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Meningococcal Group B Vaccine

Pronunciation

(me NIN joe kok al groop bee vak SEEN)

Index Terms

  • 4CMenB
  • MenB
  • MenB-4C
  • MenB-FHbp
  • rLP2086

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Suspension Prefilled Syringe, Intramuscular:

Bexsero: (0.5 mL)

Trumenba: (0.5 mL) [contains polysorbate 80]

Brand Names: U.S.

  • Bexsero
  • Trumenba

Pharmacologic Category

  • Vaccine
  • Vaccine, Inactivated (Bacterial)

Pharmacology

Bexsero: Induces immunity against meningococcal disease caused by serogroup B Neisseria meningitidis (MenB) via the formation of antibodies directed toward the recombinant protein antigens combined together with outer membrane vesicles (OMV) from a group B strain.

Trumenba: Protection against invasive meningococcal disease is conferred mainly by complement-mediated antibody-dependent killing of N. meningitidis.

Efficacy:

Bexsero: Composite hSBA titer response one month after the second dose: 63% to 88%

Trumenba: 84% of adolescents had a ≥4-fold rise in hSBA titer and composite response after the third dose.

Use: Labeled Indications

Meningococcal disease prevention:

US labeling: Active immunization of children, adolescents, and adults aged 10 to 25 years against invasive meningococcal disease caused by N. meningitidis serogroup B.

The Advisory Committee on Immunization Practices (ACIP) recommends routine vaccination of certain groups of persons ≥10 years of age (ACIP [Folaranmi 2015]):

- Persons with persistent complement component deficiencies (including patients who are taking eculizumab [Solaris])

- Persons with anatomic or functional asplenia (including sickle cell disease)

- Microbiologists routinely exposed to isolates of Neisseria meningitides

- Persons identified to be at increased risk due to a serogroup B meningococcal disease outbreak

The ACIP states that a meningococcal group B vaccination series may be administered to adolescents and young adults aged 16 to 23 years to provide short term protection against most strains of serogroup B meningococcal disease. The preferred age for vaccination is 16 to 18 years (ACIP [MacNeil 2015]).

Canadian labeling: Additional ages (not in US labeling): Bexsero: Indicated for infants ≥2 months, children, and adolescents through 17 years

Contraindications

Severe hypersensitivity to the meningococcal group B vaccine or any component of the formulation

Dosing: Adult

Meningococcal group B disease prevention:

US labeling (Bexsero): Adults ≤25 years: IM: 0.5 mL/dose given as a 2-dose series at least 1 month apart

US labeling (Trumenba): Adults ≤25 years: Note: Consider risk of exposure and patient’s susceptibility to the disease when choosing a schedule.

2-dose schedule: IM: 0.5 mL per dose given as a 2-dose series according to a 0- and 6-month schedule.

3-dose schedule: IM: 0.5 mL per dose given as a 3-dose series at 0-, 1- to 2-, and 6-months.

ACIP recommendations:

Routine vaccination is recommended for unvaccinated adults with any of the following: Persistent complement component deficiencies (including patients who are taking eculizumab [Solaris]), anatomic or functional asplenia, microbiologists routinely exposed to isolates of Neisseria meningitides, or persons identified to be at increased risk due to a serogroup B meningococcal disease outbreak (ACIP [Folaranmi 2015]).

A vaccination series may be administered to unvaccinated adults ≤23 years to provide short term protection against most strains of serogroup B meningococcal disease (ACIP [MacNeil 2015]).

Dosing: Pediatric

Meningococcal group B disease prevention:

US labeling (Bexsero): Children ≥10 years and Adolescents: IM: 0.5 mL/dose given as a 2-dose series at least 1 month apart

US labeling (Trumenba): Children ≥ 10 years and Adolescents: Note: Consider risk of exposure and patient’s susceptibility to the disease when choosing a schedule.

2-dose schedule: IM: 0.5 mL per dose given as a 2-dose series according to a 0- and 6-month schedule.

3-dose schedule: IM: 0.5 mL per dose given as a 3-dose series according to a 0-, 1- to 2-, and 6-month schedule.

ACIP recommendations:

Children ≥10 years and Adolescents: Routine vaccination is recommended for children ≥10 years and adolescents with any of the following: Persistent complement component deficiencies (including patients who are taking eculizumab [Solaris]), anatomic or functional asplenia, microbiologists routinely exposed to isolates of Neisseria meningitides, or persons identified to be at increased risk due to a serogroup B meningococcal disease outbreak (ACIP [Folaranmi 2015]).

