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Contact Information:

Dr Ben Morton
+44 (0)151 705 3295
ben.morton@lstmed.ac.uk


Dr Ben Morton
+44 (0)151 705 3295
ben.morton@lstmed.ac.uk


Dr Emma Carter
+44 (0)7756203034
emma.carter@lstmed.ac.uk


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Be Part of Research - Trial Details - Using the BCG vaccine to understand tuberculosis infection
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Using the BCG vaccine to understand tuberculosis infection

Not Recruiting

Open to: All Genders

Age: Adult

Liverpool

Medical Conditions

The use of a human challenge model for tuberculosis using BCG, which could be used to test vaccines and therapeutics

This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


Tuberculosis (TB) is a disease that usually causes an infection in the lungs but can also affect other parts of the body. The only vaccine available to prevent TB is called BCG (Bacillus Calmette–Guérin). The BCG vaccine contains a live germ similar to, but weaker than, Mycobacterium tuberculosis, the germ that causes TB infection. BCG has been around for over 100 years but unfortunately, it does not work very well, and TB remains the most common cause of death caused by infection worldwide. Human challenge models involve exposing healthy volunteers to an infectious disease in a safe and carefully controlled way. This can help researchers understand more about an infectious disease and the body’s response. It can also help develop new vaccines and treatments. The purpose of this study is to set up a human challenge model using BCG to understand how the body responds to this existing vaccine. It is hoped that if the human challenge model works well it may be used to help researchers to develop new vaccines and new tablets to treat TB in the future.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

30 Jun 2023 23 Jan 2025

Publications

2024 Protocol article in https://pubmed.ncbi.nlm.nih.gov/39219857/ (added 02/09/2024)

The first part of the study (phase A) will recruit 10 participants. The participants in phase A will receive an intradermal injection with BCG vaccine into the upper arm at three times the usual dose given to children. On day 14 after the BCG injection the following skin samples will be taken from the BCG injection site with the use of local anaesthetic: skin swab, microbiopsy, skin scrape and punch biopsy. Participants in this phase of the study will also have blood tests to ensure they are safe to take part and to monitor the immune response to BCG. The overall aim of this part of the study will be to ensure BCG can be isolated (grown in culture and by molecular techniques) from the participants' BCG injection site at 14 days after the injection. The researchers will test whether BCG can be isolated in comparable amounts by punch biopsy and minimally invasive techniques (microbiopsy, skin scrape and skin swab). If BCG can be isolated successfully using the minimally invasive methods of skin sampling and the participants have not experienced any serious adverse events, the researchers can then proceed to the next phase of the study (phase B).
In the second phase of the study (phase B) 20 participants will be recruited. These participants will receive the BCG vaccine as described for phase A. They will then have serial skin samples taken using either microbiopsy, skin scrape or skin swab (depending on which method was most successful in phase A) on days 0, 2, 7, 14 and 28. The focus of this phase of the study is to assess immune responses to intradermal injection at the local (skin), systemic (blood) and respiratory mucosal (nose) compartments. This will involve taking blood samples, skin samples, and nasal samples to measure how the BCG grows over time and the immune response over time. It will be particularly important to see the immune response to the BCG in the respiratory mucosa, given this is the area usually affected by tuberculosis disease.


Healthy volunteers aged 18-50 years with no previous history of tuberculosis or a recent TB contact and no previous vaccination with the BCG or a tuberculosis trial vaccine

You can take part if:



You may not be able to take part if:


