Meningococcal Meningitis - Serogroups A, C, Y, W-135 and Serogroup B - Winnipeg Regional Health Authority
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Meningococcal Meningitis - Serogroups A, C, Y, W-135 and Serogroup B The disease, meningococcal meningitis, is a serious, sometimes fatal bacterial infection that occurs sporadically worldwide and in focal epidemics. It is transmitted by person-to-person close contact with respiratory secretions or saliva of an infected person. Children and young adults are most at risk for the disease. Meningococcal meningitis is characterized by a short incubation period followed by sudden onset of symptoms. Meningococcal septicemia, in which bacteria rapidly disseminate through the bloodstream, is a less common form of meningococcal disease, but has been responsible for the high case fatality rate in outbreaks of group C disease in Canada. The five major serogroups most commonly associated with invasive disease are A, B, C, Y & W-135. Serogroups B & C are the most frequent causes of sporadic cases and outbreaks in Europe & the Americas, followed by Y. Although serogroup A used to be the main cause of epidemic disease, mainly in Africa and Asia, ssince 2010, 22 of the 26 countries in the African meningitis belt have introduced a meningococcal A conjugate vaccine (MACV), and the decrease in the incidence of Neisseria meningitidis (N.m) A has been confirmed and sustained. Serogroups Y and W-135 are relatively uncommon, but may be on the rise; during the past years, serogroup Y has emerged as a cause of disease in Canada and the USA, and serogroup W-135 has been associated with meningococcal disease epidemics in Saudi Arabia and Burkina Faso. Serogroup B is the most common source of meningococcal disease world-wide. Epidemics most often occur during the winter-spring in temperate regions and in the dry season (which varies by country, but typically between Nov & June) in tropical regions. The exact timing of the season varies from year to year and from country to country (occurring earlier in the east and later in the west) (See Map 7-7). Vaccines against serogroups A, B, C, Y and W-135 are available in Canada. The “meningitis belt” in Africa (see Map 7-8) is considered hyper-endemic for meningococcal meningitis. The disease is present all the time, with epidemic rates (occurring between epidemics) often exceeding those in other countries. Epidemics in the belt occur in cycles that can last 2-3 years and tend to recur every 8-12 years. Since the 1980’s the intervals between epidemics have become shorter and more irregular. During the dry season, the incidence rate of meningococcal disease can reach as high as 1,000 cases per 100,000 population. In non- epidemic periods, the rate of meningococcal disease is roughly 5 - 10 cases per 100,000 population. The fatality rate is about 5 to 10%. Since the mid-1990’s epidemics have become more frequent, and have spread beyond the usual boundaries. Outside the meningitis belt, there is no evidence of a cyclical pattern of epidemics. To identify travellers at higher risk and who should also receive vaccine (See Section II, Table 4 Meningococcal Meningitis): • Countries in the meningitis belt (endemic), noted with the year of most recent activity - children and adolescents are at increased risk • Countries that are outside of the meningitis belt that have experienced meningococcal meningitis activity (epidemic) within the last 2 -3 years - rates rise in older children and young adults Refer to the MHSAL Eligibility Criteria and to the Canadian Immunization Guide (CIG), Table 1 for individuals with underlying medical conditions who meet the criteria for publicly funded meningococcal vaccines. Revised July 7, 2020
