Dengue, mosquito (Photo: Reuters)
ICMR and Panacea Biotec have initiated the first phase three clinical trial to develop a dengue vaccine in India, the Union Health Ministry announced on Wednesday.
India’s indigenous quadrivalent dengue vaccine DengiAll has been developed by Panacea Biotec and the first participant in this trial was vaccinated on Wednesday at the Pandit Bhagwat Dayal Sharma Postgraduate Institute of Medical Sciences, Rohtak.
The phase three clinical trial will be conducted across 19 sites in 18 states and union territories, involving over 10,335 healthy adult participants.
“The initiation of this phase three clinical trial for India’s first indigenous dengue vaccine marks a major breakthrough in our fight against dengue. It reflects our commitment to protect our citizens from this widespread disease and underlines India’s capabilities in vaccine research and development,” said Union Health Minister JP Nadda.
“Through this collaboration between ICMR and Panacea Biotec, we are not only taking a step towards ensuring the health and well-being of our people but also reinforcing our vision of Atmanirbhar Bharat in the healthcare sector,” he said.
Currently, there is no licensed antiviral treatment or 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 ministry said in a statement.
The tetravalent dengue vaccine strain (TV003/TV005), originally developed by the US National Institutes of Health (NIH), has shown promising results in preclinical and clinical trials around the world.
Panacea Biotec, one of three Indian companies that will receive the strain, is in the most advanced stage of development.
The company has worked extensively on these strains to develop a complete vaccine formulation and has a process patent for this work.
Phase one and phase two clinical trials of the Indian vaccine formulation were completed in 2018-19, yielding promising results, the statement said.
The trial, funded primarily by ICMR with partial support from Panacea Biotec, is planned to follow participants for two years.
Dengue is a major public health problem in India, which is among the top 30 countries with the highest incidence of the disease.
The global incidence of dengue has been increasing steadily over the past two decades, and by the end of 2023, more than 129 countries had reported cases of dengue viral disease, according to the World Health Organization (WHO).
In India, about 75 to 80 percent of infections are asymptomatic, but these people can still transmit the infection through the bite of Aedes mosquitoes, the statement said.
In the 20 to 25 percent of cases where symptoms are clinically evident, children are at significantly increased risk of hospitalization and mortality.
In adults, the disease can lead to serious conditions such as dengue hemorrhagic fever and dengue shock syndrome, the statement said.
(Only the headline and image of this report may have been reworked by Business Standard staff; the rest of the content is auto-generated from a syndicated feed.)
First published: August 14, 2024 | 5:00 pm IS
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