Dengue vaccine: favorable results (phase 3) – Medical News


The dengue vaccine is effective in preventing any of the four virus serotypes

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Takeda Pharmaceutical Company Limited today announced that the main Phase 3 test for its dengue vaccine meets the primary efficacy endpoint.

This first analysis of the tetravalent immunization trial against the study of dengue efficacy (TIDES) showed that the in vivo attenuated tetravalent vaccine against dengue vaccine (TAK-003) of the company was effective in preventing dengue caused by any of the four serotypes of the virus. Although reviewing the extensive dataset is in progress, TAK-003 has been well tolerated and has not had significant safety issues so far.

The candidate for the Takeda dengue tetravalent vaccine (TAK-003) is based on a serotype 2 of live attenuated dengue, which provides the genetic "backbone" for the four vaccine viruses.

The TIDES trial continues and additional results are expected later this year, along with results from other Phase 3 studies.

"We are very encouraged by the performance of our dengue vaccine in the study, which brings us one step closer to helping the world deal with the enormous burden of dengue," said Rajeev Venkayya, MD, president of the Vaccine Business Unit. Global at Takeda. "We are very pleased to publish the data in a peer-reviewed journal as quickly as possible. In parallel, we are making progress in clinical development, commercial manufacturing and stakeholder consultations to support a possible future release of vaccines worldwide."

The TIDES study, Takeda's largest clinical trial so far, included more than 20,000 healthy children and adolescents aged four to 16 living in areas endemic for dengue. The study was designed to evaluate the efficacy, safety, and immunogenicity of two doses of TAK-003 in both dengue exposed and untreated individuals.

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


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