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Abstract

Formulation, Efficacy and Immunogenicity Studies of a Liquid State Rabies Vaccine with Magnesium Chloride as Stabilizer

Selvaraj J, Rajendran V, Kuruba B, Channappa SK, Pachamuthu RG and Raju MK

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.