ISARIC NewsMRC, INSERM and LKS Foundation about future of ISARIC. Institut Pasteur funds for E-learning project ISARIC-baby Isaac 'Zak' Carson born, 3 June, Congratulations Gail! WHO

Newsletter for the International Severe Acute Respiratory andEmerging Infection Consortium

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IN THIS ISSUEJeremy's MessageUpdatesWG UpdatesFeature article:ISARIC-WHO BSPDecision Support ToolSingaporeRoundtableE-learningH7N9 Conferenceand WorkshopISARIC SE Asia visitVIZIONSPREPARE (FP7)

Updates

✔ ISARIC part of PREPARE(EC FP7)✔ WHO/ISARIC SARI BSPand database in use✔ PHE/ISARIC Decisionsupport tool (nCoV)✔ Work on Convalescentplasma protocol✔ 70 members and counting- 6 networks have joined inthe last 6 months✔ GHT project funded (KathMaitland, KEMRI-WT &Kathy Rowan, ICNARC)✔ Jeremy Farrar to becomethe Director of the WT✔ Li Ka Shing award toISARIC

ISARIC NewsIssue 1 | Q1&2 | 2013

Jeremy's messageWelcome to the Q1&2/2013 ISARIC Newsletter. I amvery sorry for the lack of a Q1/2013 Newsletter,events somewhat overtook us! But we hope you willfind this update interesting and useful. The last year with the emergence of H7N9 and NCoVmight seem extra-ordinary, two potentially majoremerging infectious disease threats occurringsimultaneously in different parts of the world. But thereality is that with the much better surveillance now inplace in many parts of the world we are inevitablygoing to identify such novel (or re-emerging) threatson a much more regular basis.

In addition to the emergence of these high profilezoonotic pathogens there have also been regionaloutbreaks of Hand Foot and Mouth Disease in Asia,Dengue in new areas of the world, Chikungunya,Crimean-Congo haemorrhagic fever, Hepatitis E andmany more plus the continued emergence and spreadof perhaps the greatest emerging infectious diseaseproblem of all, antimicrobial drug resistance.

With better surveillance has come better sharing ofinformation and samples, perhaps not perfect yet andthere is much work to be done, but certainly betterthan a decade ago. Although there have been great

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✔ ISARIC/WHO NCoVclinical calls held✔ Ken Baillie and JakeDunning seconded to WHO✔ Antiviral Combinations forAvian A(H7N9) and OtherInfluenza Infections:Dunning, Baillie and HaydenSubmitted to LancetInfectious Diseases✔ Discussions withWellcome Trust, BMGF,MRC, INSERM and LKSFoundation about future ofISARIC.✔ Institut Pasteur funds forE-learning project✔ ISARIC-baby Isaac 'Zak'Carson born, 3 June,Congratulations Gail!✔ WHO and KSA jointmission, KSA, 4-9 June✔ WHO Scientific Meeting onMERS-CoV, Egypt, 18-19June✔ Singapore Roundtable:networking in South-EastAsia, 14 July✔ H7N9 conference andworkshop, China, 14-17August✔ WHO/ISARIC Mission toTunisia, 27-29 August✔ Joint KSA and WHO MassGathering Meeting, Riyadh,21-23 September✔ EC F2F Meeting, Oxford,26-28 September

Working GroupUpdates

WG1: Members fromworking group one havecontinued their work on aninterventional protocol onConvalescent plasma,intended to be a response tonCoV. There is also workbeing done on a protocol onInterferon. Another update isthat Kath Maitland and Kathy

improvements in communication and sharing andmuch better surveillance the ‘Clinical ResearchResponse” still lags behind, we still do not know howto actively treat patients, or use therapeuticinterventions to prevent secondary transmission inany of the infections I mention above.

