DengiAll

India is on the cusp of a major public health milestone, with nearly 8,000 out of a targeted 10,000 participants already enrolled in Phase-3 clinical trials of the country’s first homegrown dengue vaccine, as per the Indian Council of Medical Research (ICMR). Dr. Manoj Murhekar, Director of ICMR’s National Institute of Epidemiology in Chennai, confirmed the progress in an interaction with The Hindu. The large-scale trials, which are being conducted at 20 different centres across the country, are testing the efficacy of DengiAll, a tetravalent vaccine developed by Panacea Biotec. This formulation aims to provide protection against all four known dengue virus serotypes that co-circulate in various parts of India. “An effective vaccine must be able to offer strong immunity against all four strains,” Dr. Murhekar emphasized. The ICMR is the primary funder of the project, with Panacea Biotec offering partial financial and technical support. Once vaccinated, participants will be monitored for a period of two years at locations including Delhi, Hyderabad, Pune, and Chennai. Currently, there is no approved vaccine or antiviral treatment for dengue in India, despite the disease being a recurring and widespread health issue. India remains among the top 30 countries most affected by dengue, according to the World Health Organization (WHO). By the end of 2023, over 129 countries had reported cases of dengue globally. The candidate vaccine, DengiAll, is derived from the TV003/TV005 tetravalent strain originally created by the U.S.-based National Institutes of Health. Panacea Biotec is one of three Indian firms granted access to the strain and has advanced furthest in the development process. The company completed early-stage (Phase-1 and 2) trials in 2018–19, which delivered encouraging results. It also holds a process patent for its unique formulation. The Union Health Ministry highlighted that the first participant in the Phase-3 trial received a dose at Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences in Rohtak last year. Dengue poses a significant health threat in India. Although 75–80% of infections are asymptomatic, individuals can still spread the virus via Aedes mosquito bites. Among symptomatic cases—comprising about 20–25%—children face an elevated risk of severe outcomes, including hospitalization and death. In adults, the disease can escalate into life-threatening conditions such as dengue hemorrhagic fever and dengue shock syndrome. The challenge of controlling the virus is compounded by the presence of four distinct serotypes, each offering limited cross-immunity, making repeated infections common. With the success of this trial, India could soon have its first domestically developed and licensed dengue vaccine, marking a crucial step forward in the country’s fight against vector-borne diseases. Source: The Hindu