GEFree has collated information on the Meningococcal vaccine (MeNZB) for members interest

The parent vaccine came from the Norwegian meningococcal groupB strain. The vaccine has been specifically developed by ChironVaccines, in close collaboration with the New Zealand Ministryof Health and Norwegian Institute of Public Health.

The Norwegian meningococcal group B strain is a recombinant vaccineexpressed in E-coli and cultured in vat fermenters. The E-coliwas cultured in various synthetic and animal mediums. Fredriksenet al report the Outer Membrane Vesicle (OMV) was extracted usingthe detergent deoxycholate then adsorbed on to aluminium hydroxide.The OMV was reported to contain the respective protein, 8% phospholipid,7% lipopolysaccharide and 16% deoxycholate.

The final vaccine contains the OMV from Neisseria meningitidesgroup B (strain NZ 98/254) 25 micrograms measured as amount oftotal protein, Histidine, Aluminium hydroxide, Saline. (Medsafedata sheet)

The Chiron Vaccine web site says “A total of 350 candidateantigens were expressed in Escherichia coli, purified, and usedto immunize mice. The sera allowed the identification of proteinsthat are surface exposed, that are conserved in sequence acrossa range of strains, and that induce a bactericidal antibody response,a property known to correlate with vaccine efficacy in humans.Clinical trials are underway in New Zealand with a vaccine againststrains of meningococcal B specific to that country”.

The Medsafe data sheet sites these common vaccine reactions fromthese clinical trials of MeNZB™ across all age groups were

1. Injection site reactions (including redness, swelling, andinduration, tenderness and pain) were very common.

2. Tenderness/pain was the most common injection site reaction

3. Unusual crying, irritability, sleepiness, change in eatinghabits, diarrhoea and vomiting, and fever of at least 38.0 °C(infants, toddlers) were very common after vaccination.

4. Very commonly reported adverse reactions in children and adultsincluded:
    - Headache, Depression (malaise)
    - Nausea Muscle & joint pain (myalgia & arthralgia).

 

5. There werea few reports of fainting and febrile convulsions.

6. No data on adverse outcomes evaluated on people with

  • Pregnancy,
  • Immunesystem deficiency, on medication for immuno-compromised)
  • Who have no spleen, liver or pancreatic illness (hepatitis,diabetes, over use drugs or alcohol).
  • Heavy bleeding or blood disorders (during menses).
  • Inindividuals deficient in producing antibodies or taking medicationwith an immunosuppressive effect, vaccination may not resultin an appropriate protective antibody response.

7. Protectionagainst invasive meningococcal diseases caused by any of the otherserogroups of meningococcal bacteria has not been proven for MeNZB.

8. MeNZB will not protect against meningococcal diseases causedby any of the other types of meningococcal bacteria A, C, 29-E,H, I, K, L, W-135, X, Y, or Z, including non-typeable) or serogroupB other than the New Zealand strain.

9. Complete protection against infection caused by the New Zealandstrain cannot be guaranteed.

10. Vaccine should not be repeated if persons have shown signsof hypersensitivity after previous administration of MeNZB

11. Administration of MeNZB should usually be postponed in personswith an acute febrile illness (fever > 38.5 °C).

12. Individuals can have an immune response making them hypersensitiveto MeNZB

13. Meningococcal disease is spread through droplet infection.

14. Situations where people are most vulnerable to catching bacterialMeningitis/ Meningococcal diseases were Anaemic (Iron)and/or livedin a tobacco smoking, overcrowded environment. Had a poor dietin fresh vegetables.



Claire Bleakley (06) 3089842

 

References and web sites of interest

Fredriksen JH, Rosenqvist E, Wedege E, Bryn K,Bjune G, Froholm LO, Lindbak AK, Mogster B, Namork E, Rye U, etal. (1991), Production, characterization and control of MenB-vaccine"Folkehelsa": an outer membrane vesicle vaccine againstgroup B meningococcal disease. Entrez PubMed http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=1812438&dopt=Abstract
http://www.chironvaccines.com/company/vaccines_Pipeline_Men_B.php
http://www.pubmedcentral.nih.gov/articlerender.fcgi?artid=153225
Dr Peter Fusco, Provaxis. Prospects for a chemically modifiedpolysaccharide-protein conjugate vaccine to prevent Group B meningococcaldisease. http://www.meningitis.org/uploads/Meningitis%20and%20Septicaemia%20in%20Children%20and%20Adults.doc
The Meningococcal Gold Rush: Barbara Sumner Burstyn, Ron Law February2005 www.ias.org.nz
Hilary Butler (2005) – The Science behind a “No”decision. www.ias.org.nz
MeNZB Data sheet www.medsafe.govt.nz/Profs/Database/m/MeNZBvzc.htm
The Rise And Fall Of Meningococcal Disease In NZ – Ron Law(2005) www.ias.org.nz
www.moh.govt.nz