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Meningococcal B Disease

Ask the Experts: Diseases & Vaccines

Meningococcal B Disease

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Please tell us about meningococcal disease.
Meningococcal disease is a bacterial infection caused by Neisseria meningitidis. Meningococcal disease usually presents clinically as meningitis (about 50% of cases), bacteremia (38% of cases), or bacteremic pneumonia (9% of cases). N. meningitidis colonizes mucosal surfaces of the nasopharynx and is transmitted through direct contact with large-droplet respiratory tract secretions from patients or asymptomatic carriers. Meningococcal disease can be severe. The overall case-fatality ratio is 10%–15%, and 20% of survivors have long-term sequelae such as neurologic disability, limb or digit loss, and hearing loss.
N. meningitidis is classified into at least 13 serogroups based on characteristics of the polysaccharide capsule. Most invasive disease (such as meningitis and sepsis) is caused by serogroups A, B, C, W, and Y. The relative importance of serogroups depends on geographic location and other factors such as age. Serogroups B, C, and Y are the most frequent causes of disease in the U.S., each accounting for about one third of reported cases. Serogroup A is common in Sub-Saharan Africa but is rare in the U.S.
Nasopharyngeal carriage rates are highest in adolescents and young adults who serve as reservoirs for transmission of N. meningitidis.
How common is meningococcal disease?
The incidence of meningococcal disease has declined since a peak of reported disease in the late 1990s. Even before routine use of a meningococcal conjugate vaccine (MenACWY) in adolescents was recommended in 2005, the overall annual incidence of meningococcal disease had decreased 64%, from 1.1 cases per 100,000 population in 1996 to 0.4 cases per 100,000 population in 2005. Since 2005, declines have occurred among all age groups and in all vaccine-contained serogroups. In addition, incidence of disease caused by serogroup B, a serogroup not included in MenACWY, declined for reasons that are not known.
During 2005–2011, an estimated 800–1,200 cases of meningococcal disease occurred annually in the United States, representing an incidence of 0.3 cases per 100,000 population. A total of 372 cases was reported in 2015. Of those with known serogroup (N=152) 52% were serogroups A, C, Y or W-135 (primarily serogroups C and Y) and 48% were serogroup B.
What are the risk factors for meningococcal disease?
For all meningococcal serogroups risk factors include age, functional or anatomic asplenia, persistent complement component deficiency (an immune system disorder) including that caused by eculizumab (Soliris, Alexion Pharmaceuticals) used for treatment of atypical hemolytic uremic syndrome or paroxysmal nocturnal hemoglobinuria (the drug binds to C5 and inhibits the terminal complement pathway), and occupation as a microbiologist in a laboratory that works with meningococcal isolates.
Certain groups are at increased risk for meningococcal serogroups A, C, W, and Y but not serogroup B. These risk factors include HIV infection, travel to places where meningococcal disease is common (such as certain countries in Africa and in Saudi Arabia), and college students living in a dormitory. Other risk factors for serogroups A, C, W. and Y include having a previous viral infection, living in a crowded household, having an underlying chronic illness, and being exposed to cigarette smoke (either directly or second-hand).
Vaccine Recommendations
What meningococcal vaccines are available in the United States?
Two types of meningococcal vaccines are available in the United States that protect against meningococcal serogroups A, C, W, and Y: 1) meningococcal polysaccharide vaccine (MPSV4; Menomune, Sanofi Pasteur), which is made up of polysaccharide (sugar molecules) from the surface of the meningococcal bacteria; and 2) meningococcal conjugate vaccines (MenACWY; Menactra, Sanofi Pasteur; Menveo, GlaxoSmithKline) in which the polysaccharide is chemically bonded ("conjugated") to a protein to produce a better immune response to the polysaccharide. MenACWY is more effective in young children than the original polysaccharide vaccine. Menhibrix (GSK), licensed in 2012, contained conjugated polysaccharides of N. meningitidis serogroups C and Y and Haemophilus influenzae type b and was approved by the U.S. Food and Drug Administration for use in children age 6 weeks through 18 months. The manufacturer discontinued distribution of Menhibrix in the U.S. in 2016.
Since late 2014, vaccines have become available that offer protection from meningococcal serogroup B disease. These vaccines are composed of proteins found on the surface of the bacteria.
MPSV4 and MenACWY provide no protection against serogroup B disease, and meningococcal serogroup B vaccines (MenB) provide no protection against serogroup A, C, W, or Y disease. For protection against all 5 serogroups of meningococcus, it is necessary to receive MenACWY or MPSV4 and MenB. No currently available meningococcal vaccine contains live meningococcal bacteria.
