DengiAll: First Dengue Vaccine Phase 3 Clinical Trial in India

The Indian Council of Medical Research (ICMR) and Panacea Biotec Limited on 13 August announced the initiation of the first ever phase 3 clinical trial for a dengue vaccine in India.

  • The trial will evaluate the efficacy of India’s indigenous tetravalent dengue vaccine, DengiAll, developed by Panacea Biotec.
  • Currently, there is no antiviral treatment or licensed 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 tetravalent dengue vaccine strain (TV003/TV005), originally developed by the National Institutes of Health, U.S., has shown promising results in preclinical and clinical trials worldwide.
  • Panacea Biotec, one of three Indian companies to receive the strain, is at the most advanced stage of development.
  • Dengue is a major public health concern in India, which ranks among the top 30 countries with the highest incidence of the disease.
  • The global incidence of dengue has been steadily increasing over the past two decades, with more than 129 countries reporting the dengue viral disease by the end of 2023, according to the World Health Organization.
  • In India, approximately 75-80% of infections are asymptomatic, yet these individuals can still transmit the infection through the bite of Aedes mosquitoes.
  • The dengue virus has four serotypes, 1-4, with low cross-protection against each other, meaning individuals can experience repeated infections.

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