hepatitis B vaccine

Hepatitis B vaccine is an inactivated viral vaccine administered intramuscularly to provide protection against infection from all subtypes of hepatitis B virus. Hepatitis B virus is transmitted in body fluids and causes severe liver infection, which may become chronic in some people. Hepatitis B vaccine stimulates the production of natural antibodies to hepatitis B virus by introducing a tiny amount of harmless, dead viral particles, without causing an infection.

Hepatitis B vaccines contain purified surface antigens of the hepatitis B virus (HbsAg), mostly cultured in yeast cells, except for the PreHevbrio brand which is cultured in Chinese hamster ovary cells. Surface antigens are protein particles on the surface of the viruses which enable them to hold on to a human cell, enter inside and replicate.

Once vaccinated, the body’s immune system recognizes the surface antigens when exposed to the hepatitis B virus and produces antibodies to the surface antigens, preventing the virus from entering and infecting the cells. Hepatitis B vaccine also contains substances that preserve and stabilize the vaccine, and enhance immune response.

• Do not administer hepatitis B vaccine to individuals who had a severe allergic reaction (anaphylaxis) after a previous dose of any hepatitis B vaccine or to any vaccine component, including yeast
• There have been reports of allergic reactions to hepatitis B vaccine; appropriate medical treatment and supervision must be available to manage possible severe allergic (anaphylactic) reactions to the vaccination
• People with compromised immune systems, including individuals receiving immunosuppressant therapy, may have a reduced immune response
• Hepatitis B has a long incubation period; hepatitis B vaccination may not prevent hepatitis B infection in individuals who have an unrecognized hepatitis B infection at the time of vaccine administration

Common side effects of hepatitis B vaccine include:

• Injection site reactions including
  • Pain
  • Itching (pruritus)
  • Redness (erythema)
  • Tenderness
  • Burning sensation
  • Bruising
  • Nodule formation
  • Hardening of tissue (induration)
  • Warmth
  • Swelling
• Weakness
• Fatigue
• Headache
• Dizziness
• Feeling unwell (malaise)
• Fever
• Muscle pain (myalgia)
• Nausea
• Diarrhea
• Upper respiratory infection
• Throat inflammation (pharyngitis)

Less common side effects of hepatitis B vaccine include:

• Vertigo
• Prickling or tingling sensation (paresthesia)
• Lightheadedness
• Flushing
• Sweating
• Low blood pressure (hypotension)
• Chills
• Vomiting
• Abdominal pains or cramps
• Indigestion (dyspepsia)
• Constipation
• Reduced appetite
• Nasal inflammation (rhinitis)
• Cough
• Influenza
• Rash
• Hives (urticaria)
• Itching (pruritus)
• Swelling of the tissue under the skin and mucous membranes (angioedema)
• Insomnia
• Disturbed sleep
• Drowsiness (somnolence)
• Agitation
• Irritability
• Earache
• Swelling of lymph nodes (lymphadenopathy)
• Painful urination (dysuria)
• Joint pain (arthralgia)
• Neck pain and stiffness
• Shoulder pain
• Back pain

Rare side effects of hepatitis B vaccine may include:

• Severe allergic reactions including:
  • Bronchospasm
  • Anaphylaxis
• Severe skin reactions including:
  • Erythema multiforme
  • Erythema nodosum
  • Stevens-Johnson syndrome
• Onset or exacerbation of autoimmune conditions such as:
  • Systemic lupus erythematosus (SLE)
  • Lupus-like syndrome
  • Blood vessel inflammation (vasculitis)
  • Inflammation of arteries (polyarteritis nodosa)
• Nervous system disorders including:
  • Onset or exacerbation of multiple sclerosis
  • Guillain-Barre syndrome
  • Shingles (herpes zoster)
  • Peripheral neuropathy
  • Migraine
  • Brain inflammation (encephalitis)
  • Seizures
• Visual disturbances
• Eye inflammations
• Fainting (syncope)
• Rapid heart rate (tachycardia)
• Increased erythrocyte sedimentation rate (ESR)
• Low platelet count (thrombocytopenia)
• This is not a complete list of all side effects or adverse reactions that may occur from the use of this drug.

Call your doctor for medical advice about serious side effects or adverse reactions. You may also report side effects or health problems to the FDA at 1-800-FDA-1088.

Adult:

IM suspension, 3-antigen

• 10mcg/mL (PreHevbrio)

IM suspension, single-antigen (adult formulation)

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

IM solution, single-antigen

• 20mcg HBsAg and 3000mcg of CpG 1018 adjuvant per 0.5mL (Heplisav-B)

Hepatitis B Immunization

3-dose series

• Engerix B: 1 mL (20 mcg) IM at 0, 1, and 6 months
• Recombivax HB: 1 mL (10 mcg) IM at 0, 1, and 6 months
• PreHevbrio: 1 mL IM at 0, 1, and 6 months
• Heplisav-B: Can be used as a substitute in a 3-dose series with a different hepatitis B vaccine

2-dose series

• Heplisav-B (18 years or older): 0.5 mL IM at 0 and 1 month

Adults with diabetes mellitus

• CDC ACIP guidelines recommends immunization with hepatitis B vaccine for all unvaccinated adults with diabetes mellitus through age 59 years
• Persons with diabetes are at increased risk of hepatitis B infection
• Vaccinate diabetics aged ≥60 yr at the discretion of the treating clinician, based on increased need for assisted blood glucose monitoring in long-term care facilities, likelihood of acquiring hepatitis B infection, its complications or chronic sequelae, and likelihood of immune response to vaccination
• Vaccination for older unvaccinated diabetic patients may be done at the physician's discretion MMWR Dec 23, 2011/Vol 60(50);1709-11

