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drugset / Trial / NCT00653627

A Study to Quantify Bacille Calmette Guerin (BCG) and Characterise the Immune Response After BCG Vaccination

NCT00653627 ↗

Phase 1 Completed 40 enrolled University of Oxford
Non-randomizedParallel-groupOpen-labelBasic science

Summary

This is a human pilot study of 16 healthy BCG-naïve volunteers to quantify BCG from the BCG vaccination site. Volunteers will be vaccinated with BCG. The first 8 will go on to have a punch biopsy and suction blister of the vaccination sites at 2 weeks post vaccination (arm A) the second 8 will have a biopsy and blister at 1 or 4 weeks post-vaccination (arm B). Methods of mycobacterial quantification on these tissue samples will then be compared

Timeline

Start
2007-08
Primary completion
2010-04
Completion
2010-04

Drugs

EvaluationDrugModalityDoseRoute
Subject BCG Vaccine 0.1 ml Other

Indications

tuberculosis