Ask to take part

Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.

Contact Information:

Study Location:

Skip to Main Content
English | Cymraeg
Be Part of Research - Trial Details - Aerosol BCG Challenge Trial in Healthy UK Adults

Aerosol BCG Challenge Trial in Healthy UK Adults

Completed

Open to: ALL

Age: 18.0 - 50.0

Medical Conditions

Tuberculosis


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.


TB041 is a clinical challenge trial primarily to evaluate the safety of BCG challenge administered by the aerosol inhaled route in healthy, BCG naive UK adults. The trial will also look to evaluate and compare the amount of BCG recovered from the lungs and from the skin, following challenge by either the aerosol or the intradermal route.

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:

Mar 2016 May 2019

INTERVENTIONAL

Intervention Type : BIOLOGICAL
Intervention Description : BCG SSI (Due to a global shortage of BCG SSI, BCG Bulgaria used in Group 2)

Intervention Arm Group : Group 1A: low dose aerosol BCG SSI;Group 1B: medium dose aerosol BCG SSI;Group 1C: standard dose aerosol BCG SSI;Group 1D: standard dose intradermal BCG SSI;

Intervention Type : OTHER
Intervention Description : Saline placebo

Intervention Arm Group : Group 1C: standard dose aerosol BCG SSI;Group 1D: standard dose intradermal BCG SSI;Group 2E: close to or higher than standard intradermal BCG;Group 2F: 1 log lower than Group 2E;

Intervention Type : BIOLOGICAL
Intervention Description : BCG Bulgaria (InterVax)

Intervention Arm Group : Group 2A: lower than standard dose aerosol BCG Bulgaria;Group 2B: close to the standard dose aerosol BCG Bulgaria;Group 2C: higher than standard dose aerosol BCG Bulgaria;Group 2D: close to or higher than standard aerosol BCG;Group 2E: close to or higher than standard intradermal BCG;Group 2F: 1 log lower than Group 2E;



You can take part if:



You may not be able to take part if:


This is in the inclusion criteria above


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

  • NIHR Wellcome Trust Clinical Research Facility, University of Birmingham
    Birmingham
    West Midlands
    B15 2TH
  • Centre for Clinical Vaccinology and Tropical Medicine , University of Oxford
    Oxford
    Oxfordshire
    OX3 7LE
  • Oxford University Hospitals- John Warin Ward, University of Oxford
    Oxford
    Oxfordshire
    OX3 7LE


The study is sponsored by University of Oxford and is in collaboration with University of Birmingham.




We'd like your feedback

Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.


Is this study information helpful?

What will you do next?

Read full details for Trial ID: NCT02709278
Last updated 14 November 2023

This page is to help you find out about a research study and if you may be able to take part

You can print or share the study information with your GP/healthcare provider or contact the research team directly.