COVER User Guide
Contents
1. Page 11 of 31 6 2 Surveillance actions for suspected and confirmed cases aged lt 5 years Organisation Who needs to Case status responsible for Surveillance Action 7 take action follow up gt Complete epi surveillance form gt Request Throat Swab for local culture gt Request EDTA sample 2ml gets eee sent to MRU for PCR testing IMD case aged lt 5 gt Request ACUTE serum sample Hospital years 2ml be taken amp stored ideally clinician and within 72 hours of treatment microbiologist gt Remind need to send all meningococcal positive samples to MRU gt Complete surveillance form and upload to HPZone or return to PHE Confirmed as Hospital IMD by MRU clinician and with capsular microbiologist group 2 weeks post Hospital MRU clinician and confirmation microbiologist Page 12 of 31 6 1 SUSPECTED IMD CASES reported to HPTs Local Health Protection Teams HPTs informed of a suspected case of IMD will be requested to complete a short epidemiological surveillance questionnaire Form MENSV01 see Appendix 1 and notify the clinician of the clinical samples that need to be taken It may be necessary to contact the GP to obtain an accurate vaccination history for the case The completed MENSV01 surveillance form should be uploaded to the appropriate HPZone record for the case Because of the importance of ensuring maximal confirmation of cases of IMD by capsular group HPTs clinicians and micro2. Blood Sample s for Meningococcal Surveillance This form should be completed and sent with any blood sample taken for meningococcal surveillance Please write the date when the sample was taken and tick the appropriate box DATE Sample Taken 1 ACUTE SAMPLES ideally within 72 hours of starting treatment _ Serum sample 2 mL for acute antibody measurement EDTA sample 2 mL for non culture meningococcal characterisation 2 CONVALESCENT SAMPLE ideally 3 6 weeks after diagnosis _ Serum sample 2 mL for convalescent antibody measurement Completed By Tel Date Le li Thank you very much for your co operation All samples should be sent through your local laboratory where they will be packaged in accordance with current transport and postal regulations and MUST BE ACCOMPANIED BY THIS FORM Please send Sample s with Form to Professor Ray Borrow PHE Meningococcal Reference Unit Manchester Medical Microbiology partnership Clinical sciences Building Manchester Royal Infirmary Oxford Road Manchester M13 9WZ Tel 0161 276 6793 E mail ray borrow phe gov uk HAYS DX Meningococcal Reference Unit DX 6962410 Manchester 90M LAB use only comments Page 25 of 31 Appendix 4 Clinical questionnaire Form MENSV02 August 2015 Page 26 of 31 j A amp Immunisation T 020 8327 7828 or 6688 INY Department F 020 8327 7404 61 Colindale Avenue Email PHE meningo nhs net Public Health London NW
3. Public Health England Protecting and improving the nation s health National enhanced surveillance of vaccination programmes targeting invasive meningococcal disease in England Public Health England Immunisation Department and Meningococcal Reference Unit About Public Health England Public Health England exists to protect and improve the nation s health and wellbeing and reduce health inequalities It does this through advocacy partnerships world class science knowledge and intelligence and the delivery of specialist public health services PHE is an operationally autonomous executive agency of the Department of Health Public Health England Wellington House 133 155 Waterloo Road London SE1 8UG Tel 020 7654 8000 gov uk phe Twitter PHE_uk Facebook facebook com PublicHealthEngland Crown copyright 2014 You may re use this information excluding logos free of charge in any format or medium under the terms of the Open Government Licence v2 0 To view this licence visit OGL or email psi nationalarchives gsi gov uk Where we have identified any third party copyright information you will need to obtain permission from the copyright holders concerned Any enquiries regarding this publication should be sent to meningo phe gov uk PHE publications gateway number 2015294 Version number Date 1 0 28 08 2015 1 1 01 09 2015 Page 2 of 31 Contents About Public Health EMOIANG scans een ne an sta
4. 44 0 20 8 327 7404 Public Health 61 Colindale Avenue E PHE meningo nhs net England London NW9 5EQ UK www gov uk phe Surveillance of Invasive Meningococcal Disease Doctor PHE ref Dear Dr ccccdesicceveiwesteeudans l Patient Name NHS No HOSPITAL DOB l Public Health England PHE is conducting enhanced national surveillance of invasive meningococcal disease IMD to monitor the impact of meningococcal vaccines in the national immunisation schedule As part of the surveillance we are requesting acute serum samples from children with laboratory confirmed IMD Since more than half the cases are now diagnosed by PCR only we are also developing non culture characterisation of meningococci to monitor vaccine effectiveness We would therefore be grateful if you could also send an extra EDTA sample 2 ml with the acute serum using the enclosed Sample Submission Form gt It is critically important that all positive meningococcal samples are sent to the Meningococcal Reference Unit for confirmation capsular grouping and genetic molecular characterisation gt Could you please also arrange for a blood test for convalescent serology 2ml serum ideally at 3 6 weeks after diagnosis and send the sample to the Meningococcal Reference Unit MRU using the enclosed Sample Submission Form Our contact details are on the top right hand corner of this letter Thank you for your time and help Yours sincerely
