Immunogenicity of COVID-19 Vaccines in Tuberculosis Patients
Recruiting
Observational Study
Covid-19 PandemicsTuberculosis
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Study type
Observational
Participants needed
133 (estimated)
Sponsor
University of Oxford · Other
Who this trial is looking for
This trial is looking for adults with tuberculosis and healthy individuals to compare their immune responses after receiving COVID-19 vaccines. Participants will receive either one or two doses of a COVID-19 vaccine and be followed for several weeks afterward.
Are You a Good Fit for This Trial?
Rules you outHIV infectionCancerSerious allergic reactionsSevere psychiatric disorders
You may be able to join if
I am at least 18 years old.
I have been diagnosed with tuberculosis or I am healthy.
I will use effective contraception if I am a woman aged 18-49.
I am willing to attend follow-up appointments after vaccination.
I am able to understand the study instructions.
I am willing to undergo a pre-enrollment screening.
I can provide written consent.
You may not be able to join if
I have a history of COVID-19 or a positive COVID-19 test.
I have a history of HIV infection.
I am participating in other COVID-19 studies.
I have a history of severe allergic reactions.
I am pregnant, breastfeeding, or planning to become pregnant during the study.
I have a current diagnosis of cancer.
I have a bleeding disorder or a history of serious bleeding.
I have a history of severe psychiatric disorders.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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…
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.
Trial Locations
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Eligibility Criteria
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 fo…
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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