efficacy of a booster dose. The TIDES trial is Takeda’s largest interventional clinical trial to date, enrolling more than 20,000 healthy children and adolescents four to 16 years of age, across eight dengue-endemic countries, over the past four and a half years.

Takeda announced that its dengue vaccine candidate TAK-003 demonstrated continued protection against dengue illness and hospitalization, regardless of an individual’s previous dengue exposure, with no important safety risks identified through three years after vaccination in the ongoing pivotal Phase 3 Tetravalent Immunization against Dengue Efficacy Study (TIDES) trial. TIDES enrolled more than 20,000 healthy children and adolescents ages four to 16 years in dengue-endemic countries in Latin America and Asia. 

Safety and efficacy results from the 36-month follow-up exploratory analysis of TIDES were presented on May 22, 2021, at the 17th Conference of the International Society of Travel Medicine (CISTM). 

Through three years (36 months after the second dose), TAK-003 demonstrated overall vaccine efficacy (VE) of 62.0% (95% CI: 56.6% to 66.7%) against virologically-confirmed dengue (VCD), with 65.0% VE (95% CI: 58.9% to 70.1%) in seropositive individuals and 54.3% VE (95% CI: 41.9% to 64.1%) in seronegative individuals.

TAK-003 also demonstrated 83.6% VE (95% CI: 76.8% to 88.4%) against hospitalized dengue, with 86.0% VE (95% CI: 78.4% to 91.0%) in seropositive individuals and 77.1% VE (95% CI: 58.6% to 87.3%) in seronegative individuals. Observations of varied VE by serotype remained consistent with previously reported results.

No evidence of disease enhancement was observed. TAK-003 was generally well tolerated, and there were no important safety risks observed. The results reinforce the potential of TAK-003 to help protect those who are living in or traveling to dengue-endemic countries.