India begins Phase 3 clinical trial with 1st indigenous dengue vaccine

In a significant development, the Indian Council of Medical Research (ICMR) and Panacea Biotec on Wednesday announced they have started first-ever Phase 3 clinical trial for developing a dengue vaccine in India.

The landmark trial will evaluate the efficacy of India’s indigenous tetravalent dengue vaccine, DengiAll, developed by Panacea Biotec.

The first participant in this trial was vaccinated at Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences (PGIMS), Rohtak, according to the Ministry of Health and Family Welfare.

“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,” said J.P. Nadda, Union Minister of Health and Family Welfare.

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,” said the Minister.

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.

At the moment, there is no antiviral treatment or licensed vaccine against dengue in the country.

According to the government, the development of an effective vaccine is complex due to the need to achieve good efficacy for all four serotypes.

In India, all four serotypes of Dengue virus are known to circulate or co-circulate in many regions.

In February, Japanese drugmaker Takeda Pharmaceuticals said it is in discussions with the Indian regulator and will soon initiate bridging trials on 500 people in India, as it seeks approval of its dengue vaccine.

Meanwhile, Takeda’s dengue vaccine Qdenga, pre-approved by the WHO in May, has shown more than 50 per cent efficacy in reducing the number of cases, with lasting effects and a good safety profile, according to a review of 19 studies published in the journal Vaccines.

The government said that 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 for this work. Phase 1 and 2 clinical trials of the Indian vaccine formulation were completed in 2018-19, yielding promising results.

According to data by the National Centre for Vector Borne Diseases Control, the country recorded 19,447 cases of dengue and 16 deaths till April 30, 2024.