Meningococcal vaccine

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Meningococcal vaccine
Vaccine description
Target disease Neisseria meningitidis
Type ?
Clinical data
Trade names Menactra, Menveo, Menomune, MenAfriVac, Other
AHFS/Drugs.com monograph
MedlinePlus a607020
Pregnancy
category
  • Category C
Legal status
Routes of
administration
Intramuscular (conjugate), Subcutaneous (polysaccharide)
Identifiers
ATC code J07AH01 (WHO) J07AH02 J07AH03 J07AH04 J07AH05 J07AH06 J07AH07 J07AH08 J07AH09
 NYesY (what is this?)  (verify)

Meningococcal vaccine refers to any of the vaccines used to prevent infection by Neisseria meningitidis.[1] Different versions are effective against some or all of the following types of meningococcus: A, C, W135, and Y. The vaccines are between 85 and 100% effective for at least two years.[1] They result in a decrease in meningitis and sepsis among populations where they are widely used.[2][3] They are given either by injection into a muscle or just under the skin.[1]

The World Health Organization recommends that countries with a moderate or high rate of disease or with frequent outbreaks should routinely vaccinate.[1][4] In countries with a low risk of disease, they recommend that high risk groups should be immunized.[1] In the African meningitis belt efforts to immunize all people between the ages of one and thirty with the meningococcal A conjugate vaccine are ongoing.[4] In Canada and the United States the vaccines effective against all four types of meningococcus are recommended routinely for teenagers and others who are at high risk.[1] They are also required for people travelling to Mecca for Hajj.[1]

Safety is generally good. Some people develop pain and redness at the site of injection.[1] Use in pregnancy appears to be safe.[4] Severe allergic reactions occur in less than one in a million doses.[1]

The first meningococcal vaccine became available in the 1970s.[5] It is on the World Health Organization's List of Essential Medicines, the most important medication needed in a basic health system.[6] The wholesale cost is between 3.23 and 10.77 USD per dose as of 2014.[7] In the United States it costs 100 to 200 USD for a course.[8]

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Types

Neisseria meningitidis has 13 clinically significant serogroups, classified according to the antigenic structure of their polysaccharide capsule. Six serogroups, A, B, C, Y, W-135, and X, are responsible for virtually all cases of the disease in humans.

Quadrivalent (Serogroups A, C, W-135, and Y)

There are currently three vaccines available in the US to prevent meningococcal disease, all quadrivalent in nature, targeting serogroups A, C, W-135, and Y:

Mencevax (GlaxoSmithKline) and NmVac4-A/C/Y/W-135 (JN-International Medical Corporation) are used worldwide, but have not been licensed in the United States.

Nimenrix (GlaxoSmithKline), a new quadrivalent conjugate vaccine against serogroups A, C, W-135, and Y, is currently available in the states of the European Union and some additional countries.

The first meningococcal conjugate vaccine (MCV-4), Menactra, was licensed in the U.S. in 2005 by Sanofi Pasteur; Menveo was licensed in 2010 by Novartis. Both MCV-4 vaccines have been approved by the Food and Drug Administration (FDA) for people 2 through 55 years of age. Menactra received FDA approval for use in children as young as 9 months in April 2011[9] while Menveo received FDA approval for use in children as young as 2 months in August 2013.[10] The Centers for Disease Control and Prevention (CDC) has not made recommendations for or against its use in children less than 2 years.

Meningococcal polysaccharide vaccine (MPSV-4), Menomune, has been available since the 1970s. It may be used if MCV-4 is not available, and is the only meningococcal vaccine licensed for people older than 55. Information about who should receive the meningococcal vaccine is available from the CDC.[11]

Limitations

The duration of immunity mediated by Menomune (MPSV-4) is three years or less in children aged under 5 because it does not generate memory T cells.[12][13] Attempting to overcome this problem by repeated immunization results in a diminished, not increased, antibody response, so boosters are not recommended with this vaccine.[14][15] As with all polysaccharide vaccines, Menomune does not produce mucosal immunity, so people can still become colonised with virulent strains of meningococcus, and no herd immunity can develop.[16][17] For this reason, Menomune is suitable for travelers requiring short-term protection, but not for national public health prevention programs.

Menveo and Menactra contain the same antigens as Menomune, but the antigens are conjugated to a diphtheria toxoid polysaccharide–protein complex, resulting in anticipated enhanced duration of protection, increased immunity with booster vaccinations, and effective herd immunity.

