Abstract
Propagation of fixed rabies virus strain in vero cell line, ultra filtration of rabies viral harvest, betapropiolactone inactivation subsequent purification, total protein nitrogen quantification, Rapid Fluorescent focus inhibition test, MgCl2 based liquid rabies vaccine formulation (TCALRV-B) and immune response analysis. The vero cell derived PV 11 rabies viral titers were found that 10-5.3, ultra filtrated, betapropiolactone inactivated and viral protein qualities were within the range (WHO). The total protein concentration and PN2 was 577.6, 0.26 mg/ml respectively. The host cellular protein and residual cellular DNA was 16 ng/single human doses and below 100 pg/ml respectively it reveals within the limit. The RFFIT titer of the TCALRV-B possessed higher immune response (8 IU/ml) of rabies neutralizing antibodies on 14th on 21st day the titer was four fold increasing even after 90th day it reveals its immunopotency. The TCALRV-B contained all the quality attributes to fulfill the regulatories although it contained potency, immunogenicity and safety as in vivo study shows lesser immunogenic during the booster doses. This may be due to the unadsorption of rabies viral proteins by MgCl2 as adjuvant.
Highlights
Rabies is one of the neglected tropical diseases caused by the lyssavirus, causing severe encephalomyelitis throughout the world
Preparation and quality control of TCALRV-B The PV 11 rabies viruses were harvested at 72 hours intervals until the 4th day, and viral titers were determined and it found that 10-5.3 it was concentrated about 20 times using with 0.45 μm microfiltration and ultrafiltration (100 KDa), inactivated with β-propiolactone (1:3000) at 4°C [9]
Immunologic adjuvants are agents incorporated into vaccine formulation to enhance the immunogenicity of vaccine antigens
Summary
Rabies is one of the neglected tropical diseases caused by the lyssavirus, causing severe encephalomyelitis throughout the world. It thought to be one of the oldest diseases of mankind. 1.1 to 1.5 million persons gets post-exposure rabies vaccine annually in India and the annual requirement for rabies vaccine is approximately 6-10 million doses. The post exposure prophylaxis of rabies disease requires 4-5 doses of highly expensive cell culture derived vaccines for the entire period of immunization, in which case the poor people are unable to bear the cost. Most of the available cell culture vaccines are in freeze dried form whereas processing of the rabies vaccine the maximum cost is needed for downstream purification and lyophilization process [3]
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