This was the issue that led to the initial discussions bythe Heads of International Research Organisations(HIROS) and a subsequent meeting hosted at theWellcome Trust in 2011, which led to the setting up ofthe International Severe Acute Respiratory andEmerging Infections Consortium (ISARIC). I believe itis even more relevant today as the response to thepandemic of 2009, and subsequent epidemics haveshown. I would like to highlight a few of the major activitiesthat partners within ISARIC have been involved withover the last few months. The Middle East and in China have of course bornethe brunt of the outbreaks of nCoV and InfluenzaH7N9. ISARIC has benefited enormously by the closecollaboration with colleagues in both regions andthrough a series of teleconferences, workshops, andmeetings case management has been shared andideas discussed. The meetings in Beijing andShanghai and Cairo in August and in Riyadh inSeptember have brought together people from theregions, with clinicians with prior experience fromlooking after patients with SARS, H5N1, H1N1, andthe critically ill. Further work is planned in both Chinaand the Middle East on clinical intervention studies toestablish the best treatment for patients with bothnCoV and H7N9 and in understanding pathogenesis. Our warmest congratulations go to ProfessorsHerman Goossens and Menno de Jong andcolleagues who led a European wide consortiumgranted a large EU FP7 grant to support PREPARE -



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Rowan's MRC/WT/DFIDGlobal Health Trials bid wassuccessful. (See lastnewsletter)

WG2: Supported thedevelopment and PPI for theSARI BSP and WHO NaturalHistory Protocol. The grouphas also gone through thefirst round of the results ofthe Delphi study on CoreOutcome Measures, andhope to run the secondround in parallel withe theEC F2F meeting in Oxford.

WG3: Completed theprioritisation and integrationof biological samplingstudies to create a singlecombined biologicalsampling protocol for use insevere acute respiratoryinfection. Together with casereport forms created byothers within ISARIC andWHO, this forms an versatilebiological sampling protocolthat is designed to adapt tothe changing needs ofdifferent outbreaks, and todifferent resource levels.

WG4: Has undertaken amembership survey, aimingto document theachievements and researchcapacities of ISARIC's 40member networks, which areundertaking clinical researchin 90 countries spread overall continents. The results ofthe survey were presentedat the Singapore Roundtableand will be submitted forpublication in the nearfuture. Other activitiesundertaken by WG4 includeliaison with public healthauthorities to understandtheir perspectives aboutclinical research prioritiesand engagement withmember networks to identifytheir unmet needs toenhance their research

Platform foR European Preparedness Against(Re)-emerging Epidemics in response to the EU callfor a consortium to provide EU wide leadership on“Clinical Research in Epidemics”. This was amonumental effort superbly led Herman and Menno.PREPARE is innovative, ambitious, comprehensive,crosses boundaries and disciplines and I believeprovides real leadership within the European Unionand a model for all of us wherever we work in puttingclinical research at the heart of the response to apublic health emergency. ISARIC is intimately linkedwith and is a committed partner of PREPARE. Wewish Herman, Menno and all colleagues in PREPAREevery success with this superb programme. The relationship between ISARIC and the WorldHealth Organisation has gone from strength tostrength. We are very grateful to the commitment andencouragement of Dr Nikki Shindo and colleagues atWHO. During the development of generic and specificprotocols for H7N9 and NCoV Dr Jake Dunning andDr Ken Baillie were seconded to WHO Geneva forshort attachments to support the development ofthese projects. We are grateful to Imperial Collegeand Roslin Institute Edinburgh for facilitating theattachments and for WHO for being such a welcominghost. Finally nothing happens without the work of theCo-Ordination Centre of ISARIC led by Dr GailGarson and Kajsa-Stina Magnusson. Both have beenincredibly busy both professionally and personallywith Kajsa getting married (and forgoing herhoneymoon for the sake of ISARIC) and Gail givingbirth to Zak in July. Without their unselfish dedicationISARIC would not exist today. Kajsa has also justbeen awarded a further Li Ka Shing Foundation grantfor a flexible ‘Seed Fund” for ISARIC which can beavailable immediately to support the development orimplementation of initial clinical research studiesshould a new outbreak occur anywhere in the world.



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capacity. WG4 activities,particularly related to ethicaland regulatory pre-approvalof clinical research for futureoutbreaks will be enhancedby liaison with PREPARE.

Would you like to joina working group?

PHE/ISARICDecision SupportTool nCoV Public Health England andISARIC has published aDecision Support Tool thatis offering support toclinicians consideringoptions for treatment ofpatients diagnosed withnovel coronavirus(MERS-CoV).

Based on both publishedworks and unpublished datashared by clinicians,researchers, and publichealth experts during aseries of clinical calls onnCoV - the documentconsiders and rates potentialoptions for treatment suchas Convalescent plasma,Interferon, Proteaseinhibitors and Intravenousimmunoglobulin.

