Rabies abhayrab Rabies-The Fatal Encounter “Prevention is the only solution”

Rabies

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Rabies-The Fatal Encounter

“Prevention is the only solution”

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Interesting Historical Facts

One of the oldest disease known to mankind Oriental physicians : 3000 BC Greek physician Democritus in 500 BC and

Celsus in First Century AD In India, rabies is known since Vedic periods as

corroborated in Antherva Veda The Latin word “Rabies” seems to have

originated from the Sanskrit word “Rabhas” which means “to do violence”

The vaccine developed by Dr.Louis Pasteur was first administered on July 6, 1885

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IncidenceWorld

• Canine rabies continues to exist in 87 countries or territories of the world and this accounts for 99 per cent of all human rabies cases.

• Globally each year, 10 million people require Post-Exposure Treatment (PET)

• 70,000 people per annum fall victim to the disease, particularly in developing countries

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India• Estimated 30,000 patients suffer painful

deaths per annum,• More than 67% of all reported cases of

rabies come from India. • Approximately 20 million dogs in India

and in addition there is also threat from cats and other domestic and wild animals

• 5,00,000 undergo anti-rabies immunization

Incidence

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What is Rabies ? Highly fatal viral disease, characterized by

inflammation of the central nervous system (encephalomyelitis)

Known as hydrophobia Primarily a zoonotic disease-All warm-blooded

animals are susceptible to this infection Extremely dangerous disease: characteristic long

and variable incubation period, a short period of illness, highly distressing symptoms and as a rule ending in death

It is the only communicable disease of man that is always fatal.

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Agent factor

The causative agent : Lyssavirus type 1 Belongs to the family Rhabdoviridae –

Serotype 1 Bullet shaped neurotropic RNA containing

virus Two major antigens :

Glycoprotein (gp) – cell membraneNucleoprotein antigen (N protein)

Only gp induces virus-neutralizing antibodies

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Other important properties:

• The virus is highly resistant against cold, dryness, decay, etc.

• It can remain infectious for weeks in cadavers

• Its is inactivated by formaldehyde, sunlight, lipid solvents and antiseptics

Agent factor

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Host or Principal Reservoirs All warm-blooded animals In cities-dogs and cats

Source of infection: -saliva of rabid animals

-virus in saliva: 3-4 days before the onset of symptoms and during the course of illness in dogs and cats

Host and Source of Rabies Infection

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Mode of transmission

Animal bites: 99% rabid dog bites -Others: cat, monkey, horse, sheep, goat

Licks: Abraded skin and mucosa (abraded or unabraded)

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Incubation period

In humans, highly variable : 3-8 weeks post exposure (but may vary from one week to many years)

Factors influencing incubation period: The site of the biteSeverity of the biteNumber of woundsAmount of virus injectedSpecies of the biting animalProtection provided by the clothing and Treatment undertaken, if any.

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Pathogenesis The deadly sequel

Multiplies Locally in Muscle Fiber

Peripheral nerves

Dorsal Root Ganglia

Spinal Cord

BrainTissues

BodyFluids

Glands

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Clinical manifestations

First Warning Sign:Prodromal Symptoms 80% of patients complain of pain or

tingling at the site of the bite-reasonably specific

headache, malaise, sore throat and slight fever lasting for 3-4 days

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Widespread excitation and stimulation of Nervous system :

The sensory system, the motor system, the sympathetic and central nervous system

Intolerant to noise, bright light or a cold draught of air (sensory)

Aerophobia (fear of air) may be present Increased reflexes and muscle spasms (motor) Dilatation of the pupils and increased perspiration,

salivation and lacrimation (sympathetic) Mental changes include fear of death, anger, irritability

and depression


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Hydrophobia: This characteristic symptom of hydrophobia

(fear of water) is pathognomonic of rabies and is not characteristic in animals

Duration of illness is 2-3 days (sometimes 5-6 days)

Rabies can be classified as:- Furious or frank rabies Paralytic or dumb rabies


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Diagnosis On the basis of history of bite by a rabid

animal and characteristic signs and symptoms

Confirmation by laboratory tests: antigen detection : immunofluorescence

of skin biopsy Virus isolation from saliva and other

secretions

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Prevention of rabies in human

