ID93/GLA-SE Vaccination + BCG Challenge

NCT06670755 | Active Not Recruiting DMC

• 1 other identifier: TB045
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to:

1. 1.Demonstrate the safety of a novel TB vaccine (ID93/GLA-SE) when given to both BCG-vaccinated and BCG-naïve volunteers.
2. 2.Provide preliminary immunogenicity data of this novel TB vaccine (ID93/GLA-SE).

Conditions

Tuberculosis

Outcome Measures

Primary Outcomes (1)

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

  Safety will be assessed through actively and passively collected data on adverse events, detailed participant symptom profiles, and lung function test results. Adverse events will be collected at each visit and via diary card. Safety blood tests will be performed at baseline, day 14 and day 70. Lung function tests will be performed at day 0 post challenge and day 28, as well as later time points if clinically indicated.

  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.)

Secondary Outcomes (1)

• Differences in colony forming units recoverable of ID93/GLA-SE against a controlled human aerosol BCG infection model.

  On day 14 post-challenge

Other Outcomes (1)

• Exploratory outcome: Immunological and microbiological markers that correlate with the levels of BCG recovered from bronchial and other samples after vaccination with ID93/GLA-SE in BCG-naïve and historically BCG-vaccinated volunteers.

  Group A and C - up to day 168, Group B and D - up to day 56.

Study Arms (4)

Group A: 2 doses of ID93/GLA-SE with 1 x 10^6 cfu BCG (historically BCG-vaccinated group)

EXPERIMENTAL

12 historically BCG-vaccinated volunteers will be vaccinated with 2 doses of ID93/GLA-SE and after 112 days receive 1 x 10\^6 cfu aerosol inhaled BCG as a challenge. All Group A volunteers will have a bronchoscopy 14 days post challenge.

Biological: ID93/GLA-SE; Biological: BCG Danish

Group B: 1 x 10^6 cfu BCG (historically BCG-vaccinated group)

EXPERIMENTAL

12 historically BCG-vaccinated volunteers will receive 1 x 10\^6 cfu aerosol inhaled BCG. All Group B volunteers will have a bronchoscopy 14 days post challenge.

Biological: BCG Danish

Group C: 2 doses of ID93/GLA-SE with 1 x 10^6 cfu BCG (BCG-naïve group)

EXPERIMENTAL

12 BCG-naïve volunteers will be vaccinated with 2 doses of ID93/GLA-SE and after 112 days receive 1 x 10\^6 cfu aerosol inhaled BCG as a challenge. All Group C volunteers will have a bronchoscopy 14 days post challenge.

Biological: ID93/GLA-SE; Biological: BCG Danish

Group D: 1 x 10^6 cfu BCG (BCG-naïve group)

EXPERIMENTAL

12 BCG-naïve volunteers will receive 1 x 10\^6 cfu aerosol inhaled BCG. All Group D volunteers will have a bronchoscopy 14 days post challenge.

Biological: BCG Danish

Interventions

ID93/GLA-SE BIOLOGICAL

ID93/GLA-SE is a protein-adjuvant vaccine which has been purposefully designed to elicit a diverse immune response against M.tb bacterial antigens, improve treatment outcomes and prevent TB disease in people already infected with M.tb. ID93/GLA-SE will be administered intramuscularly.

Group A: 2 doses of ID93/GLA-SE with 1 x 10^6 cfu BCG (historically BCG-vaccinated group); Group C: 2 doses of ID93/GLA-SE with 1 x 10^6 cfu BCG (BCG-naïve group)

BCG Danish BIOLOGICAL

BCG Danish 1331 is on the WHO list of pre-qualified vaccines and has a well-defined side effect profile. BCG is licensed for delivery via the intradermal route. It is not licensed for delivery via the aerosol route. For the challenge, aerosol BCG will be administered via nebulizer.

Group A: 2 doses of ID93/GLA-SE with 1 x 10^6 cfu BCG (historically BCG-vaccinated group); Group B: 1 x 10^6 cfu BCG (historically BCG-vaccinated group); Group C: 2 doses of ID93/GLA-SE with 1 x 10^6 cfu BCG (BCG-naïve group); Group D: 1 x 10^6 cfu BCG (BCG-naïve group)

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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 examination

You may not qualify if:

• The volunteer may not enter the study if any of the following apply:
• Participation in another research study involving receipt of an investigational product in the 30 days preceding enrolment or during the trial follow up period
• Any clinically significant respiratory disease, including asthma
• Current smoker (defined as any smoking including e-cigarettes in the last 3 months)
• 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
• History of allergic reaction to Kanamycin or kanamycin-related antibiotics
• Clinically significant history of skin disorder, allergy, atopy, cancer (except basal cell carcinoma of the skin or carcinoma in situ of the cervix), bleeding disorder, cardiovascular disease (including uncontrolled hypertension), gastrointestinal disease, liver disease, renal disease, endocrine disorder, neurological illness, psychiatric disorder, drug or alcohol abuse
• Any significant autoimmune conditions or immunodeficiency (including current 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
• Currently infected with HIV, Hepatitis B or Hepatitis C based on positive serological testing (Hepatitis B surface antigen, Hepatitis C virus or HIV antibodies) and confirmatory molecular testing if indicated
• 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 enrolment date
• Administration of a live vaccine within the preceding 28 days prior to enrolment, or plan for such prior to aerosol challenge

Sponsors & Collaborators

• University of Oxford: lead

Study Sites (1)

Centre for Clinical Vaccinology and Tropical Medicine

Oxford, Oxfordshire, OX3 7LE, United Kingdom

Location

MeSH Terms

Conditions

Tuberculosis

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Officials

• Helen McShane, Professor

  University of Oxford

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a phase 1b vaccine efficacy study of ID93/GLA-SE in historically BCG-vaccinated and BCG-naïve healthy adult volunteers using an aerosol BCG challenge model. There will be four study groups with twelve volunteers in each group. Volunteers will be randomized to eligible groups based upon their BCG vaccine status, and will either be given 2 μg ID93 + 5 μg GLA-SE at Day 0 and Day 56 (Group A and C) prior to BCG aerosol challenge, or proceed directly to BCG aerosol challenge without vaccination.

Study Record Dates

• First Submitted: October 23, 2024
• First Posted: November 1, 2024
• Study Start: December 18, 2024
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: December 12, 2025

Record last verified: 2025-12

Locations

GB (1)