Trade Name Type of Vaccine Serogroups Included Year Licensed Approved Ages
Menomune Polysaccharide A, C, W, Y 1981 2 years and older
Menactra Conjugate A, C, W, Y 2005 9 months–55 years*
Menveo Conjugate A, C, W, Y 2010 2 months–55 years*
Trumenba Protein B 2014 10–25 years+
Bexsero Protein B 2015 10–25 years+
*May be given to people age 56 years or older (consult ACIP recommendations at www.cdc.gov/mmwr/pdf/rr/rr6202.pdf).
+May be given to people age 26 years or older (consult ACIP recommendations at www.cdc.gov/mmwr/pdf/wk/mm6422.pdf).
Where can I find the most current meningococcal vaccine recommendations?
The most current comprehensive recommendations from the Advisory Committee on Immunization Practices (ACIP) for meningococcal polysaccharide and conjugate vaccines, which include serogroups A, C, W, and Y, were published in March 2013. This document is available on the MMWR website at www.cdc.gov/mmwr/pdf/rr/rr6202.pdf. Recommendations for use of MenACWY among people with HIV infection were published in November 2016 and are available at www.cdc.gov/mmwr/volumes/65/wr/pdfs/mm6543.pdf, pages 1189–94. Recommendations for use of MenB among persons at increased risk were published in June 2015 and are available at www.cdc.gov/mmwr/pdf/wk/mm6422.pdf, pages 608–12. MenB recommendations for healthy adolescents and young adults were published in October 2015 and are available at www.cdc.gov/mmwr/pdf/wk/mm6441.pdf, pages 1171–6.
Who is recommended to be vaccinated against meningococcal B disease?
MenB is routinely recommended for these groups:
People age 10 years and older who have functional or anatomic asplenia
  People age 10 years and older who have persistent complement component deficiency, including people taking eculizumab (Soliris)
  People age 10 years and older who are at risk during an outbreak caused by a vaccine serogroup, such as on college campuses
  Microbiologists who work with meningococcus bacteria in a laboratory
For adolescents and young adults, ACIP recommends that a MenB series may be administered to people 16 through 23 years of age with a preferred age of vaccination of 16 through 18 years. This Category B recommendation allows the clinician to make a MenB recommendation based on the risk and benefit for the individual patient.
ACIP now designates a vaccine recommendation as either Category "A" or "B." My interpretation is that an A recommendation means the vaccine is routinely recommended for all people in an age or risk group, and a B recommendation is for use at the clinician's discretion. Does the Affordable Care Act (ACA) require health plans (non-grandfathered) to provide benefit coverage on Category B recommended vaccines?
Your understanding of A and B recommendations is correct. ACA requires coverage of vaccines with both Category A and B recommendations. The Vaccines For Children program also covers vaccines with a Category B recommendation.
The ACIP recommendations for meningococcal serogroup B (MenB) vaccine say the vaccine will provide "short term protection." What does "short term protection" mean?
MenB vaccines were approved based on the serologic response to the vaccine. No data are available on vaccine effectiveness against clinical disease or duration of protection against clinical disease. Short term protection refers to the known duration of the antibody response. Available data indicate that a protective antibody level should persist in most recipients for 24 to 48 months after vaccination. This issue will continue to be monitored. For more information, see www.cdc.gov/mmwr/pdf/wk/mm6441.pdf, pages 1171–5.
Should college students be vaccinated against meningococcal serogroup B disease?
Although several small outbreaks have occurred on college campuses since 2013, college students in general are not at higher risk of meningococcal serogroup B disease than persons of the same age who are not college students. Consequently, ACIP does not routinely recommend MenB for college students. However, college students may choose to receive MenB to reduce their risk of meningococcal serogroup B disease.
What is the schedule for MenB?
Trumenba (Pfizer) is either a 2-dose series with doses administered at least 6 months apart or a 3-dose series with the second and third doses administered 1-2 and 6 months after the first dose. Bexsero (GSK) is a 2-dose series with doses given at least 1 month apart.
Which patients should receive a 2-dose schedule of Trumenba?
Healthy adolescents who are not at increased risk for meningococcal disease should receive 2 doses of Trumenba administered at 0 and 6 months. If the second dose is given at an interval of less than 6 months, a third dose should be given at least 6 months after the first dose. The minimum interval between the second and third doses is 4 weeks.
For persons at increased risk for meningococcal disease (those with functional or anatomic asplenia or persistent complement component deficiency, including people taking eculizumab (Soliris), and microbiologists who work with meningococcus bacteria in a laboratory) and for use during serogroup B outbreaks, 3 doses of Trumenba should be administered at 0, 1-2, and 6 months.
A microbiologist in our facility received 2 doses of Trumenba 6 months apart. Does he need to receive a third dose?
