Exploring a new way to administer BCG vaccine for tuberculosis in adults

A Clinical Study Comparing the Immune Response to Revaccination With Intradermal BCG and Aerosol BCG in Previously BCG Vaccinated Healthy Adult Volunteers With and Without Type 2 Diabetes

This study is testing if inhaling the BCG vaccine for tuberculosis works better than the usual shot for adults, especially looking at how it affects healthy people and those with Type 2 Diabetes.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 36 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: University of Oxford (other)
• Locations: 1 site (Oxford, Oxfordshire)
• Trial ID: NCT06246851 on ClinicalTrials.gov

What this trial studies

This study investigates the effectiveness of aerosol inhaled BCG compared to the traditional intradermal injection in previously vaccinated adults. It aims to understand the immune response differences between healthy individuals and those with Type 2 Diabetes. The study will involve 36 participants who will undergo bronchoscopies to measure BCG recovery from bronchial samples and blood tests to identify immunological markers of immunity. The goal is to enhance protection against tuberculosis, particularly in high-risk groups.

Who should consider this trial

Good fit: Ideal candidates include healthy adults aged 18-65 who have previously received the BCG vaccine and reside in or near Oxford.

Not a fit: Patients who are not healthy adults or those with significant health issues or contraindications to vaccination may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to improved vaccination strategies against tuberculosis, especially for individuals at higher risk.

How similar studies have performed: While traditional BCG vaccination has been widely studied, the aerosol administration approach is novel and has not been extensively tested in humans.

Eligibility criteria

Inclusion Criteria:

* Healthy adults aged 18-65 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 (POCBP) only, willingness to practice continuous effective contraception (see below) during the study and a negative pregnancy test on the day(s) of screening, vaccination and bronchoscopy
* Able and willing (in the investigator's opinion) to comply with all study requirements
* No clinically relevant findings on physical examination
* Screening IGRA negative
* Willing to be tested for evidence of SARS-CoV-2 infection and to allow public health notification of the results if required
* 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)
* Group C only - Documented diagnosis of T2DM (made at least 12 months prior to enrolment) initiated on a management plan with medication including use of metformin

Exclusion Criteria:

* Participation in another research study involving receipt of an investigational product in the 30 days preceding enrolment or during the trial follow up period
* History of anaphylaxis to vaccination or any allergy likely to be exacerbated by any component of the study agent, any essential study procedure, sedative drugs, or any local or general anaesthetic agents
* Clinically significant history of skin disorder, allergy, atopy, cancer (except BCC of the skin or CIS of the cervix), bleeding disorder, cardiovascular disease, gastrointestinal disease, liver disease, renal disease, endocrine disorder (excluding T2DM in Group C only), neurological illness, psychiatric disorder, drug or alcohol abuse
* Any significant autoimmune conditions or immunodeficiency (including HIV)
* Previous diagnosis or treatment for TB disease or latent TB infections
* Clinical, radiological, or laboratory evidence of current active TB disease or latent TB infection
* Previous receipt of any investigational TB vaccine or aerosolised BCG
* More than one previous BCG vaccination
* Positive HBsAg, HCV or HIV antibodies
* Concurrent use of oral, inhaled or systemic steroid medication or use for more than 14 days within the last 6 months (steroids used as a cream or ointment are permissible), or the use of other immunosuppressive agents concurrently or for more than 14 days within the last 6 months
* Administration of immunoglobulins and/or any blood products within the three months preceding the planned study vaccination date
* Administration of a live vaccine within the preceding 28 days prior to enrolment
* Administration of any other non-live vaccine within the preceding 14 days prior to enrolment
* Pregnancy, lactation or intention to become pregnant during study period
* Previously resident for more than 12 months concurrently in the rural areas of a tropical climate where significant non-tuberculous mycobacterial exposure is likely
* Any other clinically significant abnormality of screening blood or urine tests
* 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 study or impair interpretation of the study data
* A body mass index (BMI) of \<18.5 or \>45

Group A or B Specific Exclusions:

* Any clinically significant respiratory disease, including asthma
* Current smoker (defined as any smoking including e-cigarettes in the last 3 months)
* Current use of any medication or other drug taken through the nasal or inhaled route including cocaine or other recreational drugs
* Any nasal, pharyngeal, or laryngeal finding which precludes bronchoscopy
* Shares a household with someone with clinically significant immunodeficiency (either from infection or medication) who is deemed to be at risk of developing disseminated BCG infection if exposed to BCG
* An HBA1c at screening of \> 48mmol/Lmol
* Clinically significant abnormality on screening chest radiograph
* Clinically significant abnormality of lung function testing

Where this trial is running

Oxford, Oxfordshire

• Centre for Clinical Vaccinology and Tropical Medicine — Oxford, Oxfordshire, United Kingdom (RECRUITING)

Study contacts

• Principal investigator: Helen McShane, Professor — University of Oxford
• Study coordinator: Vaccine Trials

Conditions: Tuberculosis