Hepatitis b vaccine

Dosage Forms & Strengths

IM suspension (adult formulation)

 10mcg/mL (Recombivax HB)
 20mcg/mL (Engerix B)
 40mcg/mL (Recombivax HB [dialysis formulation])

IM solution
 Adult adjuvanted formulation (Heplisav-B)
 20mcg HBsAg and 3000mcg of CpG 1018 adjuvant per 0.5mL
 physician's discretion MMWR Dec 23, 2011/Vol 60(50);1709-11

Dosing Considerations

Routine immunization against hepatitis B; also protects against

hepatitis D which always occurs in the presence of hepatitis B
Targeted groups that should receive HepB vaccination series include
 Sexually active persons who are not in a long-term, mutually monogamous
relationship persons seeking evaluation or treatment for a sexually
transmitted disease (STD); current or recent injection-drug users; and men
who have sex with men
 Health-care personnel and public-safety workers who are potentially
exposed to blood or other infectious body fluids
 Persons with diabetes, HIV infection, or chronic liver disease
 Persons with end-stage renal disease, including patients receiving
hemodialysis
 Household contacts and sex partners of hepatitis B surface antigen-positive
persons; clients and staff members of institutions for persons with
developmental disabilities; and international travelers to countries with high
or intermediate prevalence of chronic HBV infection
 All adults in the following settings: STD treatment facilities; HIV testing
and treatment facilities; facilities providing drug-abuse treatment and
prevention services; health-care settings targeting services to injection-drug
 users or men who have sex with men; correctional facilities; end-stage renal
disease programs and facilities for chronic hemodialysis patients; and
institutions and nonresidential daycare facilities for persons with
developmental disabilities
 Pregnant women who are at risk for hepatitis B virus infection during
pregnancy (eg, >1 sex partner during the previous 6 months, been evaluated
or treated for a sexually transmitted infection, recent or current injection
drug use, or had an HBsAg-positive sex partner)
 International travelers to regions with high or intermediate levels of
endemic hepatitis B virus infection should receive a HepB series

Adverse Effects
Suspected adverse events after administration of any vaccine may be reported to
Vaccine Adverse Events Reporting System (VAERS)

>10%
Pain (10-29%)
Pruritus (10-29%)
Erythema (10-29%)
Burning (10-29%)
Nodules (10-29%)
Fatigue (15%)
Headache (15%)
Fever (15%)
Vertigo (15%)

1-10%
Lightheadedness
Flushinig
Insomnia
Irritability
Arthralgia
Constipation
Pruritus
Lupus-like syndrome
Lymphadenopathy
Tachycardia
Contraindications

Severe allergic reaction (eg, anaphylaxis) after a previous dose of any hepatitis B
vaccine or to any vaccine component, including yeast

Cautions

Allergic reactions reported; appropriate medical treatment and supervision must

be available to manage possible anaphylactic reactions following administration

Immunocompromised persons, including individuals receiving immunosuppressant

therapy, may have a diminished immune response

Hepatitis B has a long incubation period; immunization may not prevent hepatitis
B infection in individuals who have an unrecognized hepatitis B infection at the
time of vaccine administration

Mechanism of Action

Hepatitis B surface antigen (HBsAg) which stimulates active immunity

Pharmacokinetics

Duration: Not established

Excretion: Not established
These products convey active immunity via stimulation of production of
endogenously produced antibodies
The onset of protection from disease is relatively slow, but duration is long lasting
(years)

Administration
IM Administration
Do not give IV or intradermal
Older children, adolescents, and adults: Administer IM in deltoid muscle
Neonates, infants, and small children: Administer IM in anterolateral thigh