Vaccine Info

TAK-003 Dengue Vaccine

TAK-003 Dengue Vaccine Description

Takeda's TAK-003 is an investigational live-attenuated tetravalent dengue vaccine, preventing dengue fever caused by any of the four serotypes of the dengue virus, each of which can cause dengue fever or Severe Dengue.

TAK-003 (TDV) is based on a live-attenuated dengue serotype 2 virus, which provides the genetic “backbone” for all 4 dengue serotypes.

Takeda's current clinical development program consists of five Phase 3 trials. Clinical Phase 1 and 2 data in children and adolescents showed that TAK-003 induced immune responses against all four dengue serotypes, in both seropositive and seronegative participants, and the vaccine was found to be generally safe and well-tolerated.

In a November 2019 study, Takeda’s dengue vaccine candidate demonstrated protection against virologically-confirmed dengue, the trial primary endpoint, in children ages 4 to 16 years. The vaccine efficacy (VE) was 80.2% in the 12-month period after the 2nd vaccine dose, which was administered 3-months after the 1st dose.

The Lancet published an article on March 17, 2020, Safety and immunogenicity of a tetravalent dengue vaccine in children aged 2–17 years: a randomized, placebo-controlled, phase 2 trial, which concluded saying 'TAK-003 elicited antibody responses against all four serotypes, which persisted to 48 months post-vaccination, regardless of baseline serostatus.'

And recently, on July 13, 2020, the Long-term safety and immunogenicity of a tetravalent dengue vaccine candidate in children and adults: a randomized, placebo-controlled, phase 2 study, found at Month 36, seropositivity rates were 97.3%, 98.7%, 88.0% and 56.0% for DENV-1, -2, -3 and -4, respectively. Seropositivity rates varied significantly for DENV-4 according to serostatus at baseline (89.5% in seropositive versus 21.6% in seronegative). No vaccine-related SAEs were reported.

The TAK-003 vaccine is not currently licensed anywhere in the world. 

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TAK-003 Denge Vaccine Indication

TAK-003 is indicated for the prevention of the Dengue virus caused by any of the 4 Dengue serotypes. Dengue is the fastest spreading mosquito-borne viral disease and is one of the World Health Organization’s top 10 threats to global health in 2019.

TAK-003 is the second dengue vaccine to enter clinical trials, after Sanofi Pasteur's Dengvaxia. Sanofi's vaccine was 56% to 61% effective in preventing dengue in children, but it was tied to severe illness in dengue-naive children who received the vaccine and then contracted the virus.

Takeda’s TAK-003 is based on a dengue 2 virus, with genes from the remaining three dengue viruses added in. Dengvaxia is based on a yellow fever virus with dengue genes added in. Takeda hopes the all-dengue design will trigger a more robust immune response.

TAK-003 Dengue Vaccine Dosage

In a phase 2 study, TAK-003 was given as a single DV 0.5 mL subcutaneous injection on Day 1 and Day 90 in the clinical trial. The onset of protection was seen after the 1st dose, with 81% VE between the 1st and 2nd doses.

TAK-003 Dengue Vaccine News

November 5, 2020 - Reuters reported 'Takeda’s dengue vaccine candidate, TAK-003, is on track for regulatory filing in Asia, Latin America, and the European Union by the end of fiscal 2020, the company said.'

July 13, 2020 - The phase 2 trial demonstrated persistence of neutralizing antibody titers against TAK-003 over three years in children and adults living in dengue-endemic countries, with limited contribution from natural infection. TAK-003 was well tolerated.

May 21, 2020 - The U.S. CDC issued a Level 1 Travel Alert which says 'Dengue is a risk in many parts of Central and South America, Mexico, and the Caribbean.'

March 17, 2020 - The Lancet published the 'Safety and immunogenicity of a tetravalent dengue vaccine in children aged 2–17 years: a randomized, placebo-controlled, phase 2 trial.'

March 17, 2020 - Commentary published by The Lancet: Evaluation of a tetravalent dengue vaccine by serostatus and serotype.

