What is the recommended hepatitis B (HBV) vaccination schedule and protocol?

Hepatitis B Vaccination Schedule and Protocol

All infants should receive the first dose of hepatitis B vaccine within 24 hours of birth, followed by a standard 3-dose series at 0,1, and 6 months, which is the most effective schedule for preventing chronic infection and its life-threatening complications including cirrhosis and hepatocellular carcinoma. 1, 2

Universal Infant Vaccination

• The first dose must be administered within 24 hours of birth for all medically stable infants weighing ≥2,000 grams born to HBsAg-negative mothers 1
• For infants born to HBsAg-positive mothers, both hepatitis B vaccine and HBIG (0.5 mL) must be given within 12 hours of birth at separate sites 3
• The complete series includes three doses, with the final dose administered no earlier than 24 weeks (164 days) of age 1, 2
• This early vaccination is critical because infants infected perinatally have a 90% risk of developing chronic hepatitis B infection, and up to 25% will die from chronic liver disease as adults 1

Standard Vaccination Schedules by Population

Children and Adolescents

• Standard schedule: 0,1, and 6 months 4, 2
• Alternative 2-dose schedule for adolescents ages 11-15 years: 0 and 4-6 months using adult formulation of Recombivax HB 2
• Catch-up vaccination should be provided to all unvaccinated children and adolescents at any age 1

Adults (General Population)

• Standard schedule: 0,1, and 6 months 4, 2
• Alternative 4-dose schedule: 0,1,2, and 12 months 2
• For the combined hepatitis A and B vaccine (Twinrix): 3 doses at 0,1, and 6 months, or accelerated 4-dose schedule at days 0,7,21-30, and month 12 4

Hemodialysis Patients

• 4-dose schedule of Engerix-B (higher dose) at 0,1,2, and 6 months 2
• Annual anti-HBs testing is required with booster doses when levels fall below 10 mIU/mL 4, 2
• Vaccinate early in the course of renal disease before dialysis begins, as patients with uremia who are vaccinated before requiring dialysis are more likely to respond 4

Critical Timing Intervals

Minimum intervals that must be respected:

• First to second dose: 4 weeks minimum 4, 2
• Second to third dose: 8 weeks minimum 4, 2
• First to third dose: 16 weeks minimum 4, 2
• Doses administered ≤4 days before the minimum interval are considered valid 4, 2

Who Must Be Vaccinated

Universal Recommendations

• All infants regardless of maternal HBsAg status 4, 1
• All unvaccinated adults at risk for HBV infection 4, 5
• Any person seeking protection from HBV infection, without requiring acknowledgment of specific risk factors 4

High-Risk Adults Requiring Vaccination

• Healthcare personnel and public safety workers with potential blood exposure 4
• Sexually active persons not in long-term mutually monogamous relationships (>1 partner in previous 6 months) 4
• Men who have sex with men 4, 5
• Current or recent injection drug users 4, 5
• Persons with end-stage renal disease including hemodialysis patients 4, 5
• Persons with chronic liver disease 4, 5
• Persons with HIV infection 4, 5
• Persons with diabetes younger than 60 years 4
• Household contacts and sex partners of HBsAg-positive persons 4, 5
• International travelers to HBV-endemic regions (>6 months stay or shorter stays with blood/sexual contact risk) 4
• Incarcerated persons 4, 5
• Pregnant women at risk 5

Managing Interrupted Schedules

If the vaccination schedule is interrupted, do NOT restart the series—simply continue where you left off 4, 2

• If interrupted after the first dose, give the second dose as soon as possible, then give the third dose at least 8 weeks after the second 4
• If only the third dose is delayed, administer it as soon as possible 4
• Inadequate doses or doses given at shorter-than-recommended intervals must be readministered using correct dosage and schedule 4

Postvaccination Serologic Testing

Testing for anti-HBs 1-2 months after completing the series is required for:

• Infants born to HBsAg-positive mothers 4
• Healthcare personnel and public safety workers 4
• Hemodialysis patients 4
• HIV-infected persons 4
• Other immunocompromised persons (e.g., hematopoietic stem-cell transplant recipients, persons receiving chemotherapy) 4
• Sex partners of HBsAg-positive persons 4

Common Pitfalls to Avoid

• Do not restart the series if interrupted—this wastes doses and delays protection 4, 2
• Do not use standard adult doses in hemodialysis patients—they require higher doses and more frequent monitoring 2
• Do not administer doses at shorter-than-recommended intervals—this results in suboptimal immune response and invalid doses that must be repeated 4, 2
• Do not delay the birth dose beyond 24 hours in infants born to HBsAg-negative mothers—early vaccination is critical for preventing perinatal and early childhood transmission 1
• Do not wait beyond 12 hours for infants born to HBsAg-positive mothers—efficacy of HBIG decreases markedly if delayed beyond 48 hours 3
• Do not require acknowledgment of specific risk factors before vaccinating adults—many infected persons have no identifiable risk factors, and universal vaccination is more effective than targeted strategies 4, 1