Class: Vaccines
ATC Class: J07AG51
VA Class: IM100
Brands: ActHIB, Comvax, Hiberix, PedvaxHIB, Pentacel (combination), TriHIBit
Introduction
Inactivated (polysaccharide) vaccine.137 144 174 223 Haemophilus b (Hib) vaccine is used to stimulate active immunity to Haemophilus influenzae type b (Hib) infection.125 144 159 174 205 223 Commercially available in the US as 2 different monovalent vaccines: Hib conjugate vaccine (meningococcal protein conjugate) (PRP-OMP; PedvaxHIB)144 and Hib conjugate vaccine (tetanus toxoid conjugate) (PRP-T; ActHIB, Hiberix).174 223 PRP-OMP (PedvaxHIB) also commercially available in fixed combination with hepatitis B vaccine (Hib-HepB; Comvax)77 and PRP-T (ActHIB) also commercially available in a kit used to provide a combination vaccine containing diphtheria, tetanus, pertussis, and Hib antigens (DTaP/Hib; TriHIBit)174 202 and in a kit used to provide a combination vaccine containing diphtheria, tetanus, pertussis, poliovirus, and Hib antigens (DTaP-IPV/Hib; Pentacel).206
Uses for Haemophilus b Vaccine
Prevention of Haemophilus influenzae type b (Hib) Infection
Prevention of Hib infection in infants and children 2 through 71 months of age (usually 2 through 59 months of age).76 125 144 159 174
Hib is a gram-negative bacteria that causes meningitis and other serious systemic infections (e.g., epiglottitis, sepsis, cellulitis, septic arthritis, osteomyelitis, pericarditis, pneumonia) in young children.23 125 205 Before Hib vaccine became available, Hib infection was the most common cause of bacterial meningitis in children.125 205 There were about 20,000 cases of invasive Hib each year in the US, principally in infants and children <5 years of age;205 the case fatality rate was 2–5% despite anti-infective treatment and 15–30% of meningitis survivors had hearing loss or neurologic sequelae.205 The incidence of invasive Hib in the US decreased ≥99% after Hib conjugate vaccines became available.125 205 Most cases now occur in infants and children who are unvaccinated or incompletely vaccinated, including infants <6 months of age who are too young to have received a complete vaccination series.125 205 The average annual rate of invasive Hib disease reported in children <5 years of age during 1998–2000 was 0.3 cases per 100,000 children.220 During 2007, there were 22 cases of invasive Hib disease and 180 cases caused by unknown serotypes of H. influenzae in US children <5 years of age.205
USPHS Advisory Committee on Immunization Practices (ACIP), AAP, American Academy of Family Physicians (AAFP), and other experts recommend that all infants be vaccinated against Hib with an appropriate vaccine regimen initiated in early infancy at 2 months of age (minimum age 6 weeks), unless contraindicated.76 125 159 (See Contraindications under Cautions.)
ACIP and AAP also recommend catch-up vaccination for all children <5 years of age who are unvaccinated or incompletely vaccinated against Hib.76 125 159
Unvaccinated children <4 years of age are at increased risk of invasive Hib disease, especially if they are in prolonged close contact (e.g., household contact) with a child with invasive Hib disease.125 Other factors associated with an increased risk of developing invasive Hib infection include asplenia,125 205 sickle cell anemia,125 205 antibody deficiency syndromes,205 HIV infection,125 184 205 other immunodeficiency syndromes,38 125 205 and Hodgkin’s disease79 or other malignancies (especially during chemotherapy).125 205 Historically, invasive Hib was more common in boys125 and in American Indians (e.g., Apache and Navajo tribes),45 125 205 Alaskan natives,40 45 85 125 Hispanics,205 and blacks.29 125 205 (See Limitations of Vaccine Effectiveness under Cautions.)
ACIP and AAP do not recommend routine use of Hib vaccine in children ≥5 years of age.76 125 146 164 170 198 Although efficacy data not available on which to base recommendations regarding use of Hib vaccine in these age groups, use of Hib vaccine can be considered in children ≥5 years of age† or adults† who did not receive the vaccine in early childhood and are at increased risk for invasive Hib disease because of altered immunocompetence (e.g., sickle cell disease, leukemia, splenectomy, HIV infection, IgG2 deficiency, chemotherapy, hematopoietic stem cell transplantation).76 125 137 159 172 184 198 205 The fact that the vaccine may be less immunogenic in immunocompromised individuals should be considered.125 137 (See Individuals with Altered Immunocompetence under Cautions.)
