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A new vaccine against serogroup W135-AC-Y meningococcal

International Distribution of serogroups of Neisseria meningitidis prevalent

Source:

Committee to Advise on Tropical Medicine and Travel (CATMAT).

Statement on Meningococcal Vaccination for Travellers. Canada Communicable Disease Report

2009 Volume 35 - ACS-4

http://www.phac-aspc.gc.ca/publicat/ccdr-rmtc/09pdf/acs -dcc-04.pdf

know

13 serogroups of Neisseria meningitidis, identified on the basis of capsular polysaccharide

. Of these, five serogroups (A, B, C, W135 and Y) cause most cases of meningococcal disease

globally.

invasive disease by N. meningitidis (meningitis and sepsis) can occur sporadically or in the form of

outbreaks. The map inserted at the beginning of this post shows the

international distribution of serogroups.

An increased risk of invasive disease by N. meningitidis was observed among individuals who are on their

called meningitis belt (sub-Saharan Africa), where outbreaks

are frequent during the dry season (which extends from December to June) due to both

of environmental factors that may affect the integrity of the upper respiratory tract (

very dry climate, cold nights), both factors social (overcrowding in housing and population movements

linked to socio-cultural or religious reasons) (1). These factors may encourage the movement of N.

meningitidis.

Outside the meningitis belt, the pilgrimage to Mecca (Hajj) is associated with a

increased risk of meningococcal disease: why the government of Saudi Arabia requires pilgrims

a certificate of vaccination meningococcal (2).

outbreaks are regularly reported in other parts of the world, including the Indian subcontinent

and other areas of Asia (3).

For developed countries, it is interesting evolution of the serogroups in the United States:

serogroup Y was responsible for only 2% of all cases in 1989-1991 but later in the mid- 90s, this proportion began to increase. In 2009 (information) serogroup Y became predominant (37%), while the remaining serogroups were as follows: B (32%), C (28%), W135 and other minor (4%) (4).

Until now, travelers who went in at-risk areas could be immunized with a

unconjugated polysaccharide vaccine containing serogroups AC-W135-Y. As with all

unconjugated polysaccharide vaccines, the immunogenicity is not optimal, there is also

induction of immune memory, is not prevented the carrier state, there is induction of herd immunity and can be determined hyporesponsive following repeated administration over time.

has recently been registered in Europe and the United States, and is also available in Italy, a new conjugate vaccine

protein C. diphtheriae CRM197, containing serogroups

AC-W135-Y (5.6).

Clinical trials conducted on this new vaccine have evaluated the immune response in adults and adolescents for each serogroup by measuring the production of antibodies specific anticapsulari, with bactericidal activity (serum bactericidal activity, SBA).

In both adults and adolescents has detected a significantly higher immune response compared to that determined by comparison of non-conjugated polysaccharide vaccine.

The vaccine is administered as a single dose, starting from 11 years of age. Has not been established

need of reminders.

The safety of the vaccine was evaluated in five RCTs with 6185 participants aged between 11 and 65. Among the most common side effects were noted local reactions (erythema, induration, itching, pain at the injection site), and general information such as nausea and headache, lasting 1-2 days.

What advantages and what problems has this new vaccine?

Benefits

are those related to conjugation with a carrier protein: induction of immunological memory

, continued protection, booster effect after a new contact with the antigen

(because, for the presence of the carrier protein, it is T-dependent antigen), decreased

carrier state, induction of herd immunity and no appearance of hyporesponsive after

doses after the first. The incident is typical of the hyporesponsive

conjugate vaccines: There is evidence that subjects who received one dose of meningococcal vaccine

unmarried show a lower immune response to subsequent doses

of the same vaccine in some studies this effect is manifested even when, in subjects previously

immunized with the unconjugated vaccine, revaccination was carried

with a meningococcal conjugate vaccine (7).

Problems

a) the vaccine is registered for use since the 11 years of age. The passenger under the age of 11 years

at the time should be vaccinated with the corresponding product

unmarried. It 's interesting, however, that the Green Book UK

permits the use of off-label even conjugate vaccine in children under one year. This position

Health UK is set out in an updated chapter on meningococcal

added in July 2010 (8);

b) currently is an expensive product (retail price 88 Euro), but this

disadvantage is offset by the fact that is administered in a single dose, while the vaccine

unmarried should be repeated after 3-5 years. For pilgrims to Mecca, unfortunately

now the Saudi government does not distinguish between old and new vaccine, so

continues to restrict the validity of 3 years of vaccination (9) and this represents, together with the high cost

, a limitation to its use in this category of travelers.

should mention that, due to its characteristics, it is not a vaccine for

exclusively for travelers: it can be used in vaccination programs

universal in Western countries even if it occurs, or is deemed possible , an increase in cases of illness

from serogroups A, Y, W135, as happened in the United States. It can also be used

subjects at increased risk for meningococcal disease, such as the

asplenia or patients suffering from deficiency of complement factors.

