haemophilus influenzae type b vaccine (ActHIB, Hiberix, Liquid PedvaxHIB)
Classes: Vaccines, Inactivated, Bacterial
Dosing and uses of ActHIB, Hiberix (haemophilus influenzae type b vaccine)
Adult dosage forms and strengths
injection
- 10mcg Haemophilus b, 25mcg tetanus toxoid/0.5mL (ActHIB, Hiberix)
- 7.5mcg Haemophilus b PRP, 125mcg Neisseria meningitidis OMPC/0.5 mL (PedVaxHib)
H. influenzae Type B Immunization
Not indicated for routine immunization in otherwise healthy adults
For more information, see the CDC vaccine guidelines at https://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 ≥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 (ie, asplenia, complement deficiency, HSCT recipient)
Pediatric dosage forms and strengths
injection
- 10mcg Haemophilus b, 25mcg tetanus toxoid/0.5mL (ActHIB, Hiberix)
- 7.5mcg Haemophilus b PRP, 125mcg Neisseria meningitidis OMPC/0.5 mL (PedVaxHib)
H. influenzae Type B Immunization
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 (T)
- 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
- >2 doses during first year of life followed by booster when older than 1 yr
Immunosuppressed individuals
- Consider administering in patients 5 years or older if not already vaccinated and are immunosuppressed (eg, 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
ActHIB, Hiberix (haemophilus influenzae type b vaccine) adverse (side) effects
Suspected adverse events after administration of any vaccine may be reported to Vaccine Adverse Events Reporting System (VAERS), 1-800-822-7967
General and by vaccine type
Irritability (10-70%), drowsiness, fever (0.5-18%), anorexia erythema >2.5cm (0.4-2.2%), swelling, tenderness
HbOC (HibTITER): erythema (3.3%), fever 2.2%
PRP-OMP (PedvaxHIB): fever (18.1%), swelling (2.5%), erythema (2.2%)
PRP-T (ActHIB, OmniHIB): Irritability (72.6%), drowsiness (57.5%), tenderness (46.3%), induration (22.5%), fever (20.1%), anorexia (15.3%), diarrhea (4.4%)
PRP-D (ProHIBiT): irritability (14%), tenderness (12%), drowsiness (8%), vomiting (7%), fever (2%)
DTP + HbOC (TETRAMUNE): tenderness, irritability, swelling, erythema, fever
Frequency not defined
Crying (unusual, high pitched, prolonged)
Fever
Irrritability
Pain
Sleepiness
Rash
Anorexia
Diarrhea
Vomiting
Injection site erythema/induration/pain/soreness/warmth/swelling
Otitis media
URI
Postmarketing Reports
Anaphylactoid reactions
Angioedema
Erythema multiforme
Facial edema
Febrile seizure
Guillain-Barre syndrome
Headache
Hypersensitivity
Hyporesponsive episodes
Hypotonia
Injection site abscess
Lethargy
Lymphadenopathy
Malaise
Mass
Seizure
Shock
Skin discoloration
Urticaria
Warnings
Contraindications
Severe allergic reaction (eg, anaphylaxis) after a previous dose of any H. influenzae type b- or tetanus toxoid-containing vaccine or any component of the vaccine
Cautions
If Guillain-Barré syndrome has occurred within 6 wk of receipt of a prior vaccine containing tetanus toxoid, the decision to give any tetanus toxoid-containing vaccine should be based on careful consideration of the potential benefits and possible risks
Syncope can occur in association with administration of injectables and may be accompanied by transient neurological signs (eg, visual disturbance, paresthesia, tonic-clonic limb movements): procedures should be in place to avoid falling injury and to restore cerebral perfusion following syncope
Apnea reported following IM vaccination in some infants born prematurely; decisions about when to administer an IM vaccine to infants born prematurely should be based on consideration of the individual infant’s medical status, and the potential benefits and possible risks of vaccination
Prior to administration, the healthcare provider should review the patient's immunization history for possible vaccine hypersensitivity; epinephrine and other appropriate agents used for the control of immediate allergic reactions must be immediately available should an acute anaphylactic reaction occur
Safety and effectiveness in immunosuppressed children have not been evaluated; if administered to immunosuppressed children, the expected immune response may not be obtained
Urine antigen detection may not have a diagnostic value in suspected disease due to H. influenzae type b within 1 to 2 weeks after receipt of a H. influenzae type b-containing vaccine
Pregnancy and lactation
Pregnancy category: C
Lactation: Excretion in milk unknown
Pregnancy categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.
C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.
D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.
X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.
NA: Information not available.
Pharmacology of ActHIB, Hiberix (haemophilus influenzae type b vaccine)
Duration: Unknown
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)
Mechanism of action
Antigenic capsular polysaccharides induce Ab production