The tool, which is freelyavailable for download onthe ISARIC and PHEwebsites, is under constantreview and includes findingsand data found through anextensive monthly literaturereview performed by the

We are very grateful to the support we have had fromthe Wellcome Trust, Bill and Melinda GatesFoundation, the Medical Research Council UK,Singapore Ministry of Health, INSERM France and theLi Ka Shing Foundation. It is only with such supportcan ISARIC continue to grow in the future and helpensure that clinical research is part of the response toany epidemic. Finally as many of you will know I will be changing myrole from the 1st October 2013. It has been a privilegeto be involved with ISARIC over the last two years.ISARIC was at its inception and I believe remainstoday ahead of its time. The challenge is havingdeveloped this concept how to now make such aparadigm shift happen in how we prepare for andrespond to a public health emergency. It is absolutelycrucial that clinical research is at the centre of thepublic health response to any emerging health threat.It is simply unacceptable that we do not have theevidence on which to develop policy, practice andguidelines for the treatment of patients with novelinfluenzas, nCoVirus, hand foot and mouth disease,hepatitis E, Chikungunya, viral haemorrhagic feversand so many more emerging infections.

The massive expansion in global surveillance will onlybe worthwhile if we learn how to look after patientsand communities who we identify to be suffering froman emerging infection or by the spread of drugresistance. Surveillance and traditional public healthresponses need an effector arm and in the early daysand months of an epidemic that will largely be byknowing how to effectively treat a patient with theinfection.

There are a huge number of regulatory, ethical,logistics, practical barriers to the conduct of anyclinical research nowadays and these are particularlyacute during an epidemic. But ISARIC needs to

Get in touch



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ISARIC Secretariat incollaboration with Oxford'sBodleian Library.

The literature review will beadapted and made availableon the ISARIC websiteshortly.

SingaporeRoundtable

A networking event forISARIC members andinterested networks inSouth-East Asia tookplace in Singapore in July.Sponsored by SingaporeMinistry of Health, theevent gathered 48participants representing20 networks and 16countries in the region andbeyond.

Though primarily anopportunity to get to knowother networks in the region,the event, hosted at theNational University ofSingapore and arranged bythe Singapore InfectiousDiseases Initiative, offeredan opportunity to present theSARI BSP, and to introduceISARIC. Both generatedinterest among the networkspresent, which is promisingfor ISARIC's further activitiesin the region.

A Regional Hub is currentlybeing set up at OUCRUVietnam, and though it is notlikely to be the only regionalhub in Asia, it is a first steptowards a sustainable globalroll-out of ISARIC.

E-learning @isaric.org

address these issues and persuade an often-skepticalresearch community, the public and the medical andpublic health communities of the critical importance ofclinical research during the early stages of anepidemic.

The European Union has shown real leadership bysupporting the PREPARE Consortium. I hope thatthrough ISARIC others will follow in the future. I willcontinue to follow the development and impact ofISARIC in the years to come in my new role. I wishISARIC every success and have every confidence inISARIC delivering on its ambitious plans.

Jeremy FarrarISARIC Chair

Pictures above: Screen shot of the protocol summary(top); Dr Do Lien Anh Ha presenting the translatedprotocol to clinicians in Ho Chi Minh City, July 2013(bottom, left); and screen shot of the database(bottom, right).



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Institut Pasteur (IP) hasset aside €30000 for thedevelopment of e-learningmodules in Good ClinicalPractice, Surveillance, andBiosafety, which will bemade available on theISARIC website.

The funding, which is part ofa collaborative effortbetween IP, ISARIC and TheGlobal Health Network(TGHN) will be used toemploy an e-learningassistant at IP Paris, whowill work closely with LiamBoggs of TGHN.

Liam has previouslydeveloped a range ofe-learning modules, whichare one of the most popularfeatures of TGHN. Since itwas launched in August2011, the E-Learning Centrehas had over 10,500 visits,and the modules have beentaken by over 5000 users todate.

"The E-Learning Centre is sosuccessful because of itsaccessibility" says LiamBoggs, "the short coursesoffer the 'how to' cross-cutting training needed toequip researchers with theskills to design, operate,report and govern research -without impeding bit rate.This setup works in areas oflow band width internetconnection" he explains.

