What is the post-exposure prophylaxis (PEP) protocol for a Hepatitis B (HepB) needle stick injury?

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Last updated: June 12, 2025View editorial policy

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From the Guidelines

Post-exposure prophylaxis for Hepatitis B needle stick injuries should be initiated as soon as possible, preferably within 24 hours, with the administration of Hepatitis B vaccine series and Hepatitis B immune globulin (HBIG) for unvaccinated individuals, and a single dose of Hepatitis B vaccine booster for previously vaccinated individuals without documented immunity. For unvaccinated individuals, the Hepatitis B vaccine series (3 doses at 0,1, and 6 months) plus HBIG 0.06 mL/kg IM should be administered as soon as possible, but effective up to 7 days after exposure 1. The protocol for post-exposure prophylaxis is as follows:

  • Unvaccinated individuals: administer Hepatitis B vaccine series and HBIG
  • Previously vaccinated individuals with documented immunity (anti-HBs ≥10 mIU/mL): no treatment is needed
  • Vaccinated individuals without documented immunity: administer one dose of Hepatitis B vaccine booster
  • If the source patient is HBsAg-positive or unknown, unvaccinated persons should receive both HBIG and begin the vaccine series, while previously vaccinated non-responders should receive two doses of HBIG (one month apart) 1. Testing the exposed person for anti-HBs 1-2 months after the last vaccine dose confirms immunity development, which is essential for preventing HBV infection and its complications, such as chronic hepatitis, cirrhosis, and hepatocellular carcinoma 1. The effectiveness of post-exposure prophylaxis diminishes the longer after exposure it is initiated, and the interval is unlikely to exceed 7 days for percutaneous exposures 1. Therefore, prompt initiation of post-exposure prophylaxis is crucial in preventing HBV infection and its associated morbidity and mortality.

From the Research

Post-Exposure Prophylaxis (PEP) for Hepatitis B (HepB) Needle Stick Injury

The PEP protocol for a HepB needle stick injury involves the use of hepatitis B immune globulin (HBIG) and hepatitis B vaccine.

  • HBIG should be administered with a minimum titre of 100 IU/ml, and most preparations contain 500 IU/ml 2.
  • The use of HBIG post-exposure prophylaxis should be limited to needlestick injury, sexual exposure, and perinatal contact of neonates with HBsAg-positive mothers 2.
  • Routine vaccination as an adjunct to HBIG administration is recommended, and HBIG does not decrease the immunogenic properties of the vaccine provided that the injection is not made at the same site 2.

Efficacy of HBIG and Vaccine Combination

Studies have shown that the combination of HBIG and hepatitis B vaccine is efficacious for postexposure immunoprophylaxis of accidental infection 3.

  • A study comparing the protective efficacy of HBIG and vaccine combination with HBIG alone in hemodialysis staff members found that only one (4%) of the 23 vaccinated members contracted hepatitis B virus infection, at a frequency significantly lower than 11 (33%) of the 33 members who did not receive vaccine (p less than 0.02) 3.

Indications for HBIG Administration

The principal indications for administration of HBIG are:

  • A single acute percutaneous exposure to hepatitis B virus (HBV) 4.
  • Mucocutaneous exposure 4.
  • Unprotected sexual exposure 4.
  • Mother-to-infant transmission 4.
  • Prevention of re-infection after liver transplantation 4.
  • Non-responders to hepatitis B vaccine and immunosuppressed patients 4.

Prevention of Type B Hepatitis after Needle-Stick Exposure

Hepatitis B immune globulin (HBIG) has been shown to be effective in preventing type B hepatitis after needle-stick exposure to hepatitis B surface antigen (HBsAG)-positive donors 5.

  • A randomized, double-blind trial found that clinical hepatitis developed in 1.4% of HBIG and in 5.9% of ISG recipients (P = 0.016), and seroconversion (anti-HBs) occurred in 5.6% and 20.7% of them respectively (P less than 0.001) 5.

Professional Medical Disclaimer

This information is intended for healthcare professionals. Any medical decision-making should rely on clinical judgment and independently verified information. The content provided herein does not replace professional discretion and should be considered supplementary to established clinical guidelines. Healthcare providers should verify all information against primary literature and current practice standards before application in patient care. Dr.Oracle assumes no liability for clinical decisions based on this content.

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