WHO EXPERT COMMITTEE ON RABIES

Has issued precise recommendation for the management of rabies in a technical report published in 1996

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WHO Recommendations

• Pre-Exposure Vaccination

• Post-Exposure Treatment (PET)

• Post-Exposure Treatment of persons who have been vaccinated previously

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WHO RecommendationsA. Pre Exposure Vaccination:

High risk group: laboratory staff working with rabies virus, veterinarians, pet

owners, animal handlers, wild life officers, sanitation workers, municipal employees working on rabies

control projects such as dog handlers persons who handle rabies patients, medical and para-medical

staff in communicable disease hospitals, naturalists, rural postmen

slaughter house personnel, taxidermists, tannery workers and those who frequently travel in rabies endemic areas should undertake pre-exposure vaccination.

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WHO Recommendations

The advantages of pre-exposure vaccination It prepares immune system to have anaemnestic

response when the actual bite takes place. It will reduce the necessity of immunoglobulin

requirements as the active immunity is triggered immediately.

It will reduce the risk, in case, Post- Exposure Treatment (PET) is delayed due to non-availability of vaccine in remote areas.

It reduces the number of Post-Exposure Treatment doses to three instead of the usual six.

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Dosage Schedule for pre-exposure vaccination three injections of cell culture vaccines

(abhayrab) with a potency of at least 2.5 IU

WHO Recommendations

Continued immune status can be maintained by a booster after one year and there after a booster once in every three years

Day 0 Day 7 Day 28 1 year every 3 years

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Important: Reduces the number of vaccinations(PET)

considerably. High risk groups: Test the antibody titres every six

months. Revaccination is recommended, if the serum antibody titre falls below 0.5 IU/ml.

A rabies vaccination pre-exposure certificate should be obtained by such persons and the following details should be provided in the certificate:-1. Type of vaccine, 2. Origin-The manufacturer, 3. Schedule used along with dates, 4. Batch number, 5. Anti- body titres (if determined)

WHO RecommendationsPre-exposure Vaccination

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WHO Recommendations

B. Post Exposure Treatment (PET)“Factors that should be considered in deciding whether

or not to initiate post-exposure treatment are”: The nature of exposure The presence of reported cases of rabies in the area The species of animal involved The clinical and vaccination status of the biting animal The availability of the animal for observation The results of laboratory testing of the animal, if

available

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Guide For Post-exposure Treatment

Administer vaccine immediately.

Stop treatment, if animal remains healthy throughout an observation period of 10 days or if animal is killed humanely and found to be negative for rabies by appropriate laboratory techniques.

Nibbling of uncovered skin.

Minor scratches or abrasions without bleeding.

Licks on broken skin

II

None, if reliable case history is available.

Touching or feeding animals. Licks on intact skin.

I

Recommended treatment Type of contact with a suspect or confirmed rabid domestic or wild animal or animal unavailable for observation

Category

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Administer rabies immunoglobulin and vaccine immediately.

Stop treatment, if animal remains healthy throughout an observation period of 10 days or if animal is killed humanely and found to be negative for rabies by appropriate laboratory techniques.

Single or multiple transdermal bites or scratches.

Contamination of mucous membrane with saliva (i.e. licks).

III

Recommended treatmentType of contact with a suspect or confirmed rabid domestic or wild animal or animal unavailable for observation

Category

Guide For Post-exposure Treatment

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1. Local Treatment of Wound- First Aid: Animal bite wound should be washed with copious

amount of running water and mild soap immediately

Wound can be cleaned using ethanol, tincture iodine/ aqueous solution of iodine

Suturing of wounds should be avoided Suturing; if at all required: wound should be

infiltrated with rabies immunoglobulin of human or equine origin before suturing

WHO RecommendationsB. Post Exposure Treatment (PET)

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2. Administration of rabies immunoglobulin:• Should be given for all Category III

exposure(severe bites), irrespective of interval between exposure and beginning of treatment

• Human rabies immunoglobulin(HRIG) OR Equine rabies immunoglobulin(ERIG) may be used

