Health
First Phase 3 clinical trial of dengue vaccine begins in India
The Phase 3 clinical trial will be conducted at 19 sites across 18 states and union territories and will involve over 10,335 healthy adults.
“The commencement of phase three clinical trials of India's first indigenously developed dengue vaccine marks a significant step forward in the fight against dengue. It reflects our determination to protect our people from this widespread disease and underscores India's vaccine research and development capabilities,” Union Health Minister JP Nadda said.
“Through the collaboration between ICMR and Panacea Biotech, we are not only taking a step towards ensuring the health and wellbeing of people; Atmanirbhart That's true in the health care field,” he said.
Currently, there are no antiviral drugs or licensed vaccines against dengue in India.
Developing an effective vaccine is complex as it needs to achieve good efficacy against all four serotypes. Dengue virus “Dengue is known to be endemic or coexisting in many areas. The quadrivalent dengue vaccine strain (TV003/TV005), first developed by the US National Institutes of Health (NIH), has shown promising results in preclinical and clinical trials around the world,” the ministry said in a statement.
Panacea Biotech, one of three Indian companies that received the strain, is in the most advanced stage of development.
The company has worked extensively with these strains to develop full-fledged vaccine formulations and holds process patents for this research.
Phase 1 and 2 clinical trials of India's vaccine formulation were completed in 2018-19 with promising results, the statement said.
The trial, primarily funded by ICMR and partially supported by Panacea Biotec, will follow up participants for two years.
Dengue fever is a major public health concern in India, which ranks among the top 30 countries with the highest incidence of the disease.
According to the World Health Organization (WHO), the global incidence of dengue has been steadily increasing over the past two decades, with more than 129 countries reporting dengue virus infections by the end of 2023.
About 75-80 percent of infected people in India are asymptomatic, but the infection can still be spread by the bite of the Aedes aegypti mosquito, the statement said.
Of the 20-25% of clinically apparent cases, children are at significantly higher risk of hospitalization and death.
In adults, the disease can worsen into severe conditions such as dengue hemorrhagic fever and dengue shock syndrome, the statement said.
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