E -Vaccination for Serogroups A, C, Y, W-135 is Recommended for the following individuals, depending on degree of exposure: In general, the following travellers do not need to receive serogroup B vaccine unless there is evidence of a hyperendemic strain or an outbreak that is known to be caused by serogroup B that can be prevented by the vaccine: (The decision to recommend vaccination should be based on a careful assessment of risk, taking into account the destination, epidemiology of disease, nature of exposure, and the health of the traveller). • All persons 2 months of age and older, travelling to an area of current epidemic disease (*within the last year) regardless of duration of exposure (Refer to Table 4, bolded countries). • Persons travelling to the meningitis belt or to African countries outside the usual boundaries of the meningitis belt, where there is not current activity but where epidemics have occurred within the past 2 – 3 years who will also be: o Living or working there o In close contact with the local population i.e.; through school, accommodations, or public transport. *Note: When making your assessment, risk in these areas is highest in the dry season (which varies between countries from Dec to June). • Persons travelling to areas (including developed countries) where sporadic epidemics (including meningococcal C) have been reported in the last 6 months (check Public Health Agency of Canada Advisories or WHO web sites). *Note: In developed countries, travellers should follow the meningococcal immunization recommendations of the destination country. • Travellers to Saudi Arabia for the purpose of “Umrah” or the Hajj pilgrimage, or for seasonal work. Saudi Arabia requires evidence of vaccination (certificate of vaccination clearly documented with the name and type) against serogroups A, C, Y, W-135 for adults and children aged two years and older, administered no less than 10 days before arrival in Saudi Arabia. The vaccine name and type must be clearly indicated on the immunization certificate. For entry purposes: o Visitors from all countries: Visitors arriving for the purpose of Umrah or pilgrimage (Hajj) or for seasonal work are required to submit a certificate of vaccination with the quadrivalent (ACYW 135) vaccine against meningitis, proving the vaccine was administered in the past 3 years with a polysaccharide vaccine (no longer available in Canada) or 5 years with a conjugate vaccine and no less than 10 days before arrival in Saudi Arabia. The responsible authorities in the visitor’s country of origin should ensure that adults and children aged over 2 years are given 1 dose of the quadrivalent (ACYW135) vaccine and state clearly the type of the vaccine used on the vaccination card. If the vaccine type is not indicated on the certificate, the certificate will only be valid for 3 years. o Interior pilgrims and the Hajj workers: Vaccination with quadrivalent (ACYW135) vaccine is required for those who have not been vaccinated in the past 3 years with a polysaccharide vaccine (no longer available in Canada) or 5 years with a conjugate vaccine: all citizens and residents of Medina and Mecca all citizens and residents undertaking the Hajj (ie; domestic pilgrims) all Hajj workers including individual working at entry points or those in direct contact with pilgrims, such as personnel in healthcare settings Revised July 7, 2020
E -Vaccination for Serogroups A, C, Y, W-135 is Recommended for the following individuals, depending on degree of exposure, in addition to consideration of serogroup B meningococcal vaccine: • Travellers staying in schools, colleges & other places where large numbers of adolescents and your adults congregate • Travellers engaging in research, industrial and/or clinical laboratory settings as well as military personnel may be at increased risk of disease or exposure to N. Meningitis • Travellers with asplenia, functional or anatomic (including sickle cell disease); congenital complement deficiency; properdin; factor D or primary antibody deficiencies; acquired complement deficiency due to receipt of the terminal complement inhibitor eculizumab (Soliris™); HIV infection, especially if congenitally acquired and those with cochlear implants are at higher risk of complications from invasive meningococcal meningitis and should be provided vaccination with the conjugate quadrivalent vaccine regardless of potential for travel. (*Note: These individuals with underlying medical conditions meet the criteria for publicly funded vaccine according