Bibliografia

(1) WHO. Meningococcal meningitis. Wkly Epidemiol Rec 2003;78:285–96 Available at: http://www.who.int/wer/2003/en/wer7833.pdf

(2) Lingappa JR, Al-Rabeah AM, Hajjeh R, Mustafa T, Fatani A, Al- Bassam T, et al.

Serogroup W-135 meningococcal disease during the Hajj, 2000. Emerg Infect Dis 2003;9:665–71.

(3) Harrison LH, Trotter CL, Ramsay ME. Global epidemiology of meningococcal disease.

Vaccine 2009;27(S2):B51-B63 doi: 10.1016/j.vaccine.2009.04.063

(4) Active Bacterial Core Surveillance (ABCs) Emerging Infections Program Network.

ABCs Report: Neisseria meningitidis, provisional-2009 [Access 23.10.2010]

http://www.cdc.gov/abcs/reports-findings/survreports/mening09.html

(5) European Medicines Agency. Menveo. Summary of product characteristics

http://www.ema.europa.eu/docs/it_IT/document_library/EPAR_-_Product_Information/human/001095/WC500090147.pdf

(6) Licensure of a Meningococcal Conjugate Vaccine (Menveo) and Guidance for Use ---

Advisory Committee on Immunization Practices (ACIP), Morbidity and Mortality Weekly Report

(MMWR) March 12, 2010 / 59(09);273  

http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5909a5.htm

(7) Bröker M and Veitch K. Quadrivalent meningococcal vaccines: Hyporesponsiveness as an important consideration when choosing between the use of conjugate vaccine or polysaccharide vaccine. Travel Medicine and Infectious Diseases 2009;8:47-50

doi:10.1016/j.tmaid.2009.12.001

(8) Immunisation against infectious disease - The Green Book. Updates to Chapter 22:

Meningococcal, 28 July 2010 http://www.dh.gov.uk/prod_consum_dh/groups/dh_digitalassets/@dh/@en/documents/digitalasset/dh_117986.pdf

(9) Kingdom of Saudi Arabia. Ministry of Hajj. Saudi Ministry of Health Requirements.

http://www.hajinformation.com/main/p3001.htm   [Access 23.10.2010]

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Squalene: from the first pages oblivion

For reasons easy to understand, influenza is a disease of travelers . The risk of exposure to influenza viruses differs depending on of the season and destination, and is substantially in the following situations: (a) in the temperate zones of the northern hemisphere between December and February, (b) in the temperate zones of the southern hemisphere between April and September, (c) in the temperate zones of both hemispheres during the summer, because of contacts with people from regions where there are cases of influenza and (d) in tropical countries, throughout the year. In addition, visiting relatives and friends and travel for more than 30 days is an independent risk factor.

Last year at this time we are preparing for pandemic vaccination campaign and all the attention was focused on squalene, the main constituent of ' adjuvant MF59 included in pandemic vaccine Focetria . One reason for the low acceptance of vaccination against pandemic dell'adiuvante was precisely the presence of which, there have been called into question the safety. Also, because data on the use of MF59 in children were scarce, there were those who feared health risks in this age group.

After one year, no longer speaks of squalene. The question is the bleak predictions have come true safety dell'adiuvante?

at all. First, the Italian Drug Agency has published online data on adverse events, which did not reveal any signals that can change the assessment on the safety of Focetria (1).

have also been published just in recent weeks, some studies regarding the administration of MF59-adjuvanted influenza vaccine in children: these are the results of clinical studies (2-4) and the analysis carried out on data obtained from five pediatric trial (5). The conclusions are all in favor of safety dell'adiuvante.

As is often the media, the news of the charges occupy the headlines, the denial of the allegations leading to the establishment of facts are relegated to inside pages. In the case of the 'affaire squalene was not even a widespread denial. We simply do not talk about it anymore.

Bibliography

(1) Italian Drug Agency. H1N1 - data on suspected adverse reactions

(2) Vesikari T, Karvonen A, Tilman D et al. Immunogenicity and safety of MF59-adjuvanted H5N1 influenza vaccine from infancy to adolescence. Pediatrics 2010; 126: e762-70.

doi: 10.1542/peds.2009-2628

(3) Esposito S, D'Angelo E, Daleno C et al. Immunogenicity, safety and tolerability of monovalent

2009 pandemic influenza A/H1N1 MF59-adjuvanted vaccine in patients with β -thalassemia major.

Vaccine [Article in Press, Uncorrected Proof ]  doi:10.1016/j.vaccine.2010.09.058

(4) Yasuda Y, Komatsu R, Matsushita K et al. Comparison of half and full doses of an MF59-adjuvanted cell culture-derived A/H1N1v vaccine in Japanese children. Advances in Therapy 2010;27:444-57. 

DOI: 10.1007/s12325-010-0043-4

(5) Black S, Della Cioppa G, Malfroot A et al. Safety of MF59-adjuvanted versus non-adjuvanted influenza vaccines in children and adolescents: an integrated analysis. Vaccine 2010;28: 7331-6.

doi:10.1016/j.vaccine.2010.08.075