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Aerosol BCG Challenge Trial in Healthy UK Adults

NCT02709278 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2023-11-18

No results posted yet for this study

Summary

TB041 is a clinical challenge trial primarily to evaluate the safety of BCG challenge administered by the aerosol inhaled route in healthy, BCG naive UK adults. The trial will also look to evaluate and compare the amount of BCG recovered from the lungs and from the skin, following challenge by either the aerosol or the intradermal route.

Conditions

Interventions

BIOLOGICAL

BCG

BCG SSI (Due to a global shortage of BCG SSI, BCG Bulgaria used in Group 2)

OTHER

Saline placebo

Saline placebo

BIOLOGICAL

BCG

BCG Bulgaria (InterVax)

Sponsors & Collaborators

  • University of Birmingham

    collaborator OTHER

  • University of Oxford

    lead OTHER

Principal Investigators

  • Professor Helen McShane · University of Oxford

  • Professor Paul Moss · University of Birmingham

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2016-03-07
Primary Completion
2019-05-09
Completion
2019-05-09

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
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 NCT02709278 on ClinicalTrials.gov