1. Laboratory evidence at screening of latent M. tb infection as indicated by a positive ELISPOT response to ESAT6 or CFP10 antigens2. Clinical, radiological, or laboratory evidence of current active TB disease3. Previous vaccination with BCG, or any candidate TB vaccine 4. Within the last year had close household contact with an individual with smear-positive pulmonary tuberculosis 5. Clinically significant history of skin disorder, allergy, immunodeficiency (including HIV), cancer, cardiovascular disease, respiratory disease, gastrointestinal disease, liver disease, renal disease, endocrine disorder, neurological illness or psychiatric disorder 6. Current medical issues:6.1. Acute respiratory tract infection in the 4 weeks preceding recruitment6.2. Any uncontrolled medical or surgical condition at the discretion of the study doctor7. Maternal:7.1. Female participants who are pregnant7.2. Female participants who are lactating7.3. Female participants who intend to become pregnant during the study7.4. Female participants who are unable to take contraception measures during the study8. Smoking:8.1. Current (defined as ≥5/week) or ex-smoker (cigarettes/cigars/e-cigarette /vaping/smoking of recreational drugs) in the last 6 months8.2. Previous significant smoking history (more than 20 cigarettes per day for 20 years or the equivalent [>20 pack years])9. Current alcohol and recreational drug use9.1. Regularly drinks ≥3 units/day (male) or ≥2 units/day (female)9.2. Uses recreational drugs9.3. Participants may be excluded at the discretion of the research clinician10. Concurrent oral or systemic steroid medication or the concurrent use of other immunosuppressive agents 11. History of anaphylaxis to vaccination or any allergy likely to be exacerbated by any component of the challenge agent12. Has received any vaccination within one month of the screening visit13. Has not completed at least two COVID-19 vaccination doses14. Any abnormality of screening blood or urine tests that is deemed to be clinically significant or that may compromise the safety of the volunteer in the study15. Positive HBsAg, HCV or HIV antibodies 16. Current involvement in another trial that involves regular blood tests or an investigational medicinal product17. Use of an investigational medicinal product or non-registered drug, live vaccine, or investigational medical device for 4 weeks prior to dosing with the study challenge agent 18. Administration of immunoglobulins and/or any blood products within the three months preceding the planned challenge date 19. Participants who meet STOP criteria at the time of screening20. Any other issue which, in the opinion of the study staff, may:20.1. Put the participant or their contacts at risk because of participation in the study20.2. Adversely affect the interpretation of the study results20.3. Impair the participant’s ability to participate in the study


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • Liverpool School of Tropical Medicine
    Pembroke Place
    Liverpool
    L3 5QA

The main benefit to participants is participating in research which could help improve vaccinations and treatments against tuberculosis. Participants may gain some protection against tuberculosis, although the BCG vaccine is not very effective against TB of the lungs in adults. An additional benefit is receiving a general health check as part of the screening process and having regular contact with medical doctors and nurses during the study.
Reactions to the BCG vaccine are uncommon and generally mild. The expected reaction to the vaccination is swelling, redness, and pain followed by the development of a small ulcer which heals to leave a scar. A swelling of lymph nodes in the armpit is also common. Uncommon side effects include headache, painful tender lymph nodes, fever, and a discharging ulcer. Rare side effects include an abscess, infection in the body, or an allergic reaction such as anaphylaxis.
Mild stinging on local anaesthetic is usual. Numbness of the area after the procedure can occur. Serious complications are very rare with a local anaesthetic. Allergic reactions may rarely occur, this may just be a localised itchy rash over the injection site or an unexpected severe allergic reaction such as anaphylaxis, but this is very rare.
A punch biopsy is a safe procedure and complications are uncommon. Pain after the procedure is common and usually mild. Bleeding will occur during the procedure, but it is uncommon for participants to get continued bleeding after the procedure. Participants will usually be left with a small faint scar. Infection is uncommon and occurs in around 1 in 500.
The risks of microbiopsy are minimal. There may be mild pain and a small drop of blood, any small wound usually heals within 24 hours. Stitches are not required.
The skin scrape may cause some mild pain or discomfort and occasionally some mild bleeding.
Blood sampling may cause temporary pain, bruising and/or bleeding to the participant's arm.
Throat swabs/COVID throat/nose swabs/nasal samples may make participants feel some discomfort, gag a little, and there may be a small amount of nasal bleeding.

Dr Ben Morton
+44 (0)151 705 3295
ben.morton@lstmed.ac.uk


Dr Ben Morton
+44 (0)151 705 3295
ben.morton@lstmed.ac.uk


Dr Emma Carter
+44 (0)7756203034
emma.carter@lstmed.ac.uk



The study is sponsored by Liverpool School of Tropical Medicine and funded by UK Research and Innovation.



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Read full details for Trial ID: ISRCTN94098600

Or CPMS 55553

Last updated 28 January 2025

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