• A skin test must be performed prior to the administration of Equine rabies immunoglobin, ERIG

WHO RecommendationsPost Exposure Treatment (PET)

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2. Administration of rabies immnoglobins:• As much as possible , the recommended dose should be

infiltrated around the wounds, if anatomically feasible• The remainder should be administered IM(into gluteal

region ) in a single dose

The WHO recommended dose : 40 IU/kg body weight, for rabies immunoglobulin of equine

origin 20 IU/kg body weight, for immunoglobulin of human origin


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3. Vaccine Administration:(Tissue-Culture) The vaccine used should have a potency of at

least 2.5 IU per dose Intramuscular Schedule One dose of vaccine should be administered on

days 0,3,7,14 , 28 & 90


Day 0 D 3 D 7 D 14 D 28 D 90

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3. Vaccine Administration:(Tissue-Culture)• All intramuscular injections must be given into

deltoid region• In small children, into the anterolateral area of the

thigh muscle• Vaccine should never be administered in the

gluteal region• A certificate of PET should be filled in and given

to each vaccinee


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Pre and Post-Exposure Treatment for Immunocompromised Pateints or cases of delayed treatment

• Day 0:- 2 or 3 doses IM

• No change for other administrations concerning vaccine and RIG

WHO Recommendations

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WHO RecommendationsC. Post-Exposure Treatment of persons who have

been vaccinated previously

Local treatment of wounds should be carried out

Persons who have previously received full pre- or post exposure treatment with a potent cell-culture vaccine

Only two doses are needed (days 0 to 3) No rabies immunoglobulin recommended

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Persons who have previously received full per- or post exposure treatment with vaccine of unproven potency, and/or low anti-body titre (<0.5 IU)

Should receive a complete post-exposure treatment course, including rabies immunoglobin if indicated

WHO RecommendationsC. Post-Exposure Treatment of persons who have

been vaccinated previously

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Composition per single dose:

• Freeze-dried vaccine: One immunizing dose contains the protective activity of equal to or greater than 2.5 International Units (IU) even after exposure at 37 degrees centigrade for one month.

abhayrab-prescribing information

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Composition per single dose:Rabies Virus (L.Pasteur 2061/Vero) propagated on Vero cell line, inactivated with beta-propiolactone(BPL).Thiomersol @ 0.015% added as preservativeMaltose……………………………….q.s. per

immunizing doseHuman Serum Albumin ……………..q.s. per

immunizing dose.Sodium Chloride (0.9%) for Injection I.P.- 0.5 ml.


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INDICATIONS:For active immunization against rabies both for

prophylaxis and post-bite therapy in all age groups of humans

• For prophylactic immunization of all high risk group of persons such as veterinarians, municipal workers, medical and paramedical personnel, forest and zoo personnel, hunters, laboratory personnel working with suspected rabies material and pet owners.

• For immunization against rabies after exposure (after contact with a rabid or suspected rabid animal)

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DOSAGE: Prophylaxis: Three immunizing doses on 0,7

and 28 (21) days followed by one annual booster and subsequently every three years

Post exposure: One immunizing dose on post exposure days 0,3,7,14,28 (30) and 90 each. (Day 0 is the day of first vaccination and not the day of bite.)


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ADMINISTRATION:• Reconstitute the freeze dried vaccine with the

diluent supplied in the ampoule• Administer the reconstituted vaccine (entire

quantity of the vial) by deep intramuscular route in the deltoid region or in small children, into the anterolateral region of the thigh muscle. The reconstituted vaccine should be used immediately and not to be stored for administration later.


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CONTRAINDICATIONS:In principle, there are no contraindications for administering the vaccine as the high risk of death outweighs all other considerations, specially in case of post-bite therapy.

CAUTIONS:• Concurrent use of immunosuppressive agents like

corticosteroids shall be avoided as it may hamper in the development of protective antibodies.

• In case of severe bites, local infiltration of the wounds with antirabies immunoglobulin is recommended.

• Delay in the commencement of post-bite therapy, incomplete and irregular therapy can cause failure of protection.