Hib disease is endemic worldwide.138 CDC recommends that children <5 years of age be immune to the disease prior to travel.138 Previously unvaccinated children <15 months of age ideally should receive at least 2 doses of Hib vaccine prior to travel;138 if necessary, the interval between these doses may be as short as 4 weeks.138 Previously unvaccinated children 15 through 59 months of age should receive a single dose of Hib vaccine prior to travel.138
Cochlear implant recipients may be at increased risk of invasive Hib disease (i.e., meningitis).114 Any child <5 years of age with a cochlear implant who has not received Hib vaccine should be vaccinated.114
For internationally adopted children whose immune status is uncertain, vaccinations can be repeated or serologic tests performed to confirm immunity.137 138 For Hib vaccine, ACIP recommends revaccination with the age-appropriate vaccination regimen in children 2 months through 4 years of age.137 (See Dosage and Administration.)
Hib vaccine will not provide protection against other types of H. influenzae (e.g., nonencapsulated strains associated with otitis media and sinusitis) or against other pathogens that cause meningitis or septicemia.144 174
Depending on age and vaccination status, Hib vaccine may be given as a monovalent vaccine (ActHIB, PedvaxHIB, Hiberix)144 174 223 or as a fixed-combination vaccine containing Hib and other antigens.77 174 206 ACIP, AAP, and AAFP state that use of a combination vaccine generally is preferred over separate injections of the equivalent component vaccines;76 226 considerations should include provider assessment (e.g., number of injections, vaccine availability, likelihood of improved coverage, likelihood of patient return, storage and cost considerations), patient preference, and potential for adverse effects.76 226
When vaccination against both hepatitis B virus (HBV) and Hib is indicated in an infant 6 weeks to 15 months of age born to HBsAg-negative women, the commercially available fixed-combination bivalent vaccine containing Hib polysaccharide conjugate (meningococcal protein conjugate) vaccine and hepatitis B vaccine (Hib-HepB; Comvax) can be used.77 ACIP states this fixed-combination vaccine also may be used to complete the HBV vaccine series in infants 6 weeks to 15 months of age born to HBsAg-positive women†.162
When a fourth dose of DTaP and a fourth dose of Hib vaccine are indicated in a child 15 through 18 months of age, a kit (DTaP/Hib; TriHIBit) containing both DTaP (Tripedia) and Hib polysaccharide conjugate (tetanus toxoid conjugate) vaccine (ActHIB) may be used.165 174 179 202 205 ActHIB in the kit is reconstituted with Tripedia to provide a combination vaccine containing diphtheria, tetanus, pertussis, and Hib antigens.174 202 TriHIBit should not be used for the first 3 doses in the primary DTaP or Hib vaccination series.165 179 205 Other commercially available Hib vaccines and DTaP vaccines should not be mixed extemporaneously to provide a combination vaccine.186 205
When doses of DTaP, poliovirus vaccine (IPV), and Hib vaccine are indicated in infants and children 6 weeks through 4 years of age and there are no contraindications to any of the individual components, a kit (DTaP-IPV/Hib; Pentacel) containing a fixed-combination DTaP-IPV vaccine and Hib vaccine (ActHIB) can be used.206 207 ActHIB in the kit is reconstituted with the fixed-combination of DTaP-IPV in the kit to provide a combination vaccine containing diphtheria, tetanus, pertussis, poliovirus, and Hib antigens.206 207 For prevention of Hib, ACIP states that Pentacel may be used for the primary immunization doses and the booster dose at 12 through 15 months of age.207
Haemophilus b Vaccine Dosage and Administration
Administration
IM Administration
Monovalent Hib vaccines (ActHIB, Hiberix, PedvaxHIB) are administered by IM injection.77 144 174 223
Hib-HepB (Comvax),77 DTaP/Hib (TriHIBit),174 202 and DTaP-IPV/Hib (Pentacel)206 are administered by IM injection.