to Manitoba Health Seniors & Healthy Living). Vaccine Usage: • Travellers who have previously received meningococcal conjugate vaccine against serogroup C (at 1 year of age and/or with the school based program) will not be protected against other serogroups and will therefore still require the quadrivalent conjugate vaccine, if indicated for their travel. Independent of travel, Conjugate C vaccine should be up-to-date for age, according to the provincial immunization schedule. • There are three conjugate quadrivalent vaccines (containing Groups A, C, Y, W-135) currently licensed in Canada; Menomune™ (a polysaccharide vaccine) has been discontinued in Canada: ® o Menactra , Menveo™ & Nimenrix™ are the vaccines of choice for travellers, as they are known to have significant advantages over the polysaccharide vaccine: • Better immune memory • Longer duration of efficacy • Lack of hypo-responsiveness with booster doses • Possible reduction of bacterial carriage rate • There are two meningococcal serogroup B vaccines currently licensed in Canada: Bexsero® and Trumenba™ Respected Timeframes Between Meningococcal Vaccines: If a meningococcal conjugate vaccine is given, wait at least 1 month before administering another meningococcal conjugate vaccine. Meningococcal serogroup B vaccines can be given concomitantly with quadrivalent meningococcal serogroup A, C, Y, W conjugate vaccines or other vaccines Interchangeability of Meningococcal Vaccines: There are no published data regarding the interchangeability of Men-C-C vaccines, but the vaccines have been safely interchanged without a noticeable decrease in efficacy. Revised July 7, 2020
When possible, an infant series should be completed with the same vaccine. Either Men-C-ACYW vaccine may be used for re- vaccination, regardless of which meningococcal vaccine was used for initial vaccination. If providers are challenged with having to consider alternate use of conjugate quadrivalent vaccines to ensure travellers are provided some protection prior to departure (ie; during times of vaccine shortages etc.), the following principles should be used in your decision making: o For individuals 2 to 23 months of age: Menveo™ should be the first-line recommendation (CIG recommendation) Nimenrix® should be the alternative option, if Menveo™ is not available (product monograph indication) If neither Menveo™ or Nimenrix® are available, Menactra® should be considered as a last option (*off-label recommendation) • Ensure parents are informed of this usage, and note that although adequate protection or efficacy may be assumed to be similar, it cannot be guaranteed. • Any prescriber who is recommending or administering this vaccine should be aware of the contents of the product monograph and/or similarly approved standards or instructions for use. The manufacturer has received approval for use of their product based on evidence as to the safety and efficacy of their product only when used in accordance with the product monograph or similarly approved standard or instruction for use. This recommendation for use may differ from that set out in the product monograph or other similarly approved standards or instructions for use by the licensed manufacturer. Such recommendations may be endorsed by NACI, CIG or CATMAT, based on the best available evidence. The two serogroup B meningococcal vaccines (MenB-fHBP and 4CMenB) are not interchangeable; the vaccine products contain different antigens and there are no published studies on the immunogenicity resulting from a vaccination series combining the two products. Therefore, the same vaccine product should be used for all doses in a vaccination series. If, in a person with an incomplete vaccination series, it is unknown what vaccine product they initially received, the initial dose(s) should be discounted and the vaccination series repeated using the same vaccine product for all doses in the new, repeated series. Sources: CIG: Meningococcal Vaccine; Trumenba Product Monograph, May 24, 2019 Bexsero Product Monograph, June 12, 2020 Menveo Product Monograph, June 3, 2020 Nimenrix Product Monograph, Dec 19, 2018 