Pune-based Serum Institute to soon start Phase I & II trials of dengue vaccine in India
The Phase 1 and Phase 2 study of Dengusiil in India will be conducted on 45 adults of 18 years and above and 75 children of 2 years of age and above and less than (<) 18 years of age
After a successful Phase-I trial of the dengue vaccine in Australia, the Serum Institute of India (SII) will soon begin Phase I and Phase II trials for its Dengusiil vaccine in India, bringing India one step closer to generating its first indigenous dengue vaccine.
Dr Rajeev Dhere, executive director of SII, said, an application has been submitted to the Drugs Controller General of India (DCGI) to conduct a Phase 1 and 2 study in India in adults and children 2 years of age and above.
“After receiving the approval, the study will be initiated in India and will be completed in a year,” said Dhere.
The Phase 1 and Phase 2 study of Dengusiil in India will be conducted on 45 adults of 18 years and above and 75 children of 2 years of age and above and less than (<) 18 years of age. After completion of the Phase 1/2 study, the Phase 3 study will be approved.
Along with the report of this Phase 1/2 study in India, SII will conduct a Phase 3 study to evaluate the efficacy of Dengusiil in collaboration with the Indian Council of Medical Research (ICMR).
After approval, the study will be conducted on approximately 10,000 children of 2 to 17 years of age and they will be followed for assessment of efficacy and safety over 3 years from the administration of a single dose of Dengusiil (0.5 ml subcutaneously), informed SII officials.
The Phase 1 study of Dengusiil was completed in Australia and the results showed that vaccine was found “safe” and “highly immunogenic” during this Phase 1 study in healthy adults 18-45 years of age in Australia in 2022
More than 84% of participants had seroconversion for neutralizing antibodies with three or four dengue virus serotypes.
These findings are similar to those seen in other Phase 1 studies conducted by the National Institutes of Health (NIH), USA. The study was published in the international peer-reviewed journal ‘Vaccine’ on 31 July 2023.
The Dengusiil vaccine virus strain has been developed by NIH. The NIH after several clinical trials conducted on their own further sub-licensed the technology to SII and other companies including Butantan Institute, Brazil; Merck, USA; Panacea Biotec, India; Indian Immunologicals, India and others.
Dr Dhere, said, “Dengusiil is a live attenuated dengue virus vaccine. Live attenuated vaccines produce both neutralizing antibodies as well as cell-mediated immune responses and thus provide protection against dengue infection in future. This protective immune response develops around four weeks after vaccination.”
“NIH has conducted several studies and shown that the vaccine induces balanced neutralizing antibody responses against all four dengue virus serotypes to protect against all four dengue virus serotype. Earlier vaccines have not been able to induce a balanced immune response against all four serotypes of the dengue virus. NIH dengue vaccine including Dengusiil will overcome this limitation,” informed Dr Dhere.
Butantan Institute has already completed a Phase 2 study and a Phase 3 study in Brazil and has shown that the vaccine is highly immunogenic and safe.
The vaccine showed an efficacy of 80% in the prevention of symptomatic dengue of any severity caused by any serotype of the dengue virus.
As per officials, the Dengusiil vaccine is likely to be rolled out in the market by 2027, if clinical trials are completed with timely approvals.
All individuals 2 years of age and above will be eligible for vaccination with Dengusiil based on approval of the regulatory authority. It is a single-dose vaccine administered at a dose of 0.5 ml below the skin on the upper arm (subcutaneous).
SII has a production capacity of 100 million doses per year for its dengue vaccine.