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TB Patients' COVID-19 vaccine response under the microscope

NCT ID NCT05571735

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study compares the immune response to COVID-19 vaccines between people being treated for tuberculosis (TB) and healthy individuals. About 133 participants in the Thailand-Myanmar border area will receive one of three vaccines (Pfizer, AstraZeneca, or Janssen). Researchers will measure antibody and cell-based immunity over one year to see if TB treatment affects vaccine effectiveness.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
COVID-19 vaccines (Pfizer-BioNTech, AstraZeneca, or Janssen)
What this could lead to
If successful, this could show that TB patients mount a similar immune response to COVID-19 vaccines as healthy people, helping guide vaccination policies for this group.
What could go wrong
This is a small observational study, not a large trial. Results may not apply to all TB patients or other settings, and immune response does not guarantee protection from COVID-19.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 133 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2023

Expected to finish

Jun 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

TB cohort - Bacteriologically confirmed TB patients (54 in cohort of patients) Comparator- Clinically healthy individuals (54 in healthy comparator)

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Shoklo Malaria Research Unit (SMRU)

    RECRUITING

    Mae Ramat, Changwat Tak, Thailand

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Other studies related to the condition(s) this trial covers.