Menactra Product Monograph, Nov 28, 2017 CATMAT Statement on Meningococcal Disease and the International Travel, May 7, 2015 Health Requirements and Recommendations for Travellers to Saudi Arabia for Hajj and Umrah; June 9, 2019 Weekly Epidemiological Record; 5 APRIL 2019, Nos. 14/15, 2019, 94, 179–188 NACI Update on Quadrivalent Meningococcal Vaccines available in Canada, April 2015 The Use of Bivalent Factor H Binding Protein Meningococcal Serogroup B (MenB-fHBP) Vaccine for the Prevention of Meningococcal B Disease, NACI, Jan 29, 2020 Advice for the Use of the Multicomponent Meningococcal Serogroup B (4CMenB) Vaccine, NACI, April 2014 Revised July 7, 2020
Recommended Quadrivalent Conjugate Meningococcal Vaccines (Men-C-ACYW-135*1) & Serogroup B Meningococcal Vaccine *2 Schedules for Travellers Recommended Booster Doses Age Schedule vaccine(s) 2 to 11 months Menveo™*3 2 or 3 doses *4 given 8 weeks apart*5 (with another Men-C-ACYW-135: of age and/or Bexsero® dose between 12-23 months of age that is at least 8 • If vaccinated at 6 years of age or younger: weeks from the previous dose) *5 every 3 to 5 years 12 to 23 Menveo™ *3 2 doses at least 8 weeks apart*5 • If vaccinated at 7 years of age & older: months of age and/or Bexsero® every 5 years • Travellers to the Hajj should check 24 months to 9 Men-C-ACYW-135*1 1 dose of Men-C-ACYW-135*1 recommendations for re-vaccination, as they years of age 2 doses of Bexsero® (4CMenB), given at least 8 may require booster vaccination no more than and/or Bexsero® weeks apart 3 years and no less than 10 days before arrival in Saudi Arabia. 10 years of age Men-C-ACYW-135*1 1 dose of Men-C-ACYW-135*1 Serogroup B: and older*6 and/or 2 doses of Bexsero®, at least 4 weeks apart or • The need for a booster dose is yet to be Bexsero® or determined Trumenba™ 2 doses of Trumenba™, at least 6 months apart or 3 doses of Trumenba™, at least 4 weeks apart, with another dose at least 4 months after dose two) *1: Men-C-ACYW-135: Menactra® (Men-C-ACYW-DT), Menveo™ (Men-C-ACYW-CRM) or Nimenrix™ (Men-C-ACYW-TT) *2: Serogroup B Meningococcal Vaccines: Bexsero® (4CMenB) - Multicomponent Meningococcal Serogroup B OR Trumenba™ (MenB-fHBP) - Bivalent Meningococcal Serogroup B *3: Men-C-ACYW-CRM (Menveo™) is authorized for use in children 2 months of age and older. Based on available published data in this age group, Menveo™ should be used because it has been found to be safe and immunogenic.The schedules in this table are based on those used in published clinical trials and the recommendation that a dose of meningococcal conjugate vaccine be given in the second year of life (12 to 23 months) for children vaccinated at less than 1 year of age. *4: For Bexsero® (4CmenB), depending on the age at which immunization is initiated, the manufacturer recommends two or three primary doses and a booster (2 + 1 schedule or 3 + 1 schedule) when the first dose is received between the ages of 2 and 5 months, and two primary doses and a booster (2 + 1 schedule) when the first dose is received between ages of 6 and 11 months. The booster dose should be administered in the second year of life.*See Biological page for schedule *5: Men-C-ACYW-135 vaccines may be given a minimum of 4 weeks apart if accelerated immunization is needed. *6: Serogroup B Meningococcal vaccines are not authorized for use in those 26 years of age and older and Men-C-ACYW-135 vaccines are not authorized for use in those 56 years of age and older; however, based on limited evidence and expert opinion their use is considered appropriate above these authorized ages (*CIG). *Refer to section above on Interchangeability Revised July 7, 2020
