The First-ever Phase 3 clinical trial for a dengue vaccine in India has been announced by the The Indian Council of Medical Research (ICMR) and Panacea Biotec.

• Phase 1 and 2 clinical trials of the Indian vaccine formulation were completed in 2018-19, yielding promising results.

About DengiAll

• DengiAll is developed by Panacea Biotec is India’s indigenous tetravalent dengue vaccine
  • The tetravalent dengue vaccine strain (TV003/TV005) was originally developed by the National Institutes of Health (NIH), USA
  • Process Patent: Panacea Biotec is one of three Indian companies to receive the strain, has developed a full-fledged vaccine formulation and holds a process patent for this work.
• The Trail: Panacea Biotec will conduct the Phase 3 clinical trial across 19 sites in 18 States and Union Territories of India in collaboration with ICMR
  • The Phase 3 trial primarily funded by ICMR will involve more than 10,335 healthy adult participants for 2 years 
• Vaccine status for Dengue in India: At present India does not have any antiviral treatment or licensed vaccine against dengue.
  • An effective vaccine for Dengue is complex as it is needed 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.

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About Dengue

• Vector: Dengue viruses are spread through the bite of an infected Aedes species (Ae. aegypti or Ae. albopictus) mosquito.
  • These mosquitoes also spread chikungunya and Zika viruses.
• Hotspots: The mosquitoes that spread dengue are found in most tropical and subtropical regions of the world, including many parts of the United States.
• Serotype:The dengue virus has four serotypes, 1-4, with low cross-protection against each other, meaning individuals can experience repeated infections.
• Incidence: India ranks among the top 30 countries with the highest incidence of the disease. 
  • As per 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 viral disease by the end of 2023
• Risk: Approximately 75-80% of infections are asymptomatic but these individuals can still transmit the infection through the bite of Aedes mosquitoes. 
  • Symptomatic: Children are at a greater risk amongst the 20-25% symptomatic cases with hospitalisation and mortality.
  • Adults can experience severe conditions like dengue hemorrhagic fever and dengue shock syndrome. 
• Dengue Burden In India: 
  • India officially recorded nearly 2.33 lakh cases with 303 deaths in  2022
  • Region Specific: A national-level survey conducted in India in 2017 reported the lowest prevalence of Dengue infections in the Northeastern region (1.6%) and the highest in the northern region (47%)
  • Endemic States: West Bengal, Uttar Pradesh, Punjab, Haryana, Delhi, Gujarat, Kerala, Karnataka and Tamil Nadu are the high dengue burden states as per the National Center for Vector Borne Diseases Control (NCVBDC).
• Prevention and control: It depends on vector control. There is no specific treatment for dengue/severe dengue, and early detection and access to proper medical care greatly lower fatality rates of severe dengue.

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