Haemophilus influenzae type B vaccine

Haemophilus influenzae type B (HIB) vaccine is an inactivated bacterial vaccine used for routine immunization in children.

Inactivated bacterial vaccines are sterile biologic products that provide acquired immunity against specific bacterial infections by stimulating the production of antibodies by the body’s own immune system. HIB vaccine is part of the routine immunization administered to children and is not intended for healthy adults.

HIB vaccine protects a person from becoming infected when exposed to H. influenzae bacteria, which can cause many types of infections ranging from mild ear infections to serious infections, including bloodstream infection, pneumonia, meningitis, epiglottitis, infectious arthritis, and cellulitis. HIB vaccine works by stimulating the immune system to produce antibodies against the H. influenzae bacteria. The onset of protection from the vaccination is relatively slow but lasts for years.

Inactivated bacterial vaccines, including HIB vaccine, are made from protein or carbohydrate fragments of the disease-causing bacteria grown in culture and then killed (inactivated) to prevent them from causing disease. If exposed to H. influenzae bacterial infection later in life, the immune system of the vaccinated person identifies the bacteria by the molecule (antigen) specific to the particular strain of bacteria, attacks and kills the bacteria, preventing illness.

The main component of the HIB vaccine is a carbohydrate biomolecule from the H. influenzae type B bacteria’s capsule (capsular polysaccharide), the bacterial antigen against which the immune system produces antibodies. HIB vaccine is conjugated with tetanus bacterial toxoid to improve the immune response. Toxoids are toxins that are chemically altered to eliminate the toxicity, but can be recognized as bacterial antigens by the immune system. HIB vaccine also contains substances that preserve and stabilize the vaccine.

Up to 4 doses of the HIB vaccine are administered to children between the ages of 2 and 15 months, failing which, catch-up vaccination may be given up to the age of 5 or 6 years. The HIB vaccine is not intended for individuals older than 6 years, except for those with conditions that compromise immunity including:

• Absence of spleen or nonfunctional spleen (asplenia), including elective spleen removal (splenectomy)
• Sickle cell disease, an inherited blood disorder
• Leukemia, a type of blood cancer
• Human immunodeficiency virus (HIV) infection
• Deficiency in the innate immune surveillance system (complement deficiency)
• Recipient of blood cell forming stem cell transplant (hematopoietic stem cell transplant [HSCT])

• Do not administer HIB vaccine to individuals who have had a severe allergic reaction (anaphylaxis) to a previous dose of:
  • Any H. influenzae type B
  • Tetanus toxoid-containing vaccine
  • Any component of the HIB vaccine
• Epinephrine and other appropriate agents must be available at the vaccine administering facility, to treat an acute anaphylactic reaction, should it occur.
• If a person has a history of developing Guillain-Barre syndrome within 6 weeks of receipt of a prior vaccine containing tetanus toxoid, the decision to give any tetanus toxoid-containing vaccine, including HIB vaccine, should be taken after carefully considering the potential benefits and possible risks.
• The vaccine may not have the expected antibody response in immunocompromised persons, including those on immunosuppressive therapy.
• Vaccination may not provide protection to 100% of vaccinated individuals.
• The tetanus toxoid component in the HIB vaccine is not a substitute for tetanus vaccination.
• Urine antigen detection may not have a diagnostic value in suspected H. influenzae type B infection within 1 to 2 weeks after receipt of a H. influenzae type B vaccine.

Common side effects of Haemophilus influenzae type B vaccine include:

• Local side effects at injection site:
  • Pain
  • Redness (erythema)
  • Swelling
  • Tenderness
  • Tissue hardening (induration)
  • Soreness
  • Abscess (less common)
• General side effects:
  • Irritability
  • Drowsiness
  • Loss of appetite (anorexia)
  • Excessive crying
  • Fever
  • Pain
  • Diarrhea
  • Skin rash
  • Middle ear infection (otitis media)
  • Upper respiratory infection
• Less common symptoms of Haemophilus influenzae type B vaccine include:
  • Bacterial infection
  • Vomiting
  • Guillain-Barre syndrome, a rare disorder in which the immune system attacks the peripheral nerves
  • Hypersensitivity reaction
  • Hives (urticaria)
  • Swelling beneath the skin and in mucous tissue (angioedema)
  • Severe allergic reaction (anaphylaxis)
  • Nonimmune anaphylaxis
  • Pause in breathing (apnea)
  • Weakness (asthenia)
  • Seizure
  • Febrile seizures
  • Hypotonic/hyporesponsive episode
  • Lymph node swelling (lymphadenopathy)
  • Swelling of extremities (peripheral edema)
  • Pneumonia
  • Itching (pruritus)
  • Swelling of the injected limb (extensive)
  • Fainting (syncope)
  • Low platelet count (thrombocytopenia)
  • Bacterial infection and inflammation of the windpipe (tracheitis)

Call your doctor immediately if you experience any of the following symptoms or serious side effects while using this drug:

• Serious heart symptoms include fast or pounding heartbeats, fluttering in your chest, shortness of breath, and sudden dizziness;
• Severe headache, confusion, slurred speech, severe weakness, vomiting, loss of coordination, feeling unsteady;
• Severe nervous system reaction with very stiff muscles, high fever, sweating, confusion, fast or uneven heartbeats, tremors, and feeling like you might pass out; or
• Serious eye symptoms include blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights.

