India has taken a significant step forward in the fight against dengue with the launch of the first-ever Phase 3 clinical trial for an indigenous dengue vaccine called DengiAll. This important trial is being conducted by the Indian Council of Medical Research (ICMR) in collaboration with Panacea Biotec, a leading biotech company in India. The first participant was vaccinated today at Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences (PGIMS) in Rohtak, Haryana.
A Milestone in India’s Fight Against Dengue
Union Minister of Health & Family Welfare, Shri J.P. Nadda, commented on this important milestone: “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.”
This trial is crucial because, currently, there is no antiviral treatment or licensed vaccine for dengue in India. Dengue is a complex disease to combat because it has four different virus types, all of which circulate in various parts of India. Developing a vaccine that effectively protects against all four types is a challenging task.
The Development of DengiAll
The tetravalent dengue vaccine strain (TV003/TV005) used for DengiAll was originally developed by the National Institutes of Health (NIH) in the USA. This strain has shown promising results in earlier preclinical and clinical trials conducted around the world. Panacea Biotec is one of three Indian companies that received this strain and is the most advanced in developing it into a full-fledged vaccine. The company completed Phase 1 and Phase 2 clinical trials of its vaccine formulation in 2018-19, which yielded encouraging results.
Panacea Biotec has worked extensively on refining these strains and holds a process patent for the work done to create DengiAll. This shows the company’s dedication and commitment to developing a reliable vaccine to combat dengue.
The Phase 3 Clinical Trial
The Phase 3 trial for DengiAll will be conducted across 19 sites in 18 States and Union Territories of India. More than 10,335 healthy adult participants will be involved in the trial, which is being conducted in collaboration with ICMR and Panacea Biotec. The trial will monitor participants for two years to assess the vaccine’s effectiveness and safety. This initiative is primarily funded by ICMR, with partial support from Panacea Biotec.
This clinical trial is a major step toward creating an indigenous vaccine for dengue, a disease that poses a significant public health challenge in India. It also highlights the country’s commitment to achieving self-reliance, or Atmanirbhar Bharat, in the healthcare sector. The success of this trial could lead to the availability of a homegrown vaccine that can protect millions of Indians from dengue in the future.
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