Bharat Biotech Gets SEC Nod to Begin Phase III Trial of Inactivated Chikungunya Vaccine
New Delhi: Noting the results of the Phase II trial for the Inactivated Chikungunya vaccine, the Subject Expert Committee (SEC) functioning under the Central Drugs Standard Control Organisation (CDSCO), has granted approval to Bharat Biotech International for the conduct of the Phase III trial as per the presented protocol.
This came after the firm presented the Phase II report of the study titled, "А Seamless Phase II / III, observer blind, multicentre, randomized Clinical trial to evaluate immunogenicity and safety of BBV87, an Inactivated Chikungunya Virus Vaccine in healthy subjects 12-65 years of age".
Chikungunya virus (CHIKV) is an alphavirus transmitted by mosquitoes that poses a threat to global public health.
Bharat Biotech International Ltd's (BBIL) Chikungunya vaccine candidate (BBV87) is an inactivated whole virion vaccine based on a strain derived from an East, Central, South African (ECSA) genotype. Based on the ECSA strain, Bharat Biotech International Ltd developed a pure, inactivated CHIKV immunogenic formulation.
BBV87 vaccine completed standard pre-clinical studies, and the adjuvanted vaccine elicited an optimum immune response in phase 1 clinical trials in India.
BBV87 uses a whole virus that has been rendered harmless by being chemically inactivated, making it incapable of causing the disease but able to stimulate the immune system to recognize and fight the actual virus.
The vaccine is formulated with an adjuvant (aluminum hydroxide) to enhance the immune response. The vaccine is administered intramuscularly in the deltoid region of the upper arm.
At the recent SEC meeting for vaccines, the expert panel reviewed the Phase II report of the study titled, "А Seamless Phase II / III, observer blind, multicentre, randomized Clinical trial to evaluate immunogenicity and safety of BBV87, an Inactivated Chikungunya Virus Vaccine in healthy subjects 12-65 years of age".
After detailed deliberation, the committee noted the results of the Phase II trial and recommended the conduct of the Phase III trial as per the presented protocol.
