No

Vaccine

For populations desiring protection against hepatitis A or for populations at high risk of exposure to hepatitis A virus (travelers to developing countries, household and sexual contacts of persons infected with hepatitis A), child day care employees, patients with chronic liver disease, illicit drug users, male homosexuals, institutional workers (eg, institutions for the mentally and physically handicapped persons, prisons, etc), and healthcare workers who may be exposed to hepatitis A virus (eg, laboratory employees); protection lasts for approximately 15 years

C

Hypersensitivity to any component of hepatitis A vaccine

Use caution in patients with serious active infection, cardiovascular disease, or pulmonary disorders; treatment for anaphylactic reactions should be immediately available

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.

>10%:

Central nervous system: Headache

Local: Pain, tenderness, and warmth

1% to 10%:

Endocrine & metabolic: Pharyngitis (1.2%)

Gastrointestinal: Abdominal pain (1.2%)

Local: Cutaneous reactions at the injection site (soreness, edema, and redness)

No interference of immunogenicity was reported when mixed with hepatitis B vaccine

As an inactivated virus vaccine, hepatitis A vaccine offers active immunization against hepatitis A virus infection at an effective immune response rate in up to 99% of subjects

Onset of action (protection): 3 weeks after a single dose

Duration: Neutralizing antibodies have persisted for >3 years; unconfirmed evidence indicates that antibody levels may persist for 5-10 years

I.M.:

Children 2-18 years: 720 ELISA units (administered as 2 injections of 360 ELISA units [0.5 mL]) 15-30 days prior to travel with a booster 6-12 months following primary immunization; the deltoid muscle should be used for I.M. injection

Adults: 1440 ELISA units(1 mL) 15-30 days prior to travel with a booster 6-12 months following primary immunization; injection should be in the deltoid

VAQTA®:

Children 2-17 years: 25 units (0.5 mL) with 25 units (0.5 mL) booster to be given 6-18 months after primary immunization

Adults: 50 units (1 mL) with 50 units (1 mL) booster to be given 6 months after primary immunization

Inject I.M. into the deltoid muscle, if possible

Liver function tests

Seroconversion for Havrix®: Antibody >20 milli-international units/mL

No information available to require special precautions

No effects or complications reported

Inform patients of side effects; explain need for booster; patients should report side effects lasting longer than 24 hours

Injection: 360 ELISA units/0.5 mL (0.5 mL); 1440 ELISA units/mL (1 mL)

Injection, pediatric: 720 ELISA units/0.5 mL (0.5 mL)

Injection (VAQTA®): 50 units/mL (1 mL)

Bancroft WH, "Hepatitis A Vaccine," N Engl J Med, 1992, 327(7):453-7.

Koff RS, "Hepatitis A," Lancet, 1998, 351(9116):1643-9.

Lemon SM, "Inactivated Hepatitis A Vaccines," JAMA, 1994, 271(17):1363-4.

Niu MT, Salive M, Krueger C, et al, "Two-Year Review of Hepatitis A Vaccine Safety: Data From the Vaccine Adverse Event Reporting System (VAERS)," Clin Infect Dis, 1998, 26(6):1475-6.