A vaccination series may be administered to adolescents ≥16 years to provide short term protection against most strains of serogroup B meningococcal disease (ACIP [MacNeil 2015]).

Canadian labeling (Bexsero):

Infants 2 to 5 months: IM: Total of 4 doses (0.5 mL each); a primary infant series is administered at 2, 4, and 6 months of age followed by a booster dose between 12 to 23 months of age; alternatively, may give first 3 doses at 2, 3, and 4 months of age, however, the immune response to 1 component (NHBA) of the vaccine is reduced with this regimen

Infants 6 months to <12 months (unvaccinated): IM: Total of 3 doses (0.5 mL each) with first and second dose administered at least 2 months apart; third dose is administered during second year of life at least 2 months after the second dose. The necessity of a booster dose has not been determined.

Children ≥1 year to <2 years (unvaccinated): IM: Total of 2 doses (0.5 mL each) administered at least 2 months apart. The necessity of a booster dose has not been determined.

Children ≥2 years to <11 years: IM: Total of 2 doses (0.5 mL each) administered at least 2 months apart. The necessity for subsequent dosing has not been determined.

Children ≥11 years to Adolescents ≤17 years: IM: Total of 2 doses (0.5 mL each) administered at least 1 month apart. The necessity for subsequent dosing has not been determined.

Dosing: Renal Impairment

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Hepatic Impairment

There are no dosage adjustments provided in the manufacturer's labeling.

Reconstitution

Shake vigorously to ensure that a homogenous white suspension is obtained. Do not use the vaccine if it cannot be resuspended.

Administration

For IM administration only, preferably into the anterolateral aspect of the thigh in infants (Bexsero [Canadian product]) and in the upper deltoid region in children, adolescents, or adults (Bexsero or Trumenba). Do not administer via IV, SubQ, or intradermal route. To prevent syncope related injuries, adolescents and adults should be vaccinated while seated or lying down (NCIRD/ACIP 2011). US law requires that the date of administration, the vaccine manufacturer, lot number of vaccine, and the administering person's name, title, and address be entered into the patient's permanent medical record.

For patients at risk of hemorrhage, the vaccine should be administered IM if, in the opinion of a health care provider familiar with the patient's bleeding risk, the vaccine can be administered by this route with reasonable safety. If the patient receives antihemophilia or other similar therapy, IM vaccination can be scheduled shortly after such therapy is administered. A fine needle (23-gauge or smaller) can be used for the vaccination and firm pressure applied to the site (without rubbing) for at least 2 minutes. The patient or family should be instructed concerning the risk of hematoma from the injection. Patients on anticoagulant therapy should be considered to have the same bleeding risks and treated as those with clotting factor disorders (NCIRD/ACIP 2011).

Compatibility

Do not mix with other vaccines or injections. Separate needles and syringes should be used for each injection.

Storage

Bexsero: Store between 2°C to 8°C (36°F to 46°F). Do not freeze; discard if frozen. Protect from light.

Trumenba: Store between 2°C to 8°C (36°F to 46°F). Do not freeze; discard if frozen. Store syringes in the refrigerator horizontally (laying flat on the shelf) to minimize the redispersion time.

Drug Interactions

Belimumab: May diminish the therapeutic effect of Vaccines (Inactivated). Management: Patients should receive inactivated vaccines prior to initiation of belimumab therapy whenever possible, due to the risk for an impaired response to the vaccine during belimumab therapy. Consider therapy modification

Fingolimod: May diminish the therapeutic effect of Vaccines (Inactivated). Management: Vaccine efficacy may be reduced. Complete all age-appropriate vaccinations at least 2 weeks prior to starting fingolimod. If vaccinated during fingolimod therapy, revaccinate 2 to 3 months after fingolimod discontinuation. Consider therapy modification

Immunosuppressants: May diminish the therapeutic effect of Vaccines (Inactivated). Management: Vaccine efficacy may be reduced. Complete all age-appropriate vaccinations at least 2 weeks prior to starting an immunosuppressant. If vaccinated during immunosuppressant therapy, revaccinate at least 3 months after immunosuppressant discontinuation. Exceptions: Cytarabine (Liposomal). Consider therapy modification

Venetoclax: May diminish the therapeutic effect of Vaccines (Inactivated). Monitor therapy

Adverse Reactions

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 or online at https://vaers.hhs.gov/esub/index. In Canada, adverse reactions may be reported to local provincial/territorial health agencies or to the Vaccine Safety Section at Public Health Agency of Canada (1-866-844-0018). Frequencies reported may include concomitant administration with routine pediatric vaccines or other vaccines.