5. et al 2012 In 2014 there were 400 laboratory confirmed MenB cases in England with a quarter of cases occurring in infants lt 1 year and a further quarter in 1 4 year olds PHE data available here 1 3 Two quadrivalent conjugate vaccines offering protection against capsular groups A C W and Y Nimenrix and Menveo are currently licensed for use in the UK Tan et al 2010 MenACWY vaccine is currently recommended for travel to endemic areas and for children and adults with asplenia or splenic dysfunction or complement deficiency who may be at increased risk of invasive meningococcal infection It is also offered to those at close prolonged contact with individuals with confirmed capsular group A W or Y disease or probable cases with capsular group A W or Y from a nasopharyngeal swab to reduce the risk of late disease 1 4 Efforts to develop an effective MenB vaccine initially focussed on MenB outer membrane vesicles OMVs which have exhibited varying efficacy and are usually restricted to specific epidemic strains because the immune dominant antigen PorA is highly variable Tan et al 2010 In order to provide broader cross protective immune responses more recent vaccines have incorporated outer membrane vesicles from multiple strains with or without recombinant surface proteins such as factor H binding protein fHbp Neisserial Heparin binding Antigen NHBA and Neisserial adhesin A NadA The first of these vaccines Be
6. 2015 Jul 16 20 28 pii 21188 Frosi G Biolchi A Lo Sapio M Rigat F Gilchrist S Lucidarme J Findlow J Borrow R Pizza M Giuliani MM Medini D Bactericidal antibody against a representative epidemiological meningococcal serogroup B panel confirms that MATS underestimates 4CMenB vaccine strain coverage Vaccine 2013 Oct 9 31 43 4968 74 Ladhani SN Beebeejaun K Lucidarme J Campbell H Gray S Kaczmarski E Ramsay ME Borrow R Increase in endemic Neisseria meningitidis capsular group W sequence type 11 complex associated with severe invasive disease in England and Wales Clin Infect Dis 2015 Feb 15 60 4 578 85 Ladhani SN Flood JS Ramsay ME Campbell H Gray SJ Kaczmarski EB Mallard RH Guiver M Newbold LS Borrow R Invasive meningococcal disease in England and Wales implications for the introduction of new vaccines Vaccine 2012 May 21 30 24 3710 6 Tan LK Carlone GM Borrow R Advances in the development of vaccines against Neisseria meningitidis N Engl J Med 2010 Apr 22 362 16 1511 20 Vogel U Taha MK Vazquez JA et al Predicted strain coverage of a Meningococcal multicomponent vaccine 4CMenB in Europe a qualitative and quantitative assessment Lancet Infect Dis 2013 May 13 5 416 25 Page 16 of 31 Appendix 1 Surveillance questionnaire Form MENSV01 August 2015 a NATIONAL EPIDEMIOLOGICAL SURVEILLANCE CONFIRMED INVASIVE MENINGOCOCCAL DISEASE Form MENSVO1 7 August 2015 Public Health
7. 31
8. Dr Shamez Ladhani Professor Ray Borrow Dr Mary Ramsay Paediatric Infectious Diseases Consultant Deputy Head of MRU Head Immunisation Department Public Health England has approval under PIAG Section 60 of the Health and Social Care Act 2001 now subsumed into the National Information Governance Board for Health and Social Care with Section 60 now Section 251 of the NHS Act 2006 to process confidential patient information for public health purposes see http Awww legislation hmso gov uk si si2002 20021438 htm Page 21 of 31 ROR Immunisation T 020 8327 7828 or 6688 ALN Department F 020 8327 7404 Public Health 61 Colindale Avenue E PHE meningo nhs net London NW9 5EQ UK www gov uk phe England Surveillance of Invasive Meningococcal Disease Doctor PHE ref Dear Dr 226 ocgogieediescesexe Patient Name NHS No HOSPITAL DOB l l Public Health England PHE is conducting enhanced national surveillance of invasive meningococcal disease IMD in England to monitor the impact of meningococcal vaccines in the national immunisation schedule We would be grateful if you could complete the enclosed CLINICAL QUESTIONNAIRE for the above named patient and return it to us by fax email or in the pre paid envelope provided along with a copy of the patients HOSPITAL and INTENSIVE CARE if admitted discharge summaries Please complete the questionnaire and send us the requested information even if the patient
9. be extended to provide rapid measurement of the proportion of children who are appropriately vaccinated with the MenB vaccine by relevant ages 9 Calculation of vaccine effectiveness e Vaccine effectiveness VE is generally defined as the reduction in the attack rate in vaccinated compared with unvaccinated children in the same birth cohorts VE will be assessed by the screening method For this method the VE can be estimated using the formula below where PCV is the proportion of cases that are vaccinated and PPV is the proportion population vaccinated coverage e VE 1 PCV x 1 PPV 1 PCV x PPV e This requires knowledge of the numbers vaccinated and unvaccinated in the population by birth cohort or age group at any given time and the numbers of cases by vaccination Status arising in the same period by birth cohort or age group e Information on the proportions vaccinated by age group and birth cohort will be generated through the COVER scheme described above The vaccination status of confirmed cases by meningococcal capsular group will be ascertained by routine follow up e Age specific vaccine effectiveness estimates will be carried out using cases occurring after implementation of the relevant vaccination campaign in that age group VE Page 14 of 31 estimates will be generated for the various meningococcal vaccines in eligible cohorts targeted for immunisation Where possible VE will also be estimated for vaccine
