Meningococcal vaccine

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
Routes of
administration		 Intramuscular (conjugate), Subcutaneous (polysaccharide)
ATC code
Legal status
Legal status
Identifiers
ChemSpider
  • none
 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, W-135, 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] Saudi Arabia requires vaccination with the quadrivalent vaccine for international travelers to Mecca for Hajj.[5][1]:15

Safety is generally good with some people developing pain and redness at the injection site.[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.[6] It is on the World Health Organization's List of Essential Medicines, the most effective and safe medicines needed in a health system.[7] The wholesale cost in the developing world is between 3.23 and 10.77 USD per dose as of 2014.[8] In the United States it costs 100 to 200 USD for a course.[9]

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[10] while Menveo received FDA approval for use in children as young as 2 months in August 2013.[11] 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.[12]

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.[13][14] Attempting to overcome this problem by repeated immunization results in a diminished, not increased, antibody response, so boosters are not recommended with this vaccine.[15][16] 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.[17][18] 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 MPSV-4 (31% protective compared with controls).[19] 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.[20][21]

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.[22]

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.[23][24]

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.[25]

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,[26][27][28] but it was granted a licence only for research purposes in the United States[29] as political differences limited cooperation between the two countries.[30]

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 GlaxoSmithKline), 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.[31] 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.[32] This decision was reverted in favor of Bexsero vaccination in March 2014.[33] 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.[34]

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.[35] Bexsero was subsequently approved by the FDA in February 2015.[36]

In October 2014, Trumenba, a serogroup B vaccine produced by Pfizer, was approved by the FDA.[37]

Serogroup X

The occurrence of serogroup X has been reported in North America, Europe, Australia, and West Africa.[38] Current meningoccocal meningitis vaccines are not known to protect against serogroup X N. meningitidis disease.[1]

Side effects

Common side effects include pain and redness around the site of injection (up to 50% of recipients). A small percentage of people develop a mild fever. As with any medication, a small proportion of people develop a severe allergic reaction.[39] In 2016 Health Canada warned of an increased risk of anemia or hemolysis in people treated with eculizumab (Soliris). The highest risk was when individuals "received a dose of Soliris within 2 weeks after being vaccinated with Bexsero".[40]

Despite initial concerns about Guillain-Barré syndrome, subsequent studies in 2012 have shown no increased risk o GBS after meningococcal conjugate vaccination.[41]

In 2016 Health Canada warned of an increased risk of anemia or hemolysis in people treated with eculizumab (Soliris). The highest risk was when individuals "received a dose of Soliris within 2 weeks after being vaccinated with Bexsero".[42]

