NEW DELHI: In a significant announcement, the centre on Wednesday said that the first-ever Phase 3 clinical trial for a made-in-India dengue vaccine has been initiated. The Indian Council of Medical Research (ICMR) and Panacea Biotec have announced the initiation of this landmark trial, which will evaluate the efficacy of India’s indigenous tetravalent dengue vaccine, DengiAll, developed by Panacea Biotec. Currently, in India, there is no antiviral treatment or licensed vaccine against dengue, a viral infection that spreads from mosquitoes to people.
Dengue is a significant public health concern in India, ranking among the top 30 countries with the highest disease incidence. The first participant in this trial was vaccinated on Wednesday at Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences (PGIMS) in Haryana's Rohtak, according to a statement from the Union Health Ministry. Commenting on this milestone, Union Minister of Health and Family Welfare, J.
P. Nadda, said, “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 vaccine research and development capabilities.
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,” he added. Developing an effective vaccine is complex due to the need to achieve good efficacy for all four serotypes. In India, the statement said that all four serotypes of the Dengue virus are known to circulate or co-circulate in many regions.
In collaboration with ICMR, Panacea Biotec will conduct the Phase 3 clinical trial across 19 sites in 18 States and Union Territories, involving more than 10,335 healthy adult participants. The trial, primarily funded by ICMR with partial support from Panacea Biotec, is set to follow up with participants for two years. The statement added that this initiative represents a significant step towards developing an indigenous vaccine for one of India’s most pressing public health challenges and exemplifies the nation’s commitment to Atmanirbhar Bharat.
The tetravalent dengue vaccine strain (TV003/TV005), initially developed by the National Institutes of Health (NIH), US, 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 development. “The company has worked extensively on these strains to develop a full-fledged vaccine formulation and holds a process patent.
Phase 1 and 2 clinical trials of the Indian vaccine formulation were completed in 2018-19, yielding promising results,” it added. Dengue, also known as break-bone fever, has increased in India over the past four years. In 2022, a total of 2.
33 lakh cases and 303 deaths were reported. In 2023, a total of 2.89 lakh cases and 485 dengue deaths were reported in the country.
The urban areas have contributed 55-58% of the total cases for the last few years. However, in 2023, it had increased to around 68%. Although dengue cases generally peak in October, this year’s trend shows that, as of July 31, 2024, the number of cases is already almost 50% higher than at the same time last year.
In India, approximately 75-80% of infections are asymptomatic, yet these individuals can still transmit the disease 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 like dengue hemorrhagic fever and dengue shock syndrome.
The global incidence of dengue has been steadily increasing over the past two decades, with more than 129 countries reporting dengue viral disease by the end of 2023, according to the World Health Organization (WHO). The dengue virus has four serotypes, 1-4, with low cross-protection against each other, meaning individuals can experience repeated infections..
