Dosing and uses of Trumenba, Bexsero (meningococcal group B vaccine)
Adult dosage forms and strengths
IM suspension
- 0.5mL/syringe
Meningococcal Serogroup B Immunization
Indicated for active immunization to prevent invasive meningococcal disease caused by Neisseria meningitidis serogroup B in individuals aged 10 through 25 yr
Trumenba: 0.5 mL IM as a 3-dose series at months 0, 2, and 6
Bexsero: 0.5 mL IM as a 2-dose series administered at least 1 month apart
ACIP recommendations
- The Advisory Committee on Immunization Practice (ACIP) from the Center for Disease Control and Prevention (CDC) recommends serogroup B meningococcal vaccination (in addition to the current meningococcal vaccines which covers serogroups A, C, Y and W-135) to high risk population aged ≥10 yr
- High risk populations
- People with persistent complement component deficiencies
- Persons receiving the drug eculizumab (Soliris) also are at increased risk because the drug binds to C5 and inhibits the terminal complement pathway
- Patients with anatomic or functional asplenia
- Microbiologists who are regularly exposed to Neisseria meningitidis isolates
- People at increased risk owing to an outbreak of serogroup B meningococcal disease
- NOTE: The vaccine is not currently recommended for routine use in first-year college students living in residence halls, military recruits, or all adolescents; physicians should determine vaccination needs for 16-23 year olds on an individual basis; recommendations for broader use of MenB vaccines in adolescents and college students will be considered separately by the ACIP
- Reference: MMWR Morb Mortal Wkly Rep. June 12, 2015/64(22);608-12
Dosing Considerations
Approval for each vaccine was based on the demonstration of immune response, as measured by serum bactericidal activity against 4 serogroup B strains representative of prevalent strains in the United States
Trumenba: Vaccine is a suspension composed of 2 recombinant lipidated factor H binding protein (fHbp) variants from N meningitidis serogroup B – 1 from fHbp subfamily A and 1 from subfamily B (A05 and B01, respectively)
Bexsero: Vaccine is a suspension composed of 4 distinct antigens including factor H binding protein (fHbp), Neisserial adhesin A (NadA), Neisserial heparin-binding antigen (NHBA), and PorA P1.4 immunodominant antigen of OMV NZ (strain NZ98/254)
Pediatric dosage forms and strengths
IM suspension
- 0.5mL/syringe
Meningococcal Serogroup B Immunization
Indicated for active immunization to prevent invasive meningococcal disease caused by Neisseria meningitidis serogroup B in individuals aged 10 through 25 yr
<10 years: Safety and efficacy not established
Trumenba: 0.5 mL IM as a 3-dose series at months 0, 2, and 6
Bexsero: 0.5 mL IM as a 2-dose series administered at least 1 month apart
ACIP recommendations
- The Advisory Committee on Immunization Practice (ACIP) from the Center for Disease Control and Prevention (CDC) recommends serogroup B meningococcal vaccination (in addition to the current meningococcal vaccines which covers serogroups A, C, Y and W-135) to high risk population aged ≥10 yr
- High risk populations
- People with persistent complement component deficiencies
- Persons receiving the drug eculizumab (Soliris) also are at increased risk because the drug binds to C5 and inhibits the terminal complement pathway
- Patients with anatomic or functional asplenia
- Microbiologists who are regularly exposed to Neisseria meningitidis isolates
- People at increased risk owing to an outbreak of serogroup B meningococcal disease
- NOTE: The vaccine is not currently recommended for routine use in first-year college students living in residence halls, military recruits, or all adolescents; physicians should determine vaccination needs for 16-23 year olds on an individual basis; recommendations for broader use of MenB vaccines in adolescents and college students will be considered separately by the ACIP
- Reference: MMWR Morb Mortal Wkly Rep. June 12, 2015/64(22);608-12
Dosing Considerations
Approval for each vaccine was based on the demonstration of immune response, as measured by serum bactericidal activity against 4 serogroup B strains representative of prevalent strains in the United States
Trumenba: Vaccine is a suspension composed of 2 recombinant lipidated factor H binding protein (fHbp) variants from N meningitidis serogroup B – 1 from fHbp subfamily A and 1 from subfamily B (A05 and B01, respectively)
Bexsero: Vaccine is a suspension composed of 4 distinct antigens including factor H binding protein (fHbp), Neisserial adhesin A (NadA), Neisserial heparin-binding antigen (NHBA), and PorA P1.4 immunodominant antigen of OMV NZ (strain NZ98/254)
Trumenba, Bexsero (meningococcal group B vaccine) adverse (side) effects
>10%
Trumenba
- Injection site pain (≥85%)
- Fatigue (≥40%)
- Headache (≥35%)
- Muscle pain (≥30%)
- Joint pain (17-21.6%)
- Chills (≥15%)
- Diarrhea (8.9-15.2%)
Bexsero
- Injection site pain (≥83%)
- Myalgia (≥48%)
- Erythema (≥45%)
- Fatigue (≥35%)
- Headache (≥33%)
- Induration (≥28%)
- Nausea (≥18%)
- Arthralgia (≥13%)
1-10%
Trumenba
- Vomiting (2.5-7.4%)
- Fever ≥38°C (1.1-6.4%)
Warnings
Contraindications
Severe allergic reaction after a previous dose of meningococcal B vaccine
Cautions
Epinephrine and other appropriate agents used to manage immediate allergic reactions must be immediately available should an acute anaphylactic reaction occur following administration
Syncope reported
Reduced immune response may occur in immunosuppressed individuals
Sufficient data are not available on the safety and effectiveness of interchanging meningococcal group B vaccines to complete the vaccination series
Bexsero: The tip caps of the prefilled syringes contain natural rubber latex which may cause allergic reactions in latex sensitive individuals (Trumenba's caps are not made with natural rubber latex)
Pregnancy and lactation
Pregnancy category: B
Lactation: Unknown if distributed in human breast milk
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 Trumenba, Bexsero (meningococcal group B vaccine)
Mechanism of action
Protection against invasive meningococcal disease is conferred mainly by complement-mediated antibody-dependent killing of N meningitidis
Administration
Preparation
Shake syringe vigorously to ensure that a homogenous white suspension is obtained
Do not use the vaccine if it cannot be resuspended
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit
Do not use if particulate matter or discoloration is found
IM Administration
Inject each 0.5-mL dose IM using a sterile needle attached to the supplied prefilled syringe
Preferred site for injection is the deltoid muscle of the upper arm
Do not mix with any other vaccine in the same syringe
Storage
Upon receipt, store refrigerated at 2-8°C (36-46°F)
Store syringes in the refrigerator horizontally (ie, lay flat on the shelf) to minimize the redispersion time
Do not freeze
Discard if the vaccine has been frozen
