ICMR, Panacea Biotec begin Ph-3 trial of indigenous dengue vaccine

Tribune News Service

Advertisement

New Delhi, August 14

The Indian Council of Medical Research (ICMR) and Panacea Biotec on Wednesday announced the initiation of the first-ever Phase-3 clinical trial for a dengue vaccine in India.

The Health Ministry said the trial would evaluate the efficacy of India’s indigenous tetravalent dengue vaccine, DengiAll. The first participant in this trial was vaccinated today at Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences (PGIMS), Rohtak.

Over 10K participants

• The trial will be conducted across 19 sites in 18 states and UTs 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.
• Phases 1 and 2 clinical trials of the Indian vaccine formulation were completed in 2018-19, yielding promising results.
• Currently, there is no antiviral treatment or licensed vaccine against dengue in India.

Phases 1 and 2 clinical trials of the Indian vaccine formulation were completed in 2018-19, yielding promising results. Currently, there is no antiviral treatment or licensed vaccine against dengue in India. 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.

“The tetravalent dengue vaccine strain (TV003/TV005), originally developed by the National Institutes of Health (NIH), USA, has shown promising results in preclinical and clinical trials worldwide. 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,” the Health Ministry said in a statement.

Health Minister JP Nadda said: “The initiation of this 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 the collaboration between ICMR and Panacea Biotec, the country was not only taking a step towards ensuring health and well-being of people but also reinforcing the vision of Atmanirbhar Bharat in the healthcare sector, Nadda added.

The trial will be conducted across 19 sites in 18 states and Union Territories of India, 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.