References

  1. 1 2 3 4 5 6 7 8 9 10 "Meningococcal vaccines: WHO position paper" (PDF). Weekly epidemiological record. 86 (47): 521–540. Nov 2011. PMID 22128384.
  2. ↑ Patel, M; Lee, CK (25 January 2005). "Polysaccharide vaccines for preventing serogroup A meningococcal meningitis.". The Cochrane database of systematic reviews (1): CD001093. PMID 15674874. doi:10.1002/14651858.CD001093.pub2.
  3. ↑ Conterno, LO; Silva Filho, CR; Rüggeberg, JU; Heath, PT (19 July 2006). "Conjugate vaccines for preventing meningococcal C meningitis and septicaemia.". The Cochrane database of systematic reviews (3): CD001834. PMID 16855979. doi:10.1002/14651858.CD001834.pub2.
  4. 1 2 3 "Meningococcal A conjugate vaccine: updated guidance, February 2015." (PDF). Weekly epidemiological record. 90: 57–68. 20 Feb 2015. PMID 25702330.
  5. ↑ https://wwwnc.cdc.gov/travel/yellowbook/2018/select-destinations/saudi-arabia-hajj-umrah-pilgrimage
  6. ↑ Barrett, Alan D.T. (2015). Vaccinology : an essential guide. p. 168. ISBN 9780470656167.
  7. ↑ "WHO Model List of Essential Medicines (19th List)" (PDF). World Health Organization. April 2015. Retrieved 8 December 2016.
  8. ↑ "Vaccine, Meningococcal". International Drug Price Indicator Guide. Retrieved 6 December 2015.
  9. ↑ Hamilton, Richart (2015). Tarascon Pocket Pharmacopoeia 2015 Deluxe Lab-Coat Edition. Jones & Bartlett Learning. p. 315. ISBN 9781284057560.
  10. ↑ April 22, 2011 Approval Letter - Menactra http://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm252511.htm
  11. ↑ http://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm363785.htm
  12. ↑ "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
  13. ↑ Reingold AL, Broome CV, Hightower AW, et al. (1985). "Age-specific differences in duration of clinical protection after vaccination with meningococcal polysaccharide A vaccine". Lancet. 2 (8447): 114–18. PMID 2862316. doi:10.1016/S0140-6736(85)90224-7.
  14. ↑ Lepow ML, Goldschneider I, Gold R, Randolph M, Gotschlich EC (1977). "Persistence of antibody following immunization of children with groups A and C meningococcal polysaccharide vaccines". Pediatrics. 60 (5): 673–80. PMID 411104.
  15. ↑ Borrow R, Joseh H, Andrews N, et al. (2000). "Reduced antibody response to revaccination with meningococcal serogroup A polysaccharide vaccine in adults". Vaccine. 19 (9–10): 1129–32. PMID 11137248. doi:10.1016/S0264447454-410X(00)00317-0.
  16. ↑ MacLennan J, Obaro S, Deeks J, et al. (1999). "Immune response to revaccination with meningococcal A and C polysaccharides in Gambian children following repeated immunization during early childhood". Vaccine. 17 (23–24): 3086–93. PMID 10462244. doi:10.1016/S0264-410X(99)00139-5.
  17. ↑ Hassan-King MK, Wall RA, Greenwood BM (1988). "Meningococcal carriage, meningococcal disease and vaccination". J Infect. 16 (1): 55–9. PMID 3130424. doi:10.1016/S0163-4453(88)96117-8.
  18. ↑ Moore PS, Harrison LH, Telzak EE, Ajello GW, Broome CV (1988). "Group A meningococcal carriage in travelers returning from Saudi Arabia". J Am Med Assoc. 260 (18): 2686–89. PMID 3184335. doi:10.1001/jama.260.18.2686.
  19. ↑ Vu D, Welsch J, Zuno-Mitchell P, Dela Cruz J, Granoff D (2006). "Antibody persistence 3 years after immunization of adolescents with quadrivalent meningococcal conjugate vaccine". J Infect Dis. 193 (6): 821–8. PMID 16479517. doi:10.1086/500512.
  20. ↑ Centers for Disease Control and Prevention (CDC) (January 2011). "Updated recommendations for use of meningococcal conjugate vaccines --- Advisory Committee on Immunization Practices (ACIP), 2010". MMWR Morb Mortal Wkly Rep. 60 (3): 72–6. PMID 21270745.
  21. ↑ Centers for Disease Control and Prevention (CDC) (September 2009). "Updated recommendation from the Advisory Committee on Immunization Practices (ACIP) for revaccination of persons at prolonged increased risk for meningococcal disease". MMWR Morb Mortal Wkly Rep. 58 (37): 1042–3. PMID 19779400.
  22. ↑ FDA approves new combination vaccine that protects children against two bacterial diseases, FDA Press Release, June 14, 2012
  23. ↑ LaForce FM, Okwo-Bele JM (June 2011). "Eliminating epidemic Group A meningococcal meningitis in Africa through a new vaccine". Health Aff (Millwood). 30 (6): 1049–57. PMID 21653956. doi:10.1377/hlthaff.2011.0328.
  24. ↑ Kristiansen PA, Diomandé F, Wei SC, Ouédraogo R, Sangaré L, Sanou I, Kandolo D, Kaboré P, Clark TA (March 2011). "Baseline Meningococcal Carriage in Burkina Faso before the Introduction of a Meningococcal Serogroup A Conjugate Vaccine". Clin Vaccine Immunol. 18 (3): 435–43. PMC 3067389 Freely accessible. PMID 21228139. doi:10.1128/CVI.00479-10.
  25. ↑ 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).
  26. ↑ Pérez O, Lastre M, Lapinet J, Bracho G, Díaz M, Zayas C, Taboada C, Sierra G (July 2001). "Immune Response Induction and New Effector Mechanisms Possibly Involved in Protection Conferred by the Cuban Anti-Meningococcal BC Vaccine". Infect Immun. 69 (7): 4502–8. PMC 98525 Freely accessible. PMID 11401992. doi:10.1128/IAI.69.7.4502-4508.2001.
  27. ↑ Uli L, Castellanos-Serra L, Betancourt L, Domínguez F, Barberá R, Sotolongo F, Guillén G, Pajón Feyt R (June 2006). "Outer membrane vesicles of the VA-MENGOC-BC vaccine against serogroup B of Neisseria meningitidis: Analysis of protein components by two-dimensional gel electrophoresis and mass spectrometry". Proteomics. 6 (11): 3389–99. PMID 16673438. doi:10.1002/pmic.200500502.
  28. ↑ http://www.finlay.sld.cu/english/products/pregunvamengocbcenglish.htm
  29. ↑ "World: Americas Cuba vaccine deal breaks embargo". BBC News. 29 July 1999. Retrieved 25 October 2009.
  30. ↑ "Cuban scientist barred from receiving U.S. prize". MSNBC. 12 November 2005. Retrieved 25 October 2009.
  31. ↑ "First ever MenB vaccine available for use", Oxford Vaccine Group openminds blog article, 24 January 2013
  32. ↑ Joint Committee on Vaccination and Immunisation (JCVI) (July 2013). "JCVI interim position statement on use of Bexsero® meningococcal B vaccine in the UK" (PDF). Retrieved 16 November 2013.
  33. ↑ John Porter (Novartis) (March 2014). "UK review of vaccines flawed, says Novartis' John Porter". Retrieved 6 October 2014.
  34. ↑ "Meningitis B vaccine deal agreed - Jeremy Hunt". BBC News. 29 March 2015. Retrieved 7 May 2015.
  35. ↑ Aleccia, JoNell (2013-11-15). "Emergency meningitis vaccine will be imported to halt Ivy League outbreak". NBC News. Retrieved 16 November 2013.
  36. ↑ "FDA approves a second vaccine to prevent serogroup B meningococcal disease" (Press release). United States Food and Drug Administration. January 23, 2015. Retrieved 2015-03-15.
  37. ↑ Thomas, Katie (29 Oct 2014). "F.D.A. Approves Pfizer’s Trumenba, a Vaccine for a Rare Meningitis". New York Times. Retrieved 14 March 2015.
  38. ↑ Clonal Groupings in Serogroup X Neisseria meningitidis.
  39. ↑ "Vaccines: Vac-Gen/Side Effects". Centers for Disease Control and Prevention. National Center for Immunization and Respiratory Diseases. Retrieved 27 March 2017.
  40. ↑ Health Canada September 16, 2016
  41. ↑ Yih, Weiling Katherine; Weintraub, Eric; Kulldorff, Martin (1 December 2012). "No risk of Guillain-Barré syndrome found after meningococcal conjugate vaccination in two large cohort studies". Pharmacoepidemiology and Drug Safety. 21 (12): 1359–1360. ISSN 1099-1557. doi:10.1002/pds.3353.
  42. ↑ Health Canada September 16, 2016

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