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 section trials, about 8,000 of the focused 10,000 individuals have enrolled within the third section of scientific trials for a dengue vaccine in India, Manoj Murhekar, Director, Nationwide Institute of Epidemiology, ICMR, Chennai, advised The Hindu.

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

The trial is primarily funded by ICMR, with partial assist from Panacea Biotec. Contributors can be adopted up for 2 years below tasks unfold throughout numerous centres, together with Chennai, Pune, Hyderabad, and Delhi.

There may be presently no antiviral therapy 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 yr at Pandit Bhagwat Dayal Sharma Publish Graduate Institute of Medical Sciences, Rohtak,’’ a launch issued by the Union Well being Ministry mentioned.

The tetravalent dengue vaccine pressure (TV003/TV005) initially developed by the Nationwide Institutes of Well being, the U.S., has proven promising ends in preclinical and scientific trials worldwide. Panacea Biotec, one in all three Indian corporations to obtain the pressure, is on the most superior stage of creating 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 have been accomplished in 2018-19, yielding promising outcomes.

Dengue is a significant public well being concern in India, which ranks among the many prime 30 international locations with the very best incidence of the illness. The worldwide incidence of dengue has been steadily rising over the previous 20 years, with greater than 129 international locations reporting dengue viral illness by the tip of 2023, in keeping 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 via the chew of Aedes mosquitoes. Among the many 20-25% of instances the place signs are clinically obvious, youngsters are at a considerably greater danger 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 suggests people can expertise repeated infections.