Endurance

A study published in March 2006 comparing the two kinds of vaccines found that 76% of subjects still had passive protection three years after receiving MCV-4 (63% protective compared with controls), but only 49% had passive protection after receiving MSPV-4 (31% protective compared with controls).[18] As of 2010, there remains limited evidence that any of the current conjugate vaccines offer continued protection beyond three years; studies are ongoing to determine the actual duration of immunity, and the subsequent requirement of booster vaccinations. The CDC offers recommendations regarding who they feel should get booster vaccinations.[19][20]

Bivalent (Serogroups C and Y)

On June 14, 2012, the FDA approved a new combination vaccine against two types of meningococcal disease and Hib disease for infants and children 6 weeks to 18 months old. The vaccine, Menhibrix, will prevent disease caused by Neisseria meningitidis serogroups C and Y and Haemophilus influenzae type b. This is the first meningococcal vaccine that can be given to infants as young as six weeks old.[21]

Serogroup A

A vaccine called MenAfriVac has been developed through a program called the Meningitis Vaccine Project and has the potential to prevent outbreaks of group A meningitis, which is common in sub-Saharan Africa.[22][23]

Serogroup B

Vaccines against serotype B meningococcal disease have proved difficult to produce, and require a different approach from vaccines against other serotypes. Whereas effective polysaccharide vaccines have been produced against types A, C, W-135, and Y, the capsular polysaccharide on the type B bacterium is too similar to human neural antigens to be a useful target.[24]

A vaccine for serogroup B was developed in Cuba in response to a large outbreak of meningitis B during the 1980s. The VA-MENGOC-BC vaccine proved safe and effective in randomized double-blind studies,[25][26][27] but it was granted a licence only for research purposes in the United States[28] as political differences limited cooperation between the two countries.[29]

Due to a similarly high prevalence of B-serotype meningitis in Norway between 1975 and 1985, Norwegian health authorities developed a vaccine specifically designed for Norwegian children and young adolescents. Clinical trials were discontinued after the vaccine was shown to cover only slightly more than 50% of all cases. Furthermore, lawsuits for damages were filed against the State of Norway by persons affected by serious adverse reactions. Information that the health authorities obtained during the vaccine development were subsequently passed on to Chiron (now a Novartis subsidiary), who developed a similar vaccine, MeNZB, for New Zealand.

A MenB vaccine was approved for use in Europe in January 2013. Following a positive recommendation from the European Union's Committee for Medicinal Products for Human Use, Bexsero, produced by Novartis, received a licence from the European Commission.[30] However, deployment in individual EU member states still depends on decisions by national governments. In July 2013, the United Kingdom's Joint Committee on Vaccination and Immunisation (JCVI) issued an interim position statement recommending against adoption of Bexsero as part of a routine meningococcal B immunisation program, on the grounds of cost-effectiveness.[31] This decision was reverted in favor of Bexsero vaccination in March 2014.[32] In March 2015 the UK government announced that they had reached agreement with GlaxoSmithKline who had taken over Novartis' vaccines business, and that Bexsero would be introduced into the UK routine immunization schedule later in 2015.[33]

In November 2013, in response to an outbreak of B-serotype meningitis on the campus of Princeton University, the acting head of the Centers for Disease Control meningitis and vaccine preventable diseases branch told NBC News that they had authorized emergency importation of Bexsero to stop the outbreak.[34] Bexsero was subsequently approved by the FDA in February 2015.[35]

In October 2014, Trumenba, a serogroup B vaccine produced by Pfizer, was approved by the FDA.[36]

Serogroup X

The occurrence of serogroup X has been reported in North America, Europe, Australia, and West Africa.[37] Current meningoccocal meningitis vaccines are not known to protect against serogroup X N. meningitidis disease.[1]

References

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  9. April 22, 2011 Approval Letter - Menactra http://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm252511.htm
  10. http://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm363785.htm
  11. "Menningococcal Vaccines - What You Need to Know" (2008). Center for Disease Control and Prevention. http://www.cdc.gov/vaccines/pubs/vis/downloads/vis-mening.pdf
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  21. FDA approves new combination vaccine that protects children against two bacterial diseases, FDA Press Release, June 14, 2012
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  24. Finne J et al. An IgG monoclonal antibody to group B meningococci cross-reacts with developmentally regulated polysialic acid units of glycoproteins in neural and extraneural tissues. Journal of Immunology 138(12), 4402–4407 (1987).
  25. Lua error in package.lua at line 80: module 'strict' not found.
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  27. http://www.finlay.sld.cu/english/products/pregunvamengocbcenglish.htm
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  29. Lua error in package.lua at line 80: module 'strict' not found.
  30. "First ever MenB vaccine available for use", Oxford Vaccine Group openminds blog article, 24 January 2013
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  37. Clonal Groupings in Serogroup X Neisseria meningitidis.

Further reading

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External links