{"doc_desc":{"title":"COVID-19 vaccine cohort for special populations","idno":"FRESH-PEF73983-en","producers":[{"name":"Aude BARQUIN","affiliation":"UNIVERSITE DE BORDEAUX"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF73983-en","IDno":{"metadata_no":[{"agency":"PEF","code":"73983"},{"agency":"FReSH","code":"FRESH-PEF73983"}]},"title":"COVID-19 vaccine cohort for special populations","alternate_title":"ANRS 0001 S COV-POPART"},"study_authorization":{"agency":[]},"authoring_entity":[{"type":"investigator","name":"Linda;WITTKOP","PILabo":"Institut de Sant\u00e9 Publique d'Epid\u00e9miologie et de D\u00e9veloppement, INSERM, Bordeaux Population Health Research Center, UMR 1219, Centre d'Investigation Clinique-Epid\u00e9miologie Clinique 1401, Universit\u00e9 de Bordeaux, Service d'Information M\u00e9dicale, CHU de Bordeaux, P\u00f4le de Sant\u00e9 Publique, Bordeaux,","affiliationName":"UNIVERSITE DE BORDEAUX","extlink":[{"title":"ORCID","uri":"0000-0003-2403-0960","role":"pi id"},{"title":"IdRef","uri":"149763875","role":"pi id"},{"title":"SIREN","uri":"130018351","role":"organisation id"},{"title":"RNSR","uri":"201622170H","role":"labo id"}],"email":"","isContact":"No"},{"type":"investigator","name":"Paul;LOUBET","PILabo":"INSERM U1047, Department of Infectious and Tropical Diseases, CHU N\u00eemes, Universit\u00e9 Montpellier, N\u00eemes, France","affiliationName":"UNIVERSITE DE MONTPELLIER","extlink":[{"title":"ORCID","uri":"0000-0002-1218-9432","role":"pi id"},{"title":"IdRef","uri":"169126951","role":"pi id"},{"title":"SIREN","uri":"130029796","role":"organisation id"},{"title":"RNSR","uri":"201119395N","role":"labo id"}],"email":"","isContact":"No"},{"type":"investigator","name":"Odile;LAUNAY","PILabo":"APHP, Universit\u00e9 de Paris, Covireivac","affiliationName":"UNIVERSITE PARIS CITE","extlink":[{"title":"ORCID","uri":"0000-0003-3242-7247","role":"pi id"},{"title":"IdRef","uri":"147398916","role":"pi id"},{"title":"SIREN","uri":"130025737","role":"organisation id"},{"title":"RNSR","uri":"201722263E","role":"labo id"}],"email":"","isContact":"No"}],"oth_id":[{"name":""}],"production_statement":{"prod_place":"Epidemiology France Portal (PEF)","producers":[{"name":"AGENCE NATIONALE DE RECHERCHES SUR LE SIDA ET LES HEPATITES VIRALES (ANRS MIE)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/01kv58h76","role":"sponsor id"},{"title":"SIREN","uri":"180089385","role":"sponsor id"}],"role":"sponsor"}],"funding_agencies":[{"name":"AGENCE NATIONALE DE RECHERCHES SUR LE SIDA ET LES HEPATITES VIRALES (ANRS MIE)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/01kv58h76"},{"title":"SIREN","uri":"180089385"}]}]},"distribution_statement":{"contact":[{"name":"Sophie;GUILMIN-CREPON","email":"sophie.guilmin-crepon@aphp.fr","type":"contact","affiliationName":"ASSISTANCE PUBLIQUE HOPITAUX DE PARIS (AP-HP)","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/00pg5jh14","role":"organisation id","title":"ROR"},{"uri":"267500452","role":"organisation id","title":"SIREN"}]},{"name":"Aude;BARQUIN","email":"aude.barquin@inserm.fr","type":"contact","affiliationName":"UNIVERSITE DE BORDEAUX","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/057qpr032","role":"organisation id","title":"ROR"},{"uri":"130018351","role":"organisation id","title":"SIREN"}]}]},"study_info":{"keywords":[{"keyword":"Covid-19 vaccines \/ Immunogenicity \/ Immunosuppression \/ At-risk populations"}],"topics":[{"topic":"Clinical immunology","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/7a3cf568-46ba-4840-be8f-f22fc030139f"},{"title":"MeSH","uri":"http:\/\/id.nlm.nih.gov\/mesh\/D000486"}]},{"topic":"Infectious disease medicine","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/fa2ceeab-3b2f-45e9-9243-e5a8005b98de"},{"title":"MeSH","uri":"http:\/\/id.nlm.nih.gov\/mesh\/D055552"}]},{"topic":"COVID-19","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/1730556128","title":"CIM-11"}]}],"purpose":"Main objectives common to all sub-populations: To evaluate in a standardized way in each sub-population the humoral immune response to Covid-19 vaccination at 1, 6, 12, 24 months after the first injection (one-injection scheme) or after the second injection of the vaccine (two- or three-injection schemes) and to evaluate in a standardized way the humoral response 1 month after receipt of the third injection in participants receiving a third injection according to current recommendations... Secondary objectives common to all sub-populations: 1. to evaluate and characterize the antigen-specific T-lymphocyte cellular immune response (at INC, M06, M12 and M24) induced after the first injection (one-injection regimen) or after the second injection of the vaccine (two- or three-injection regimens) in each subpopulation.. 