hepatitis B Protocol for Neonatal Prophylaxis

Disclaimer to the Online Edition

This Manual has been designed for use in the NICU at London Health Sciences Centre (LHSC), London, Ontario, Canada, and represents clinical practice at this institution. The information contained within the Manual may not be applicable to other centres. If users of this Manual are not familiar with a drug, it is recommended that the official monograph be consulted before it is prescribed and administered. Any user of this information is advised that the contributors, Editor and LHSC are not responsible for any errors or omissions, and / or any consequences arising from the use of the information in this Manual.

hepatitis B Protocol for Neonatal Prophylaxis

Purpose

  • To provide guidelines for Medical, Nursing, Laboratory and Pharmacy staff working in Maternal Child units, in the administration of:
    1. Hepatitis B Immune Globulin (HBIG)
    2. Hepatitis B Vaccine (Recombinant)

Policy

  • Hepatitis B Immunoprophylaxis Scheme by Infant Birth Weight 

Maternal Status

Birth Weight > 2kg

Birth Weight < 2kg

HBsAg Positive

 

Hepatitis B vaccine + HBIG (both within 12 h of birth)

Hepatitis B vaccine + HBIG (both within 12 h of birth)


Immunize with 4 vaccine doses; do not count birth dose as part of vaccine series

HBsAg status UNKNOWNTest mother for HBsAg immediately after admission for delivery
Hepatitis B vaccine (within 12 h of birth)
Administer HBIG (within 7 days) if mother tests HBsAg positive; if mother’s HBsAg status remains unknown, some experts would administer HBIG (within 7 days)

Test mother for HBsAg immediately after admission for delivery
Hepatitis B vaccine (within 12 h of birth)
Administer HBIG if mother tests HBsAg positive or if mother’s HBsAg result is not available within 12 h of birth


Immunize with 4 vaccine doses; do not count birth dose as part of vaccine series

  • This table is based on the “Red Book”, the 2009 report of the Committee on Infectious Diseases”, and only reflects initial doses. The most recent “Red Book” should always be consulted for complete dosing schedules and serology testing.

Recommended Dosage

  • Hepatitis B Immune Globulin (HBIG) 0.5 mL, IM
  • Hepatitis B Vaccine (Recombinant) 5mcg (0.5mL)*, IM
    • This Hepatitis B Vaccine dosage applies specifically to recombivax-hb(R)
    • The dose of the other commercially available product (Engerix – B (R)) is also 0.5 mL; however, the concentration is 10 mcg / 0.5 mL.
  • IM injections are preferably administered in the anterolateral aspects of the upper thigh in infants and neonates. Hepatitis B Vaccine and Hepatitis B Immune Globulin may be administered simultaneously but must be given at separate sites.
  • Blood Tissue Fluid Precautions, as per Infection Control Manual, are instituted for mother and newborn, who are Hepatitis B Antigen-positive.

Procedure

  1. Check chart on admission to the Nursery for documentation of Hepatitis B screening of Mothers. Universal screening of all pregnant women is the standard of practice in Ontario. If the maternal status is unknown, Hepatitis B Antigen status is to be identified
  2. Follow steps #4 through #6 if mother is Hepatitis B Antigen positive
  3. Contact the mother's attending physician for confirmation/clarification, and/or attending physician's orders, if there is no evidence of Hepatitis B Screening prenatally
  4. Contact the infant's attending physician immediately if the mother has a positive Hepatitis B screen, and obtain orders for Hepatitis B Immune Globulin, and Hepatitis B Vaccine (Recombinant)
  5. Contact Blood Bank (Extension. 64264) for Hepatitis B Immune Globulin (HBIG)
  6. Obtain Hepatitis B Vaccine (Recombinant) by FAXING a copy of the Physician's order to the Pharmacy. The vaccine will then be delivered on the next Pharmacy delivery, or if needed more urgently, the vaccine may be picked up directly from Pharmacy on receipt of a physician's order.

Administer

  • Hepatitis B Immune Globulin (HBIG) 0.5 mL intramuscularly in anterolateral thigh of one leg
  • Hepatitis B Vaccine (Recombinant) 0.5 mL (5 mcg) intramuscularly in the anterolateral thigh of the other leg. (Hepatitis B Vaccine (Recombinant) and HBIG MUST be administered at separate injection sites, if given at the same time.)
    • Record on Medication Profile stating the injection sites of each product. Also record the LOT # of each product
    • Report all Hepatitis B Vaccine injections to the Public Health Liaison Nurse
  • High fever and serious local or systemic reactions temporally associated with injection must be reported to the medical officer of health (Middlesex-London Public Health Unit (519) 663-5317)
  • The family physician should be notified that the Vaccine must be repeated at 1 and 6 months of age, and that testing for anti-HBs should be conducted at 9 to 18 months of age
References
  1. Ecombivax-HB Brochure (Date of Preparation: January 23, 1992)
  2. Hyper Hep Brochure (Rev. June 1994)
  3. Red Book : 2009 Report of the Committee on Infectious Diseases. 28th ed. Elk Grove Village, IL: American Academy of Pediatrics; 2009 : 347-9