Aligarh: The first-ever phase three clinical trial of a dengue vaccine is being rolled out in India.

The study was initiated at Jawaharlal Nehru Medical College at Aligarh Muslim University on September 17. A two-year follow-up of the vaccinated participants has been proposed.

The trial is majorly funded by ICMR and partly by Panacea Biotech, with no financial support from any external agency. This trial is a unique example of India’s pursuit to have an indigenous vaccine for one of the biggest public health problems.

Prof Mohd Shameem, the Chairman, the Department of TB and Respiratory Disease at JNMC and Principal Investigator of Project ‘DengiALL’ said that this project is Under the National Health Research Priority Project. He informed that there is no antiviral or licensed vaccine currently available against dengue in India. The complexity of developing an effective vaccine is challenged by the need to have good efficacy for all four serotypes individually. All four serotypes are found to circulate in many parts of India.

A tetravalent dengue vaccine strain i.e. TV003/TV005, was developed by NIH, USA and studied extensively in preclinical and clinical trials across the world. The results were promising for all four serotypes. The strain has been transferred to three companies in India, of which Panacea Biotech is in the most advanced stage of development.

Panacea has further worked on these strains to develop a full-fledged vaccine formulation of their own. The company possesses a process patent on this work. Phase 1 and 2 clinical trials with the Indian vaccine formulation were completed earlier in 2018-19.

“Based on the promising results of the trial, the Indian Council of Medical Research has partnered with Panacea Biotech to undertake a full-fledged phase 3 clinical trial in more than 10,335 healthy adults at 19 sites spread across 18 States/UTs of India”, Prof Shamim added.