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

Hepatitis B Vaccination Schedule and Administration

Standard Vaccination Schedule

All infants should receive their first dose of hepatitis B vaccine within 12 hours of birth, before hospital discharge, followed by doses at 1-2 months and 6 months of age. 1, 2

Infants Born to HBsAg-Positive Mothers

• These infants require both hepatitis B vaccine AND hepatitis B immune globulin (HBIG) 0.5 mL within 12 hours of birth to achieve 85-95% efficacy in preventing chronic HBV carrier state. 3, 4
• Both should be administered intramuscularly at different sites concurrently. 3, 4
• The vaccine schedule is: birth (within 12 hours), 1 month, and 6 months. 3
• Delaying the birth dose beyond 12 hours significantly increases infection risk, and efficacy of HBIG decreases markedly if delayed beyond 48 hours. 1, 4
• Post-vaccination serologic testing (anti-HBs and HBsAg) should be performed 1-2 months after completing the series. 1

Infants Born to HBsAg-Negative Mothers

• First dose should be given at birth (preferably before hospital discharge), second dose at 1-2 months, and third dose at 6 months. 3, 1
• The birth dose can be delayed up to 2 months of age if necessary, though earlier administration is preferred. 3
• Optimal antibody response occurs when the last two doses are spaced at least 4 months apart, though 2-month intervals are acceptable and align with other childhood vaccines. 3

Infants Born to Mothers with Unknown HBsAg Status

• If maternal HBsAg status is unknown at delivery, initiate hepatitis B vaccine within 12 hours using the dose appropriate for infants of HBsAg-positive mothers. 3
• If mother is later found HBsAg-positive, administer HBIG as soon as possible and within 7 days of birth (though efficacy after 48 hours is uncertain). 3
• If HBIG is not given, ensure the second vaccine dose is administered at 1 month and not later than 2 months due to high infection risk. 3

Adolescents and Adults

Standard Adult Schedule

• The standard schedule is 3 doses at 0,1, and 6 months for adults and adolescents. 1, 2, 5
• Alternative 2-dose schedule: Heplisav-B at 0 and 1 month for adults ≥18 years achieves ~90% protective response. 5
• Alternative adolescent schedule: 2 doses of adult formulation Recombivax HB at 0 and 4-6 months for ages 11-15 years. 2

High-Risk Adolescents

• All adolescents who inject drugs or have multiple sex partners (>1 partner per 6 months) should be vaccinated. 3
• Universal vaccination should be implemented in communities with high rates of injection drug use, teen pregnancy, or sexually transmitted diseases. 3

Special Populations

Hemodialysis Patients and Immunocompromised Adults

• Use higher doses: Recombivax HB 40 μg (1.0 mL) in 3-dose schedule OR Engerix-B 40 μg (2.0 mL) in 4-dose schedule at 0,1,2, and 6 months. 1, 2, 5
• Annual anti-HBs testing is recommended with booster doses when levels fall below 10 mIU/mL. 1, 5
• Post-vaccination serologic testing should be performed 1-2 months after series completion. 1

Critical Timing Intervals

• Minimum interval between first and second doses: 4 weeks 1, 2, 5
• Minimum interval between second and third doses: 8 weeks 1, 2, 5
• Minimum interval between first and third doses: 16 weeks 1, 2, 5
• Doses administered ≤4 days before the minimum interval are considered valid. 2

Interrupted Schedules

• If the vaccination schedule is interrupted, do NOT restart the series—simply continue where you left off. 2, 5
• The second dose should be administered as soon as possible, with subsequent doses following minimum interval requirements. 5

Post-Vaccination Testing

Populations Requiring Serologic Testing

• Infants born to HBsAg-positive mothers 1
• Healthcare personnel 1
• Hemodialysis patients 1
• HIV-infected persons 1
• Other immunocompromised persons 1
• Testing should be performed 1-2 months after completing the vaccination series. 1
• Anti-HBs level ≥10 mIU/mL indicates adequate protection. 1

Vaccine Response Rates

• After the first dose, approximately 30-55% of healthy adults <40 years develop protective antibody levels. 5
• After the third dose, >90% of healthy adults <40 years develop protective antibody levels. 5
• Response rates decrease with age: only ~75% of persons aged 60 years achieve protection after a complete series. 5

Common Pitfalls to Avoid

• Do not use standard adult doses in hemodialysis patients—they require higher doses (40 μg). 2
• Do not restart the series if interrupted—continue from where you left off. 2, 5
• Do not delay the birth dose in infants of HBsAg-positive mothers beyond 12 hours—this significantly increases infection risk. 1, 6
• Do not administer doses at shorter-than-recommended intervals, as this may result in suboptimal immune response. 2
• Do not assume serologic testing is required before vaccination—lack of testing should not be a barrier to vaccination. 5