Do not administer monovalent Hib vaccines or combination vaccines containing Hib and other antigens IV, sub-Q, or intradermally.77 144 174 202 206 223
Shake vaccine before administering.77 144 202 206 223
Depending on patient age, administer IM into the deltoid muscle or anterolateral thigh.137 144 174 202 206 For young children (up to 12 months of age), IM injections should be made into the anterolateral thigh.137 206 For children 1–2 years of age, IM injections should preferably be administered into the anterolateral thigh; deltoid muscle is an alternative if muscle mass is adequate.137 For children ≥3 years of age, deltoid muscle is preferred, although anterolateral thigh is an alternative.137
To ensure delivery into muscle, IM injections should be made at a 90° angle to the skin using a needle length appropriate for the individual's age and body mass, the thickness of adipose tissue and muscle at the injection site, and the injection technique.137 208 209 Consider anatomic variability, especially in the deltoid, and use clinical judgement to avoid inadvertent underpenetration or overpenetration of muscle.208 209
Take care to avoid injection into the gluteal area or into or near blood vessels or nerves.77 137 144 174 202 206 Generally do not administer vaccines into buttock muscle in children because of potential for injection-associated injury to sciatic nerve.137
Although some experts state that aspiration (i.e., pulling back on the syringe plunger after needle insertion and before injection) can be performed to ensure that a blood vessel has not been entered, ACIP and AAP state this procedure is not required because large blood vessels are not present at recommended IM injection sites.137
May be given simultaneously with other age-appropriate vaccines during the same health-care visit (using different syringes and different injection sites).137
When multiple vaccines are administered during a single health-care visit, each vaccine should be given with a different syringe and at different injection sites.137 Separate injection sites by at least 1 inch (if anatomically feasible) to allow appropriate attribution of any local adverse effects that may occur.137
Reconstitution (ActHIB)
Reconstitute lyophilized ActHIB by adding entire amount of 0.4% sodium chloride diluent supplied by the manufacturer; agitate thoroughly.174 Administer within 24 hours of reconstitution.174
Reconstitution (Hiberix)
Reconstitute lyophilized Hiberix by adding entire amount of 0.9% sodium chloride diluent supplied by the manufacturer;223 agitate thoroughly.223 Administer promptly or store at 2–8°C and administer within 24 hours.223
Do not mix with any other vaccine or solution.223
Reconstitution (TriHIBit)
TriHIBit is commercially available as a kit containing single-dose vials of lyophilized Hib (ActHIB) and single-dose vials of DTaP (Tripedia).174 202
Prior to administration, reconstituted a vial of lyophilized ActHIB by adding 0.6 mL of the Tripedia vaccine according to manufacturer's instructions to provide a combination vaccine containing diphtheria, tetanus, pertussis, and Hib antigens.174 Agitate thoroughly.174 Do not mix with any other vaccine or solution.174
Administer TriHIBit immediately (within 30 minutes) after reconstitution.174 202
Reconstitution (Pentacel)
Pentacel is commercially available as a kit containing single-dose vials of a fixed-combination vaccine containing diphtheria, tetanus, pertussis, and poliovirus antigens (DTaP-IPV vaccine) and single-dose vials of lyophilized Hib vaccine (ActHIB).206
Prior to administration, reconstitute a vial of lyophilized ActHIB vaccine by adding the entire contents of a vial of the DTaP-IPV vaccine according to manufacturer's instructions to provide a combination vaccine containing diphtheria, tetanus, pertussis, IPV, and Hib antigens.206 Shake thoroughly until a cloudy, uniform suspension is obtained.206
Administer Pentacel immediately after reconstitution.206
Dosage
Dosing schedule varies according to the specific vaccine administered and the age at which vaccination is started.144 159 174 223 Follow dosage recommendations for the specific preparation used.144 159 174 223
Commercially available PedvaxHIB and ActHIB monovalent Hib vaccines can be considered interchangeable for both primary and booster immunization.125 205 If both PedvaxHIB and ActHIB are administered as part of the primary series, 3 primary doses and a booster dose are needed to complete the series.205
ACIP and AAP recommend use of a vaccine preparation that includes PRP-OMP (PedvaxHIB or Comvax) for the first primary dose in American Indian and Alaskan native children.125 207 (See Limitations of Vaccine Effectiveness under Cautions.)
