Aerosol BCG Challenge Trial in Healthy UK Adults

• Register: ClinicalTrials.gov
• Last refreshed on: 27 November 2023
• Main ID: NCT02709278
• Date of registration: 12/02/2016
• Prospective Registration: Yes
• Primary sponsor: University of Oxford
• Public title: Aerosol BCG Challenge Trial in Healthy UK Adults
• Scientific title: A Clinical Challenge Trial to Evaluate Controlled Human Infection With BCG Administered by the Aerosol Inhaled Route Compared With the Intradermal Route in Healthy, BCG-naïve, UK Adult Volunteers
• Date of first enrolment: March 7, 2016
• Target sample size: 46
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/ct2/show/NCT02709278
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Other. Masking: Double (Participant, Outcomes Assessor).
• Phase: Phase 1

Countries of recruitment

United Kingdom

Contacts

• Name: Professor Paul Moss
• Affiliation: University of Birmingham

• Name: Professor Helen McShane
• Affiliation: University of Oxford

Key inclusion & exclusion criteria

Inclusion Criteria:

- Healthy adult aged 18-50 years

- Resident in or near Oxford (CCVTM or OUH) or Birmingham (NIHR-WTCRF) for the =
duration of the trial period

- Screening IGRA negative

- Chest radiograph normal

- No relevant findings in medical history or on physical examination

- Allow the Investigators to discuss the individual's medical history with their GP

- Use effective contraception (see below) for the duration of the trial period (females
only)

- Refrain from blood donation during the trial

- Give written informed consent

- Allow the Investigator to register volunteer details with a confidential database (The
- Over-volunteering Protection Service) to prevent concurrent entry into clinical
studies/trials

- Able and willing (in the Investigator's opinion) to comply with all the trial
requirements

Exclusion Criteria:

- Previously resident for more than 12 months concurrently in a tropical climate where
significant non-tuberculous mycobacterial exposure is likely

- Participation in another research trial involving receipt of an investigational
product in the 30 days preceding enrolment, or planned use during the trial period

- Prior vaccination with BCG or any candidate TB vaccine

- Administration of immunoglobulins and/or any blood products within the three months
preceding the planned trial challenge date

- Clinically significant history of skin disorder, allergy, atopy, immunodeficiency
(including HIV), cancer (except BCC or CIS), cardiovascular disease, gastrointestinal
disease, liver disease, renal disease, endocrine disorder, neurological illness,
psychiatric disorder, drug or alcohol abuse

- Concurrent oral or systemic steroid medication or the concurrent use of other
immunosuppressive agents

- History of anaphylaxis to vaccination or any allergy likely to be exacerbated by any
component of the trial agent, sedative drugs, or any local or general anaesthetic
agents

- Pregnancy, lactation or intention to become pregnant during trial period Any
respiratory disease, including asthma

- Current smoker

- Clinically significant abnormality on screening chest radiograph

- Clinically significant abnormality of spirometry

- Any nasal, pharyngeal, or laryngeal finding which precludes bronchoscopy

- Current use of any medication taken through the nasal or inhaled route including
cocaine or other recreational drugs

- Clinical, radiological, or laboratory evidence of current active TB disease

- Past treatment for TB disease

- Any clinically significant abnormality of screening blood or urine tests

- Positive HBsAg, HCV or HIV antibodies

- Any other significant disease, disorder, or finding, which, in the opinion of the
Investigator, may either put the volunteer at risk, affect the volunteer's ability to
participate in the trial or impair interpretation of the trial data



Age minimum: 18 Years
Age maximum: 50 Years
Gender: All

Health Condition(s) or Problem(s) studied

Tuberculosis

Intervention(s)

Other: Saline placebo

Biological: BCG

Primary Outcome(s)

Adverse Events (AE) [Time Frame: Up to day 168]

Secondary Outcome(s)

Quantification of BCG [Time Frame: At day 14]

Secondary ID(s)

TB041

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

University of Birmingham