10. has since been discharged transferred to another hospital or died following the infection Could you please also arrange for a blood test for convalescent serology 2ml serum ideally at 3 6 weeks after diagnosis and send the sample to the Meningococcal Reference Unit MRU using the enclosed Sample Submission Form Our contact details are on the top right hand corner of this letter Thank you for your time and help Yours sincerely Dr Shamez Ladhani Professor Ray Borrow Dr Mary Ramsay Paediatric Infectious Diseases Consultant Deputy Head MRU Head Immunisation Department Public Health England has approval under PIAG Section 60 of the Health and Social Care Act 2001 now subsumed into the National Information Governance Board for Health and Social Care with Section 60 now Section 251 of the NHS Act 2006 to process confidential patient information for public health purposes see http www legislation hmso gov uk si si2002 20021438 htm Page 22 of 31 A Immunisation T 020 8327 7828 or 6058 Department F 020 8327 7404 Public Health 61 Colindale Avenue E PHE meningo nhs net England London NW9 5EQ UK www gov uk phe Surveillance of Invasive Meningococcal Disease Doctor PHE ref DEAD Patient Name NHS No HOSPITAL DOB l Public Health England PHE is conducting enhanced national surveillance of invasive meningococcal disease IMD in England and Wales to monitor the impact of meningococca
11. 4 e Arrange for the child with confirmed IMD to have an additional blood test at 3 6 weeks after diagnosis for convalescent serology 2 ml serum sample PHE Colindale may contact the GP if further epidemiological clinical and or immunisation information is required Page 13 of 31 7 Possible future considerations for further investigations Under HTA license acute EDTA samples or CSF samples sent to MRU will be stored where possible to allow genetic studies on cases of IMD Ethics committee approval will be sought before any such use of stored samples is made 8 Measurement of vaccine coverage e Routine coverage data for the proportion of children receiving 2 doses of MCC vaccine by 1st 2nd and 5th birthday is collected and the proportion of children receiving a dose of MCC Hib vaccine by 2nd and 5th birthday is currently collected on a quarterly basis through the PHE COVER scheme National data are also published annually for England by the Department of Health e Vaccine coverage data collection for the teenage age group targeted by MCC and MenACWY conjugate vaccine is under review Routine collection of vaccine coverage data in teenagers Is likely to operate in a similar way to detail currently collected by PHE for the HPV vaccine delivered to teenage girls These data are collected using the ImmForm website managed by PHE which coordinates and manages the collection and reporting of national data e Coverage data collection will
12. 9 5EQ UK England Enhanced National Surveillance of Meningococcal Disease Clinical Questionnaire Form MENSVO2 August 2015 Patient name NHS Number Date of Birth Date of sample PHE reference Section B Demographics B1 Ethnicity White Black African Black Caribbean Indian Pakistani Indian Bangladeshi Chinese Mixed Other specify If born prematurely gestation at birth Underlying Risk Factors O None O Asplenia Splenic Dysfunction including sickle cell disease a Known complement deficiency including complement inhibitor therapy O Immunosuppression including HIV Comments Any other underlying medical condition Yes No __ Comments Travel abroad in the previous 28 days Yes No NK If yes where amp date of return Recently entered UK Yes J No __ NK Section A Reporter Details A1 D D MMAMMINIM Date of completion of questionnaire A2 Consultant responsible Page 27 of 31 Section C Presentation Clinical features C1 Date of onset of illness C2 Date of hospital admission C3 Date of hospital discharge DI DJAMIMIAYWIYIYILY DI DIAMIMAY YYY DIDAMIMIAY Y LY LY C4 Symptoms and signs at presentation tick all that apply History B Fever 238 C a Sore throat coryza C Reduced feeding appetite U Thirst O Nausea vomiting B Diarrhoea U Abnormal skin colour O Rash C5 Examination on admission O Lethargy B Breathing
13. IMD is defined as e An individual meeting the case definition for IMD 4a above with a meningococcal isolate other than MenB or positive sterile site PCR for a capsular group other than MenB plus MATS positive e OR b A confirmed case meeting case definition 4a above with no sterile isolate but positive sterile site PCR for a capsular group other than MenB plus meningococcal isolate other than MenB from a throat swab which is MATS positive Page 7 of 31 4 Enhanced Surveillance for meningococcal disease 4 1 Existing national surveillance activities Surveillance of meningococcal disease in England currently relies on collation of information on cases of laboratory confirmed infection identified by the PHE Meningococcal Reference Unit MRU in Manchester Confirmation of IMD cases by MRU relies on serogrouping isolates from culture proven cases and identification of the responsible capsular group by PCR Regular electronic downloads are made from MRU to the Immunisation Department PHE Colindale reporting all meningococcal infections confirmed by MRU and those known by MRU to have a fatal outcome Ascertainment of fatal laboratory confirmed cases is supplemented at PHE Colindale by linkage of laboratory reports with meningococcal deaths reported to the Office of National Statistics ONS MenC cases have been routinely followed up since the introduction of the MCC vaccine in November 1999 in order to ascertain vaccination history and ot
