Dengue is a viral illness caused by the dengue virus, which is transmitted to humans through the bite of infected Aedes mosquitoes, primarily Aedes aegypti. Dengue is a significant public health concern, particularly in tropical and subtropical regions. The symptoms of dengue can range from mild to severe and may include high fever, severe headache, joint and muscle pain, rash, and mild bleeding manifestations such as nose or gum bleeding. In some cases, dengue can progress to a more severe form called dengue hemorrhagic fever (DHF), which can be life-threatening.
There is no specific antiviral treatment for dengue. Management typically involves supportive care such as fluid replacement to maintain hydration, management of symptoms, and close monitoring for signs of severe dengue. Dengue prevention relies mainly on eliminating mosquito breeding sites, using insecticide-treated bed nets, and applying insecticides to control mosquito populations.
A clinical trial for a tetravalent dengue vaccine called TAK-003 has shown promising results in children and adolescents living where dengue is endemic. This study analyzed safety data from two phase 2 and three phase 3 clinical trials of TAK-003, involving 14,627 vaccine recipients and 7,167 placebo recipients.
The most common adverse events reported were injection site pain and headache. These events were mostly mild and resolved within 1-3 days. Unsolicited adverse events and events leading to discontinuation occurred with similar frequency in both the vaccine and placebo groups. Serious adverse events were fewer in TAK-003 recipients than in the placebo. Only four vaccine-related SAEs in the placebo group involved hypersensitivity, dengue fever, and dengue hemorrhagic fever. No deaths were considered vaccine-related. Subgroup analyses showed no differences in safety based on baseline dengue serostatus or gender. However, there were higher rates of local adverse reactions at the injection site in adolescents and adults compared to children.
TAK-003 was well tolerated in recipients aged 4-60, regardless of age, gender, or baseline dengue serostatus. No significant safety risks were identified in this integrated data analysis from multiple clinical trials. These findings suggest that TAK-003 has an acceptable safety profile and may be a promising option for dengue vaccination in populations living in dengue-endemic areas, including individuals with or without previous dengue exposure. Further research and regulatory approval are needed to establish the effectiveness and safety of TAK-003 as a dengue vaccine for broader use.