The completion date for theproject is not yet decided,but the modules will beadded to ISARIC's websitecontinuously.

Feature article: ISARIC-WHOSARI Biological SamplingProtocolKajsa-Stina Longuere, Jake Dunning, Ken Baillie andLaura Merson - ISARIC, in collaboration withWHO, has developed and published a BiologicalSampling Protocol (BSP) for Severe AcuteRespiratory Infections (SARI). Designed to begeneric and flexible, the protocol aims to captureall emerging SARI, including current threats suchas H7N9 avian influenza and the novelcoronavirus, MERS-CoV. The SARI BSP and supporting documents areavailable for download through the ISARIC website,and is building on previous work towards a BSP byISARIC's Working Group 3, chaired by Ken Baillie atthe Roslin Institute, in collaboration with WHO throughNikki Shindo and her team at WHO Geneva. Having a pre-prepared, generic protocol is a key stepto enabling research teams around the world tolaunch studies quickly in the event of an outbreak. It isvital that key biological samples are collected in astandardised manner from as many patients aspossible within a typically narrow window ofopportunity. Utilising the expertise of membernetworks, the selection of samples and the samplingfrequencies have been designed by WP3 to ensurethis can happen. In addition to collecting biological samples, thecollection of a core clinical data set is essential for theinterpretation of any laboratory findings. Furthermore,high-quality clinical data that are made availablerapidly can assist the development of clinicalmanagement guidelines and public health policies.Again, ISARIC is working with WHO to developfocused case report forms (CRFs) and associated



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WHO and ChinaCDC H7N9Conference andWorkshop in Beijingand Shanghai

Peter Horby - The recentoutbreak of a novel avianinfluenza A/H7N9 in China,which has resulted in 135cases and 44 deaths as of27th August, is a reminderof the ever present threatof the emergence of newpathogens, and avalidation of the need forISARIC.

The Chinese authorities andclinicians have acted withgreat expertise, competenceand transparency, and this isreflected in the rapidpublication of a largenumber of articles in highimpact journals.

Much however remains to belearned about this novelvirus, leading the ChineseCenter for Disease Controland Prevention to convene aconference in Beijing andShanghai (August 14-16),bringing together expertsand provide an update onthe current situation and thelatest research progress ofhuman infections with H7N9in China.

This was followed on August17th by a WHO workshop onthe clinical care and

documents to meet these demands. A core SARI CRFand a more detailed CRF are already available on theISARIC website. Versions that can be completedelectronically have also been developed, along withan accompanying database (see below). “Panic and fear have ruled the initial responsesto almost every emerging infectious diseaseoutbreak. The public health and laboratory sciencecommunities have gained confidence throughexperience, but what about the clinical community?asks Nikki Shindo. “We have to make a step forwardin clinical research that can inform patient care inepidemics, or we will just regret further missedopportunities!” she continues. Nikki Shindoemphasizes that the only solution is to have thesystem set up in the time between epidemics andmake sure good data are collected to generate theknowledge necessary to better treat and managepatients when these events inevitably occur. In thistime of mass air travel and internationalhuman movement and trade, an emerging pathogencan travel around the world in a matter of hours andcan cause multiple, international outbreaks. Initialsporadic cases and clusters occur here and there, butwith standardized protocols freely available, goodsample sizes can be achieved much faster andpatient lives can be saved and secondarytransmission reduced. “Quality data give power to thestudy and this will enable WHO to makerecommendations with greater confidence.We consistently suffer from only having access to ‘lowquality evidence’” and hence can only make weakrecommendations. WHO and ISARIC are workingtogether closely, attempting to fill this gap in the globalpublic health landscape" Tiered approachThe protocol with supporting documents is currentlybeing rolled out or being considered forimplementation in more than 13 countries globally,



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research agenda for humaninfection with novel influenzaviruses, at which ISARICwas represented and wherethe ISARIC observationalprotocols for Severe AcuteRespiratory Syndrome(SARI) were presented anddiscussed. Following theworkshop, the team travelledto the Shanghai Emergingand Re-emerging InfectiousDiseases Institute, for furtherdetailed discussions withShanghai clinicians on H7N9research.

In partnership with WHO,ISARIC members are nowworking with clinicalcolleagues in Beijing andShanghai to adapt andimplement the ISARICobservational protocol inlocal clinical networks inthese two large cities inreadiness for the potentialreturn of H7N9, or any otherSARI, in the winter.