14. Public Health England immunisation Hepatitis and Blood Safety Department 61 Colindale Avenue London NW9 5EQ England Tel 020 8327 7828 or 6058 Secure Fax 020 8327 7404 Email meningo phe aov uk PLEASE COMPLETE IN BLOCK CAPITAL LETTERS IN CONFIDENCE Patient Details Surname Forename D O B DD MM YYYY Gender Male _ Female NHS number HPZone reference number PHE reference PART A Ethnicity please tick below L White British White other L Black Caribbean _ Black African Indian J Pakistani Bangladeshi Chinese _ Mixed Other Please specify PART B Vaccination History This covers Men B Men C and MenACWY vaccination Please complete details for all vaccines below as fully as possible Did this case receive any 1 dose 1 dose 1 dose 2 dose 2 dose 2 dose 3 dose 3 dose 3 dose Vaccine doses of each vaccine before daia batch ren pin daia batch sr ii daie batch nr ni disease onset number number Sar a T Not MenC as MenC Hib Yes Not eligible _ All high risk groups complement deficiency or asplenia vaccination O MenACWY a Yes PF should be offered MenB and MenACWY vaccination vaccination eligible O i Men B vaccine Bexsero included in the routine infant programme since 1 9 2015 and any baby born from 1 5 2015 should have been offered the vaccine at 2 4 months Men C vaccine Meningitec Menjugate or Neissvac included in the routine infant programme s
15. biologists are reminded of the importance of taking a throat swab on admission With immediate plating positive cultures can be obtained in up to 45 of cases of meningococcal disease Throat swabs are now routinely recommended for investigation of suspected meningococcal disease because they allow detailed characterisation of the meningococcal isolate in cases that not confirmed by culture e g PCR confirmed In order to monitor the different national meningococcal immunisation programmes currently in place it is also critical that all IMD positive samples are sent to the MRU for confirmation and characterisation 6 2 CONFIRMED CASES reported to PHE Colindale PHE Colindale will liaise with the local HPTs to ensure that they are aware of the meningococcal capsular group responsible and ensure that that the surveillance form is completed and uploaded on HPZone PHE Colindale will also liaise with the hospital to ensure that the appropriate clinical samples have been forward to the MRU For children younger than 5 years the clinical team will also be asked letters at Appendix 2 e to send serum 2 ml within 72 hours of treatment for acute serology and an additional EDTA 2 ml sample for further bacterial characterisation where it is important to use the appropriate sample submission form see Appendix 3 to complete the clinical questionnaire Form MENSVO02 and return the form to PHE Colindale by fax post or email see Appendix
16. difficulty _ Apnoea O Floppy muscle tone O Leg pain O General aches B Cold hands and feet C Bone joint pain swelling a Fever temp on admission UUL C C Rash macular popular maculo papular petechial purpuric fulminant O Reduced GCS state score if reduced C Seizure Total seizure duration mins a a O Time at Presentation am pm O Irritability O Bulging fontanelle C Headache O Neck Stiffness B Photophobia O Confusion delirium B Drowsy O Seizures Convulsions C Unconscious C focal or O generalised Page 28 of 31 Section D Complete if admitted to PICU attach discharge summary if available D1 Date of PICU admission OI VOU L discharge ALAINI D2 Reason for admission D3 Type of Support a Ventilation LJ CJ LS If Yes No days b Inotropes UJ CJ LS If Yes No of days c Haemofiltration J v ED If Yes No of days d Surgical procedures CJ OJ L If Yes explain Section E Lumbar Puncture cross out this section if not applicable DID AMIMNY YY Y E1 If LP done date Time taken am pm E2 LP performed before or AFTER antibiotics If after how many hours after E3 If No state why cardiovascular instability respiratory instability unable to other E4 CSF WBC count per mm Neutrophils Lymphocytes CSF RBC count per mm CSF protein mg dl CSF glucose mmol l Plasma glucose mmol l Section F Blood Investigations on admi
17. eee steel sec 2 Executive SUMMAry ee 4 22e se dames ne de me ti dnens nn ie nnn 4 The BAG KC roU PRO RO SR D EE ne 5 2 ODJECUVOS ee eee a ent ane ee cn 6 3 Definition of a confirmed case Of IMD siennes 6 SM NC INDO e E E 6 2 MN N 7 3 2 1 confirmed case of MATS positive MenB IMD case is defined as T 3 2 2 A non MenB MATS positive confirmed case of IMD is defined as T 4 Enhanced Surveillance for meningococcal disease ccscceseeeeeeeeeeeeeeeeeeneseenenees 8 4 1 Existing national surveillance activities 8 4 2 Routine laboratory investigation of IMD at MRU cc ceccceeeceeeeeeeeeeeeeeeeeeas 8 4 3 Neisseria meningitidis isolate characterisation cccccceccseeceeeeeeceeeeeeseeeeeeseeeeees 8 4 3 1 Phenotypic CNAFACTEFISATION boss seisecdsnctsccwedaaenatcsneasnce iaeenne bwntaevawstiewed sede savewsseaeooenedsebee 8 4 3 2 Genotypic characterisation sis 8 4 4 Antibiotic susceptibility testing wiccceteccccdatossnseancsmoranesaceacenuessteehiwesscuimereineeansedsedoasel bans 9 4 5 Acute and Convalescent serum samples ccceccceccceecseeeeeeeeeeeeeeteeeteeeeseeaeeeenees 9 4 6 Optimum clinical specimens for suspected meningococcal disease 9 5 National surveillance database cccceescseeeseeeeeeeeeeneeeeeeeeseeeeeseeseeeneseenseeneseeaeeenenoeees 10 6 Follow p DIOCOC UN CS ic ciccisccssaenccaesdacsnsevdesanssi
