COVID-19 vaccine immune responses in people being treated for tuberculosis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a non-randomized observational comparison enrolling 54 bacteriologically confirmed TB patients on treatment and 54 healthy comparator participants. Each person will receive one of the authorized COVID‑19 vaccines (Pfizer‑BioNTech, AstraZeneca, or Janssen) according to local practice and will have blood drawn to measure humoral and cellular immune responses. Follow‑up includes sampling four weeks after the second dose for Pfizer/AstraZeneca or eight weeks after the single Janssen dose, with total participation lasting about one year. The work is conducted at the Shoklo Malaria Research Unit (SMRU) in Thailand and is funded by the Wellcome Trust.

Why it matters

Who can join: the full rules

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).

Where it's running

• Shoklo Malaria Research Unit (SMRU)
  Mae Ramat, Changwat Tak, Thailand Recruiting

Study contacts

• Principal investigator: François Nosten, Professor — Shoklo Malaria Research Unit
• Study coordinator: François Nosten, Professor
• Email: francois@tropmedres.ac
• Phone: (+66) 055 532026

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.