[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100483184":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":34,"centralContacts":39,"locations":47,"responsibleParty":66,"collaborators":10,"id":68,"slug":69,"hasResults":70,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":74,"eligibilityCriteria":75,"healthyVolunteers":76,"sex":77,"minAge":78,"maxAge":10,"enrollmentInfo":79,"targetDuration":10,"studyType":82,"phases":10,"briefSummary":83,"conditions":84,"keywords":10,"overallStatus":50,"whyStopped":10,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":96},{"fullName":5,"class":6},"University of Oxford","OTHER",[8,16],{"label":9,"type":10,"description":11,"interventionNames":12},"TB cohort",null,"TB cohort - Bacteriologically confirmed TB patients (18 years and above)\n\nOne of the following three COVID-19 vaccines will be provided based on availability of supply from the Ministry of public health, Thailand as an intervention for the study.",[13,14,15],"Biological: Pfizer-BioNTech COVID-19 vaccine","Biological: AstraZeneca vaccine","Biological: Janssen Ad26.COV2.S COVID-19 vaccine",{"label":17,"type":10,"description":18,"interventionNames":19},"Healthy comparator","Comparator- Clinically healthy individuals (54 in healthy comparator)\n\nOne of the following three COVID-19 vaccines will be provided based on availability of supply from the Ministry of public health, Thailand as an intervention for the study.",[13,14,15],[21,26,30],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":10},"BIOLOGICAL","Pfizer-BioNTech COVID-19 vaccine","Pfizer-BioNTech COVID-19 vaccine, Messenger RNA (mRNA) based vaccine encoding the viral spike glycoprotein (S) Formulation: Frozen concentrate before dilution with 0.9% sodium chloride solution for injection Route of Administration: Intramuscular (IM) Dosing regimen: Two doses (0.3 mL per dose) (at least 3 weeks apart)",[17,9],{"type":22,"name":27,"description":28,"armGroupLabels":29,"otherNames":10},"AstraZeneca vaccine","AstraZeneca vaccine, a replication-deficient simian adenoviral vector expressing the spike (S) protein of SARS-CoV-2 Formulation: Aqueous solution for injection Route of Administration: Intramuscular (IM) Dosing regimen: Two doses (0.5 mL per dose) (at least 12 weeks apart)",[17,9],{"type":22,"name":31,"description":32,"armGroupLabels":33,"otherNames":10},"Janssen Ad26.COV2.S COVID-19 vaccine","Janssen Ad26.COV2.S COVID-19 vaccine, recombinant, replication-incompetent adenovirus serotype 26 (Ad26) vector encoding a full-length and stabilized SARS-CoV-2 spike protein.\n\nFormulation: Suspension for injection Route of Administration: Intramuscular (IM) Dosing regimen single dose (0.5 mL)",[17,9],[35],{"name":36,"affiliation":37,"role":38},"François Nosten, Professor","Shoklo Malaria Research Unit","PRINCIPAL_INVESTIGATOR",[40,44],{"name":36,"role":41,"phone":42,"phoneExt":10,"email":43},"CONTACT","(+66) 055 532026","francois@tropmedres.ac",{"name":45,"role":41,"phone":42,"phoneExt":10,"email":46},"Htet Ko Ko Aung, MD","htetkoko@shoklo-unit.com",[48],{"facility":49,"status":50,"city":51,"state":52,"zip":10,"country":53,"countryCode":54,"cosmosGeoPoint":55,"geoPoint":60,"contacts":61},"Shoklo Malaria Research Unit (SMRU)","RECRUITING","Mae Ramat","Changwat Tak","Thailand","TH",{"type":56,"coordinates":57},"Point",[58,59],98.51665,16.98403,{"lat":59,"lon":58},[62,64],{"name":63,"role":41,"phone":42,"phoneExt":10,"email":43},"Prof. François Nosten",{"name":65,"role":41,"phone":42,"phoneExt":10,"email":46},"Htet Ko Ko Aung",{"type":67,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","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":80,"type":81},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.",[85,86],"Covid-19 Pandemics","Tuberculosis","2026-04-07",{"date":89,"type":90},"2026-04-13","ACTUAL",{"date":92,"type":90},"2023-04-15",{"date":94,"type":81},"2026-06-30",{"name":5,"class":6},1]