18. ensscatcssbenseiderwndadesnneaubssesienkadeauendsessanaasiean 11 6 1 SUSPECTED IMD CASES reported to HPTSs 13 6 2 CONFIRMED CASES reported to PHE Colindale cccecccecceeceeeeeeeeeeeeeeesees 13 7 Possible future considerations for further investigations 14 8 Measurement Of vaccine coverage ccccceseceeeeeeeneeaeeeeeneeeeeseaeeeeneseanesaessanesenesaaees 14 9 Calculation of vaccine effectiveness is ssssssrssserrrennrrernrrennnnnnnns 14 10 Dissemination of information and outputs ss 15 1i MOTO ONG CS en ne ann idee eee de desde ta tandis de 16 Appendix 1 Surveillance questionnaire Form MENSV01 August 2015 17 Appendix 2 PHE Letters 0 ccc ccccceeescceeeceeeeeeeeneeneceeseneca eee seneseeseaseaaseaeceesonseaeseneeeesensoness 20 Appendix 3 Sample submission form ses 24 Appendix 4 Clinical questionnaire Form MENSV02 August 2015 26 Page 3 of 31 Executive Summary This document updates and replaces the Joint protocol from the Public Health Laboratory Service now Public Health England PHE and the Institute of Child Health for Surveillance of the impact of the meningococcal group C MCC conjugate vaccination programme and protocol for investigation of vaccine failures in England and Wales published in November 1999 The national surveillance protocol for invasive meningococcal disease IMD in England has been extended in recognition of Changes to t
19. f yes what were their co morbidities C Congenital heart disease _ Congenital or chromosomal abnormality L Chronic lung disease _ CNS disease CSF leak VP shunt etc LC Chronic renal disease _ Chronic gastrointestinal disease C Metabolic disease _ Other COMMON ere ses cr asc ess 4 Was the patient pregnant at the time C Yes C No L Unknown PART F Outcome 5 Was the patient admitted to ITU C Yes No C Unknown 6 Is the patient currently alive C Yes U No C Unknown 6 1 If patient died Date of death afsit essasi dd mm yyyy Date PART G Travel History 7 Was the patient born in the UK Yes C No _ Unknown 7 1 If no when did they arrive in the UK mnvVyyyy 7 2 Country of birth 8 Has the patient recently travelled abroad returning in the last 28 days L Yes No L Unknown 8 1 If yes where did they travel 8 2 When did they return un l d n dd mm yyyy PART H Please provide any further comment nn nn nn CRM nm nm nn ns Surgery hospital HPT Thank you for your time and assistance Please return by post secure fax email both as detailed overleaf or upload to HPZone Page 19 of 31 Appendix 2 PHE Letters a Requesting Acute Serum Sample b Requesting Convalescent Serum Sample C Requesting EDTA sample from 25 year olds if not already submitted to M ah Immunisation T 020 8327 7828 or 6058 Department F
20. he MCC programme including the removal of the infant MCC dose at 4 months and the introduction of an adolescent MCC dose in June 2013 https www gov uk government collections meningococcal c menc vaccination programme The emergency introduction of a quadrivalent conjugate vaccine against meningococcal groups A C W and Y MenACWY for 14 18 year olds in August 2015 in response to a national outbreak of a hypervirulent MenW strain belonging to ST 11 clonal complex Ladhani et al 2015 Campbell et al 2015 https www gov uk government collections meningococcal acwy menacwy vaccination programme The introduction of a MenB vaccine Bexsero into the national infant immunisation schedule in September 2015 at 2 4 12 months of age 2 1 with a small catch up for 3 month olds 3 4 12 months and 4 month olds 4 12 months https www gov uk government collections meningococcal b menb vaccination programme This protocol covers the enhanced surveillance plan for invasive meningococcal disease in England with the aim of collecting data for the JCVI to inform national vaccination policy Page 4 of 31 1 Background 1 1 Meningococcal C conjugate MCC vaccines were introduced into the routine infant schedule in England from November ist 1999 Campbell 2010 A phased catch up programme for all other children up to 18 years began concurrently and was later extended to all students aged up to 25 years In clinical trials MCC vaccines we
21. her epidemiological data 4 2 Routine laboratory investigation of IMD at MRU This section summarises the current routine investigations offered by the PHE MRU for suspected cases of invasive meningococcal disease IMD The MRU user manual can be accessed directly for more detailed information on the use of these services http www hpa org uk webc hpawebfile npaweb_c 1194947367872 The MRU also offers a free national reference service for meningococcal PCR of clinical samples from suspected IMD cases If IMD is confirmed by a local diagnostic laboratory the original sample including extracts from local PCRs should be referred to MRU to allow the capsular group to be identified In addition to the routine testing additional typing may be undertaken in certain situations such as outbreaks 4 3 Neisseria meningitidis isolate characterisation 4 3 1 Phenotypic characterisation Phenotypic confirmation of N meningitidis isolates is based on morphology and biochemical reactions Phenotype identification is routinely undertaken by e Serogroup e Identification of capsular polysaccharide antigens by serological reactions is available on request but PCR is preferred for acute samples e Serotype e Identification of PorB outer membrane protein OMP by a dot blot ELISA using monoclonal antibodies mabs e Serosubtype e Identification of PorA OMP by a dot blot ELISA using monoclonal antibodies 4 3 2 Genotypic characterisation Genotype c
