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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            

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Three cases of indigenous dengue fever in Europe is just the beginning?

Over the past two issues of Eurosurveillance, the online magazine of ECDC, appeared in two separate notices, one from France el 'the other from Germany, regarding cases of dengue fever contracted in Europe rather than, as usually happens in the tropics.

The first article describes two cases in which the transmission of the virus occurred in Nice in fact neither of the two patients had a history of recent international travel (1). The first case (A man in his sixties) developed fever, myalgia and asthenia August 23 last year and was hospitalized August 27. Laboratory tests, as well as highlighting thrombocytopenia, confirmed the diagnosis of infection with dengue virus - serotype 1 - and through the detection of specific antibodies or via PCR. The patient recovered within a few days.

The second case, an eighteen year old boy who lives about 70 meters the first patient, on 11 September showed fever, myalgia, headache and fatigue. The diagnosis of dengue was confirmed by PCR analysis. It was revealed the serotype 1, with characteristics quite similar to strains circulating in Martinique. The clinical picture, which also included moderate thrombocytopenia resolved without complications.

Eurosurveillance The second article was published on October 7 and describes the case of a seventy-two that appeared last August 16 with fever, chills, arthralgia, retro-orbital pain and headache (2) . The patient had just returned to Germany from a vacation in Croatia, where he stayed from 1 to 15 August. The clinical picture was resolved in about two weeks. The diagnosis was confirmed serologically. Again there was a moderate thrombocytopenia.

The two articles in Eurosurveillance document a new fact for Europe: local transmission of dengue virus by the Aedes albopictus , normally one of the two carriers involved (the other is Aedes aegypti that, as we know, is present in tropical areas but not in Europe). Since the '70s, Aedes albopictus has been established in some countries of Southern Europe, where it has come primarily through imports of truck tires. Its presence is indicated both in southern France and Croatia, as well as in Italy, Greece, Slovenia, Spain, Albania and other Balkan countries and even in Switzerland.

In particular in our country, we need a lot of attention for at least three reasons:

a) climatic conditions favorable to the proliferation of Aedes albopictus

b) frequent trips for tourism, business or other reasons to areas where the diseases transmitted by mosquitoes of the genus Aedes such as dengue and chikungunya, are endemic

c) the well-known previous outbreak of chikungunya in Cervia (3), with more than 300 cases (the index case was then a traveler from India).

surveillance of dengue and other vector diseases must be especially careful, since the cases with mild or moderate symptoms may escape the etiologic diagnosis. To this end, the general practitioners, pediatricians and family doctors in the DEA should also receive training on diseases hitherto considered unusual, such as dengue, chikungunya and West Nile Virus infections.

surveillance activities to be complemented by local monitoring and control of the carrier. Finally, a role it is for the Centers Travel Medicine: the well-informed traveler is less likely to become infected and then introduce the virus in our country.

Bibliography

(1) La Ruche G, Souarès Y, Armengaud A et al. First two autochthonous dengue virus infections in metropolitan France, September 2010. Euro Surveill. 2010, 15 (39): pii = 19676. Available online: http://www.eurosurveillance.org/ViewArticle.aspx?ArticleId=19676   

(2) Schmidt-Chanasit J, Haditsch M, Schöneberg I, Günther S, Stark K, Frank C. Dengue virus infection in a traveller returning from Croatia to Germany. Euro Surveill. 2010;15(40):pii=19677. Available online: http://www.eurosurveillance.org/ViewArticle.aspx?ArticleId=19677

(3) Angelini R, Finarelli AC, Angelini P, Po C, Petropulacos K, Silvi G, et al. Chikungunya in north-eastern Italy: a summing up of the outbreak. € Surveill. 2007, 12 (47). pii: 3313. Available online:
http://www.eurosurveillance.org/ViewArticle.aspx?ArticleId=3313

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Atovaquone-proguanil (Malarone) and pregnancy

A traveler, returning from a stay of twenty days in an area at risk of malaria from chloroquine-resistant Plasmodium falciparum, continues to take atovaquone + proguanil (Malarone) as required, even for a week. A few days later asking for our opinion on a problem: he has just done a pregnancy test, which is positive. The woman recalls the recommendation not to become pregnant during treatment with Malarone and asks us what the risks are.

How to proceed?

The technical details of the drug and the various guidelines on malaria prophylaxis consider pregnancy a contraindication to treatment with Malarone, due to lack of data on it.

The question is no experience of administration of the combination atovaquone-proguanil in pregnancy?

perform a Medline search through and find some clinical trials in which the drug was administered for the treatment of malaria rather than prophylaxis.

We find three trials conducted by the same research group (1-3). Warning: reading the three studies is not clear whether the same patients appear in more than one trial. The one with the highest number of enrolled patients comparing 39 pregnant women (2nd and 3rd trimester) treated with artesunate-atovaquone-proguanil vs.. 42 treated with quinine; not been detected differences in the following parameters: birth weight, gestation length, birth defects, growth parameters and development of children monitored for a year (1).

Other two trials come to similar conclusions (2.3).

Finally, there is a pharmacokinetic and pharmacodynamic study of 26 women in the third trimester of pregnancy with malaria and treated with atovaquone-proguanil without severe adverse events or premature birth or miscarriage (4 ).

What can you conclude?

available studies were conducted on a limited population of pregnant women suffering from malaria, so these studies are not of sufficient magnitude to make a risk assessment. The doses of atovaquone-proguanil were, naturally, much higher than those for the chemoprophylaxis of malaria. It was not revealed an increased risk, but we must emphasize that the patients were in second and third in the first quarter instead. In any case, exposure Accident Malarone in pregnancy is not a sufficient reason for deciding whether to break the same. This is also the position of the UK National Travel Health Network and Centre (NaTHNaC), see:

http://www.nathnac.org/pro/misc/faq_malaria.htm # pregnancy

Bibliography

(1) McGready R, Ashley EA, Moo E, Cho T, Barends M, Hutagalung R, Looareesuwan S, White NJ, Nosten F . A randomized comparison of artesunate-atovaquone-proguanil versus quinine in treatment for uncomplicated falciparum malaria during pregnancy. J Infect Dis 2005;192:846-53.

DOI: 10.1086/432551

(2) McGready R, Keo NK, Villegas L, White NJ, Looareesuwan S, Nosten F.

Artesunate-atovaquone-proguanil rescue treatment of multidrug-resistant Plasmodium falciparum malaria in pregnancy: a preliminary report.

Trans R Soc Trop Med Hyg 2003;97(5):592-4

DOI:10.1016/S0035-9203(03)80040-8

(3) McGready R, Stepniewska K, Edstein MD, Cho T, Gilveray G, Looareesuwan S, White NJ, Nosten F. The pharmacokinetics of atovaquone and proguanil in pregnant women with acute falciparum malaria.

Eur J Clin Pharmacol 2003;59:545-52.

DOI: 10.1007/s00228-003-0652-9

(4) Na-Bangchang K, Manyando C, Ruengweerayut R, Kioy D, Mulenga M, Miller GB, Konsil J. The pharmacokinetics and pharmacodynamics of atovaquone and proguanil for the treatment of uncomplicated falciparum malaria in third-trimester pregnant women.

Eur J Clin Pharmacol 2005; 61:573-82.

DOI: 10.1007/s00228-005-0969-7