{"doc_desc":{"title":"CRS","idno":"DDI-MWI-MEIRU-TB-LIS-1979-01","producers":[{"name":"Themba Chirwa","abbr":"TC","affiliation":"MEIRU","role":"Metadata Entry and Editing Officer"},{"name":"Elizabeth Nancy Munthali","abbr":"ENM","affiliation":"MEIRU","role":"Metadata Supervisor"},{"name":"Chifundo Kanjala","abbr":"CK","affiliation":"MEIRU","role":"Data Documentation project management"},{"name":"Jacky Saul","abbr":"JS","affiliation":"LSHTM and MEIRU","role":"Production of the documentation used to create this DDI document"},{"name":"Keith Branson","abbr":"KB","affiliation":"LSHTM and MEIRU","role":"Production of the documentation used to  create this DDI document"},{"name":"Malawi Epidemiology and Intervention Research Unit","abbr":"MEIRU","affiliation":"MEIRU","role":"Agency"}],"prod_date":"2018-08-28","version_statement":{"version":"version 1 (January 2018)"}},"study_desc":{"title_statement":{"idno":"MWI-MEIRU-TB-LIS-2008-v01","title":"LIS Latent TB infection phase 1 and 2 2009"},"authoring_entity":[{"name":"Dr. Anne Ben-Smith","affiliation":"London School of Hygiene & Tropical Medicine, UK"},{"name":"Prof. Amelia C Crampin","affiliation":"MEIRU & LSHTM"}],"oth_id":[{"name":"MEIRU Core datamanagement team","affiliation":"","email":"","role":""}],"production_statement":{"producers":[{"name":"Dr Neil French, Programme Director","abbr":"HF","affiliation":"London School of Hygiene & Tropical Medicine, UK","role":"Co-applicant"},{"name":"Professor Hazel Dockrell","abbr":"HD","affiliation":"London School of Hygiene & Tropical Medicine, UK","role":"Co-applicant"},{"name":"Mr Hazzie Mvula, Epidemiologist","abbr":"HM","affiliation":"MEIRU\/KPS","role":"Co-applicant"},{"name":"KPS\/MEIRU","abbr":"","affiliation":"MEIRU\/KPS","role":"Original Producer"},{"name":"Dr Nuala McGrath, Field Director","abbr":"NM","affiliation":"London School of Hygiene & Tropical Medicine, UK","role":"Co-applicant"},{"name":"Dr Andreas Jahn, Epidemiologist","abbr":"NJ","affiliation":"London School of Hygiene & Tropical Medicine, UK","role":"Co-applicant"},{"name":"Michael Kayange","abbr":"MK","affiliation":" Malawi Ministry Of Health","role":"Co-applicant"},{"name":"Felanji Simukonda","abbr":"FS","affiliation":"MEIRU\/KPS","role":"Co-applicant"},{"name":"Themba Mzembe","abbr":"TM","affiliation":"MEIRU\/KPS","role":"Co-applicant"}],"prod_date":"2016-10-27","funding_agencies":[{"name":"Wellcome Trust, UK","abbr":"WT-UK","role":""}]},"distribution_statement":{"depositor":[{"name":"","abbr":"","affiliation":"","uri":""}]},"series_statement":{"series_name":"Intervention Study"},"version_statement":{"version":"- v1:  Edited data,First version, for internal use only","version_date":"2018-02-28"},"study_info":{"abstract":"1 Tuberculosis (TB) has been declared a global emergency by WHO and remains a major public health problem worldwide, with more than 8 million new cases and over 2 million deaths each year. It has been estimated that one third of the global population is latently infected with Mycobacterium tuberculosis (Mtb). Ordinarily only 5-10% of latently infected people will develop TB disease, but co-infection with HIV has been shown to dramatically increase the annual risk of developing TB, especially in sub-Saharan Africa. Despite years of effort there are currently no reliable biomarkers for identifying protective immunity against tuberculosis disease or for progression to disease, or for predicting response to intervention. This proposed study, to be undertaken at Karonga Prevention Study (KPS), will investigate immune responses to Mtb in subjects with and without active TB disease, latent TB infection and HIV infection over a period of two years. Peripheral blood samples will be collected for antigen-specific immunoassays and RNA and serum will be stored for future analyses of hosbiomarkers of disease and protection. This study will be part of a multi-centre study involving other laboratories in Africa (Uganda, Ethiopia, Gambia, and South Africa), Europe (UK, Germany, Netherlands and Denmark) and USA. The results of this study will allow insights into the mechanisms of protection and TB disease progression and will enable the definition of immune correlates and host markers of disease that will aid the development of TB vaccines that will be effective in an African setting.