RABIES VACCINE -B.HARISHA 4 t h y e a r ( C L B M )
INTRODUCTION It is primarily a ZOONOTIC disease of warm blooded. Acute rapid progressive &highly fatal viral disease of CNS Transmitted to man by the bite of rabid animals. Non-bite exposure:aerosol generated in lab. corneal transplantation. Human to human transmission is rare. CAUSATIVE AGENT: Lyssa virus type 1belongs to the family RHABDOVIRUSES which is a bullet shaped neurotropic single stranded RNA Virus.
ANTIRABIES VACCINES In 1883,Louis Pasteur performed the first successful Human Antirabies virus(HAP) The original vaccine was the suspension of nervous tissue of animals infected with fixed rabies virus.
STEPS IN VACCINE PRODUCTION
SELECTION :It involves the viruses that is derived from seed lot system. GROWING: Methods used are 1.cell culture 2. Bird embroyos 3.Live animal inoculation 4.Transgenic animals. ISOLATION &PURIFICATION: It involves 1.centrifugation 2.Filteration 3.chromatography
SEED LOT SYSTEM A seed lot system is a system in which successive products of the batch are derived from the same master seed lot at a given passage level.For routine production,a working seed lot is prepared from master seed lot.(ensure uniformity, contamination,stability)
INACTIVATION: (virus INACTIVATION)It can be done by dismantling a virus’s ability to infect cells without actually eliminating the virus. METHODS: 1.Solvent/detergent inactivation. Eg:TRITON-X 100. 2.Pasteurization(60 C for 10 hrs) 3.Acidic pH inactivation (pH 4 incubation btw 6 hrs and 21 days) 4.UV inactivation(diminish replication) 5.Inactivation by extraction (nucleic acid….)
FORMULATION: it includes 1.suspending fluids(sterile water,saline or fluids containing protein) 2.preservative(thimerasal) and stabilizer(albumin,phenol,glycine.MSG-stimulator, antibiotics) 3.inactivating agent(beta propiolactone) 4.adjuvants or enhancer
TECHNIQUES By utilizing free living animals By utilizing fertilized egg Tissue culture method
BY UTILIZING FREE LIVING ANIMALS STAGE 1- selection of animals STAGE 2-Inoculation(intracerebral) STAGE 3-Incubation(24hrs) STAGE 4-Harvesting (homogenized with Nacl) STAGE 5-Purification and inactivation
Neural vaccines: FERMI VACCINE:fixed virus is grown in sheep brain& treated with phenol at 22 C.some residual virus is present. SAMPLE VACCINE:Fixed virus is grown in sheep brain and inactivated with phenol at 37 C leaving no residual virus.widely used. BETA PROPIOLACTONE VACCINE:The sheep brain vaccine is inactivated by this which is more antigenic. INACTIVATED VACCINES:Prepared in brain of suckling animals(rat,mice,rabbit).risk of neurological complications.
BY UTILIZING FERTILIZED EGG DUCK EGG VACCINE:In this fixed virus is adapted for growth in duck embryos and inactivated with Betapropiolactone. Not effective as brain vaccines for post exposure treatment. Occasional neurological complications.
LIVE ATTENUATED CHICK EMBRYO VACCINE:In this flury strain of attenuated rabies virus is used.Two types available they are 1.Low egg passage(40-50 egg passage) 2.High egg passage (180 th passage for cattles..used for human also-preimmunization)
TISSUE CULTURE METHOD It is a great advance in prophylaxis. More potent and cheap and much safer than the other. There are two types of tissue culture vaccines they are 1.Human diploid cell vaccine(HDCV) 2.Non human source vaccine
HUMAN DIPLOID CELL VACCINE: It is prepared by propogating the rabies virus in human diploid fibroblast cells. Safe and high potent but not in use for pre and post immunization. NON HUMAN SOURCE: The viruses grown in hamster kidney cells,chick embryo fibroblast,dog kidney cells,vero cells(kidney epithelial cells of African green monkey- used in cell culture) Hypersensitivity: headache, palpitation,giddiness, diarrhoea,itching,pain,redness and swelling at site of reaction, anaphylactic reaction.
EVALUATION OR TESTS OF VACCINES Increase in virulence tests Assessing risk to the environment. Interference test Consistency of production Stability tests Batch/serial purity test Batch/serial safety test Batch/serial potency test Other tests(moisture,pH,residual inactivate, physical stability etc…)
SAMPLING: Samples should be selected from each batch /serial of product. LABELLING:Standards for labelling products will vary from country to country