Medically stable preterm and low birthweight infants should be vaccinated at the usual chronologic age using usual dosage.125 144 170 174
Interruptions resulting in an interval between doses longer than recommended should not interfere with the final immunity achieved; there is no need to administer additional doses or start the vaccination series over.137 144 174
PRP-OMP (PedvaxHIB): Used in infants and children 2 through 71 months of age.144
PRP-T (ActHIB): Used in infants 2 through 18 months of age.174
PRP-T (Hiberix): Used in infants and children 15 months through 4 years of age.223
Hib-HepB (Comvax): Used in infants 6 weeks to 15 months of age.77
DTaP/Hib (TriHIBit): Used when a fourth dose of DTaP and a fourth dose of Hib vaccine are both indicated in infants 15 through 18 months of age.76 165 174
DTaP-IPV/Hib (Pentacel): Used in infants and children 6 weeks through 4 years of age.206
Pediatric Patients
Prevention of Haemophilus influenzae Type b (Hib) Infection
Infants 2 through 18 Months of Age (PRP-T; ActHIB)
IM
Each dose is 0.5 mL.174
Routine primary immunization in early infancy consists of a series of 3 doses and a booster dose.76 125 174 ACIP, AAP, and AAFP recommend that doses be given at 2, 4, 6, and 12 through 15 months of age.76 125 Initial dose may be given as early as 6 weeks of age.125
Catch-up vaccination using the age-appropriate number of doses indicated below is recommended in those who are unvaccinated or incompletely vaccinated.76
Previously unvaccinated children 7 through 11 months of age: Primary immunization consists of a series of 2 doses and a booster dose.76 125 174 ACIP, AAP, and AAFP recommend that first 2 doses be given 2 months apart (minimum interval 4 weeks) and the third dose be given at 12 through 15 months of age (at least 8 weeks after second dose).76 125 Manufacturer recommends that 2 doses be given 8 weeks apart and a third dose (booster dose) be given at 15 through 18 months of age.174
Previously unvaccinated children 12 through 14 months of age: Primary immunization consists of 2 doses given 8 weeks apart.76 125 174
Previously unvaccinated children 15 through 18 months of age: Single dose.76 125
Infants and Children 2 through 71 Months of Age (PRP-OMP; PedvaxHIB)
IM
Each dose is 0.5 mL.144
Routine primary immunization in early infancy consists of a series of 2 doses and a booster dose.125 144 ACIP, AAP, AAFP, and manufacturer recommend that doses be given at 2, 4, and 12 through 15 months of age.76 125 144 159 Initial dose may be given as early as 6 weeks of age.125 Minimum interval between doses is 2 months.144
Catch-up vaccination using the age-appropriate number of doses indicated below is recommended in all children up to 71 months of age who are unvaccinated or incompletely vaccinated.76
Previously unvaccinated children 7 through 11 months: Primary immunization consists of a series of 2 doses and a booster dose.76 125 Give first 2 doses 2 months apart (minimum interval is 4 weeks); give third dose at 12 through 15 months of age (at least 8 weeks after second dose).76 125
Previously unvaccinated children 12 through 14 months of age: Primary immunization consists of 2 doses given 2 months apart.76 125
Previously unvaccinated children 15 through 71 months of age: Single dose.76 125 144
Infants and Children 15 Months through 4 Years of Age (Hiberix)
IM
A single 0.5-mL dose.223
Used as a booster dose in infants and children 15 months through 4 years of age who received a primary series of an appropriate Hib vaccine (primary series consists of 2 or 3 doses depending on the manufacturer).223 225
To facilitate timely administration of a booster dose of Hib vaccine for routine or catch-up vaccination, ACIP states that the booster dose of Hiberix may be given as early as 12 months of age†.76 225
Do not use for primary immunization.223 225 However, if Hiberix is inadvertently given during the primary vaccination series, ACIP states that the dose may be counted as a valid PRP-T primary dose if it was administered at an appropriate interval according to the recommended PRP-T primary vaccination schedule.225
Infants 6 Weeks to 15 Months of Age (Hib-HepB; Comvax)
IM
Each dose is 0.5 mL.77
May be used when primary immunization against Hib and HBV is indicated in infants and children 6 weeks to 15 months of age born to HBsAg-negative women.77
Primary immunization consists of a series of 3 doses given ideally at 2, 4, and 12–15 months of age.77
Interval between first 2 doses should be at least 6 weeks and interval between second and third dose should be as close as possible to 8–11 months.77