Dosage Modifications

Adults receiving dialysis or other immunocompromising conditions

Engerix B or Recombivax HB

• Primary immunization consists of a series of 4 doses (40 mcg) at 0, 1, 2, and 6 months
• Antibody response is lower in patients on hemodialysis compare with healthy persons and protection may persist only as long as antibody levels remain above 10 mIU/mL
• Assess need for booster doses by annual antibody testing
• Administer 2-mL booster dose for antibody levels <10 mIU/mL

Dosing Considerations

• Routine immunization against hepatitis B; also protects against hepatitis D which always occurs in the presence of hepatitis B
• Single-antigen vaccines: Engerix B, Heplisav-B (adjuvanted), Recombivax HB
• 3-antigen vaccine: PreHevbrio

Targeted groups that should receive hepatitis B 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 (e.g., more than 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 hepatitis B series

Pediatric:

IM suspension (pediatric/adolescent formulations)

• 5mcg/0.5mL (Recombivax HB)
• 10mcg/0.5mL (Engerix B)

Hepatitis B Immunization

Primary immunization

First dose

• Medically stable infants weighing 2,000 grams or more, born to HBsAg-negative mothers: 0.5 ML IM within 24 hours of birth
• Preterm infants weighing less than 2,000 g born to HBsAg-negative mothers: 0.5 mL IM 1 month after birth or at hospital discharge
• Infants born to HBsAg-positive mothers: 0.5 mL IM within 12 hours of birth PLUS hepatitis B immune globulin (HBIG); test for HBsAg and antibody to HBsAg (anti-HBs) 1-2 months after completion of hepatitis B vaccination series, at age 9 through 18 months
• Mother's HBsAg status unknown: 0.5 mL IM within 12 hours of birth PLUS give HBIG; if newborn weight is below 2 kg, determine mother's HBsAg status as soon as possible and, if she is HBsAg-positive, also administer HBIG for infants weighing 2 kg or more (no later than age 1 week)

Second dose

• Administered at age 1-2 months monovalent hepatitis B vaccine should be used for doses administered before age 6 weeks
• Infants who did not receive a birth dose should receive 3 doses of a hepatitis B-containing vaccine on a schedule of 0, 1 to 2 months, and 6 months starting as soon as feasible
• Minimum interval between dose 1 and dose 2 is 4 weeks, and between dose 2 and 3 is 8 weeks

Final (3rd or 4th) dose

• Administered no earlier than age 24 weeks, and at least 16 weeks after the first dose
• A total of 4 doses of hepatitis B vaccine is recommended when a combination vaccine containing hepatitis B is administered after the birth dose

Catch-up schedule

• Unvaccinated children should complete a 3-dose series
• Children aged 11-15 years: 2-dose series (doses separated by at least 4 months) of adult formulation
• Recombivax HB is licensed for use in children aged 11 through 15 years

Administration

Intramuscular (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

Subcutaneous (SC) Administration

• Engerix B or Recombivax HB may be administered SC to persons at risk for hemorrhage following IM injections (e.g., persons with blood clotting disorders such as hemophiliacs)
• SC administration known to result in lower antibody response
• Increased incidence of local reactions, including SC nodules, observed when other aluminum-adsorbed vaccines have been administered SC

Inform your doctor of all medications you are currently taking, who can advise you on any possible drug interactions. Never begin taking, suddenly discontinue, or change the dosage of any medication without your doctor’s recommendation.

• Severe Interactions of Hepatitis B Vaccine include:
  • belimumab
• Hepatitis B Vaccine has serious interactions with at least 37 different drugs.
• Moderate Interactions of Hepatitis B Vaccine include:
  • cyclosporine
  • dengue vaccine
  • ibrutinib
  • mechlorethamine
  • melphalan
  • mercaptopurine
  • methotrexate
  • onasemnogene abeparvovec
  • oxaliplatin
  • rituximab
• Mild Interactions of Hepatitis B Vaccine include:
  • chloroquine
  • ozanimod

The drug interactions listed above are not all of the possible interactions or adverse effects. For more information on drug interactions, visit the RxList Drug Interaction Checker.

It is important to always tell your doctor, pharmacist, or health care provider of all prescription and over-the-counter medications you use, as well as the dosage for each, and keep a list of the information. Check with your doctor or health care provider if you have any questions about the medication.

There are no adequate and well-controlled studies of hepatitis B vaccination during pregnancy. Animal studies reveal no fetal harm from the vaccine and available data do not suggest an increased risk of major birth defects and miscarriage in women who received hepatitis B vaccine during pregnancy.

There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to Heplisav-B or PreHevbrio during pregnancy. Women who receive Heplisav-B during pregnancy may contact 1-844-443-7734, and women who receive PreHevbrio may contact 1-888-421-8808.

It is not known if hepatitis B vaccine is present in breast milk and there are no data on its effects on milk production or the breastfed infant. Decision for vaccination should be made based on the mother’s clinical need for hepatitis B vaccination because of susceptibility to infection and potential adverse effects on the breastfed infant.

Current vaccination schedules are available at http://www.cdc.gov/vaccines/schedules/hcp/index.html