No

Vaccine

Immunization against infection caused by all known subtypes of hepatitis B virus, in individuals considered at high risk of potential exposure to hepatitis B virus or HB_sAg-positive materials; see list below.

Health care workers*

• Special patient groups (eg, adolescents, infants born to HB_sAg-positive mothers, military personnel, etc): Hemodialysis patients**, recipients of certain blood products***
• Lifestyle factors: Homosexual and bisexual men, intravenous drug abusers, heterosexually active persons with multiple sexual partners or recently acquired sexually transmitted diseases
• Environmental factors: Household and sexual contacts of HBV carriers, prison inmates, clients and staff of institutions for the mentally handicapped, residents, immigrants and refugees from areas with endemic HBV infection, international travelers at increased risk of acquiring HBV infection

*The risk of hepatitis B virus (HBV) infection for health care workers varies both between hospitals and within hospitals. Hepatitis B vaccination is recommended for all health care workers with blood exposure.

**Hemodialysis patients often respond poorly to hepatitis B vaccination; higher vaccine doses or increased number of doses are required. A special formulation of one vaccine is now available for such persons (Recombivax HB®, 40 mcg/mL). The anti-Hb_s (antibody to hepatitis B surface antigen) response of such persons should be tested after they are vaccinated, and those who have not responded should be revaccinated with 1-3 additional doses.

Patients with chronic renal disease should be vaccinated as early as possible, ideally before they require hemodialysis. In addition, their anti-HB_s levels should be monitored at 6-12 month intervals to assess the need for revaccination.

***Patients with hemophilia should be immunized subcutaneously, not intramuscularly.

C

Hypersensitivity to yeast, hypersensitivity to hepatitis B vaccine or any component

All serious adverse reactions must be reported to the U.S. Department of Health and Human Services (DHHS) Vaccine Adverse Event Reporting System (VAERS) 1-800-822-7967.

Central nervous system: Fever, malaise, fatigue (14%), headache

Local: Mild local tenderness (22%), local inflammatory reaction

1% to 10%:

Gastrointestinal: Nausea, vomiting

Respiratory: Pharyngitis

<1%: Tachycardia, hypotension, sensation of warmth, flushing, lightheadedness, chills, somnolence, insomnia, irritability, agitation, pruritus, rash, erythema, urticaria, GI disturbances, constipation, abdominal cramps, dyspepsia, anorexia, dysuria, arthralgia, myalgia, stiffness in back/neck/arm or shoulder, earache, rhinitis, cough, epistaxis, diaphoresis

Decreased effect: Immunosuppressive agents

Refrigerate, do not freeze

Recombinant hepatitis B vaccine is a noninfectious subunit viral vaccine. The vaccine is derived from hepatitis B surface antigen (HB_sAg) produced through recombinant DNA techniques from yeast cells. The portion of the hepatitis B gene which codes for HB_sAg is cloned into yeast which is then cultured to produce hepatitis B vaccine.

Duration of action: Following all 3 doses of hepatitis B vaccine, immunity will last approximately 5-7 years

Routine Immunization Regimen of Three I.M. Hepatitis B Vaccine Doses, by product/age:

Recombivax HB®

Birth* to 10 years: Initial dose 0.25 mL**; repeat in 1 month and 6 months

11-19 years: Initial dose 0.5 mL; repeat in 1 month and 6 months

greater than or equal to 20 years: Initial dose 1 mL; repeat in 1 month and 6 months

Energix-B®

Birth* to 10 years: Initial dose 0.5 mL; repeat in 1 month and 6 months

11-19 y: Initial dose 1 mL; repeat in 1 month and 6 months

greater than or equal to 20 y: Initial dose 1 mL; repeat in 1 month and 6 months

Dialysis or immunocompromised patients: Initial dose 2 mL***; repeat in 1 month and 6 months

*Infants born of HB_sAg, negative mothers

**0.5 mL of the 5 mcg/0.5 mL (adolescent/high-risk infant) product or 0.5 mL of the 25 mcg/0.5 mL pediatric formulation

***Two 1 mL doses given at different sites.

Postexposure prophylaxis recommended dosage for infants born to HB_sAg-Positive mothers, by product/age:

Engerix-B® (pediatric product dose 10 mcg/0.5 mL):

Give 0.5 mL within 7 days. Alternately, the first dose may be given at birth at the same time as HBIG, but give in the opposite anterolateral thigh. This may better ensure vaccine absorption.

Repeat 0.5 mL at 1 month and 6 months.

Recombivax HB® (high-risk infant product dose 5 mcg/0.5 mL):

Give 0.25 mL within 7 days, or 0.5 mL of the pediatric product (0.25 mcg/0.5 mL). Alternately, the first dose may be given at birth at the same time as HBIG, but give in the opposite anterolateral thigh. This may better ensure vaccine absorption.

Repeat 0.25 mL at 1 month and 6 months, or with 0.5 mL if using the pediatric product (0.25 mcg/0.5 mL)

Hepatitis B immune globulin:

Give 0.5 mL at birth

Note: An alternate regimen is administration of the vaccine at birth, within 7 days of birth, and 1, 2, and 12 months later.

Dialysis regimen: Use Recombivax HB® formulation (40 mcg/mL); initial: 40 mcg/mL, then at 1 and 6 months; revaccination: if anti-HB_s <10 mIU/mL greater than or equal to 1-2 months after 3rd dose

It is possible to interchange the vaccines for completion of a series or for booster doses; the antibody produced in response to each type of vaccine is comparable, however, the quantity of the vaccine will vary

No information available to require special precautions

No effects or complications reported

Must complete full course of injections for adequate immunization

Rare chance of anaphylactoid reaction; have epinephrine available

Injection:

Pediatric formulation: Hepatitis B surface antigen 10 mcg/0.5 mL (0.5 mL)

Adult formulation: Hepatitis B surface antigen 20 mcg/mL (1 mL)

Recombinant DNA (Recombivax HB®):

Pediatric formulation: Hepatitis B surface antigen 2.5 mg/0.5 mL (0.5 mL/3 mL)

Adolescent/high-risk infant formulation: Hepatitis B surface antigen 5 mcg/0.5 mL (0.5 mL)

Adult formulation: Hepatitis B surface antigen 10 mcg/mL (1 mL, 3 mL)

Dialysis formulation, recombinant DNA: Hepatitis B surface antigen 40 mcg/mL (1 mL)

Gardner P and Schaffner W, "Immunization of Adults," N Engl J Med, 1993, 328(17):1252-8.