Initial Series Reinforcements Specific Contraindications Expected Reactions Meningococcal Dosage: If vaccinated at 6 years 1. Known hypersensitivity to any Common Local Reactions: Meningitis 1 Dose of age or younger: component of the vaccine: Sodium 2 to 10 year olds: Conjugate 0.5 ml IM (deltoid every 3 to 5 years Chloride, Sodium Phosphate, - Pain at the injection site (40 – 48%) preferred site or Anhydrous, *Syringes & vial Adolescents and adults: Menactra® anterolateral part of If vaccinated at 7 years stopper latex-free - Pain at the injection site (52 - 64%) A, C, Y, W-135 the thigh in those of age & older: 2. Anaphylactic reaction to a Common Systemic Reactions: (Men-C-ACYW-DT) 12 to 23 months of every 5 years previous dose. 2 to 10 year olds age) 3. Previous history of Guillain-Barré - Drowsiness (10 – 26%) Sanofi Pasteur Syndrome - Irritability (11 – 35%) *Travellers to Saudi - Diarrhea (12 –16%) *Authorized in Protection is Arabia for the purpose Caution: Adolescents and adults: Canada for ages 9 established 8 – 28 of Umrah and Hajj Menactra® has not been studied - Headache (37 – 41%) months to 55 years days after require the vaccine with pregnant women; use only if the - Fatigue (30 – 34%) vaccination. within past 5 years with benefits outweigh the risks. May be Very Rare: a conjugate vaccine administered to women who are - Guillain Barré Syndrome and no less than 10 breastfeeding. - Thrombocytopenia days before arrival. - Urticaria Biological Initial Series Reinforcements Specific Contraindications Expected Reactions Meningococcal Dosage: If vaccinated at 6 years 1. Known hypersensitivity to any Very common (greater than 1 in 10): Meningitis 1 Dose of age or younger: component of the vaccine: Sucrose, Loss of appetite, irritability, Conjugate 0.5 ml IM (deltoid every 3 to 5 years Trometamol. Sodium chloride drowsiness, headache, fever, swelling, preferred site or 2. Anaphylactic reaction to a pain & redness at the injection site, Nimenrix™ anterolateral part of If vaccinated at 7 years previous dose. fatigue A, C, Y, W-135 the thigh in those 6 of age & older: 3. Previous history of Guillain-Barré Common (greater than 1 in 100): (Men-C-ACYW-TT) to 23 months of every 5 years Syndrome Diarrhea, vomiting, nausea, injection age) site hematoma Pfizer Canada Protection is Uncommon (greater than 1 in 1,000): established 8 – 28 Caution: Insomnia, crying, dizziness, decreased *Requires days after NIMENRIX® should be used during feeling or sensitivity especially in the reconstitution vaccination. pregnancy only when clearly needed skin, itching, rash, aching muscles, and the possible advantages pain in extremity (pain in the limb), *Authorized in Note: Although outweigh the potential risks for the generally feeling unwell, and injection Canada for ages 6 NIMENRIX® *Travellers to Saudi fetus. May be administered to site reaction (such as a hard lump at weeks to 55 years contains tetanus Arabia for the purpose women who are breastfeeding. the injection site, itching warmth and toxoid, this vaccine of Umrah and Hajj loss of feeling) does not substitute require the vaccine Rare (up to 1 in 1,000): for tetanus within past 5 years with Large swelling of the vaccinated limb immunization a conjugate vaccine associated with redness and no less than 10 days before arrival. Revised July 7, 2020
Biological Initial Series Reinforcements Specific Contraindications Expected Reactions Meningococcal Dosage: If vaccinated at 6 years 1. Known hypersensitivity to any Common (greater than 10%): Meningitis 1 Dose of age or younger: component of the vaccine: Swelling, redness and soreness at Conjugate 0.5 ml IM (deltoid every 3 to 5 years CRM197 or other diphtheria- injection site headache, diarrhea, preferred site or containing vaccines; feeling tired or achy Menveo™ anterolateral part of If vaccinated at 7 years Potassium dihydrogen phosphate, Not Common (1 – 10%): A, C, Y, W-135 the thigh in those of age & older: sucrose, sodium chloride, sodium Fever, vomiting, rash (Men-C-ACYW-CRM) 12 to 23 months of every 5 years dihydrogen phosphate monohydrate, Very Rare: age) di-sodium hydrogen phosphate Anaphylaxis (itchy hives, swelling of GlaxoSmithKline bihydrate; *Latex Free and T-Free the lips, face, tongue, legs and arms) Protection is 2. Anaphylactic reaction to a *Requires established 8 – 28 previous dose. reconstitution days after *Travellers to Saudi 3. Previous history of Guillain-Barré vaccination. Arabia for the purpose Syndrome *Authorized in of Umrah and Hajj Canada for ages 2 require the vaccine Caution: months to 55 years within past 5 years with Menveo™ should be given during a conjugate vaccine pregnancy only if the benefits of and no less than 10 vaccination clearly outweigh the days before arrival. risks. May be administered to women who are breastfeeding. Revised July 7, 2020
