The Indian Council of Medical Research (ICMR) and Panacea Biotec announced in August 2024 that they have initiated the “first-ever” Phase III clinical trial for a dengue vaccine in India. The trial will evaluate the efficacy of Panacea Biotec’s tetravalent dengue vaccine, DengiAll. The first participant in the trial was vaccinated at Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences (PGIMS), Rohtak. Although there is no antiviral treatment or licensed vaccine against dengue in India, the development of an effective vaccine is “complex” as good efficacy must be achieved across four serotypes.
Dengue in India
Dengue is described as a “major public health concern” in India, and global incidence has been “steadily increasing” over recent decades. Around 75%-80% of infections in India are asymptomatic, but this does not prevent further transmission. Among the remaining cases that present with “clinically apparent” symptoms, children are at a greater risk of hospitalisation and mortality. Dengue virus has four serotypes, but these have low cross-protection against each other, which means that individuals can suffer repeated infections. All four serotypes are known to circulate or co-circulate in “many regions” of India.
DengiAll
DengiAll is a lyophilised tetravalent live-attenuated dengue vaccine developed by Panacea Biotec in collaboration with the US National Institutes of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH). It is a single dose subcutaneous vaccine, “analogous to NIH Tetravalent Vaccine”, which has been evaluated in “numerous” Phase I & II trials in the US to demonstrate an “acceptable” safety profile and “robust” responses.
Panacea Biotec was one of three Indian companies to receive the vaccine strain and has achieved the “most advanced stage” with this strain. In collaboration with ICMR, Panacea Biotec is conducting the Phase III clinical trial at 19 sites in 18 States and Union Territories. The trial will involve more than 10,335 healthy adult participants; it is primarily funded by ICMR with partial support from Panacea Biotec.
Union Minister of Health and Family Welfare, Shri J.P. Nadda commented that the initiation of the trial for “India’s first indigenous dengue vaccine marks a critical advancement” in the 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.”
Atmanirbhar Bharat, or “self-reliant India” is an effort to “make the country and its citizens independent and self-reliant in all senses”.
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