ISARIC visitingSouth East Asia

ISARIC's ProgrammeManager visitedSouth-East Asia in July,meeting with ISARICmembers and potentialmembers in Thailand,Hong Kong, Singaporeand Vietnam.

Aiming to forward ISARIC'sglobal ambitions, the trip'smain objective was todiscuss collaboration withpartners in the region,introduce ISARIC and theSARI BSP and to mappotential challenges andinterests related to theestablishment of a RegionalHub in Ho Chi Minh City.

including Vietnam, UK, and Singapore. To facilitateglobal implementation, the BSP includes a tieredapproach to sampling and data collection, whichmakes it adaptable to high, medium and low resourcesettings and sensitive to resource limitations that mayoccur during outbreaks. It is up to the sites andnetworks implementing the protocol to choose whichtier they wish to implement. When the protocol isadapted to local context for submission to the EthicalCommittee a single tier can be selected, or all tierscan be included in the protocol. Sites that obtainapproval to implement all tiers have the flexibility ofreal-time adaptation as an outbreak hits or evolves toensure that the most relevant sampling schedule isused for all patients. This approach has been used inHo Chi Minh City, Vietnam to minimize the risks topatients while maximizing the critical scientific output. SamplingAs the pathogen affecting research participants mayyet be unknown, the BSP includes sampling of blood,the respiratory tract, urine, stool and other infectedsites. The protocol is flexible such that samples,which are not of relevance to a particular pathogen,will not be taken. The tiered approach also offersoptions of sampling frequencies so that only samples,which answer the most pertinent scientific questions,will be drawn. These may change throughout thecourse of an outbreak and can be adjusted accordingto availability of local resources, number of patientsdiagnosed regionally/internationally, severity ofdisease, etc. The structure of the BSP ensures thatsamples required for clinical care have priority overresearch sampling and that clinical and researchsampling should coincide whenever possible. Data managementThe BSP comes with a Core Case Record Form(CRF) and a Core Follow Up Form, all of which areavailable online. Additional data collection moduleswill be added in the coming months to allow the



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VIZIONS' Dak Lak studyteam, Daklak Hospital,Vietnam

Network in Focus:VIZIONS - ExploringZoonotic Infections

Aiming to developbaseline data on exposurerisk and develop theinfrastructure to study andrespond to the nextemerging infection inSouth-East Asia, VIZIONS-The Wellcome TrustVietnamese Initiative onZoonotic Infections - is amultifaceted project tostudy disease trends, thepotential of zoonoticinfection and emerginginfectious diseases inVietnam.

Supported by a WellcomeTrust Strategic Award toOUCRU, EdinburghUniversity, The SangerInstitute and the Global ViralForecasting Initiative (GVFI),VIZIONS is aiming to fill theanimal/human disease gapby investigating viralpathogens on both sides ofthe species barrier.

The project, led by ProfessorJeremy Farrar and DrStephen Baker in Vietnam,has been running for 18months and has establisheda functional diseasesurveillance system withinthe Vietnamese healthcaresystem and a cohort study of

amalgamation of additional types of data with theclinical data where desired. An online database is available for input of data fromthe CRFs. International data can be combined on asingle server, or copies of the database can be hostedin regional servers for any sites that require a moreregional approach to data management. The database is built on the CliRes data managementplatform, produced and maintained by Hien Ho Vanand his team at OUCRU, Ho Chi Minh City. "Thedesign of the CliRes allows for rapid production ofnew databases - in a matter of hours a CRF can beprogrammed into an electronic database and readyfor input" says Laura Merson, Head of Clinical Trialsat OUCRU Ho Chi Minh City and an active member ofthe SARI BSP working group. Being web basedmakes it accessible globally, and its flexibility andsimple design makes it very easy to use. The database has been reviewed and piloted byinvestigators around the world, and ISARIC and WHOhave plans to move forward with CliRes and jointinitiatives on open-access software. A library of CRFsand robust data protection/ data sharing policies arein the pipeline. ISARIC-WHO collaborationAs an ISARIC Observer (participating non-member),the WHO is working closely with ISARIC to designand promote the BSP and other aspects related to aclinical research response to current threats nCoVand H7N9. The collaboration has resulted in twosecondments, one of Ken Baillie and the other of JakeDunning (Imperial College London/MOSAIC) to WHOGeneva. In addition to working on protocolharmonisation, they also helped set-up and run jointinternational clinical teleconferences, which aim toprovide assistance to clinicians on the ground,facilitate sharing of clinically-relevant information,



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those hypothesised to be atthe higher risk of zoonoticpathogens.