No. The 3-dose series (at 0, 1-2 and 6 months) is intended to rapidly induce immunity to serogroup B meningococcal bacteria. If a microbiologist or other person at increased risk has received 2 doses of Trumenba separated by 6 months their vaccine series can be considered to be complete.
I have a patient who was given Trumenba in August. Two months later she was given a dose of Bexsero. How should I proceed with her MenB vaccination series? We stock both vaccines.
The ACIP meningococcal serogroup B vaccine recommendations (www.cdc.gov/mmwr/pdf/wk/mm6441.pdf, pages 1171–6) state that the same vaccine must be used for all doses in the MenB series. So the clinician needs to complete a series with one or the other vaccine. If a person has already received 1 dose of Bexsero and one of Trumenba, then pick a brand and finish a recommended schedule with that brand. Ignore the extra dose of the other product. The next dose in the series (either Trumenba or Bexsero) should be separated from the previous dose of Bexsero by at least 1 month.
Can you provide a comprehensive overview of the MenB recommendations?
IAC has prepared a document that provides a summary of the ACIP recommendations for use of MenB. The document is available at www.immunize.org/catg.d/p2035.pdf.
Are the two MenB vaccines interchangeable?
No. The ACIP meningococcal serogroup B vaccine recommendations (www.cdc.gov/mmwr/pdf/wk/mm6441.pdf, pages 1171–6) state that the same vaccine must be used for all doses in the MenB series.
For People with Risk Factors Back to top
Do any of the bacterial vaccines that are recommended for people with functional or anatomic asplenia need to be given before splenectomy? Do the doses count if they are given during the 2 weeks prior to surgery?
Pneumococcal conjugate vaccine (PCV13), Haemophilus influenzae type b vaccine, meningococcal conjugate vaccine, and meningococcal B vaccine should be given 14 days before splenectomy, if possible. Doses given during the 2 weeks (14 days) before surgery can be counted as valid. If the doses cannot be given prior to the splenectomy, they should be given as soon as the patient's condition has stabilized after surgery. Pneumococcal polysaccharide vaccine should be administered 8 weeks after the dose of PCV13 for people 2 years of age and older.
I have a patient with paroxysmal nocturnal hemoglobinuria who is being treated with Soliris (eculizumab). Should he receive meningococcal vaccine?
Eculizumab binds to C5 and inhibits the terminal complement pathway. Persons with persistent complement component deficiency are at increased risk for meningococcal disease. This person should receive a series of both quadrivalent meningococcal conjugate (2 doses separated by at least 8 weeks) and a 2 or 3 dose series (depending on brand) of meningococcal serogroup B vaccine.
We have a 10-year-old getting renal dialysis. The nephrologist will be starting her on a monoclonal antibody that interferes with C5 complement. If we administer MenACWY and pneumococcal polysaccharide vaccine (PPSV23) now, and then give her PCV13 in 8 weeks, will the PCV13 interfere with the efficacy of the PPSV23 or the MenACWY?
Recommendations to separate MenACWY and PCV13 only apply to persons with functional or anatomic asplenia. So the best schedule is to give MenACWY (either brand) simultaneously with PCV13, and then PPSV23 in eight weeks. ACIP recommends giving PCV13 before PPSV23 in order to maximize the immune response from PCV13. PPSV23 may blunt the immune response to PCV13 if PCV13 is given after PPSV23, although in children there is a smaller effect than in adults. A 10 year-old with persistent complement component deficiency should also receive a 2 or 3 dose series (depending on brand) of meningococcal B vaccine.
Are people who are HIV-positive in a risk group for meningococcal disease?
Yes. Accumulating evidence indicates that HIV infection increases the risk of meningococcal disease. ACIP recommends routine MenACWY vaccination of people with HIV infection. People age 2 years and older with HIV infection who have not been previously vaccinated should receive a 2-dose primary series of MenACWY administered 2 months apart followed by booster doses every 5 years. ACIP does not recommend routine MenB vaccination of people with HIV infection.
I have a 7-year-old patient with congenital asplenia. She has already received PCV13 and meningococcal conjugate vaccine. Would you consider giving her meningococcal B vaccine?
Use of either meningococcal serogroup B vaccine in persons younger than age 10 years is off-label in the U.S. There is currently no ACIP recommendation for use of this vaccine for this age group. However, Bexsero brand meningococcal B vaccine has been studied among infants and is approved for infants by the European Medicines Agency (the European version of the U.S. Food and Drug Administration). It is routinely recommended for infants in the United Kingdom (see www.nhs.uk/conditions/vaccinations/pages/meningitis-b-vaccine.aspx for details). A clinician may choose to use a vaccine off-label if, in their opinion, the benefit of the vaccine exceeds the risk from the vaccine. Product information for Bexsero can be found on the European Medicines Agency website at www.ema.europa.eu/ema.
