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{{Short description|Meningococcal vaccine in New Zealand}}
⚫ {{Refimprove|date=February 2009}}
{{More citations needed|date=February 2009}}
⚫ {{Use dmy dates|date=February 2021}}
{{Drugbox {{Drugbox
| Verifiedfields = changed
⚫ | type = vaccine
| verifiedrevid = 447123851
| image =
<!-- Vacine data -->
⚫ | target = group B ] strain
⚫ | type = vaccine
⚫ | vaccine_type = subunit
⚫ | target = group B ] strain
⚫ | CAS_number =
⚫ | vaccine_type = subunit
⚫ | ATC_prefix = J07
<!-- Clinical data -->
⚫ | ATC_suffix = AH06
| tradename =
| PubChem =
| DrugBank = | pregnancy_AU = <!-- A / B1 / B2 / B3 / C / D / X -->
| pregnancy_AU = <!-- A / B1 / B2 / B3 / C / D / X --> | pregnancy_US = <!-- A / B / C / D / X -->
| pregnancy_US = <!-- A / B / C / D / X --> | legal_AU = <!-- S2, S3, S4, S5, S6, S7, S8, S9 or Unscheduled -->
⚫ | legal_CA = <!-- Schedule I, II, III, IV, V, VI, VII, VIII -->
| pregnancy_category=
| legal_AU = <!-- S2, S3, S4, S5, S6, S7, S8, S9 or Unscheduled--> | legal_UK = <!-- GSL, P, POM, CD, or Class A, B, C -->
| legal_CA = <!-- Schedule I, II, III, IV, V, VI, VII, VIII --> | legal_US = <!-- OTC / Rx-only / Schedule I, II, III, IV, V -->
⚫ | legal_status = Prescription Only
| legal_UK = <!-- GSL, P, POM, CD, or Class A, B, C -->
⚫ | routes_of_administration = Injected
⚫ | legal_US = <!-- OTC / Rx-only / Schedule I, II, III, IV, V -->
<!-- Identifiers -->
⚫ | legal_status =
⚫ | CAS_number = 1107585-19-2
⚫ | routes_of_administration =
⚫ | ATC_prefix = J07
⚫ | ATC_suffix = AH06
| ChemSpiderID_Ref = {{chemspidercite|changed|chemspider}}
| ChemSpiderID = none
<!-- Chemical data -->
}} }}
'''MeNZB''' is a ] against a specific strain of group B ],<ref>PMID 18804134</ref> currently being used to control an epidemic of meningococcal disease in ]. Most people are able to carry the meningococcus bacteria safely with no ill effects. However, meningococcal disease can cause ] and septicaemia, resulting in brain damage, failure of various organs, severe skin and soft-tissue damage, and death. '''MeNZB''' was a ] against a specific strain of group B ],<ref>{{cite journal | vauthors = Loring BJ, Turner N, Petousis-Harris H | title = MeNZB vaccine and epidemic control: when do you stop vaccinating? | journal = Vaccine | volume = 26 | issue = 47 | pages = 5899–5904 | date = November 2008 | pmid = 18804134 | doi = 10.1016/j.vaccine.2008.08.062 }}</ref> used to control an epidemic of meningococcal disease in ]. Most people are able to carry the meningococcus bacteria safely with no ill effects. However, meningococcal disease can cause ] and ], resulting in brain damage, failure of various organs, severe skin and soft-tissue damage, and death.


Immunisation with MeNZB requires three doses, administered approximately six weeks apart (except in newborns, who have them in conjunction with their 6-week, 3-month and 5-month injections). People who have been fully immunised may still carry the meningococcus bacteria and may still contract meningococcal disease. Immunisation with MeNZB requires three doses, administered approximately six weeks apart (except in newborns, who have them in conjunction with their 6-week, 3-month and 5-month injections). People who have been fully immunised may still carry the meningococcus bacteria and may still contract meningococcal disease.


