3 min readPuneJul 16, 2024 02:59 PM IST
First published on: Jul 15, 2024 at 07:02 PM IST
As many as 10,335 healthy adults between the age of 18 and 60 years will be taking part in a new clinical trial to test the efficacy of DengiAll, a vaccine to prevent dengue fever. This vaccine has been prepared by Panacea Biotec in collaboration with National Institutes of Health, USA, for preventing dengue fever, and clinical trials in humans will commence soon across 19 sites in the country, said biomedical scientist Dr Sheela Godbole, who is also principal investigator of the trial. Godbole, who is also director of Indian Council of Medical Research – National Institute of Translational Virology and AIDS Research (NITVAR), Pune, was speaking to The Indian Express.
Panacea Biotec through a licensing agreement with National Institutes of Health (NIH), United States of America has prepared the vaccine indigenously. The vaccine, manufactured by Panacea Biotec, has the same virus composition as that of the vaccine developed by NIH, USA except for the inactive ingredients.
“The vaccine was also evaluated by NIH in the USA and the results were found to be promising in early stage clinical studies.‘Dengiall’ has undergone phase 1 studies in India,” Dr Godbole said. ” This vaccine includes constructs of all the four dengue virus subtypes wherein some parts of the viral genes are deleted. Thus, the vaccine cannot cause dengue fever as such on its own,” Dr Godbole explained.
ICMR-NITVAR are jointly conducting the trial. ICMR institutes like National Institute of Virology and National Institute of Epidemiology are also taking up other components of the trial.
Earlier, pre-clinical studies were designed to assess the safety and tolerability of dengue tetravalent vaccine in mice, rats and rabbits. Subsequently, the Dengue Tetravalent Vaccine Phase I/II clinical trial was conducted in an Indian population. (100 healthy adults) and results (published in Vaccine journal) has shown this vaccine is safe and produces sufficient immune response for all dengue serotypes. A single dose of live attenuated tetravalent dengue vaccine was well tolerated and had induced robust neutralising antibody response against four dengue virus serotypes, according to researchers of the report.
“Now, the current trial will test its efficacy, and 19 sites across India will be part of this trial,” Dr Nivedita Gupta, Head Communicable Diseases ICMR HQ , National Coordinator for the Trial said. These include Pune, Rishikesh, Rohtak, Ludhiana, Delhi, Aligarh, Patna, Ranchi, Jodhpur, Bhubaneshwar, Guwahati, Imphal, Kolkata, Bibinagar, Puducherry, Bengaluru, Mysuru, Kochi and Chennai. A total of 10,335 healthy adults between the ages of 18-60 will be involved of whom a third will receive a placebo.
Dengue is a mosquito-borne viral disease that leads to a wide spectrum of symptoms ranging from fever, headache, muscle pain, nausea and so on. Severe dengue hemorrhagic fever and dengue shock syndrome can threaten a patient’s life and while there is no specific antiviral treatment, the management is symptomatic and supportive. As per data from the National Centre for Vector Borne Disease Control, till April this year, a total of 19,447 cases of dengue and 16 deaths have been reported. In 2023, there were 2.9 lakh cases of dengue and 485 deaths across the country as per data.
ICMR institutes like National Institute of Virology and National Institute of Epidemiology are also taking up other components of the trial. (File/ Representational) 
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