New Delhi, May 16 (PTI) The phase-3 trial of a dengue vaccine developed by Panacea Biotech in collaboration with the Indian Council of Medical Research (ICMR) is likely to begin in August or September, a senior official said on Tuesday.
Also, the phase 1/2 paediatric trials are underway for another dengue vaccine for which apex health research body ICMR has signed a Memorandum of Understanding with the Serum Institute of India (SII).
Dr Nivedita Gupta, who heads the ICMR’s Division of Epidemiology and Communicable Diseases (ECD), said Panacea Biotech has already completed the phase 1/2 trials in India on healthy adults and the safety of the vaccine has been established.
Phase 1/2 trials refer to a situation when the first and second phase of trials are conducted together.
“We have some preliminary immunogenicity results also. So all the paperwork has been done and the approval for phase-3 randomised double-blind, placebo controlled trial from the Drugs Controller General of India (DCGI) has also been obtained in January. The trial will be conducted on 10,335 healthy adults aged 18-80 years at 20 sites,” Dr Gupta said at an event organised by ICMR to observe the National Dengue Day.
Panacea Biotech, meanwhile, is now trying to upscale vaccine production and the phase-3 trial is likely to begin in August or September, Dr Gupta stated.
The Serum Institute of India has completed its phase 1 trial on 60 adults in Australia during which the safety and preliminary immunogenicity of the vaccine were established. Now it is conducting a phase 1/2 trial in children in India.
“The ICMR has also got into an MoU with Serum Institute for developing this dengue vaccine. Once the phase 1/2 trial is completed, based on the results, we will start the phase 2/3 trial in paediatric population,” Dr Gupta said.
She said immediately after Covid, the ICMR prioritised dengue vaccine development in India.
Serum Institute and Panacea Biotech had applied after an expression of interest was floated on the website of ICMR in February 2022 inviting manufacturers in India who have a potential vaccine and are ready to go to phase 3 trials.
“Dengue is a big challenge for the country and a vaccine is definitely required. This is a disease because of which needless lives are lost every year and we should and could do better than what we are doing now,” Dr Rajiv Bahl, Director General of ICMR said on Tuesday.
“If we have to be a developed country in 25 years, one of the things we need to get rid of is vector-borne diseases like Lymphatic filariasis, Kala azar, malaria and also dengue,” Dr Bahl said.
Vector-borne disease control will be one of the 10 most important priorities of the ICMR in the coming years along with the same level as EMR (Emergency Medical Response), one Health and Tuberculosis, Dr Bahl said.
“We will launch a series of research studies in all different ways to address various aspects where innovations are required whether it’s vector control strategies of different types or others,” he said.
“Vector Control research is extremely important with changing vector behaviour and many of the known things we used to read in textbooks changing. We need not only be abreast with whatever is happening but also find solutions to those problems that how we enhance vector control,” he said.
“We are also working on vaccines and waiting for the vaccine trial to start,” Dr Bahl said. PTI PLB TIR TIR
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