Bacille Calmette Guérin

(BCG) & Hepatitis B

Vaccination
Michael Jay Linebarger
 Bacille Calmette Guérin
Vaccination
• Vaccine against tuberculosis
• Strain of M. bovis
• Attenuated by subculture every 3 wk for 13 yr  many
BCG vaccines that differ widely in:
• Morphology,
• Growth characteristics
• Sensitizing potency
• Animal virulence
 BCG: Route of
Administration
• Intradermal injection with a syringe and needle
• Only method that permits accurate measurement of an
individual dose
 BCG Vaccine Schedule
• Vary widely among countries

• WHO: single dose administered during infancy, in

populations where the risk of tuberculosis is high
 National Immunization
Program
• BCG single dose given at birth

• Dose
• 0.05 ml for children < 12 months of age
• 0.1 ml for children > 12 months of age
• Given at the earliest possible age after birth preferably
within the first 2 months of age
 National Immunization
Program
• PPD is recommended prior to BCG vaccination if
any of the following is present:
• Suspected congenital TB
• History of close contact to known or suspected
infectious cases
• Clinical findings suggestive of TB and/or chest x-ray
suggestive of TB

• Induration of > 5mm is considered positive

 BCG: Efficacy
• Published meta-analysis
• 50% effective in preventing pulmonary tuberculosis
• 50-80% effective in preventing disseminated and meningeal
tuberculosis

• Little effect on the ultimate control of tuberculosis

throughout the world
• Best use of BCG vaccine
• Prevent life-threatening forms of tuberculosis in infants and
young children
 BCG: Adverse Reaction
• Extremely safe in immunocompetent hosts

• Local ulceration & regional suppurative adenitis

• 0.1-1%

• Mild and usually resolve spontaneously

• Osteitis – Rare complication

• Related to certain strains of the vaccine
 BCG: Adverse effects
• Systemic complaints – fever convulsions, loss of
appetite, and irritability
• Extraordinarily rare

• Immunocompromised patients  disseminated

BCG infection after vaccination

• Pregnancy – further studies are needed to prove its

safety
 Hepatitis B Vaccination
• Recombinant vaccine:
• Produced by inserting a plasmid containing the gene for
HBsAg into common baker’s yeast (Saccharomyces
cerevisiae)
• Yeast cells then produce HBsAg, which is harvested
and purified
• The recombinant vaccine contains:
• More than 95% HBsAg protein (5 to 40 mcg/mL)
• Yeast-derived proteins may constitute up to 5% of the
final product
• But no yeast DNA is detectable in the vaccine.
Recombivax HB and Engerix-
B
• The two single-antigen vaccines are approved for
children

• The only preparations approved for infants younger

than age 6 mo.
 HBV Vaccine: Dose
• IM suspension (pediatric/adolescent formulations)
• 5mcg/0.5mL (Recombivax HB)
• 10mcg/0.5mL (Engerix B)
 Routine Vaccination
• First dose: given at birth or within the 1st 12 hours of
life

• Minimum interval between doses is 4 weeks

• Final dose is administered not earlier than 24 weeks

• Another dose is needed if the last dose was given at

age < 24 weeks
For preterm infants:

• If born to HBsAg (-) mothers, medically stable, 1st dose given at 30 days
regardless of weight

• Another dose of HBV is needed for those < 2 kgs whose 1st dose was
received at birth

For infants born to HBsAg (+) mothers

• administer HBV and HBIG (0.5ml) within 12 hours of life

• HBIG should be administered not later than 7 days if not immediately

available
For infants born to mothers with unknown status:

• With birth weight ≥ 2 kgs, administer HBV within 12

hours of birth
• Determine mother’s HBsAg as soon as possible.
• If HBsAg (+), administer HBIG not later than 7 days of age

• With birth weight < 2 kgs, administer HBIG in addition

to HBV within 12 hours of life
 Catch-up Vaccination
• Unvaccinated children should complete a 3-dose
series

• Children aged 11-15 years: 2-dose series (doses

separated by at least 4 months) of adult formulation
Recombivax HB is licensed for use in children aged
11 through 15 years
 Contraindications and
Precaution
• History of hypersensitivity to yeast
• Moderate or severe illness
deferred until illness resolves

• Not contraindicated
• Multiple sclerosis
• Guillain-Barré syndrome
• Autoimmune diseases
• Other chronic diseases
• Pregnancy
HBV Vaccine: Adverse Effects

• Excellent safety profile

• Pain at the injection site (up to 29%)

• Fever (up to 6%)

• Anaphylaxis – one case per 1.1 million doses

Vaccine Storage and Handling

• HepB vaccine should be maintained at refrigerator

temperature between 35°F and 46°F (2°C and 8°C).
 Sources
• Nelson Textbook of Pediatrics 20th Edition

• Epidemiology and Prevention of Vaccine-

Preventable Diseases 13th Edition

• Department of Health: Expanded Program on

Immunization