22. ince 1 11 1999 Catch up vaccination means all those born from 1 9 1981 should have been offered at least one dose of MenC vaccine MenC vaccine was offered to teenagers aged 13 14 years and Freshers June 2013 May 2015 A single dose of Menitorix vaccine combined MenC Haemophilus influenzae type B Hib has been offered at 12 13 months of age from 1 9 2006 DOB gt 1 8 2005 Men ACWY vaccine Menveo Nimenrix replaced MenC vaccine for teenagers and fresher doses given from 1 9 2015 catch up vaccination is also being offered for those aged 14 18 years DOB gt 1 9 1996 and aged 14 years Menitorix PART C Clinical presentation 1 What was the clinical presentation C Meningitis C Septicaemia C Both meningitis amp septicaemia _ Septic arthritis C Epiglottitis C Pneumonia C Other C Unknown Comments ceci ceec eee PART D Risk factors 2 At the time of onset did the patient have any known risk factors for meningococcal disease Yes No 2 1 If yes what were their risk factor s _ Unknown C Asplenia splenic dysfunction _ Complement deficiency C Malignancy Immune Deficiency _ Immunosuppressive drug Including complement inhibitors e g eculizumab Completed by Contact Number PART E Co morbidities and pregnancy 3 At the time of meningococcal disease did the patient have any co morbidities C Yes No LC Unknown 3 1 I
23. l vaccines in the national immunisation schedule Since more than half the cases are now diagnosed only by PCR we are also developing non culture characterisation of meningococci We would be grateful if you could also send an EDTA sample 2 ml using the enclosed Sample Submission Form even if an EDTA sample has already been sent to PHE Meningococcal Reference Unit MRU for diagnostic testing Our contact details are on the top right hand corner of this letter Thank you for your time and help Yours sincerely Dr Shamez Ladhani Professor Ray Borrow Dr Mary Ramsay Paediatric Infectious Diseases Consultant Deputy Head MRU Head Immunisation Department Public Health England has approval under PIAG Section 60 of the Health and Social Care Act 2001 now subsumed into the National Information Governance Board for Health and Social Care with Section 60 now Section 251 of the NHS Act 2006 to process confidential patient information for public health purposes see http www legislation nhmso gov uk si si2002 20021438 htm Page 23 of 31 Appendix 3 Sample submission form Page 24 of 31 AS PER Professor Ray Borrow PHE Meningococcal Reference Unit Clinical sciences Building Manchester Royal Infirmary Public Health Oxford Road Manchester M13 9W2Z England Tel 0161 276 6793 E mail ray borrow phe gov uk Surveillance of Invasive Meningococcal Disease Patient Name NHS No HOSPITAL DOB l Name of Paediatrician
24. ly Page 9 of 31 5 National surveillance database The existing system of electronic downloads from MRU to PHE Colindale of all laboratory confirmed IMD cases will continue but at shorter intervals of 1 3 times a week In the near future this process will be succeeded by a joint PHE Colindale and MRU meningococcal database currently in development National data on laboratory confirmed IMD cases will continue to be published quarterly in the Health Protection Report HPR A database holding demographic clinical serological and immunological information from the follow up Page 10 of 31 6 Follow up procedures The follow up procedure will depend on the age of the patient lt 5 years or 25 years 6 1 Surveillance and Actions for suspected and confirmed cases aged 25 years Organisation Surveillance Acton Who needs to responsible take action for follow up Case status gt Complete epi surveillance form gt Request Throat Swab for local culture rene dee gt Request two EDTA samples aged 25 years 2ml each get sent to MRU for Hospital clinician PCR testing With one sample and microbiologist submission form gt Remind need to send all meningococcal positive samples to MRU gt Ensure epi surveillance form completed and upload to HPZone or return to PHE Confirmed as IMD by MRU with capsular group gt Review HPZone record amp request completion of epi surveillance form by HPT if not already done
