Enrolment in third phase clinical trials for India’s first dengue vaccine nearly complete, says ICMR

Following an announcement by the Indian Council of Medical Analysis (ICMR) and Panacea Biotec Restricted to provoke third part trials, about 8,000 of the focused 10,000 contributors have enrolled within the third part of scientific trials for a dengue vaccine in India, Manoj Murhekar, Director, Nationwide Institute of Epidemiology, ICMR, Chennai, instructed The Hindu.

The trial might be rolled out at 20 centres throughout the nation, Dr. Murhekar stated. “In India, all 4 serotypes of the dengue virus are recognized to flow into or co-circulate in lots of areas, so it’s important to make sure that we have now an efficient vaccine that achieves good efficacy for all 4 serotypes,’’ he added.

The trial is primarily funded by ICMR, with partial help from Panacea Biotec. Members might be adopted up for 2 years beneath initiatives unfold throughout varied centres, together with Chennai, Pune, Hyderabad, and Delhi.

There may be at the moment no antiviral remedy or licensed vaccine for dengue in India.

“This landmark trial will consider the efficacy of India’s indigenous tetravalent dengue vaccine, DengiAll, developed by Panacea Biotec. The primary participant on this trial was vaccinated final 12 months at Pandit Bhagwat Dayal Sharma Put up Graduate Institute of Medical Sciences, Rohtak,’’ a launch issued by the Union Well being Ministry stated.

The tetravalent dengue vaccine pressure (TV003/TV005) initially developed by the Nationwide Institutes of Well being, the U.S., has proven promising leads to preclinical and scientific trials worldwide. Panacea Biotec, one in every of three Indian firms to obtain the pressure, is on the most superior stage of growing a vaccine. The corporate has labored extensively on these strains to develop a full-fledged vaccine formulation and holds a course of patent for this work. The primary and second phases of the scientific trials of Indian vaccine formulations had been accomplished in 2018-19, yielding promising outcomes.

Dengue is a serious public well being concern in India, which ranks among the many high 30 international locations with the best incidence of the illness. The worldwide incidence of dengue has been steadily growing over the previous twenty years, with greater than 129 international locations reporting dengue viral illness by the tip of 2023, in accordance with the World Well being Group (WHO).

In India, roughly 75-80% of infections are asymptomatic, but these people can nonetheless transmit the an infection by means of the chew of Aedes mosquitoes. Among the many 20-25% of instances the place signs are clinically obvious, youngsters are at a considerably increased threat of hospitalisation and mortality. In adults, the illness can escalate into extreme circumstances, together with the dengue hemorrhagic fever and dengue shock syndrome. The dengue virus has 4 serotypes, 1-4, with low cross-protection towards one another, which implies people can expertise repeated infections.