The first phase III clinical trial for a dengue vaccine in India commenced on Wednesday, with the initial dose administered at Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences (PGIMS), Rohtak, Haryana. The vaccine, named DengiAll, has been developed by Panacea Biotech and targets all four serotypes of dengue.
The trial will be conducted at 19 sites across 18 states and Union Territories, involving 10,335 healthy adults over a two-year period. The Indian Council of Medical Research (ICMR) is primarily funding the trial, with Panacea Biotech partially covering the expenses.
Union Health Minister JP Nadda hailed the trial’s initiation as a significant step in combating dengue and said, “The initiation of this Phase 3 clinical trial for India’s first indigenous dengue vaccine marks a critical advancement in our fight against dengue. It reflects our commitment to protecting our citizens from this pervasive disease and underscores India’s capabilities in vaccine research and development.”
DengiAll uses live, weakened versions of all four dengue serotypes, developed by the National Institute of Allergy and Infectious Diseases (NIAID) in the US. The vaccine’s development involved deleting parts of the genetic code of DENV1, DENV3 and DENV4 and genetically engineering a DENV2 backbone using parts from the weakened DENV4.
One of the major challenges in developing a dengue vaccine is the limited cross-protection between the four serotypes, which can lead to antibody-dependent enhancement (ADE). ADE can cause more severe infections in individuals with low antibody levels against one serotype when infected with another.
ADE was the reason why the first dengue vaccine faced controversy after it was found to increase the risk of severe disease in individuals who had not been previously infected. This was discovered only after a vaccination programme was rolled out in the Philippines.
The Serum Institute of India has also developed a vaccine candidate using the same weakened virus from the US, which has completed initial trial phases. The company plans to conduct a large phase III trial in collaboration with ICMR for children aged 2 to 18 years.
Similarly, Indian Immunologicals Limited is developing a vaccine using the same technology, currently in initial human trial phases. Hyderabad-based BiologicalE has partnered with global pharmaceutical company Takeda to produce its dengue vaccine, based on the same principle as the NIAID vaccine.
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