India’s indigenous tetravalent dengue vaccine, DengiAll, has been developed by Panacea Biotec and the first participant in this trial was vaccinated on Wednesday at the Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences, Rohtak, as per a Health Ministry statement
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The Indian Council of Medical Research (ICMR) and Panacea Biotec Limited on Wednesday announced the initiation of the first ever phase 3 clinical trial for a dengue vaccine in India.
The trial will evaluate the efficacy of India’s indigenous tetravalent dengue vaccine, DengiAll has been developed by Panacea Biotec. The first participant in this trial was vaccinated on Wednesday at the Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences in Rohtak.
The tetravalent dengue vaccine strain (TV003/TV005), originally developed by the National Institutes of Health, U.S., has shown promising results in preclinical and clinical trials worldwide.
Panacea Biotec, one of three Indian companies to receive the strain, , is at the most advanced stage of developing the vaccine. The company has worked extensively on these strains to develop a full-fledged vaccine formulation and holds a process patent for this work. Phases 1 and 2 in the clinical trials of the Indian vaccine formulation were completed in 2018-19 and yielded promising results, a release issued by the Health Ministry said.
In collaboration with the ICMR, Panacea Biotec will conduct the phase 3 clinical trial across 19 sites in 18 States and Union Territories of India, involving more than 10,335 healthy adult participants. The trial, primarily funded by the ICMR with partial support from Panacea Biotec, is set to follow up with the participants for two years.
Currently, there is no antiviral treatment or licensed vaccine against dengue in India. The development of an effective vaccine is complex as good efficacy has to be achieved for all four serotypes. In India, all four serotypes of the dengue virus are known to circulate or co-circulate in many regions.
“The initiation of this phase 3 clinical trial for India’s first indigenous dengue vaccine marks a critical advancement in our fight against dengue. It reflects our commitment to protecting our citizens from this pervasive disease and underscores India’s capabilities in vaccine research and development. Through this collaboration between ICMR and Panacea Biotec, we are not only taking a step towards ensuring the health and well-being of our people but also reinforcing our vision of Atmanirbhar Bharat in the healthcare sector,” Union Health Minister J.P. Nadda said.
Dengue is a major public health concern in India, which ranks among the top 30 countries with the highest incidence of the disease. The global incidence of dengue has been steadily increasing over the past two decades, with more than 129 countries reporting the dengue viral disease by the end of 2023, according to the World Health Organization.
In India, approximately 75-80% of infections are asymptomatic, yet these individuals can still transmit the infection through the bite of Aedes mosquitoes. Among the 20-25% of cases where symptoms are clinically apparent, children are at a significantly higher risk of hospitalisation and mortality. In adults, the disease can escalate into severe conditions, including dengue haemorrhagic fever and dengue shock syndrome. The dengue virus has four serotypes — 1-4 — with low cross-protection against each other, and as a result, individuals can experience repeated infections.