==Components== ==Components==
Each dose is 0.5 ml and contains: Each dose is 0.5 ml and contains:


*25 mcg of outer membrane vesicles from the '']'' group B strain NZ98/254. The vaccine does not contain any whole ] (alive or dead). The "outer membrane vesicles" it contains are a small part of the "skin" of the bacteria that let the immune system recognise and prepare for being infected with the real thing. MeNZB vaccine does not contain any human, ], or bovine (cow)products, ] products, ] or the preservative thiomersal (mercury). There are no live meningococcal bacteria in the vaccine and it is not possible to catch the disease or become a carrier of the disease from the vaccine. *25 mcg of outer membrane vesicles from the '']'' group B strain NZ98/254. The vaccine does not contain any whole ] (alive or dead). The "outer membrane vesicles" it contains are a small part of the "skin" of the bacteria that let the immune system recognise and prepare for being infected with the real thing. MeNZB vaccine does not contain any human, ], or bovine (cow) products, ] products, ] or the preservative ] (mercury). There are no live meningococcal bacteria in the vaccine and it is not possible to catch the disease or become a carrier of the disease from the vaccine.
⚫ *1.65&nbsp;mg of ] (an ]). The immune system will normally not mount an immune response to the outer membrane vesicles if they are presented alone. The presence of the adjuvant forces the immune system to respond to the membrane vesicles by acting to prevent their breakdown and elimination, while causing local tissue damage to provoke the desired immune reaction.
⚫ *] (to stabilise the ]). The histidine pH buffer is to ensure the vaccine stays as close as possible to the pH of human body fluids. This is to ensure the immune system does not waste time trying to neutralise the vaccine instead of responding to the outer membrane vesicles.
⚫ *normal ]. The saline (sterile salt and water) is also like packaging. It is required so that all of the above can be dissolved into a solution that can be injected. It is the same salinity (saltiness) as normal human body fluid.


⚫ The antigen in MeNZB is prepared from B:4:P1.7b,4 (NZ 98/254 ) ''N. meningitidis'' strain, grown in a fermentor. The bacteria are grown in a synthetic culture medium containing sugar, essential amino acids and essential elements such as iron and potassium. The fermentation does not use bovine or porcine products. The cellular outer membranes are extracted with the detergent deoxycholate, which kills the bacteria. Outer membrane vesicles are purified out of the culture medium by ultracentrifugation, stabilised by histidine and then adsorbed to aluminium hydroxide Al(OH)<sub>3</sub> as an adjuvant. Purification is achieved by ultrafiltration/diafiltration.
⚫ *1.65&nbsp;mg of ] (an ]). The immune system will normally not mount an immune response to the outer membrane vesicles if they are presented alone. The presence of the adjuvant forces the immune system to respond to the membrane vesicles by acting to prevent their breakdown and elimination, while causing local tissue damage to provoke the desired immune reaction.

⚫ *] (to stabilise the ]). The histidine pH buffer is to ensure the vaccine stays as close as possible to the pH of human body fluids. This is to ensure the immune system does not waste time trying to neutralise the vaccine instead of responding to the outer membrane vesicles.

⚫ *normal ]. The saline (sterile salt and water) is also like packaging. It is required so that all of the above can be dissolved into a solution that can be injected. It is the same salinity (saltiness) as normal human body fluid.

⚫ The antigen in MeNZB is prepared from B:4:P1.7b,4 (NZ 98/254 ) N. meningitidis strain, grown in a fermentor. The bacteria are grown in a synthetic culture medium containing sugar, essential amino acids and essential elements such as iron and potassium. The fermentation does not use bovine or porcine products. The cellular outer membranes are extracted with the detergent deoxycholate, which kills the bacteria. Outer membrane vesicles are purified out of the culture medium by ultracentrifugation, stabilised by histidine and then adsorbed to aluminium hydroxide Al(OH)3 as an adjuvant. Purification is achieved by ultrafiltration/diafiltration.


