Actively Recruiting
Immunogenicity of COVID-19 Vaccines in Tuberculosis Patients
Led by University of Oxford · Updated on 2026-04-13
133
Participants Needed
1
Research Sites
167 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Immunogenicity of COVID-19 Vaccines in Tuberculosis Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults 18 years and older with newly diagnosed bacteriologically confirmed TB, including drug sensitive and resistant TB, currently receiving anti-TB or MDR-TB treatment in the initial treatment period or clinically healthy individuals for comparison
- Willing to attend follow-up visits for four weeks after the second dose of Pfizer-BioNTech or AstraZeneca vaccines or eight weeks after a single dose of Janssen vaccine
- Agree to participate in pre-enrollment screening
- For women aged 18 to 49 with childbearing potential, willingness to use effective contraception during the study
- For women aged 18 to 49 with childbearing potential, negative pregnancy test on screening and vaccination days
- Able and willing to comply with all study procedures and provide written informed consent
You will not qualify if you...
- History of confirmed COVID-19 infection or positive COVID-19 test at screening
- History of HIV infection
- Participation in other COVID-19 related studies during this study
- Participation in other vaccine trials within 90 days before or 30 days after study vaccination
- Receipt of immunoglobulins or any COVID-19 vaccine within 90 days before study vaccination
- History of allergic reactions to vaccine components
- Previous serious side effects from any vaccine
- History of angioedema or anaphylaxis
- Pregnancy, breastfeeding, or planning pregnancy during the study
- Current cancer diagnosis or treatment
- Severe psychiatric conditions affecting study participation
- Bleeding disorders, history of thrombosis, or significant bleeding after injections or blood draws
- Suspected or known alcohol or drug dependency (except well controlled)
- Any condition judged by the investigator to pose undue risk or interfere with study results
- Severe or uncontrolled cardiovascular, gastrointestinal, liver, kidney, endocrine, or neurological diseases (mild or well-controlled conditions allowed)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Shoklo Malaria Research Unit (SMRU)
Mae Ramat, Changwat Tak, Thailand
Actively Recruiting
Research Team
F
François Nosten, Professor
CONTACT
H
Htet Ko Ko Aung, MD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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