Moving closer to being able to develop the country’s first vaccine against dengue, drug-makers Serum Institute of India and Panacea Biotec have applied to the Indian Council of Medical Research’s (ICMR) call for ‘Expression of Interest’ for collaborative Phase-III clinical trials for indigenous manufacturers.
Phase-III clinical 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 for the adult vaccine, confirmed a senior Health official.
According to ICMR, dengue virus disease causes significant morbidity and mortality across the globe; in India, 2 to 2.5 lakh cases are reported annually.
The global incidence of dengue has grown dramatically with about half of the world’s population now at risk. Although an estimated 100-400 million infections occur each year, over 80% are generally mild and asymptomatic. Hence, the World Health Organization (WHO) has identified dengue to be one among the top ten global health threats in 2019. As of now, there is no specific treatment for dengue/severe dengue. “Therefore, there is an urgent need to develop effective vaccines against dengue viral disease,’” ICMR said.
Meanwhile, giving details about the two potential vaccines, Dr. Nivedita Gupta, the Head of Virology, ICMR, said that Serum Institute of India’s vaccine initiated 1/2 studies in paediatric population and the plan for Panacea’s vaccine is to conduct Phase-III randomised, double-blind, placebo-controlled trial in 10,335 healthy adults (aged 18-80 years) in 20 sites (ICMR-funded).
She added that the Phase-III protocol has been approved by Drugs Controller General of India (January 2023) and the company is trying to upscale vaccine production with the trials expected to start in August-September this year.
ICMR has noted that the desirable characteristics of a dengue vaccine includes acceptable short- and long-term safety profile (no antibody dependent enhancement), inducing protection against all four serotypes of dengue, reducing risk of severe diseases and deaths, inducing a sustained immune response and effectiveness irrespective of the earlier sero-status and age of the individual.