>10%:

Central nervous system: Irritability (infants and children ≤10 years: 43% to 79%), drowsiness (infants and children <2 years: 53% to 72%; children 2 to 10 years: 30% to 51%), excessive crying (infants and children <2 years: 56% to 69%; children 2 to 10 years: 27% to 33%), fatigue (children ≥10 years, adolescents, and adults: 35% to 62%), headache (10 to 25 years: 33% to 55%; children 2 to 10 years: 10% to 20%; adults >14%), malaise (children and adolescents 11 to 17 years: 50% to 56%; adults: 14%), chills (children and adolescents 11 to 17 years: 16% to 29%)

Gastrointestinal: Change in appetite (infants and children ≤10 years: 21% to 51%), diarrhea (children 2 to 10 years: 2% to 37%; infants and children <2 years: 18% to 24%; children and adolescents 11 to 17: years 9% to 15%), nausea (children ≥10 years, adolescents, and adults: 16% to 19%), vomiting (infants, children, and adolescents: ≤13%)

Local: Pain at injection site (children ≥2 years, adolescents, and adults: 82% to 98%), erythema at injection site (children 2 to 10 years: 60% to 98%; infants and children <2 years: 60% to 64%; children ≥10 years, adolescents, and adults 45% to 54%), tenderness at injection site (children 2 to 10 years: 81% to 89%; infants and children <2 years: 65% to 66%), swelling at injection site (children 2 to 10 years: 26% to 63%; children and adolescents 11 to 17 years: 18% to 39%; infants and children <2 years: 26% to 31%), induration at injection site (infants and children ≤10 years: 33% to 56%; children ≥10 years, adolescents, and adults: 28% to 40%)

Neuromuscular & skeletal: Myalgia (children ≥10 years, adolescents, and adults: 31% to 57%), arthralgia (children ≥2 years, adolescents, and adults: 13% to 33%)

Miscellaneous: Fever (infants and children <2 years: 69% to 79%, ≥40°C [104°F] ≤1%; children 2 to 10 years: 10% to 28%, ≥40°C [104°F] ≤3%; children 10 years, adolescents, and adults: 1% to 8%)

1% to 10%:

Dermatologic: Skin rash (children 2 to 10 years: ≤9%), urticaria (infants and children <2 years: 5% to 6%)

Respiratory: Upper respiratory tract infection (infants ≤7 months: 10%; mostly considered unrelated to vaccination), nasopharyngitis (children ≥10 years, adolescents, and adults: ≥2%)

<1% (limited to important or life-threatening): Eczema (infants and children <2 years), febrile seizures (infants and children <2 years), hypersensitivity reaction (includes anaphylaxis), injection site blister formation, Kawasaki syndrome (infants and children <2 years), pallor (infants and children <2 years), seizure (infants and children <2 years), syncope, vasodepressor syncope

Warnings/Precautions

Concerns related to adverse effects:

• Anaphylactoid/hypersensitivity reactions: Immediate treatment (including epinephrine 1 mg/mL) for anaphylactoid and/or hypersensitivity reactions should be available during vaccine use (NCIRD/ACIP 2011).

• Apnea: Post immunization apnea may occur in premature infants, particularly if history of respiratory immaturity.

• Syncope has been reported with use of injectable vaccines and may result in serious secondary injury (eg, skull fracture, cerebral hemorrhage); typically reported in adolescents and young adults and within 15 minutes after vaccination. Procedures should be in place to avoid injuries from falling and to restore cerebral perfusion if syncope occurs (NCIRD/ACIP 2011).

Disease-related concerns:

• Acute illness: The decision to administer or delay vaccination because of current or recent febrile illness depends on the severity of symptoms and the etiology of the disease. Consider deferring administration in patients with moderate or severe acute illness (with or without fever); vaccination should not be delayed for patients with mild acute illness (with or without fever) (NCIRD/ACIP 2011).