2. compare the humoral immune response at 1, 6, 12, 24 months after the first injection (single-injection regimen) or after the second injection of the vaccine (two- or three-injection regimens) in each subpopulation with a group of subjects free of the chronic conditions studied or other pathologies\/treatments influencing the immune response 3. compare the humoral response after three injections (M02) with that after two injections (M01) in participants who received a third injection in accordance with current recommendations.. 4. to evaluate and characterize the humoral immune response of participants who received a booster dose of mRNA vaccine in accordance with current recommendations 5. in each subpopulation, study the factors associated with the humoral immune response at 1 month and with the persistence of the humoral immune response at 6, 12 and 24 months as a function of age, stage of disease, treatment, type of vaccine (as well as the specific characteristics of the subpopulations studied) 6. compare the humoral immune response between different subpopulations 7. describe seroconversion for anti-nucleoprotein antibodies at inclusion and during follow-up 8. immuno-virological characterization of vaccine failures (SARS-CoV-2 infection within the time frame defined by current protocol) 9. investigate the genetic determinants of the immune response according to the underlying pathology and current treatments, if any (response and resistance to vaccination) Secondary objectives of the subpopulation of subjects not suffering from one of the chronic conditions of interest or other pathologies \/ under treatment with a known influence on the immune response and vaccinated with a 1st injection of Astra-Zeneca AZD1222 vaccine who will be vaccinated with a 2nd injection of Pfizer BNT162b2 mRNA vaccine 1. compare the immune response (humoral and cellular) obtained before and after the BNT162b2 vaccine dose 2. assess clinical reactogenicity (local and general) after an injection of BNT162b2 vaccine administered in accordance with current recommendations after an injection of AZD1222 vaccine","abstract":"","coll_dates":[{"start":"2021-01-01","end":"2024-01-01"}],"nation":[{"name":"France","abbreviation":"fr","extLink":{"vocab":"ISO","vocabURI":"fr"}}],"geog_coverage":"","analysis_unit":"Individuals","universe":"{\n    \"level_sex_clusion_I\": [\n        {\n            \"value\": \"Male\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D008297\"\n            }\n        },\n        {\n            \"value\": \"Female\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D005260\"\n            }\n        }\n    ],\n    \"level_age_clusion_I\": [\n        {\n            \"value\": \"Child, Preschool (2 to 5 years)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D002675\"\n            }\n        },\n        {\n            \"value\": \"Child (6 to 12 years)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D002648\"\n            }\n        },\n        {\n            \"value\": \"Young Adult (19 to 24 years)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D055815\"\n            }\n        },\n        {\n            \"value\": \"Adult (25 to 44 years)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D000328\"\n            }\n        },\n        {\n            \"value\": \"Middle Aged (45 to 64 years)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D008875\"\n            }\n        },\n        {\n            \"value\": \"Aged (65 to 79 years)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D000368\"\n            }\n        },\n        {\n            \"value\": \"Aged, 80 and over (80 years and more)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D000369\"\n            }\n        }\n    ],\n    \"level_type_clusion_I\": \"General population\",\n    \"level_type_clusion_other\": \"\",\n    \"clusion_I\": \"\",\n    \"clusion_E\": \"\"\n}","data_kind":"['Clinical data','Participant-reported health data','Biological data','Socio-demographic