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ID93/GLA-SE Vaccination + BCG Challenge

NCT06670755 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2025-12-12

No results posted yet for this study

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.

Conditions

Interventions

BIOLOGICAL

ID93/GLA-SE

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.

BIOLOGICAL

BCG Danish

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.

Sponsors & Collaborators

  • University of Oxford

    lead OTHER

Principal Investigators

  • Helen McShane, Professor · University of Oxford

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-12-18
Primary Completion
2027-07-31
Completion
2027-07-31

Countries

  • United Kingdom

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06670755 on ClinicalTrials.gov