A new vaccine to prevent dengue fever in children and adults is showing positive results in its ongoing late-stage trial.
Takeda Pharmaceutical Co. reported that the experimental vaccine prevented all four strains of dengue virus. While investigators are still reviewing the extensive data from the ongoing trial, the vaccine has been proven to be safe and effective.
"We are very encouraged by the performance of our dengue vaccine candidate in the study," stated Rajeev Venkayya, president of the Global Vaccine Business Unit at Takeda Pharmaceutical Co. "This brings us one step closer to helping the world tackle the massive burden of dengue."
The Phase 3 Trial
The Tetravalent Immunization against Dengue Efficacy Study, or TIDES for short, is the company's largest interventional clinical trial to date, with over 20,000 children and adolescents ages 4 to 16 years, who live in dengue-endemic areas. The Phase 3 study was designed to test the efficacy and safety of two doses of TAK-003, the dengue vaccine candidate, in people who have previously been exposed and have not been infected with dengue fever in the past.
The ongoing trial is taking place in areas where dengue fever is endemic, including Brazil, Colombia, Panama, Dominican Republic, Philippines, Thailand, and Sri Lanka. The investigators hope to publish the complete results of the trials in a peer-reviewed journal in the near future.
"In parallel, we are advancing the clinical development, commercial manufacturing, and stakeholder consultations to support a potential future global launch of the vaccine," added Venkayya in a press release.
Global Dengue Problem
Dengue is a growing threat around the world. According to the World Health Organization, an estimated 390 million people are infected every year, 96 million of which manifest clinically.
The disease is spread by the mosquito Aedes aegypti, which also transmits Zika. The insects live in urban habitats and breed and lay eggs mostly in man-made containers.
Symptoms of dengue include high fever, severe headache, pain behind the eyes, muscle and joint pains, nausea, vomiting, swollen glands, and rashes. More severe cases might be accompanied with abdominal pain, persistent vomiting (sometimes with blood), rapid breathing, fatigue and restlessness, and bleeding gums.