BCG Madhav short talk

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BCG vaccine


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BCG VACCINE Dr. Madhav Thakur Dr. Sheetu Jailkhani M.D. Community Medicine GMC, Miraj , Maharashtra.


CONTENTS History Description of BCG AIM of vaccination BCG Vaccine- Development - Types of Vaccine strains - Types of Vaccines - Storage & Reconstitution - Vaccine stability - Indications - Dosage - Route of administration - Phenomena after vaccination

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What is direct BCG vaccination? Results of vaccination. Duration of immunity. Adverse effects Contraindications Safety Other uses of BCG Strengths & weakness of BCG Other anti TB vaccines.


HISTORY M. bovis Isolated by Nocardia -1902 BCG developed from serial passage of virulent M. bovis strain-1908 to 1921 First human BCG vaccination-1921 in Paris (Oral) League of nations adopts BCG as standard vaccine-1928

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Lubeck disaster: 72 children die from oral BCG preparation contaminated with virulent strain- 1929 -1930. First human vaccinated by intradermal technique- 1927. Multiple puncture technique-1939 Scarification technique-1947

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First international BCG congress concluded-BCG is effective-1948 In India, first intradermal vaccine - Madanapalle in South India in 1948. Mass BCG vaccination campaign in 1951.


DEVELOPMENT OF BCG BCG developed by- Two French scientist Calmette ( Physician) & Guerin ( Veterinarian). Strain used- M. bovis . (1908) The isolate was cultured in medium containing glycerol, potato slices & beef bile. Organism was subcultured every 3 weeks for 13 years for 230 cycles.

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Two types of strains- 1. Strong - Pasteur 1173 P 2 & Danish(Copenhagen) 1331. 2. Weak - Glaxo 1077 & Tokyo 172. Strong strains are more immunogenic, induce greater degree of cutaneous hypersensitivity, local granuloma formation, residual virulence & better protection.

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BCG vaccine is manufactured at BCG laboratory at Guindy, Chennai since 1948. Quality control is ensured by the international reference centre at Copenhagen. Danish 1331 strain is being used since 1966. Included in EPI vaccination schedule- 1974


AIM T o induce a benign artificial primary infection with attenuated tubercle bacilli, and thus reduce the morbidity and mortality from primary tuberculosis among those most at risk.


BCG VACCINE Type - Live Attenuated Bacterial Vaccine. WHO recommends - Danish 1331 (bovine strain). Two types of vaccines- Liquid ( Fresh) vaccine. Freeze dried vaccine ( Stable)

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Storage - away from direct light. 0 to +8º C (at all levels of the cold chain.) Reconstituent - Normal Saline. Distilled water is hypotonic and may cause rupture of bacterial cells- so not used - Reconstituted vaccine must be used within 3 hrs.


VACCINE STABILITY Any change in manufacturing procedure should be accompanied by field trials in Tuberculin negative humans to determine the optimal content of BCG bacilli. Study should be carried out in children on at least one batch of vaccine per year. Extent of local reaction to BCG vaccination is proportional to Total bacterial mass.

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Level of Tuberculin sensitivity induced is related to number of viable particles. Test for number of viable bacilli- 1) Colony growth in media. 2) Measurement of Bioluminescence. Other tests- Test of - Identity - contamination - Safety.


INDICATIONS: WHO recommends single dose in Infancy. According to IAP BCG can be given upto 5 yrs. Repeat vaccine can be given if absence of scar or lack of tuberculin sensitivity. Routine BCG vaccination is not recommended in countries like USA & Netherlands.

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WHO recommends BCG Vaccination to asymptomatic HIV infected infants who live in high risk areas of TB. GACVS- Advices WHO to change its recommendation – such that not to immunize HIV-infected, with BCG even if asymptomatic, BCG Vaccination is not recommended to symptomatic HIV infected infants.


DOSAGE Dose differs by vaccine strain and age of recipient. protective effect & adverse effect depends on total mass of organism & viable bacilli count in the vaccine. Up to 1 month-0.05ml. >1 month up to 1 yr -0.1ml (0.1mg) 1×10 6 - 33×10 6 CFU per ml


ROUTE OF ADMINISTRATION Most accurate route is- Intradermal. Other route- Percutaneous with multipuncture device. (Japan ). Most common site- Deltoid region of left arm. Other sites- Thigh, Forearm Tuberculin syringe (26 gauge Omega microstat syringe, 0.1ml)

Why Intradermal route is favoured?:

Why Intradermal route is favoured ? Oral vaccination required larger doses of BCG (e.g. from10 mg to 300 mg.) Difficult to control the effective dose with oral administration. Intradermal injection is more efficient at inducing tuberculin conversion Cervical lymphadenopathy attributed to oral administration.

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Methods of Administration Intradermal injection (WHO recommended) Method of choice. Introduced in 1927. SITE is the lower deltoid area - to involve the axillary instead of the upper clavicular lymph nodes-to minimize complications from post-vaccination lymphadenopathy . Multiple puncture with 20-point Heaf gun applied two times* Large volume of vaccine required, and it is operationally difficult. Multiple puncture with bifurcated needle applied 20 times* Inferior to intradermal vaccine * Not recommended by WHO.