"We are currently samplingpatients with enteric disease,respiratory disease, centralnervous system infectionsand jaundice from sixhospitals countrywide togather data on the aetiologyof these infections" saysStephen Baker. "We areworking closely with localcollaborators and partners,and hope that this willsupport the local researchinfrastructure and capacitybuilding in healthcaresystems to improve thediagnosis triage of disease",he continues.

To study how frequentlyindividuals working withanimals are exposures tozoonotic infection, theproject team is longitudinallysampling people workingwith animals to study thepotential for viral chatterbetween humans and theiranimals. This component ofthe project is followingapproximately 1,000individuals that includesfarmers, market workers,abattoir workers and is beingconducted in 3 Vietnameseprovinces.

Do you havesomething to say?If you or your network wantsto contribute to our nextnewsletter, or makesuggestions for futurearticles - let us know

provide access to expert advice and promote highquality, standardised research. Ken Baillie has also recently been visiting colleaguesin Tunisia as part of a WHO/ISARIC joint mission todiscuss the SARI BSP in relation to nCoV, and anJake Dunning also presented ISARIC and WHO’Scollaborative efforts on MERS-CoV and SARI at thePublic Health England Novel CoronavirusConference, which was held in London in July 2013. ISARIC was also represented at the H7N9Conference and Workshop in Beijing and Shanghai inAugust, where Peter Horby presented the BSP andISARIC (see article above, left).

PREPARE-ing Europe forepidemicsKajsa-Stina Longuere and Adrian Wilder-Smith -ISARIC is, alongside several Europe-basedmember networks, taking on an active role withinPREPARE, Platform for European PreparednessAgainst (Re-)emerging Epidemics. PREPARE is alarge new European Commission funded (FP7)clinical research consortium aiming to addressthe urgent need to equip Europe againstre-emerging epidemics. Awarded €24M over 5 years and led by ProfessorHerman Goossens at the University of Antwerp andJoin ISARIC



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Professor Menno de Jong Amsterdam MedicalCentre, PREPARE will kick off in January 2014,gathering 22 partners across Europe and Australia, 10are these partners are also directly linked with ISARICand ISARIC member networks. Menno will be at theISARIC Meeting in September. Aiming to improve preparedness, PREPARE offers aplatform for key stakeholder within clinical research,diagnostics, ethics, data management and otherinterested parties to collaborate and createoperational readiness for rapid deployment of clinicalstudies during an outbreak in Europe but with stronglinks to the rest of the world. Inter-epidemic research aims towards optimizingclinical management of patients. PREPARE willenable harmonized, fit-for-purpose and large-scaleclinical research studies. With five key objectives,experts in infectious disease preparedness fromEurope and beyond will be united through 5 platforms:Pathos, Practice, Predict, Crisp and Create.

Briefly, the platforms are characterised as follows:

PRACTICE is the clinical and regulatory platform forconducting harmonized, large, effective, safe andclinically-useful patient oriented research and clinicaltrials in children and adults in Europe. Practice alsoincludes ethics, administration and logistics. PATHOS is the platform for pathogenesis researchstudies using systems medicine approach and aims toidentify host and pathogen factors to severe diseasedevelopment and to generate predictive algorithms toanticipate severity. PREDICT is the platform that provides “State-of-the-Art” diagnostics and laboratory support forinter-epidemic clinical trials in PRACTICE and futureID outbreaks.



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CRISP is the IT platform that provides robust andreliable network to enable rapid data collection,secure storage, analyses and exchange of clinicaldata. CREATE is the IT platform that aims toempower/ensure incorporation of clinical research andthe results into optimized clinical practice as well asengaging interactions with main stakeholdersinvolved.

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ISARIC NewsMRC, INSERM and LKS Foundation about future of ISARIC. Institut Pasteur funds for E-learning project ISARIC-baby Isaac 'Zak' Carson born, 3 June, Congratulations Gail! WHO