25. onfirmation is routinely based on identification by Page 8 of 31 e Capsular group Use of PCR based capsular group confirmation enables identification of non viable organisms All suitable submitted samples are tested with an internal control in a N meningitidis specific capsular transport gene ctrA screening PCR test which also incorporates the PCR MenB specific assay based on the sialyltransferase gene siaD B and the pneumolysin assay All non MenB N meningitidis reactive specimens are then tested by the capsular group specific PCR assays based on siaD to detect and distinguish MenC MenY and MenW Testing for MenA can be performed where indicated using the mynA assay e Subtype Genetic characterisation of subtype PorA by DNA sequencing has been routinely undertaken and reported on all clinical isolates since October 2007 From Jan 2012 MRU has introduced porA subtyping for non culture samples that are ctrA ve under cycle number 34 e Additional characterisation following the introduction of the infant MenB immunisation programme an additional 2 ml EDTA sample will be requested from IMD cases of all ages to undertake additional phenotypic and or genotypic characterisation to assess whether the infection was potentially vaccine preventable This EDTA sample is for storing and must be accompanied by the sample submission form at Appendix 3 4 4 Antibiotic susceptibility testing The Minimum Inhibitory Concentrations MICs rou
26. re found to be safe immunogenic and to prime for memory and licensure was based on immunogenicity rather than efficacy data At that time the fundamental requirement for enhanced case confirmation strain characterisation and surveillance was recognised in order to monitor the impact of these MCC immunisation programmes An appropriate surveillance strategy was therefore published in November 1999 and has been in place ever since Information generated from this surveillance has been key in furthering understanding of the impact of MCC vaccines and has influenced the way that meningococcal conjugate vaccines vaccine programmes were subsequently introduced in other countries including the MenA vaccination programme in African countries across the meningitis belt It has also led to changes in the MCC programme in England with a reduction from a 3 dose to 2 dose infant programme based on comparable immunogenicity and the introduction of a Hib MCC booster at 12 months of age to address waning immunity Campbell et al 2010 1 2 The MCC immunisation programmes had a very rapid and marked impact on invasive MenC disease in the cohorts targeted by vaccine An indirect effect on age groups outside the immunised group was also apparent with a large reduction in cases in older ages There have been around 30 MenC cases confirmed annually in England and Wales since 2006 07 MenB now accounts for the vast majority of invasive meningococcal disease IMD Ladhani
27. roup but is based on recombinant surface proteins including an outer membrane vesicle from a specific New Zealand outbreak strain Although the vaccine was developed to maximise protection against MenB it also has the potential to protect against invasive disease caused by other capsular groups Similarly the vaccine will not protect against all MenB strains in England it is estimated that Bexsero will protect against 73 88 of currently circulating MenB strains Vogel et al 2013 Frosi et al 2013 Thus additional definitions are required to capture antigen specific vaccine effectiveness against MenB cases and against all IMD cases The impact of Bexsero 4CMenB will be monitored using the Meningococcal Antigen Typing System MATS assay by the MRU The definition of an isolate with a positive MATS assay result MATS positive is a N meningitidis strain with at least one vaccine antigen fHbp NadA NHBA above the positive bactericidal threshold PBT or a positive result for PorA P1 4 by sequencing of VR2 and or by serosubtyping 3 2 1 A confirmed case of MATS positive MenB IMD case is defined as e Aconfirmed case meeting case definition 4a above plus MATS positive e OR b A confirmed case meeting case definition 4a above with no sterile isolate but positive MenB specific PCR from a sterile site plus isolation of MenB from a throat swab which is MATS positive 3 2 2 non MenB MATS positive confirmed case of
28. specific antigens 10 Dissemination of information and outputs Successful implementation of the national surveillance programme will continue to depend on collaboration of health protection units immunisation co ordinators microbiologists and clinicians looking after patients with IMD Information on the surveillance scheme will be disseminated widely through PHE Web Pages This information will include names contact numbers and addresses of lead individuals for different parts of the programme Regular reporting already undertaken through publication in the HPR will continue It is recognised that the MenB vaccine programme will require rapid monitoring and early feedback to assess the impact of the programme Reports to Joint Committee on Vaccination and Immunisation JCVI to include disease incidence and coverage and VE when this becomes available Page 15 of 31 11 References Campbell H Andrews N Borrow R Trotter C Miller E Updated postlicensure surveillance of the meningococcal C conjugate vaccine in England and Wales effectiveness validation of serological correlates of protection and modelling predictions of the duration of herd immunity Clin Vaccine Immunol 2010 May 17 5 840 7 Campbell H Saliba V Borrow R Ramsay M Ladhani SN Targeted vaccination of teenagers following continued rapid endemic expansion of a single meningococcal group W clone sequence type 11 clonal complex United Kingdom 2015 Euro Surveill
