[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"covid-19-pandemics\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:covid-19-pandemics":40},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":5},"100483184","immunogenicity-of-covid-19-vaccines-in-tuberculosis-patients-100483184",false,"NCT05571735","Immunogenicity of COVID-19 Vaccines in Tuberculosis Patients","Immunogenicity of COVID-19 Vaccines Against Coronavirus Disease (COVID-19) Among Tuberculosis (TB) Patients in Thailand-Myanmar Border.","CVTB","Inclusion Criteria:\n\n* 18 years and above, newly diagnosed bacteriologically confirmed TB patients including both drug sensitive and resistant TB, who are taking anti TB or MDR-TB treatment in initial period during study period or clinically healthy individuals for comparator arm.\n* Willing to be followed for four weeks following second dose of Pfizer-BioNTech COVID-19 vaccine and AstraZeneca vaccine or eight weeks following single dose of Janssen Ad26.COV2.S COVID-19 vaccine\n* Willing to be involved in the pre-enrolment screening.\n* For women with child bearing potential only (aged 18-49 years), willing to continue to use effective contraception methods through the study.\n* For women with child bearing potential only (aged 18-49 years), negative pregnancy test on the day of screening and on the day of vaccination to be eligible to receive the vaccination.\n* Able and willing to comply with all study requirements.\n* Ability to understand the study instructions and provide written informed consent\n\nExclusion Criteria:\n\n* History of laboratory confirmed COVID-19 for any duration before or positive COVID-19 PCR or antigenic test at screening.\n* History of HIV infection\n* Participation in other COVID-19 related studies for the duration of the study.\n* Participation in other vaccine trials within 90 days before and 30 days after the study vaccination.\n* Administration of any immunoglobulins or any type of COVID-19 vaccine within 90 days before administration of the vaccine.\n* History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.\n* Any previous history of a serious side effect with any kind of vaccine.\n* Any history of angioedema.\n* Any history of anaphylaxis.\n* Women with pregnancy, lactation or planning to get pregnant during the duration of the study.\n* Current diagnosis of or treatment for cancer.\n* History of severe psychiatric disorders likely to affect participation in the study.\n* Bleeding disorder (e.g. coagulation factor deficiency, coagulopathy or platelet disorder), history of thrombosis or prior history of significant bleeding or bruising following IM injections or venipuncture.\n* Suspected or known current alcohol or drug dependency (except well controlled condition).\n* Presence of any condition which in the judgement of the investigator would place the patient at undue risk or interfere with the results of the study.\n* Severe and\u002For uncontrolled cardiovascular disease, gastrointestinal disease, liver disease, renal disease, endocrine disorder and neurological illness (mild\u002Fmoderate well controlled comorbidities are allowed).",true,"ALL","18 Years",{"count":21,"type":22},133,"ESTIMATED","OBSERVATIONAL","This study is a non-randomized observation and comparison of immune response between bacteriologically confirmed TB patients under treatment cohort who received COVID-19 vaccine (n=54) vs healthy individuals (n=54).\n\nEach participant will receive single or double doses of one of COVID-19 vaccines (Pfizer-BioNTech COVID-19 vaccine, AstraZeneca vaccine or Janssen Ad26.COV2.S COVID-19 vaccine) in the deltoid muscle of the non-dominant arm. Study Duration approximately 1 year. The main focus of this study is to compare the humoral and cellular immunological responses of the COVID-19 vaccines between bacteriologically confirmed TB patients under treatment vs healthy individuals.\n\nThis study is funded by the Wellcome Trust. The grant reference number is 220211\u002FA\u002F20\u002FZ.",[26,27],"Covid-19 Pandemics","Tuberculosis","RECRUITING","2026-04-07",{"date":31,"type":32},"2026-04-13","ACTUAL",{"date":34,"type":32},"2023-04-15",{"date":36,"type":22},"2026-06-30",{"name":38,"class":39},"University of Oxford","OTHER","COVID-19 Pandemics"]