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.

Injection

• 10 mcg Haemophilus B, 25 mcg tetanus toxoid/0.5 mL (ActHIB, Hiberix)
• 7.5 mcg Haemophilus B PRP, 125 mcg Neisseria meningitidis OMPC/0.5 mL (PedVaxHib)

Adult:

H. influenzae Type B Immunization

• Not indicated for routine immunization in otherwise healthy adults
• For more information, see the CDC vaccine guidelines at http://www.cdc.gov/vaccines/schedules/hcp/index.html

Asplenia

• Indicated for adults with functional or anatomic asplenia (including sickle cell disease) or are undergoing elective splenectomy
• One dose of HIB vaccine should be administered if HIB vaccine not previously received
• HIB vaccination should be given within 14 days before splenectomy

Complement deficiency

• Indicated for adults with persistent complement component deficiencies
• One dose of HIB vaccine should be administered if HIB vaccine not previously received

Post-HSCT Recipients

• Recipients of a hematopoietic stem cell transplant (HSCT) should be vaccinated with a 3-dose regimen 6 to 12 months after a successful transplant, regardless of vaccination history
• At least 4 weeks should separate doses

Dosing Considerations

• Not recommended for adults with HIV infection since their risk for HIB infection is low, unless another risk factor is present (i.e., asplenia, complement deficiency, HSCT recipient)

Pediatric:

H. influenzae Type B Immunization

• Intramuscular (IM) injection indicated for routine immunization in children aged 2 months to 15 months and up to 5 years for catch up vaccination
• Primary series (6 weeks to 12 months): 2 or 3 doses
• Booster: 3rd or 4th dose between 12-15 months

PRP-OMP

• Monovalent vaccine; polyribosylribotol phosphate (PRP) conjugated to outer membrane protein (OMP) complex from Neisseria meningitidis
• PEDvaxHIB: 2 and 4 months (primary series); 12-15 months (booster)

PRP-T

• Monovalent vaccines; polyribosylribotol phosphate (PRP) conjugated to tetanus toxoid
• ActHIB, Hiberix: 0.5 mL IM as 4-dose series at 2, 4, and 6 months (primary series) and between 12-15 months (booster)

Combination vaccines

• PRP-OMP-HepB (Comvax): 2 and 4 months (primary series); 12-15 months (booster)
• DTap-IPV/PRP-T (Pentacel): 2, 4, and 6 months (primary series); 12-15 months (booster)
• MenCY-PRP-T (MenHibRix): 2, 4, and 6 months (primary series); 12-15 months (booster)

Considered fully immunized if

• At least 1 dose after age 14 months, or
• 2 doses between 12-14 months old, or
• More than 2 doses during first year of life followed by booster when older than 1 year

Immunosuppressed individuals

• Consider administering in patients 5 years or older if not already vaccinated and are immunosuppressed (e.g., sickle cell disease, leukemia, HIV or anatomic/functional asplenia)

Dosing Considerations

• PRP-T: Polyribosylribotol phosphate conjugated to tetanus toxoid
• OMP: Outer membrane protein complex from Neisseria meningitidis
• Minimum age for vaccination is 6 weeks old for PRP-T (ActHIB), DTaP-IPV/Hib (Pentacel), and Hib-MenCY (MenHibrix), or PRP-OMP (PedvaxHIB, Comvax)
• Minimum age for vaccination is 12 months old for PRP-T (Hiberix)
• ActHIB: Reconstituted with 0.4% NaCl diluent is indicated for active immunization of children aged 2 months through 5 years for prevention of invasive disease caused by Haemophilus influenzae type b
• TriHIBit: ActHIB reconstituted with Tripedia (DTP) vaccine creates TriHIBit vaccine; it is indicated for the active immunization of children aged 15 through 18 months for prevention of invasive disease caused by Haemophilus influenzae type b and diphtheria, tetanus and pertussis

Overdose

• There is little data available on an overdose of Haemophilus influenzae type B vaccine. Available data indicate that adverse events from an excess dose of vaccine are comparable to those of standard vaccination dose.

• Haemophilus influenzae type B vaccine is approved for use only in children below 5 or 6 years of age, and not for use in older individuals. The vaccine is not intended for use in pregnant or breastfeeding women.

• Complete the routine immunization program recommended for your child without missing any of the series of primary and booster doses.
• Full information on vaccine schedules is available at http://www.cdc.gov/vaccines/schedules/hcp/index.html