MedTrace Logo

BCG Vaccination Delivered Intradermally, Orally and by Combined Routes

NCT00396370 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 69

Last updated 2019-11-12

No results posted yet for this study

Summary

This study will assess the safety of a Bacillus Calmette-Guérin (BCG) vaccine against tuberculosis (TB) and will evaluate if giving the vaccine by mouth, injection, or by both methods produces greater results. BCG vaccine and/or placebo (substance containing no medication) will be given by mouth and/or by injection into the skin. This study, conducted at Saint Louis University, will enroll 60 (up to 80) healthy volunteers, 18-40 years old, who are negative for a TB test (QuantiFERON®-Gold) and human immunodeficiency virus (HIV). Study procedures will include a physical exam; review of TB exposure history and medical history; collection of multiple samples of blood, urine, stool, tears, and nose fluid; and skin and blood tests for TB. Volunteers may participate for about 24 months.

Conditions

Interventions

BIOLOGICAL

BCG strain Connaught

Connaught strain Bacillus Calmette-Guerin (BCG), 8-32 x 10\^5 CFU vaccine for intradermal administration.

BIOLOGICAL

BCG strain Danish

Bacillus Calmette-Guerin (BCG) strain Danish from the Statens Serum Institute (SSI BCG). 1.2 X 10\^8 colony-forming units (CFU) oral (PO) in 60 mililiters phosphate buffered saline (PBS).

BIOLOGICAL

BCG strain Danish

Bacillus Calmette-Guerin (BCG) strain Danish from the Statens Serum Institute (SSI BCG). 2-8 X 10\^5 colony-forming units (CFU) intradermal in 100 microliters diluent.

OTHER

Placebo

0.1 mL of sterile Sauton medium for intradermal administration.

OTHER

Placebo

60 mL of sterile phosphate buffered saline (PBS) for oral administration.

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2008-12-02
Primary Completion
2012-07-23
Completion
2012-07-23
FDA Drug
Yes

Countries

  • United States

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 NCT00396370 on ClinicalTrials.gov