• Bleeding disorders: Use with caution in patients with bleeding disorders (including thrombocytopenia) and patients on anticoagulant therapy; bleeding/hematoma may occur from IM administration; if the patient receives antihemophilia or other similar therapy, IM injection can be scheduled shortly after such therapy is administered (NCIRD/ACIP 2011).

• Meningococcal infections: Not to be used to treat meningococcal infections or to provide immunity against N. meningitidis serogroups A, C, W-135, or Y. In addition, vaccine does not provide protection against all circulating meningococcal group B strains.

Concurrent drug therapy issues:

• Vaccines: In order to maximize vaccination rates, the ACIP recommends simultaneous administration (ie, >1 vaccine on the same day at different anatomic sites) of all age-appropriate vaccines (live or inactivated) for which a person is eligible at a single clinic visit, unless contraindications exist. The ACIP prefers each dose of a specific vaccine in a series come from the same manufacturer when possible (NCIRD/ACIP 2011).

Special populations:

• Altered immunocompetence: Use with caution in severely immunocompromised patients (eg, patients receiving chemo/radiation therapy or other immunosuppressive therapy [including high-dose corticosteroids]); may have a reduced response to vaccination. In general, household and close contacts of persons with altered immunocompetence may receive all age appropriate vaccines (IDSA [Rubin 2014]; NCIRD/ACIP 2011); inactivated vaccines should be administered ≥2 weeks prior to planned immunosuppression when feasible (IDSA [Rubin 2014]).

• Pediatric: Apnea has occurred following intramuscular vaccine administration in premature infants; consider clinical status implications. In general, preterm infants should be vaccinated at the same chronological age as full-term infants (NCIRD/ACIP 2011).

Dosage form specific issues:

• Kanamycin: May contain kanamycin.

• Latex: The packaging (needle cover of prefilled syringe) may contain latex.

• Polysorbate 80: Some dosage forms may contain polysorbate 80 (also known as Tweens). Hypersensitivity reactions, usually a delayed reaction, have been reported following exposure to pharmaceutical products containing polysorbate 80 in certain individuals (Isaksson, 2002; Lucente 2000; Shelley 1995). Thrombocytopenia, ascites, pulmonary deterioration, and renal and hepatic failure have been reported in premature neonates after receiving parenteral products containing polysorbate 80 (Alade 1986; CDC 1984). See manufacturer’s labeling.

Other warnings/precautions:

• Antipyretics: Antipyretics have not been shown to prevent febrile seizures; antipyretics may be used to treat fever or discomfort following vaccination (NCIRD/ACIP 2011). One study reported that routine prophylactic administration of acetaminophen to prevent fever prior to vaccination decreased the immune response of some vaccines; the clinical significance of this reduction in immune response has not been established (Prymula 2009).

• Appropriate use: Use of this vaccine for specific medical and/or other indications (eg, immunocompromising conditions, hepatic or kidney disease, diabetes) is also addressed in the ACIP Recommended Adult Immunization Schedule (ACIP [Kim 2016]).

• Effective immunity: Vaccination may not result in effective immunity in all patients. Response depends on multiple factors (eg, type of vaccine, age of patient) and may be improved by administering the vaccine at the recommended dose, route, and interval. Vaccines may not be effective if administered during periods of altered immune competence (NCIRD/ACIP 2011).

Monitoring Parameters

Respiratory function for 48 to 72 hours following vaccination in premature infants (particularly if born ≤28 weeks gestation or if prior history of respiratory immaturity). Monitor for syncope for 15 minutes following administration (NCIRD/ACIP 2011). If seizure-like activity associated with syncope occurs, maintain patient in supine or Trendelenburg position to reestablish adequate cerebral perfusion.

Pregnancy Risk Factor

B

Pregnancy Considerations

Adverse events were not observed in animal reproduction studies. The manufacturer notes that vaccination should not be withheld in pregnant women at clear risk for infection. Inactivated vaccines have not been shown to cause increased risks to the fetus (NCIRD/ACIP 2011).

Health care providers are encouraged to enroll women exposed to Bexsero during pregnancy (1-877-683-4732).

Patient Education

• Discuss specific use of vaccine and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience injection site pain or irritation, loss of strength and energy, headache, muscle pain, joint pain, chills, diarrhea, or nausea. Have patient report immediately to prescriber shortness of breath, severe dizziness, or passing out (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for healthcare professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience and judgment in diagnosing, treating and advising patients.

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