Active — Not RecruitingNot Applicable

ID93/GLA-SE Vaccination + BCG Challenge

United Kingdom48 participantsStarted 2024-12-18

Plain-language summary

The purpose of this study is to: 1. Demonstrate the safety of a novel TB vaccine (ID93/GLA-SE) when given to both BCG-vaccinated and BCG-naïve volunteers. 2. Provide preliminary immunogenicity data of this novel TB vaccine (ID93/GLA-SE). This clinical trial will apply an aerosol BCG challenge model involving 48 participants - 24 historically BCG-vaccinated volunteers and 24 BCG-naïve volunteers. Bronchoscopies will be performed 14 days post-challenge to measure BCG recovered from bronchial samples. Blood tests will be taken to look at potential immunological markers of immunity.

Who can participate

Age range18 Years – 55 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: The volunteer must satisfy all the following criteria to be eligible for the study: * Healthy adults aged 18-55 years * Resident in or near Oxford for the duration of the study period * Provide written informed consent * Willing to allow the investigators to discuss the volunteer's medical history with their General Practitioner (or review summary care record, if available) * Allow the investigator to register volunteer details with a confidential database (The Over-volunteering Protection Service) to prevent concurrent entry into clinical studies/trials * Agreement to refrain from blood donation during the course of the study * For persons of child-bearing potential only, willingness to practice continuous effective contraception (see below) during the study and a negative pregnancy test on the day(s) of screening, vaccination, challenge and bronchoscopy * Able and willing (in the investigator's opinion) to comply with all study requirements * No clinically relevant findings in medical history or on physical examination * Screening IGRA (interferon gamma release assay) negative * Willing to be tested for evidence of COVID-19 infection and to allow public health notification of the results if required * EITHER Previously vaccinated with the BCG (at least 12 months prior to enrolment, as evidenced by a visible scar or documentation in medical or occupational health records) OR Never previously vaccinated with BCG and no evidence of BCG scar at physical ex…

What they're measuring

Safety of BCG challenge by the aerosol inhaled route in healthy volunteers and recently ID93/GLA-SE-vaccinated adult volunteers.

Timeframe: Group A and C - up to day 168, Group B and D - up to day 56 (Adverse events are collected throughout the duration of the study. Specific timepoints for blood and lung function tests have been mentioned in the measure description.)

Trial details

NCT IDNCT06670755

SponsorUniversity of Oxford

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-07

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