Checks how COVID-19 vaccines work in people with tuberculosis
Compares immune response to COVID-19 vaccines in adults with tuberculosis and healthy adults.
Plain-language title generated from the registry record
Registry title: Immunogenicity of COVID-19 Vaccines in Tuberculosis Patients
Key facts
- Where
- Mae Ramat, ThailandSee the site
Where in Thailand
- Shoklo Malaria Research Unit (SMRU)Mae Ramat, ThailandTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- University of Oxford
- Trial code
- NCT05571735
- Record updated
- 13 April 2026
- Original description
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).Read full original descriptionShow less
Immunogenicity of COVID-19 Vaccines Against Coronavirus Disease (COVID-19) Among Tuberculosis (TB) Patients in Thailand-Myanmar Border.
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.
Inclusion: 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: 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; Any previous history of a serious side effect with any kind of vaccine; History of HIV infection; Participation in other COVID-19 related studies for the duration of the study; History of allergic disease or reactions likely to be exacerbated by any component of the vaccine; Any history of angioedema; Any history of anaphylaxis; Current diagnosis of or treatment for cancer; History of severe psychiatric disorders likely to affect participation in the study; 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); History of laboratory confirmed COVID-19 for any duration before or positive COVID-19 PCR or antigenic test at screening; 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; Women with pregnancy, lactation or planning to get pregnant during the duration of the study.