==Impact== ==Impact==
Since its introduction in 2004 the vaccine has had a dramatic impact on the meningitis epidemic began in 1991.<ref name="pmid19481313">{{cite journal | vauthors = Holst J, Martin D, Arnold R, Huergo CC, Oster P, O'Hallahan J, Rosenqvist E | title = Properties and clinical performance of vaccines containing outer membrane vesicles from Neisseria meningitidis | journal = Vaccine | volume = 27 | pages = B3-B12 | date = June 2009 | issue = Suppl 2 | pmid = 19481313 | doi = 10.1016/j.vaccine.2009.04.071 }}</ref> Between 2004 and 2006 New Zealand offered free MeNZB vaccination to anyone under the age of 20. Routine immunisation for babies and preschoolers continued until June 2008. The last phase of this programme, immunisation for people with a high medical risk, ended in March 2011. <ref>{{cite web | title = Meningococcal vaccines | publisher = Ministry of Health website | url = https://www.health.govt.nz/our-work/preventative-health-wellness/immunisation/immunisation-programme-decisions/meningococcal-b-immunisation-programme-and-menzbtm-vaccine }}</ref> Reasons given for this halt of the programme include that the epidemic was coming to an end, and that immune protection given by the vaccine is only short-term.<ref name="pmid21803101">{{cite journal | vauthors = Arnold R, Galloway Y, McNicholas A, O'Hallahan J | title = Effectiveness of a vaccination programme for an epidemic of meningococcal B in New Zealand | journal = Vaccine | volume = 29 | issue = 40 | pages = 7100–6 | date = September 2011 | pmid = 21803101 | doi = 10.1016/j.vaccine.2011.06.120 }}</ref> The primary analysis estimated MeNZB to have an effectiveness of 77% after 3 doses and a mean follow-up time of 3.2 years.<ref>{{cite book | chapter = Vaccines |title=Meningococcal: New Insights for the Healthcare Professional| edition = 2012 | chapter-url = https://books.google.com/books?id=kn5oUAs5h_4C&pg=PA51 |date=10 December 2012 |publisher=ScholarlyEditions |isbn=978-1-4649-7337-6 |pages = 48–64 (51) }}</ref>
Since its introduction the vaccine has had a dramatic impact on the epidemic.{{Fact|date=June 2007}} In April 2008 it was unexpectedly announced by the New Zealand Ministry of Health that the MeNZB vaccination programme will be completed by 31 December 2008, and that after this period no further vaccination will be given. Reasons given for this halt of the programme include that the epidemic was already finishing, and that immune protection given by the vaccine is only short-term. Others speculate that the cost of providing the vaccine is too high for the NZ government to justify.


As '']'' and ''N. meningitidis'' are closely related bacteria and have 80–90% homology in their genetic sequences some cross-protection by meningococcal vaccines against ''N. gonorrhoeae'' infections is plausible. A study published in 2017 showed that MeNZB vaccine provided a partial protection against ].<ref name=Gottlieb2017>{{cite journal | vauthors = Gottlieb SL, Johnston C | title = Future prospects for new vaccines against sexually transmitted infections | journal = Current Opinion in Infectious Diseases | volume = 30 | issue = 1 | pages = 77–86 | date = February 2017 | pmid = 27922851 | pmc = 5325242 | doi = 10.1097/QCO.0000000000000343 }}</ref> The vaccine efficiency was calculated to be 31%.<ref name="Petousis-Harris2017">{{cite journal | vauthors = Petousis-Harris H, Paynter J, Morgan J, Saxton P, McArdle B, Goodyear-Smith F, Black S | title = Effectiveness of a group B outer membrane vesicle meningococcal vaccine against gonorrhoea in New Zealand: a retrospective case-control study | journal = Lancet | volume = 390 | issue = 10102 | pages = 1603–1610 | date = September 2017 | pmid = 28705462 | doi = 10.1016/S0140-6736(17)31449-6 | s2cid = 4230156 }}</ref>
The vaccine, originally developed in ] and subject to considerable public controversy as recently as October 2007, was never released for widespread use in that country because the Norwegian ] was finishing before it was released.


==References== == References ==
{{reflist}} {{reflist}}


==External links== == External links ==
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{{Vaccines}} {{Vaccines}}


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Latest revision as of 07:15, 2 September 2023

Meningococcal vaccine in New Zealand
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Pharmaceutical compound
MeNZB
Vaccine description
Targetgroup B meningococcus strain
Vaccine typeSubunit
Clinical data
Routes of
administration		Injected
ATC code
Legal status
Legal status
  • In general: ℞ (Prescription only)
Identifiers
CAS Number
ChemSpider
  • none
  (what is this?)  (verify)

MeNZB was a vaccine against a specific strain of group B meningococcus, used to control an epidemic of meningococcal disease in New Zealand. Most people are able to carry the meningococcus bacteria safely with no ill effects. However, meningococcal disease can cause meningitis and sepsis, resulting in brain damage, failure of various organs, severe skin and soft-tissue damage, and death.

Immunisation with MeNZB requires three doses, administered approximately six weeks apart (except in newborns, who have them in conjunction with their 6-week, 3-month and 5-month injections). People who have been fully immunised may still carry the meningococcus bacteria and may still contract meningococcal disease.

