Context: Moving a step closer to developing India’s first vaccine against dengue, drug-makers Serum Institute of India and Panacea Biotec have submitted their responses to the call by the Indian Council of Medical Research (ICMR) for an Expression of Interest for collaborative Phase 3 clinical trials for indigenous manufacturers.
Major Highlights:
- The Phase 3 trial is being done for evaluation of efficacy, along with safety and immunogenicity of tetravalent dengue vaccine candidate developed by Indian manufacturers. Trials could start close to August 2023 for the adult vaccine.
- Serum Institute of India’s vaccine initiated one/two studies in the paediatric population and the plan for Panacea’s vaccine is to conduct Phase 3 randomised, double-blind, placebo-controlled trial in 10,335 healthy adults (aged 18-80) in 20 sites (ICMR-funded).
- The desirable characteristics of a dengue vaccine include:
- Acceptable short- and long-term safety profile (no antibody-dependent enhancement), inducing protection against all four serotypes of dengue, reducing the risk of severe diseases and deaths.
- Inducing a sustained immune response and effectiveness irrespective of the earlier serostatus and age of the individual.
Dengue:
- Dengue fever 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 cannot spread directly from person to person.
- Dengue is commonly found in tropical and subtropical regions around the world, especially in urban and semi-urban areas.
- Symptoms: Dengue fever typically presents with flu-like symptoms, including high fever, severe headache, joint and muscle pain, and rash. In severe cases, dengue can lead to dengue hemorrhagic fever (DHF) which can be life-threatening.
- Treatment: There is no specific antiviral treatment for dengue fever and early detection and access to proper medical care greatly lower fatality rates of severe dengue. Prevention and control of dengue depend on vector control.
Dengue causes significant morbidity and mortality across the globe and in India, 2 to 2.5 lakh cases are reported annually. In 2019, the World Health Organization (WHO) identified dengue to be one of the top 10 global health threats.
