CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 12 enrolled
Drug / intervention
BCG Danishbiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04777721
NCT04777721Phase 1Completed
CompareCT.gov

A Clinical Challenge Study to Evaluate Controlled Human Infection With BCG Administered by the Aerosol Inhaled Route in Historically BCG-vaccinated Healthy Adult Volunteers

University of Oxford·interventional·Posted Mar 2, 2021·Updated Feb 6, 2025

In Brief

A Phase 1 clinical trial evaluating BCG Danish for Tuberculosis. Completed, enrolled 12 participants across 1 site.

Detailed Summary

The purpose of this study is to evaluate the human clinical response to BCG challenge in historically BCG-vaccinated healthy adult volunteers. It will involve 12 participants in a controlled dose escalation. 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsTuberculosis
CountriesUnited Kingdom
Collaborators--

Timeline

Phase 1CompletedFinished
20222023202420252026
First PostedMar 2, 2021
Enrollment StartMay 17, 2022
Primary CompletionJun 20, 2023
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 5.3 years ago

Interventions

BCG Danishbiological

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.