ID93/GLA-SE vaccination + BCG challenge
Research type
Research Study
Full title
A clinical trial evaluating the safety of an aerosol BCG controlled human infection model in assessing the immunogenicity of historical BCG vaccination and vaccination with ID93/GLA-SE in healthy adult volunteers
IRAS ID
1006525
Contact name
Helen McShane
Contact email
Sponsor organisation
University of Oxford
Clinicaltrials.gov Identifier
Research summary
TB is a disease caused by a bacteria (Mycobacterium tuberculosis). TB disease remains one of the top 10 causes of death worldwide. BCG is the only vaccine currently licenced for use against TB, but is not always protective. BCG works well against disease in childhood, but it is not good enough at protecting against disease in adulthood, which leads to the majority of TB deaths.
A new vaccine has been developed, called ID93/GLA-SE, it has recently undergone clinical trials to show that it can be given safely to healthy people. The purpose of this study is to understand more about the body’s immune response to the vaccine and provide some evidence about whether or not this investigational TB vaccine is likely to work. It is important to understand this both in people who have been previously vaccinated with BCG and those who have never been vaccinated with BCG, so we are recruiting both volunteers who know that they have had a BCG vaccine before and those who know that they have never had the BCG vaccine before. To help understand how well the experimental vaccine works this study uses a Controlled Human Infection approach or “challenge". This study is split into 4 different groups, some groups will be given two doses of the investigational TB vaccine (ID93/GLA-SE), while other volunteers will not receive any vaccines. Although not all volunteers in this study will have the investigational vaccine, all volunteers will have an aerosol BCG Challenge. To understand how effective the new vaccine is at helping the body’s immune system to “fight off” the BCG in the lungs, all volunteers will also have washings taken from their lungs in a procedure called a bronchoscopy. The bronchoscopy will take place 14 days after the aerosol BCG challenge. The lung washings and blood samples collected during the study will be used to compare between groups. This will help us understand how much the new vaccine helps in stopping the BCG infection.REC name
South Central - Oxford A Research Ethics Committee
REC reference
23/SC/0388
Date of REC Opinion
9 Sep 2024
REC opinion
Further Information Favourable Opinion