Components

Each dose is 0.5 ml and contains:

  • 25 mcg of outer membrane vesicles from the Neisseria meningitidis group B strain NZ98/254. The vaccine does not contain any whole bacteria (alive or dead). The "outer membrane vesicles" it contains are a small part of the "skin" of the bacteria that let the immune system recognise and prepare for being infected with the real thing. MeNZB vaccine does not contain any human, blood, or bovine (cow) products, egg products, neomycin or the preservative thiomersal (mercury). There are no live meningococcal bacteria in the vaccine and it is not possible to catch the disease or become a carrier of the disease from the vaccine.
  • 1.65 mg of aluminium hydroxide (an adjuvant). The immune system will normally not mount an immune response to the outer membrane vesicles if they are presented alone. The presence of the adjuvant forces the immune system to respond to the membrane vesicles by acting to prevent their breakdown and elimination, while causing local tissue damage to provoke the desired immune reaction.
  • histidine (to stabilise the pH). The histidine pH buffer is to ensure the vaccine stays as close as possible to the pH of human body fluids. This is to ensure the immune system does not waste time trying to neutralise the vaccine instead of responding to the outer membrane vesicles.
  • normal saline. The saline (sterile salt and water) is also like packaging. It is required so that all of the above can be dissolved into a solution that can be injected. It is the same salinity (saltiness) as normal human body fluid.

The antigen in MeNZB is prepared from B:4:P1.7b,4 (NZ 98/254 ) N. meningitidis strain, grown in a fermentor. The bacteria are grown in a synthetic culture medium containing sugar, essential amino acids and essential elements such as iron and potassium. The fermentation does not use bovine or porcine products. The cellular outer membranes are extracted with the detergent deoxycholate, which kills the bacteria. Outer membrane vesicles are purified out of the culture medium by ultracentrifugation, stabilised by histidine and then adsorbed to aluminium hydroxide Al(OH)3 as an adjuvant. Purification is achieved by ultrafiltration/diafiltration.

Impact

Since its introduction in 2004 the vaccine has had a dramatic impact on the meningitis epidemic began in 1991. Between 2004 and 2006 New Zealand offered free MeNZB vaccination to anyone under the age of 20. Routine immunisation for babies and preschoolers continued until June 2008. The last phase of this programme, immunisation for people with a high medical risk, ended in March 2011. Reasons given for this halt of the programme include that the epidemic was coming to an end, and that immune protection given by the vaccine is only short-term. The primary analysis estimated MeNZB to have an effectiveness of 77% after 3 doses and a mean follow-up time of 3.2 years.

As N. gonorrhoeae and N. meningitidis are closely related bacteria and have 80–90% homology in their genetic sequences some cross-protection by meningococcal vaccines against N. gonorrhoeae infections is plausible. A study published in 2017 showed that MeNZB vaccine provided a partial protection against Gonorrhea. The vaccine efficiency was calculated to be 31%.

References

  1. Loring BJ, Turner N, Petousis-Harris H (November 2008). "MeNZB vaccine and epidemic control: when do you stop vaccinating?". Vaccine. 26 (47): 5899–5904. doi:10.1016/j.vaccine.2008.08.062. PMID 18804134.
  2. Holst J, Martin D, Arnold R, Huergo CC, Oster P, O'Hallahan J, Rosenqvist E (June 2009). "Properties and clinical performance of vaccines containing outer membrane vesicles from Neisseria meningitidis". Vaccine. 27 (Suppl 2): B3 – B12. doi:10.1016/j.vaccine.2009.04.071. PMID 19481313.
  3. "Meningococcal vaccines". Ministry of Health website.
  4. Arnold R, Galloway Y, McNicholas A, O'Hallahan J (September 2011). "Effectiveness of a vaccination programme for an epidemic of meningococcal B in New Zealand". Vaccine. 29 (40): 7100–6. doi:10.1016/j.vaccine.2011.06.120. PMID 21803101.
  5. "Vaccines". Meningococcal: New Insights for the Healthcare Professional (2012 ed.). ScholarlyEditions. 10 December 2012. pp. 48–64 (51). ISBN 978-1-4649-7337-6.
  6. Gottlieb SL, Johnston C (February 2017). "Future prospects for new vaccines against sexually transmitted infections". Current Opinion in Infectious Diseases. 30 (1): 77–86. doi:10.1097/QCO.0000000000000343. PMC 5325242. PMID 27922851.
  7. Petousis-Harris H, Paynter J, Morgan J, Saxton P, McArdle B, Goodyear-Smith F, Black S (September 2017). "Effectiveness of a group B outer membrane vesicle meningococcal vaccine against gonorrhoea in New Zealand: a retrospective case-control study". Lancet. 390 (10102): 1603–1610. doi:10.1016/S0140-6736(17)31449-6. PMID 28705462. S2CID 4230156.

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