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Investigating Immune Responses to Aerosol BCG Challenge in Healthy UK Adults

NCT03912207 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 94

Last updated 2024-01-03

No results posted yet for this study

Summary

TB043 is a clinical challenge trial primarily to evaluate the safety of BCG challenge administered by the aerosol inhaled route in healthy, BCG naive (Group 1-7) as well as historically BCG vaccinated UK adults (Group 8) . The trial will also look to evaluate and compare the amount of BCG recovered from the lungs as various points after challenge.

Conditions

Interventions

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.

OTHER

Saline placebo

Saline is a routinely used placebo.

Sponsors & Collaborators

  • Wellcome Trust

    collaborator OTHER

  • National Institute for Health Research, United Kingdom

    collaborator OTHER_GOV

  • University of Leicester

    collaborator OTHER

  • University of Oxford

    lead OTHER

Principal Investigators

  • Professor Helen McShane · University of Oxford

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2019-04-19
Primary Completion
2024-06-30
Completion
2024-06-30

Countries

  • United Kingdom

Study Locations

More Related Trials

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 NCT03912207 on ClinicalTrials.gov