Phenomena after vaccination :

Phenomena after vaccination Intradermal BCG injection 5 mm wheal (Immediately) 2-3wks Papule 5 wks 4-8 mm Papule Shallow Ulcer covered with crust 6- 12 wks Healing with permanent tiny round scar ( 4-8 mm) 8-14 wks Mantoux test positive

What is direct BCG vaccination?:

What is direct BCG vaccination? Vaccination without a prior Tuberculin test. It permits rapid & complete coverage of eligible population. Reduces cost. No adverse effects even if BCG is given to Tuberculin positive reactors.

Benefits of vaccination::

Benefits of vaccination: Protection against most serious forms of disease like Meningitis and disseminated disease. BCG vaccination prevents massive lympho-haematogenous dissemination.

Protective efficacy of BCG against various clinical forms of tuberculosis. (Myint et al. 1987).:

Protective efficacy of BCG against various clinical forms of tuberculosis. (Myint et al. 1987). Clinical form of tuberculosis Protective efficacy (%) Clinical form of tuberculosis of BCG Primary complex formed in the lung 20 Primary complex with local extension 32 Lymphadenitis 32 Tuberculosis of the bone 39 Tubercular meningitis 52 Disseminated tuberculosis 80


DURATION OF IMMUNITY BCG-induced immunity develops about six weeks after vaccination. Protection - 15-20 years of vaccination. Efficacy- 0-80 %


ADVERSE EFFECTS Complications Local subcutaneous abscess Most common Prolonged severe Ulceration Regional lymphadenopathy Axillary , Cervical, Supraclavicular . ( Ipsilateral side) Musculoskelatal lesions Osteomyelitis Multiple lymphadenitis Non fatal disseminated lesions Fatal disseminated lesions Immuno -suppressed Individuals.




CONTRAINDICATIONS: Immunodeficiency (symptomatic HIV infected infants, Leukemia, lymphoma, congenital immunodeficiency etc.) Pts on immunosuppressive T/t. Pregnancy. Hypogammaglobulinemia Generalized eczema Infective dermatosis.


SAFETY OF BCG Complications are rare & depends on- - Skill & method of administration. - Type, Strength & Dose of vaccine. - Age & immune status of vaccinee. - Local reactions & abscesses are more common in women & older children.

Other uses of BCG:

Other uses of BCG BCG vaccination also protects against - Leprosy. (50% protection) -Lymphadenitis. (M. Avium complex) - Buruli’s ulcer  (M.ulcerans) Immune- modulating agent (in nephrotic syndrome) Urinary Bladder cancer

Does TB spreads through ulcerated lesion of vaccination?:

Does TB spreads through ulcerated lesion of vaccination? It would be unusual for TB bacilli to become airborne from ulcerated site.

When to shift from routine universal BCG vaccination to selective vaccination of high risk group?:

When to shift from routine universal BCG vaccination to selective vaccination of high risk group? Efficient notification system Low endemicity criteria- 1. Average annual notification rate of smear positive pulmonary TB cases below 5 per 1 lakh. or

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2. Average annual notification rate of TB Meningitis in children aged < 5 yrs below 1 per 10 Million during previous 5 yrs or, 3. Average annual risk of Tb infection below 0.1 %.


STRENGTHS Effective against disseminated forms of disease Long track record of safety Low cost Heat stable in a freeze dried form Scar indicates a dose received Positive effect on control of other diseases No alternative vaccine available


WEAKNESSES Difficult route of administration, especially in infants. Needs special route (intradermal), special syringe and needle and special dose (0.5ml for neonates and 0.1ml for older children and adults) Uncertain protection against adult disease Significance of 'no scar' remains uncertain


Continued…. Frequent mild side effects Concern in HIV - infected areas Problems related to reconstitution and potential for unsafe injection practices Fragile vaccine supply Difficulties with quality control

Other Anti TB vaccines:

Other Anti TB vaccines Vole vaccine- R 1 V 1 - derived from an attenuated strain of M. tuberculosis. H 37 Ra-mutant strain of M. Tuberculosis. INH Resistant vaccine Plasmid DNA vector based vaccine Recombinant & Mutant BCG vaccines. Subunit Vaccines- Mycobacterial protein antigens


References Vaccines. Plotkin & Orenstein.4 th Edi.2004. Chapter 12, BCG. . 179-210. Essentials of TB in children, Vimlesh seth & S K Kabra.2 nd Edi. 371-381. BCG Complications, epidemiology & management. James Nuttal . Paediatric infectious disease unit. Red cross childrens hospital, University of cape town 2009. Indian Journal for the Practicing Doctor. BCG (Bacillus Calmette Guerin). Rehana Kausar , MD Vol. 2, No. 3 (2005-08). Safe vaccine handling, cold chain and Immunizations. A manual for the newly independent states. Global programme for vaccines and immunization.Expanded programme on immunization . World health organization, Geneva, 1998. The immunological basis for immunization series. Module 5:tuberculosis. Global programe for vaccines and immunization. Expanded programe on immunization. Dr Julie Milstien . Scientist, Biologicals Unit. WHO .Geneva 1993.

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