Infants 15 through 18 Months of Age (DTaP/Hib; TriHIBit)
IM
A single 0.5-mL dose.174
May be used whenever a fourth dose of DTaP is indicated in addition to a fourth dose of Hib vaccine in children 15 through 18 months of age.76 125 165 174 ACIP, AAP, and AAFP state may be used in children ≤12 months of age, provided at least 6 months have elapsed since the last DTaP dose.76
Do not use for first 3 doses of the primary series.76 165 174 179 205
Infants and Children 6 Weeks through 4 Years of Age (DTaP-IPV/Hib; Pentacel)
IM
Each dose is 0.5 mL.206
May be used when immunization against diphtheria, tetanus, pertussis, poliovirus, and Hib is indicated in children 6 weeks through 4 years of age.206 207
In previously unvaccinated children 6 weeks through 4 years of age, Pentacel is given in a series of 4 doses.206 Give doses at 2, 4, 6, and 15 through 18 months of age.206 Initial dose usually given at 2 months of age, but may be given as early as 6 weeks of age.206 To complete the recommended primary and booster regimen against diphtheria, tetanus, and pertussis, children who received the 4-dose series of Pentacel should receive a fifth dose of DTaP (Daptacel) at 4 through 6 years of age.206 Pentacel should not be used for the booster dose of DTaP indicated at 4 through 6 years of age; however, if a dose of Pentacel is inadvertently given to a child ≥5 years of age, ACIP states the dose may be counted as a valid dose.207
In children 6 weeks through 4 years of age who previously received 1 or more doses of IPV, Pentacel can be used to complete the IPV series when doses of IPV and DTaP also are indicated and there are no contraindications to any of the individual components.206 207
In children 6 weeks through 4 years of age who previously received 1 or more doses of DTaP (Daptacel), Pentacel can be used to complete the DTaP series when doses of IPV and Hib vaccine also are indicated and there are no contraindications to any of the individual components.206 207
In children 6 weeks through 4 years of age who previously received 1 or more doses of Hib vaccine, Pentacel can be used to complete the Hib series when doses of IPV and DTaP, and Hib vaccine also are indicated and there are no contraindications to any of the individual components.206 207
Children 12 through 59 Months of Age with Medical Conditions Associated with Increased Risk of Invasive Hib Disease
IM
Unvaccinated or previously received 1 dose of Hib vaccine before 12 months of age: AAP recommends 2 doses of Hib vaccine given 2 months apart.125
Previously received 2 doses of Hib vaccine before 12 months of age: AAP recommends 1 dose of Hib vaccine.125
Children ≥5 Years of Age with Medical Conditions Associated with Increased Risk of Invasive Hib Disease
IM
Unvaccinated: Although safety and efficacy not established, ACIP, AAP, and AAFP state that a dose of Hib vaccine is not contraindicated in those with sickle cell disease, leukemia, HIV infection, or splenectomy.76
Unvaccinated: AAP suggests 2 doses of Hib vaccine given at least 1–2 months apart in those with HIV infection or IgG2 deficiency.125 184
Special Populations
Hepatic Impairment
No specific dosage recommendations.144 174 223
Renal Impairment
No specific dosage recommendations.144 174 223
Cautions for Haemophilus b Vaccine
Contraindications
PRP-OMP (PedvaxHIB) and PRP-T (ActHIB): Hypersensitivity to any vaccine component.144 174
PRP-T (Hiberix): Severe allergic reaction (e.g., anaphylaxis) after a dose of any Hib vaccine, a dose of any vaccine containing tetanus toxoid, or any component in Hiberix.223
Hib-HepB (Comvax): Hypersensitivity to yeast or any vaccine component.77
DTaP/Hib (TriHIBit): Hypersensitivity to any ingredient in the vaccine.174 202 Also contraindicated (because of the pertussis antigen) in individuals who had encephalopathy (e.g., coma, decreased level of consciousness, prolonged seizures) within 7 days of a previous dose of a vaccine containing pertussis antigens that is not attributable to another identifiable cause and in individuals with progressive neurologic disorder, including infantile spasms, uncontrolled epilepsy, or progressive encephalopathy.202
DTaP-IPV/Hib (Pentacel): Severe allergic reaction (e.g., anaphylaxis) to any ingredient in the vaccine or after previous dose of the vaccine or any vaccine containing diphtheria, tetanus, pertussis, poliovirus, or Hib antigens.206 Also contraindicated (because of the pertussis antigen) in individuals who had encephalopathy (e.g., coma, decreased consciousness, prolonged seizures) within 7 days of a dose of pertussis-containing vaccine and in individuals with progressive neurologic disorder, including infantile spasms, uncontrolled epilepsy, or progressive encephalopathy.206