\n\n2, Latent infection with M.tuberculosis (M.tb) may not always be life-long in the absence of intervention and some individuals may be able resolve infection. Understanding these natural pathways and recognising the individual host characteristics that affect these processes are key to development of vaccines capable of protecting individuals from active tuberculosis life-long and understanding whether elimination of TB can ever be achieved given the long standing nature of infection. Studying this requires life-time cohorts of infected individuals which is a rare opportunity presented by the Karonga Programme with its detailed databases of individuals tuberculin skin tested (TST) decades ago , and ability to reliably trace and identify people in the community. Pilot work on a group of individuals with very high TST reactivity in the 1980s has shown exciting results, with some individual showing exaggerated immune responses consistent with active protection and others displaying a phenotype suggesting that spontaneous resolution has taken place. We proposed to extend this work, by including other groups of individuals with known TST histories to act as appropriate controls to convincingly demonstrate the differences between individuals who can successfully control or clear infection and those who develop disease. Cohorts of individuals will be traced and a sample of each will be bled for immunological and gene expression profiling.","coll_dates":[{"start":"2008-01-05","end":"2009-09-29","cycle":"1"},{"start":"2012-01-10","end":"2012-12-12","cycle":"1"}],"nation":[{"name":"Malawi","abbreviation":"MWI"}],"geog_coverage":"Karonga district","analysis_unit":"Individual, Household","universe":"1, HIV-infected and -uninfected participants with\/without TB infection, with\/without active TB disease; age 18-60 years.\n2, Healthy adults from the community, On the basis of historical tuberculin skin test data in Karonga district.","data_kind":"Observational episodes","notes":"Long term Infection Study - Tracing ticket - KPS- VITAL status, Household and Residence, TB history, TB case finding\nTBID - DEFAULT\/WITHDRAWL form - KPS- Status of patient\nTBI-DEO - Disease Episode Outcome Form - KPS - Status of patient at date of TBI-DEO, Outcome of illness assessment\nKPS - TB ImmBio Questionnaire and Examination Form (TBI) - Eligibility checklist, Specimens collected, Other forms filled, During follow-up visit for females only, Current symptoms, Disability questions, Past medical history, Drug History, Systematic enquiry, Skin, Cardio-respiratory, GI tract, CNS, GU, Examination (General, Cardiovascular, Respiratory, Abdominal, Neurological, Eyes, Genito Urinary, Locomotor)"},"method":{"data_collection":{"data_collectors":[{"name":"Malawi Epidemiology and Intervention Research Unit","abbr":"MEIRU","role":"","affiliation":""}],"coll_mode":["Face-to-face [f2f]"],"research_instrument":"All questionnaires and modules are provided as external resources.","sources":[{"name":"","origin":"","characteristics":""}]}},"data_access":{"dataset_availability":{"original_archive":"Karonga District"},"dataset_use":{"contact":[{"name":"Malawi Epidemiology and Intervention Research Unit","affiliation":"","email":"","uri":""}],"conditions":"This data is made available for licensed access under the following conditions:\n\n1. Data and other material provided by MEIRU will not be redistributed or sold to other individuals, institutions or organisations without MEIRU's written agreement.\n\n2. In the case of multi-centre datasets, data originating from a single contributing member centre of the collaboration may not be analysed or reported on in isolation without the express permission of the member centre concerned.\n\n3. No attempt will be made to re-identify respondents, and there will be no use of the identity of any person or establishment discovered inadvertently. Any such discovery will be reported immediately to MEIRU.\n\n4. No attempt will be made to produce links between datasets provided by MEIRU or between MEIRU data and other datasets that could identify individuals.\n\n5. Any books, articles, conference papers, theses, dissertations, reports or other publications employing data obtained from MEIRU will cite the source, in line with the citation requirement provided with the dataset.\n\n6. An electronic copy of all publications based on the requested data will be sent to MEIRU."}}},"schematype":"survey"}