‘Enrolment nearly done in third phase trials for India’s first dengue vaccine’, Pg9

Context:

• India is in the final enrolment stage of Phase-3 clinical trials for its first indigenous tetravalent dengue vaccine (DengiAll), developed by Panacea Biotec in collaboration with the ICMR, to address the growing burden of dengue.

Key Highlights:

• Around 8,000 of 10,000 participants have been enrolled in the ongoing third phase clinical trial.
• The vaccine, DengiAll, targets all four serotypes of the dengue virus.
• Trials are being conducted at 20 centres nationwide, including Chennai, Delhi, Pune, and Hyderabad.
• The project is primarily funded by ICMR, with Panacea Biotec providing additional support.
• India currently has no licensed vaccine or antiviral for dengue.
• Earlier Phase 1 and 2 trials (2018–19) showed promising safety and immunogenicity.
• India is among the top 30 countries with the highest dengue incidence.

Detailed Insights:

• The vaccine strain (TV003/TV005) was originally developed by the U.S. NIH and adapted by Panacea Biotec under a process patent.
• The clinical trial involves two-year follow-up for efficacy, targeting regions where co-circulation of serotypes is common.
• Children are at higher risk of severe complications such as dengue hemorrhagic fever and dengue shock syndrome.
• WHO data shows 129+ countries reported dengue as of 2023, indicating a global public health challenge.

Scientific/Technical Concepts Involved:

• Tetravalent Vaccine: A vaccine designed to provide immunity against all four dengue virus serotypes (DEN-1 to DEN-4).
• Dengue is a viral disease transmitted by Aedes mosquitoes causing flu-like symptoms. 
• Serotype: A distinct variation within a virus species; infection with one dengue serotype provides little protection against others.
• Process Patent: Legal protection for the method of creating a product, in this case, the dengue vaccine formulation.