Warnings/Precautions
Sensitivity Reactions
Hypersensitivity Reactions
Take all known precautions to prevent adverse reactions, including a review of the patient’s history with respect to possible hypersensitivity to the vaccine or similar vaccines.144 174 223
Epinephrine and other appropriate agents should be readily available in case an immediate allergic reaction occurs.144 174 223
Do not administer additional doses of Hib vaccine to individuals with symptoms of hypersensitivity after a previous dose.144
Latex Sensitivity
The stopper on the vial of sodium chloride diluent supplied with ActHIB contains dry natural latex.174 The stopper on vials of Comvax contains natural rubber latex.77
Some individuals may be hypersensitive to natural latex proteins.137 190 192 193 Take appropriate precautions if these preparations are administered to individuals with a history of latex sensitivity.137 190 192 193
ACIP states that vaccines supplied in vials or syringes containing dry natural rubber or natural rubber latex may be administered to individuals with latex allergies other than anaphylactic allergies (e.g., history of contact allergy to latex gloves), but should not be used in those with a history of severe (anaphylactic) allergy to latex unless the benefits of vaccination outweigh the risk of a potential allergic reaction.137
Yeast Allergy
Hib-HepB (Comvax): Manufacturing process for HepB vaccine component involves baker's yeast (Saccharomyces cerevisiae) and final product contains yeast protein (≤1%).77 Manufacturer states the vaccine is contraindicated in individuals hypersensitive to yeast.77
Allergy to Neomycin or Other Anti-infectives
DTaP-IPV/Hib (Pentacel): Contains trace amounts of neomycin sulfate (≤4 pg) and polymyxin B (≤4 pg).206
Neomycin allergy usually results in delayed-type (cell-mediated) hypersensitivity reactions manifested as contact dermatitis.125 137 ACIP and AAP state that vaccines containing trace amounts of neomycin should not be used in individuals with a history of anaphylactic reaction to neomycin, but use of such vaccines may be considered in those with a history of delayed-type neomycin hypersensitivity if benefits of vaccination outweigh risks.125 137
General Precautions
Use of Fixed Combinations
When the combination vaccine containing Hib and hepatitis B antigens (Hib-HepB; Comvax) is used, consider the cautions and precautions associated with both antigens.77
When the combination vaccine containing diphtheria, tetanus, pertussis, and Hib antigens (DTaP/Hib; TriHIBit) is used, consider the cautions and precautions associated with each antigen.174
When the combination vaccine containing diphtheria, tetanus, pertussis, poliovirus, and Hib antigens (DTaP-IPV/Hib; Pentacel) is used, consider the cautions and precautions associated with each antigen.206
Limitations of Vaccine Effectiveness
May not protect all vaccine recipients against Hib.144 174
Protection against Hib disease may not be provided until 1–2 weeks after primary immunization with 2 or 3 doses of Hib vaccine.144 146 148 174
When a complete vaccine series is administered as recommended, regimens that include PRP-T (ActHIB) or PRP-OMP (PedvaxHIB, Comvax) are considered equivalent.125 144
There is some evidence that vaccines containing PRP-OMP (PedvaxHIB, Comvax) result in more rapid seroconversion to protective antibody concentrations within the first 6 months of life compared with vaccines containing PRP-T (ActHIB).125 204 207 This is particularly important in American Indian and Alaskan native children because these children are at increased risk for Hib disease during the first 6 months of life.125 204
Although antibodies to the outer membrane protein complex (OMPC) of Neisseria meningitidis have been demonstrated in patients who received PRP-OMP (PedvaxHIB), the clinical relevance of these antibodies not established.144 PedvaxHIB should not be considered an immunizing agent against meningococcal disease.159
Although Hiberix contains Hib antigen conjugated to tetanus toxoid, the vaccine is not a substitute for routine immunization against tetanus.223
Individuals with Altered Immunocompetence
May be administered to individuals immunosuppressed as the result of disease or immunosuppressive therapy.77 125 137 144 172 174 184 Consider possibility that the immune response to the vaccine may be reduced in individuals with altered immunocompetence (e.g., HIV infection, immunoglobulin deficiency, stem cell transplant recipients, cancer patients receiving chemotherapy).77 125 137 144 174 223
