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The Indian Council of Medical Research (ICMR) and Panacea Biotec have initiated India's first-ever Phase 3 clinical trial for an indigenous dengue vaccine. The trial, focused on the tetravalent dengue vaccine DengiAll, marks a pivotal moment in the country's ongoing battle against dengue fever, a disease that continues to pose a significant public health threat across the nation.
The Phase 3 trial commenced with the vaccination of the first participant at Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences (PGIMS) in Rohtak. This event signifies the beginning of a comprehensive evaluation process that will assess the efficacy and safety of DengiAll, bringing the country one step closer to having its own licensed dengue vaccine.
Union Minister of Health & Family Welfare, Shri J.P. Nadda, hailed the trial as a critical advancement in the fight against dengue.
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.
Shri J.P. Nadda, Union Minister of Health & Family Welfare.
Dengue remains a significant health challenge in India, with all four serotypes of the virus circulating in various regions of the country. Despite ongoing efforts, there is currently no antiviral treatment or licensed vaccine available in India. The complexity of developing a vaccine that provides effective immunity against all four serotypes has been a major hurdle. This trial is a crucial step toward addressing this gap in public health infrastructure.
The tetravalent dengue vaccine strain (TV003/TV005), originally developed by the National Institutes of Health (NIH) in the USA, serves as the foundation for DengiAll. Panacea Biotec, one of the three Indian companies granted access to this strain, has made significant strides in developing a viable vaccine. The company completed Phase 1 and 2 clinical trials of the Indian formulation in 2018-19, with results indicating strong potential.
Panacea Biotec has further refined the vaccine formulation, earning a process patent for its innovative work. The initiation of the Phase 3 trial places Panacea Biotec at the forefront of dengue vaccine development in India.
The Phase 3 clinical trial will be conducted across 19 sites in 18 States and Union Territories in India, making it one of the most extensive vaccine trials in the country. Over 10,335 healthy adult participants will be involved in this rigorous study, which is expected to provide crucial data on the vaccine's efficacy and safety.
This large-scale trial is primarily funded by ICMR, with Panacea Biotec providing partial financial support. The trial is set to follow up with participants over two years, ensuring a comprehensive assessment of the vaccine's long-term effects.
Dengue: Background
Dengue is a rapidly emerging mosquito-borne viral disease and a significant public health concern in India, ranking among the top 30 countries for dengue incidence. The global spread has increased dramatically, with over 129 countries reporting cases by 2023, according to the WHO. In India, 75-80% of dengue infections are asymptomatic but can still be transmitted through the bite of Aedes mosquitoes. Among the 20-25% of symptomatic cases, children are particularly vulnerable, facing higher risks of severe illness, hospitalization, and mortality. Adults can also experience severe forms like dengue hemorrhagic fever and dengue shock syndrome. The virus has four serotypes, with low cross-protection, leading to potential repeated infections.
(Input From Various Sources)
Rehash/Pratiksha Jadhav/MSM