Biological Initial Series Reinforcements Specific Contraindications Expected Reactions Bivalent Standard Dosage The need for a booster 1.Known hypersensitivity to any Very Common (more than 1 in 10) Meningococcal B for Routine dose following primary component of the vaccine: aluminum Headache, nausea, diarrhea, muscle Vaccine Immunization: immunization series has phosphate, histidine, polysorbate 80, pain, joint pain, redness, swelling and not been established. & sodium chloride pain at the injection site, chills and 2 doses 2. Anaphylactic reaction to a fatigue Trumenba™ 0.5ml IM*from a previous dose (MenB-fHBP) prefilled syringe at This vaccine is Common (more than 1 in 100 Recombinant 0 & 6 months immunogenic, although *syringes & plunger latex free Vomiting, fever its effectiveness, impact The tip cap and rubber plunger of the Dosage strength of syringe are not made with natural 60 mcg of subfamily Dosage for on carriage and herd Individuals at immunity, and its duration rubber latex A and 60 mcg of subfamily B rLP2086 Increased Risk of of protection remain Invasive unknown. Caution: (120 mcg total There are no data from the use of protein) per 0.5 mL Meningococcal Disease (IMD): Trumenba™ in immunocompromised dose. individuals or in pregnant women. It Pfizer Canada 3 doses is unknown if Trumenba™ is 0.5ml IM* from a excreted in human milk. Only use in prefilled syringe these circumstances, if the potential with the first 2 benefits clearly outweighs the Notes: potential risks. Shake vigorously doses at least 1 before use to ensure month apart, Give with caution to individuals with a homogeneous followed by a third thrombocytopenia or any coagulation white suspension is dose at least 4 disorder or to those receiving obtained. months after the anticoagulant therapy, unless 2nd dose the potential benefit clearly Do not use the outweighs the risk of administration. vaccine if it cannot be re-suspended or if *Deltoid preferred particulate matter or site discolouration is found. Note: Due to lack of Syringes should be data, stored in the meningococcal refrigerator group B vaccines horizontally (laying are not flat on the shelf) to interchangeable. minimize the re-dispersion time. *Authorized in Canada for ages 10 through 25 years Revised July 7, 2020
Biological Initial Series Reinforcements Specific Contraindications Expected Reactions Dosage: The need for a booster 1. Known hypersensitivity to any Local Reactions: Multicomponent 0.5 ml IM dose is yet to be component of the vaccine: Tenderness and redness at the Meningococcal determined. Kanamycin, Sodium Chloride, injection site; induration. Vaccine *See chart below Histidine, Sucrose, Aluminum for Schedule: Hydroxide, Natural Rubber Latex Systemic Reactions: Bexsero® (tip cap of the syringe) Adults: Headache, malaise, myalgia, (4CMenB) 2. Anaphylactic reaction to a Recombinant, previous dose Infants & children: Fever, irritability, unusual crying, adsorbed Caution: sleepiness - Not expected to provide protection Uncommon (≥ 1/1,000 to < 1/100): GlaxoSmithKline against all circulating meningococcal Fever ≥40°C, nervous system serogroup B strains or other invasive disorders, seizures (including febrile meningococcal disease (IMD). seizures), skin & subcutaneous tissue - In immunocompromised disorders, eczema, urticaria, vascular individuals, vaccination may not disorders, pallor (rare after booster) result in a protective antibody Rare (≥ 1/10,000 to < 1/1,000): response. Kawasaki syndrome - Should only be given during pregnancy or when breastfeeding if the benefits of vaccination clearly outweigh the risks, as there are no studies. White opalescent liquid suspension in a prefilled syringe. A fine off-white deposit may form when the product stands for a long period. Shake the vaccine well before use. *Authorized in Canada for ages 2 months to 25 years Revised July 7, 2020
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