Immune responses have been obtained following administration of Hib vaccine in patients with sickle disease, leukemia, or HIV infection, and in those who have undergone splenectomies;76 198 205 response in HIV-infected individuals varies with the degree of immunocompromise.205
Manufacturer of Hiberix monovalent Hib vaccine states that safety and efficacy not evaluated in immunosuppressed children.223
AAP states that children who have received the usual age-appropriate regimen of Hib vaccine (primary and booster doses) and have decreased or absent splenic function do not need additional doses of the vaccine;125 however, those who are scheduled for splenectomy (e.g., for Hodgkin's disease, spherocytosis, immune thrombocytopenia, hypersplenism) may benefit from an additional dose of a Hib vaccine given at least 7–10 days before surgery.125 Although children with HIV infection or IgG2 deficiency or those receiving chemotherapy also are at increased risk of invasive Hib disease, it is unclear whether these children would benefit from additional doses of Hib vaccine after completion of the usual age-appropriate vaccination regimen.125
Efficacy data not available to base recommendations on use of Hib vaccine in older children and adults at increased risk for Hib disease.76 198 However, ACIP, AAP, and AAFP state that Hib vaccine is not contraindicated in these individuals.76 198
Concomitant Illness
Delay administration in individuals with acute febrile illness until symptoms have subsided.137 ACIP states that minor illness (with or without fever) generally does not preclude vaccination.137
Guillain-Barré Syndrome
If Guillain-Barré syndrome (GBS) occurred within 6 weeks of receipt of a vaccine containing tetanus toxoid, a decision to administer a dose of a vaccine containing tetanus toxoid, including Hiberix, should be based on careful consideration of potential benefits and possible risks.223
Individuals with Bleeding Disorders
ACIP states that vaccines may be given IM to individuals who have bleeding disorders or are receiving anticoagulant therapy if a clinician familiar with the patient's bleeding risk determines that the preparation can be administered with reasonable safety.137 In these cases, use a fine needle (23 gauge) to administer the vaccine and apply firm pressure to the injection site (without rubbing) for ≥2 minutes.137 If patient is receiving therapy for hemophilia, administer the IM vaccine shortly after a scheduled dose of such therapy.137
Advise individual and/or their family about the risk of hematoma from IM injections.137
Thimerosal Precautions
Although there is no convincing evidence that the low concentrations of thimerosal (a mercury-containing preservative) contained in some vaccines is harmful to vaccine recipients,137 210 211 212 213 214 215 216 217 218 efforts to eliminate or reduce the thimerosal content in vaccines is recommended as a prudent measure to reduce mercury exposure in infants and children and part of an overall strategy to reduce mercury exposures from all sources, including food and drugs.137 187 188 189 196
ActHIB, PedvaxHIB, Hiberix, Comvax, and Pentacel do not contain thimerosal or any other preservatives.77 144 174 206 223
When the kit (TriHIBit) containing both DTaP (Tripedia) and Hib vaccine (ActHIB) is used, the reconstituted vaccine contains trace amounts of thimerosal from the DTaP manufacturing process (≤0.3 mcg of mercury per 0.5-mL dose).174 202 FDA states that trace amounts of thimerosal from the manufacturing process are not considered clinically important.196
Improper Storage and Handling
Improper storage or handling of vaccines may result in loss of vaccine potency and reduced immune response in vaccinees.137
Do not administer monovalent Hib vaccines or combination vaccines containing Hib and other antigens that have been mishandled or have not been stored at the recommended temperature.77 137 144 174 (See Storage under Stability.)
Inspect all vaccines upon delivery and monitor during storage to ensure that the appropriate temperature is maintained.137 201 If there are concerns about mishandling, contact the manufacturer or state or local health departments for guidance on whether the vaccine is usable.137 201
Specific Populations
Pregnancy
Category C.77 144 174 223 Not labeled by FDA for use in adults144 174 223 and not usually recommended for this age group.93 125 146 164 170 198
Lactation
Not labeled by FDA for use in adults144 174 223
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