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โ† Trials
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Immunogenicity of COVID-19 Vaccines in Tuberculosis Patients

Recruitingn/aAges 18 Years - anyAllUniversity of Oxford
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In plain words

What the trial is, and whether it could suit you

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). Each 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. This study is funded by the Wellcome Trust. The grant reference number is 220211/A/20/Z.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * 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. * 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 * Willing to be involved in the pre-enrolment screening. * For women with child bearing potential only (aged 18-49 years), willing to continue to use effective contraception methods through the study. * 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. * Able and willing to comply with all study requirements. * Ability to understand the study instructions and provide written informed consent Exclusion Criteria: * History of laboratory confirmed COVID-19 for any duration before or positive COVID-19 PCR or antigenic test at screening. * History of HIV infection * Participation in other COVID-19 related studies for the duration of the study. * Participation in other vaccine trials within 90 days before and 30 days after the study vaccination. * Administration of any immunoglobulins or any type of COVID-19 vaccine within 90 days before administration of the vaccine. * History of allergic disease or reactions likely to be exacerbated by any component of the vaccine. * Any previous history of a serious side effect with any kind of vaccine. * Any history of angioedema. * Any history of anaphylaxis. * Women with pregnancy, lactation or planning to get pregnant during the duration of the study. * Current diagnosis of or treatment for cancer. * History of severe psychiatric disorders likely to affect participation in the study. * 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. * Suspected or known current alcohol or drug dependency (except well controlled condition). * 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. * Severe and/or uncontrolled cardiovascular disease, gastrointestinal disease, liver disease, renal disease, endocrine disorder and neurological illness (mild/moderate well controlled comorbidities are allowed).
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What it tests

  • Pfizer-BioNTech COVID-19 vaccine
  • AstraZeneca vaccine
  • Janssen Ad26.COV2.S COVID-19 vaccine
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Where

1 site
Shoklo Malaria Research Unit (SMRU)
Mae Ramat, Thailand
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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