data']","quality_statement":{"standards":[{"name":"['Concomitant Pathologies: ICD-10. Ongoing Treatments: WHO Drug']","committee":"","governance":""}],"other_quality_statement":"['CMG-EC quality system (ISO 9001 certified), consistency checks after data entry, data monitoring according to a monitoring plan: remotely + on site by a specialised CRO (return to source file for data management and verification)']"}},"study_development":{"development_activity":[]},"method":{"data_collection":{"time_method":"","frequency":"","sampling_procedure":"['{\"concept\":{\"vocabURI\":\"Other\",\"vocab\":\"CESSDA\"},\"value\":\"Other\"}']","sample_frame":{"frame_unit":{"unit_type":"['Through organizations (health services or institutions, schools, businesses, etc.)']"}},"coll_mode":["{\"concept\":{\"vocabURI\":\"Transcription\",\"vocab\":\"CESSDA\"},\"value\":\"Converting or copying information into a structured record\"}"],"research_instrument":"","sources":[{"sourceCitation":{"titlStmt":{"titl":""},"holdings":"","notes":{"subject":"source purpose","value":""}},"srcOrig":["Medico-administrative database"]}],"target_sample_size":"","response_rate":"Enrolments closed on 31 December 2021 in the adult cohort: 6,112 participants. Enrolments ongoing in the paediatric ancillary study: enrolment target of 810 participants (enrolment expected to close in July 2022)."},"method_notes":"Observational Study","study_class":"Unknown","notes":[{"subject":"research type","values":["Observational Study"]},{"subject":"observational study method","values":["Cohort study"]}]},"data_access":{"dataset_availability":{"access_place":"","complete":"","status":"{\"value\":\"Restricted access\",\"extLink\":[{\"title\":\"COAR\",\"uri\":\"http:\/\/purl.org\/coar\/access_right\/c_16ec\"}]}"},"dataset_use":{"restrictions":"","conditions":"Via the PRS form, which must be validated by the cohort's Steering Committee and Scientific Board.","conf_dec":[{"txt":""}],"spec_perm":[{"txt":"","required":""}],"contact":[{"name":""}],"deposit_req":"","cit_req":""},"notes":""}},"additional":{"IsImport":true,"versionLang":"en","originLang":"en","autoTranslation":false,"status":"imported","creationDate":"----","lastUpdatedAuto":null,"lastUpdatedManual":"23-08-2022","isContributorPI":"No","contributorName":"Aude BARQUIN","contributorAffiliation":"UNIVERSITE DE BORDEAUX","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":[]},"relatedDocument":[],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":["Public (France)"],"otherFundingAgentType":[""]},"sponsor":{"sponsorType":["Public (France)"],"otherSponsorType":[""]},"governance":{"committee":"Yes"},"collaborations":{"networkConsortium":""},"theme":{"complementaryInformation":"","RareDiseases":""},"activeFollowUp":{"isActiveFollowUp":"Yes","followUpModeOther":""},"interventionalStudy":{"researchPurpose":[],"trialPhase":[],"interventionalStudyModel":"","isClinicalTrial":"","otherResearchPurpose":""},"isInclusionGroups":"","allocation":{"allocationMode":"","allocationUnit":""},"masking":{"maskingType":"","blindedMaskingDetails":[]},"arms":[],"intervention":[],"inclusionGroups":[],"collectionProcess":{"collectionModeDetails":"eCRF","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":"Yes"},"geographicalCoverage":{"geoDetail":"Metropolitan France"},"dataTypes":{"clinicalDataDetails":"","biologicalDataDetails":"A common blood bioassay (CBS, CRP, creatinine) + a blood panel specific to the target pathology (\u2022 For diabetic and\/or obese participants: HbA1c, Creatine (eDFG: CKD-EPI), lipid balance, liver balance, Albumin, Pre-albumin, CPK \u2022 For participants allogreffed from hematopoietic stem cells: absolute values of CD4 cells CD4, CD19\/mm3, and Plasma protein electrophoresis: gammaglobulins rate (for CD8 count, a historical value of less than 30 days may be collected) \u2022 For participants transplanted: DSA research and liver balance for liver transplant patients \u2022 For PVHIV: CD4-CD8 and Viral Charge HIV levels \u2022 For participants in the control group over 75 years of age: Albumine) \/ At each visit general study: serum aliquots \/ At each visit immunology and virology studyBRTB biodeficiency, savinots, savinots, total blood aliquots, blood aliquots, opiots opiots, total opiots","isDataInBiobank":"Yes","biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[""]},"isHealthTheme":"Yes","fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}