Dengue Vaccine: Phase 3 Clinical Trial Kicks Off At Bhubaneswar’s KIMS

Bhubaneswar: In a significant development, the third phase of clinical trial for India’s first indigenous dengue vaccine ‘DengiAll’ commenced at Kalinga Institute of Medical Sciences (KIMS) here on Monday.

Phase 3 trial is being conducted at 18 other sites across 18 states in India, with KIMS being the only hospital selected for the exercise in Odisha.

“We have to recruit more than 500 participants in Bhubaneswar who will volunteer for the third phase of the trial,” said a doctor involved in the process.

The aim of this trial is to evaluate the efficacy of the indigenous tetravalent dengue vaccine, developed by Panacea Biotec in collaboration with Indian Council of Medical Research (ICMR).

There is no antiviral treatment or licensed vaccine against dengue in India currently.

The tetravalent dengue vaccine strain (TV003/TV005), originally developed by 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.

Phase 1 and 2 clinical trials were completed in 2018-19, yielding promising results.

HOD Community Medicine Dr Sonali Kar is the Principal Investigator for the study. HoD of Dept of Internal Medicine Dr L Mohanty, HoD of Dept. of Microbiology Prof. Dr Dipti Pattnaik and he Director of KIMS Central Laboratory Prof. Dr Saurav Patra will oversee the operations, supported by an investigation team led by Prof. Dr P C Samantaray.

The site initiation visit (SIV) started on August 29, when an ICMR team, sponsor from Panacea Biotech and JSS as CRO for the study visited KIMS to guide the trial team on operating procedures.