November 23, 2019 - Takeda presented 18-month data from the pivotal Phase 3 Tetravalent Immunization against Dengue Efficacy Study (TIDES) trial of its dengue vaccine candidate (TAK-003) at the 68th American Society of Tropical Medicine and Hygiene (ASTMH) taking place in National Harbor, MD from November 20-24. The trial met all secondary endpoints for which there were a sufficient number of cases, looking at overall vaccine efficacy, as well as secondary efficacy by serotype, baseline serostatus, and disease severity including hospitalizations as well as severe dengue. The additional data build upon the 12-month primary efficacy endpoint data published online in the New England Journal of Medicine. Safety and efficacy will continue to be assessed over a total of 4.5 years.

November 6, 2019 - Takeda’s Dengue Vaccine Candidate Demonstrates Protection in Children Ages Four to 16 Years, Regardless of Previous Dengue Exposure. The results from this Phase 3 study, Efficacy, Safety, and Immunogenicity of Takeda's Tetravalent Dengue Vaccine (TIDES) concluded the Takeda vaccine candidate TAK-003 was efficacious against symptomatic dengue in countries in which the disease is endemic. Results demonstrated overall vaccine efficacy of 80.2% (12-month follow-up after the second dose) against virologically confirmed dengue; exploratory analyses of secondary endpoints showed 82.2% vaccine efficacy among baseline seropositive and 74.9% vaccine efficacy among baseline seronegative.

November 5, 2019 – Takeda Pharmaceutical Company announced the opening of its new manufacturing plant in Singen, Germany, for its dengue vaccine candidate, TAK-003. 

January 29, 2019 - Takeda announced TAK-003 which is in a pivotal Phase 3 trial met the primary efficacy endpoint. This first analysis of the Tetravalent Immunization against Dengue Efficacy Study (TIDES) trial showed that the company’s investigational live-attenuated tetravalent dengue vaccine was efficacious in preventing dengue fever caused by any of the 4 serotypes of the virus. While the review of the extensive data set is ongoing, TAK-003 was well tolerated with no significant safety concerns to date. The TIDES trial is continuing and additional results are expected later this year, along with results from other Phase 3 studies.

October 31, 2018 - About dengue and Takeda's dengue vaccine candidate (TAK-003).

September 7, 2016 - Takeda Initiates Global Phase 3 Clinical Trial (TIDES) of Dengue Vaccine Candidate (TAK-003).

TAK-003 Dengue Vaccine Clinical Trials

Takeda’s investigational live-attenuated tetravalent dengue vaccine candidate, TAK-003, is being studied in both healthy children and adults, in dengue-endemic and non-endemic countries. Its clinical development program consists of five Phase 3 trials.

Clinical Trial NCT03999996Long-Term Safety and Antibody Persistence of TDV and Impact of a Booster Dose - Last Update Posted: June 25, 2020.

  • This new Phase 3 study will look at the long-term antibody persistence and safety of Takeda's TDV in healthy adolescents and adults and will assess the impact of a booster dose.

Clinical Trial NCT02747927: Efficacy, Safety, and Immunogenicity of Takeda's Tetravalent Dengue Vaccine (TDV) in Healthy Children (TIDES) - Last Update Posted: November 6, 2020.

  • This Phase III, Double-Blind, Randomized, Placebo-Controlled Trial is to Investigate the Efficacy, Safety and Immunogenicity of a Tetravalent Dengue Vaccine (TDV) Administered Subcutaneously in 21,000 Healthy Children Aged 4 - 16 Years Old

Clinical Trial NCT02302066Safety and Immunogenicity of Different Schedules of Takeda's Tetravalent Dengue Vaccine Candidate (TDV) in Healthy Participants

  • TDV is being tested in this Phase 2 study to assess how different dosing schedules of the vaccine effect immunity to dengue fever in dengue-endemic countries. This study will look at the number of antibodies to dengue fever formed in people who are administered different dosing schedules of TDV.

Clinical Trial NCT01765426Phase 1b Study Investigating Safety & Immunogenicity of TDV Given Intradermally by Needle or Needle-Free PharmaJet Injector

  • This is an exploratory trial to assess the safety, tolerability, and immunogenicity of vaccination with a tetravalent dengue vaccine (TDV) in healthy adults delivered intradermally using the conventional needle/syringe or a needle-free PharmaJet® injector.