29. ssion F1 Full Blood count Hb _ g dL WBC count x107 L Neutrophil count ___x10 L Platelets ____x107 L C reactive protein mg L Not done a F2 Liver Function Test Bilirubin mg dL Alanine Transaminase ALT IU L Not done Section G Treatment G1 Antibiotics on admission Time of FIRST antibiotic dose am pm Total duration of antibiotics IV days then oral Steroid given for meningitis diagnosis Yes No If yes how many hours after the first antibiotic dose Page 29 of 31 Section H Please complete if any imaging performed Investigation Performed Scan Normal Date Yes No NK Yes No NK DIDUAMIMAYIYIYIN G1 Cranial Ultrasound L DIDUMIM AYIYIYIY G2 CT Head L JULI L JUJ J 1 7 DIDUMIMIAYIYIY LY G3 MRI Head L BES J G4 Major findings you can please attach copy of report instead Section l Outcomes 11 Did the patient survive the infection Yes a No DIDYMIMILY Y If died date Cause of death If survived DIDMIM Y LY 2 Date of last follow up 13 At follow up did the patient have any of the following a Epilepsy b Other Neurological complications Thank you for taking the time to complete the Questionnaire Please return the completed form to Immunisation Department Public Health England 61 Colindale Avenue London NW9 5EQ UK Any questions Please call or email us at PHE meningo nhs net Page 30 of
30. tinely determined on submitted isolates are penicillin cefotaxime rifampicin ciprofloxacin and sulphonamide sulphamethoxazole using Etest Biomerieux gradient diffusion methodology Other antibiotic susceptibility tests may be performed on request 4 5 Acute and Convalescent serum samples Acute and convalescent serum samples are being requested from all vaccine eligible confirmed probable MenC cases to help decide on future vaccination of these cases and to investigate the mechanism of disease post vaccination Following the introduction of the MenB programme acute and convalescent serum samples will also be requested from all children younger than 5 years with laboratory confirmed IMD irrespective of the meningococcal capsular group responsible or the child s prior meningococcal immunisation status 4 6 Optimum clinical specimens for suspected meningococcal disease The recommended clinical specimens for the investigation of suspected IMD should be taken as soon as possible after hospital admission and include e Blood culture e EDTA blood for PCR 2 ml to be sent to the MRU e CSF culture if meningitis suspected and LP not contra indicated e CSF for PCR if meningitis suspected and LP not contra indicated e Throat swab for culture even if antibiotics have been administered e Culture PCR of other sterile sites if clinically indicated e g joint fluid etc e Rash aspirate if this investigation identified as useful local
31. troduction of the MenB immunisation programme The monitoring of vaccine safety is also a key aspect of immunisation programme surveillance and will be undertaken by the Medicines and Healthcare Regulatory Agency MHRA in collaboration with PHE 3 Definition of a confirmed case of IMD a A case of IMD is defined as an individual with a culture of N meningitidis or identification of meningococcal DNA from a normally sterile site For the purposes of surveillance cases will be further classified as follows 3 1 Men A C W Y IMD A case of Men A C W Y IMD is defined as in individual meeting the case definition for IMD 4a above and one or more of the following e Phenotypically Men A C W Y culture positive from samples taken from a normally Sterile site or from rash aspirate e PCR capsular group siaD A C W Y positive from sample taken from a normally Sterile site or rash aspirate e Meningococcal A C W Y antigen detected by latex in blood CSF or urine Note Positivity by a latex method which does not distinguish between A C Y and W will not be considered confirmation of any individual group Page 6 of 31 3 2 MenB IMD A confirmed case of MenB IMD is defined as an individual meeting the case definition for IMD 4a above with isolation of MenB or positive capsular group B specific PCR from a normally sterile site The licensed MenB vaccine Bexsero does not target the polysaccharide capsule which determines the capsular g
32. xsero GSK Biologicals was licensed in Europe in January 2013 and introduced into the UK infant immunisation programme on 01 September 2015 https www gov uk government collections meningococcal b menb vaccination programme Page 5 of 31 1 5 This national surveillance plan describes the surveillance of meningococcal disease to inform and evaluate future vaccine policy The surveillance plan aims to encompass all meningococcal vaccines in the national immunisation programme and their impact on all meningococcal capsular groups across all ages in England The surveillance plan will be reviewed after the first year in the light of the surveillance data generated the programmes adopted and actual vaccine usage which at present is uncertain 2 Objectives a To continue to monitor the impact and age specific vaccine effectiveness of the MCC immunisation programme b To monitor the impact and age specific vaccine effectiveness of the MenB immunisation programme in children c To monitor the impact and age specific vaccine effectiveness of the MenACWY immunisation programme in adolescents and evidence of any indirect impact across the population d To continue to monitor the phenotypic and genetic characteristics of invasive meningococcal isolates e To describe the clinical characteristics risk factors and outcomes of IMD as well as acute and convalescent serology in children aged lt 5 years with laboratory confirmed IMD following the in
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