Are microbiologists recommended to receive meningococcal B vaccine? And if so, how frequently?
ACIP recommends that microbiologists who work with meningococcus bacteria in a laboratory receive both MenB and MenACWY vaccines. MenB can be given at the same time as any other vaccine. You can administer either two doses of Bexsero 4 weeks apart, or three doses of Trumenba on a 0-, 1–2-, and 6- month schedule. There is currently no recommendation for a booster dose of MenB vaccine for any age or risk group.
We have a 19-year-old patient with a history of vasculitis, nephritis, and asthma. She is on azathioprine (Imuran) and is immunosuppressed. Her rheumatologist recommends she receive pneumococcal conjugate vaccine (PCV13, Prevnar 13, Pfizer) and meningococcal B vaccine. How often should these vaccines be given? Will she require a series of PCV13 doses or just a booster?
For people with iatrogenic immunosuppression, ACIP recommends 1 dose of PCV13 followed by a dose of PPSV23 at least 8 weeks later (see www.cdc.gov/mmwr/pdf/wk/mm6434.pdf, pages 944–7). Meningococcal serogroup B vaccine (MenB) is not specifically recommended for immunosuppressed people. However, people age 16 through 23 years who are not at increased risk may receive routine MenB vaccination (a category B recommendation) of either a 2-dose series of Bexsero (GSK) 4 weeks apart, or a 2-dose series of Trumenba (Pfizer) 6 months apart.
I have a 9-year-old patient traveling to Kenya for one week. In addition to MenACWY vaccine, should she be offered meningococcal serogroup B (MenB) vaccine?
ACIP does not recommend routine MenB vaccination for travel to countries in sub-Saharan Africa or to other countries for which MenACWY vaccine is recommended. Meningococcal disease in these areas is generally not caused by serogroup B.
Booster Doses Back to top
Which groups should receive a booster dose of MenB?
ACIP does not currently recommend booster doses of MenB for any group.
Administering Vaccine Back to top
By what route should meningococcal vaccines be administered?
All meningococcal conjugate vaccines should be administered by the intramuscular route. MPSV4 should be given by the subcutaneous route. MenB is given by the intramuscular route.
Can MenACWY and MenB vaccines be given at the same visit?
MenB and MenACWY vaccines can be administered at the same visit or at any interval before or after each other. There is no need for spacing between these two vaccines.
Vaccine Safety Back to top
What adverse events are expected after receiving MenB?
In clinical trials the most common adverse events within 7 days of receiving MenB were injection site pain, swelling or redness (80%%–90% of recipients). Up to 30% of recipients considered the pain to be severe. Other reported symptoms included fatigue (35%–40%), headache (33%%–35%), and myalgia (30%%–49%). In general adverse events were more frequent with the first dose than with subsequent doses.
Is MenB included in the National Vaccine Injury Compensation Program?
No. The National Vaccine Injury Compensation Program includes payment only for injuries determined to have occurred following vaccination with a vaccine routinely recommended for children in the United States. The recipient can be of any age, but the vaccine must be routinely recommended for children and teens through age 18 years. MenB is not routinely recommended for children; it is recommended only for select high-risk groups of children and adults. More information about the program and the covered vaccines is at www.hrsa.gov/vaccinecompensation/coveredvaccines/index.html.
Contraindications and Precautions Back to top
What are the contraindications and precautions for MenB?
As with all vaccines, a severe allergic reaction (for example, anaphylaxis) to a vaccine component or to a prior dose is a contraindication to further doses of that vaccine. The tip caps of the Bexsero pre-filled syringes contain natural rubber latex which may cause allergic reactions in latex sensitive individuals. A moderate or severe acute illness is a precaution; vaccination should be deferred until the person’s condition has improved. Because MenB is an inactivated vaccine it can be administered to persons who are immunosuppressed as a result of disease or medications; however, response to the vaccine might be less than optimal.
Can a pregnant woman receive MenB vaccine?
Few data are available on the effect of MenB vaccines on pregnancy. The manufacturers do not consider pregnancy to be a contraindication to use of MenB. GlaxoSmithKline has established a Vaccination in Pregnancy registry. Women who receive Bexsero during pregnancy are encouraged to participate in the registry by calling 877-683-4732. Pfizer has not established a Vaccination in Pregnancy registry for Trumenba.
Vaccine Storage and Handling Back to top
What is the storage requirements for MenB?
Store at MenB at refrigerator temperature, 2° to 8°C (36° to 46°F). The vaccines must not be frozen. Vaccine that has been frozen or exposed to freezing temperature should not be used. Do not use after the expiration date.
 
This page was updated on April 14, 2017.
This page was reviewed on January 12, 2017.
 
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