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STORAGE: To be stored at temperature between 2 to 8 degrees

centigrade. Do not store the vaccine in deep freezer.

PRESENTATION:

• The vaccine is supplied as a single dose vial in a carton and the diluent for reconstitution is supplied separately in ampoules along with syringe & needles.


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Advantages of Vero cell vaccine over Nervous tissue

1. Highly potent and immunogenic2. High titres of antibodies are obtained3. Virtually free of side-effects ; No neuroparalytic

complications4. Lesser number of injections per course, which are

spaced and not given daily5. Dose per injection is also much less – 0.5ml compared to

2 to 5 ml6. No variation in dose according to age or body weight7. Convenient site of inoculation: Deltoid region is

preferred

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8. Sterile disposable syringe or pre-filled syringe are provided with the vaccines

9. Longer shelf life10. Freeze-dried formulation, therefore better

temperature resistant11. Can be used for pre-exposure vaccination12. Immunity lasts up to 3-5 years13. Can be used to immunize patients who develop

allergy to nervous tissue vaccines

Advantages of Vero cell vaccine over Nervous tissue

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Advantages Over PCEC

Relevant abhayrab benefits:• Abhayrab is manufactured using vero cell line as

a substrate and is virtually free of side effects • PVCV is the latest reference vaccines by WHO• Abhayrab is available as single dose vials, which

can be conveniently used by the doctors• Abhayrab is much economical• Abhayrab is an indigenous product and thus offers

assured supplies.• Abhayrab requires only 0.5 ml diluent to be

administered to the patients

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HBI-AbhayrabTechnological Expertise

• Nestled atop the Niligiri hills in Ooty, the ‘state-of-the-art’ vaccine production facility of Human Biologicals Institute is designed strictly as per the WHO norms

• Each batch of Abhayrab goes through a battery of tests at every stage ensuring that the vaccine consistently exceeds all WHO norms for purity, potency and immunogenic activity

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Human Biologicals Institute

Immunity Made Affordable

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Human Biologicals Institute - Lineage

Established by National Dairy Development Board

White revolution and operation flood

Cooperative movement in India

India-largest producer of Milk and milk products in the World

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Division of Indian Immunologicals Limited :-Division of Indian Immunologicals Limited :-

Experience and expertise of two decades in vaccine productionExperience and expertise of two decades in vaccine production

India’s first tissue culture rabies vaccine for veterinary useIndia’s first tissue culture rabies vaccine for veterinary use

Asia’s largest and World’s second largest manufacturers of Asia’s largest and World’s second largest manufacturers of veterinary vaccinesveterinary vaccines

State-of-the-art manufacturing facilities-WHO and ISO-9002 State-of-the-art manufacturing facilities-WHO and ISO-9002 approvedapproved


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An ISO-9002 company

World class manufacturing facilities at Ooty

ISO-9002 and WHO GMP approved

India’s first and most affordable PVRV

World’s second manufacturing facility of PVRV

Capacity to produce 3 million doses of PVRV


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Abhay ClinicAbhay ClinicThe one stop vaccination centre

ObjectiveObjective

To provide quality vaccinationTo provide quality vaccination

To ensure potency and safety of the vaccinesTo ensure potency and safety of the vaccines

To ensure reliable and dependable servicesTo ensure reliable and dependable services

To ensure vaccines are provided under strict cold To ensure vaccines are provided under strict cold chain maintenance systemchain maintenance system

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Nation wide network of vaccination centre for all Nation wide network of vaccination centre for all immunization needsimmunization needs

Range of world class quality, vaccinesRange of world class quality, vaccines

Information nodesInformation nodes

Strict cold chain maintenanceStrict cold chain maintenance

Affordable vaccinationAffordable vaccination

Free antibody titre tests, to guarantee the performance Free antibody titre tests, to guarantee the performance of the vaccineof the vaccine

Only company in world to provide antibody titre tests at Only company in world to provide antibody titre tests at field levelfield level


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abhayrabIndia’s first PVRV


The most affordable anti-rabies vaccine

Rabies abhayrab Rabies-The Fatal Encounter “Prevention is the only solution”

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