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Sponsored by: |
National Institute of Allergy and Infectious Diseases (NIAID) |
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Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00396370 |
This study will assess the safety of a Bacillus Calmette-Guerin (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. A second vaccine and/or placebo will be given 12 months later. This study, conducted at Saint Louis University, will enroll 70 healthy volunteers, 18-40 years old, for up to 26 months, which includes a 60-day screening period. Study procedures will undergo 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. Some participants may volunteer to have a bronchoscopy (inserting a small viewing device into the lung passages) and bronchoalveolar lavage (washing out cells and fluid from the lung).
Condition | Intervention | Phase |
---|---|---|
Tuberculosis |
Biological: BCG (ID) Biological: BCG (PO) Drug: Placebo (ID) Biological: Connaught strain BCG Drug: Placebo (PO) |
Phase I |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Subject, Investigator), Active Control, Factorial Assignment, Safety Study |
Official Title: | Phase I Studies of the Safety and Immunogenicity of Primary and Secondary BCG Vaccination Delivered Intradermally, Orally and by Combined Routes of Administration in Healthy and Previously Immunologically Naïve Volunteers |
Estimated Enrollment: | 60 |
Study Start Date: | December 2008 |
Estimated Study Completion Date: | June 2010 |
Estimated Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Group A: BCG ID/Placebo PO; Placebo ID/Placebo PO: Experimental
Primary vaccination: BCG ID (Danish)/Placebo PO; secondary vaccination (1 year later): Placebo ID/Placebo PO.
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Biological: BCG (ID)
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..
Drug: Placebo (ID)
Sauton medium for intradermal administration.
Drug: Placebo (PO)
Phosphate buffered saline (PBS) for oral administration.
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Group B: BCG ID/Placebo PO; BCG ID/Placebo PO: Experimental
Primary vaccination: BCG ID (Danish)/Placebo PO; secondary vaccination (1 year later): BCG ID (Danish)/Placebo PO.
|
Biological: BCG (ID)
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..
Drug: Placebo (PO)
Phosphate buffered saline (PBS) for oral administration.
|
Group C: Placebo ID/BCG PO; Placebo ID/Placebo PO: Experimental
Primary vaccination: Placebo ID/BCG PO (Danish); secondary vaccination (1 year later): Placebo ID/Placebo PO.
|
Biological: BCG (PO)
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).
Drug: Placebo (ID)
Sauton medium for intradermal administration.
Drug: Placebo (PO)
Phosphate buffered saline (PBS) for oral administration.
|
Group D: Placebo ID/BCG PO; Placebo ID/BCG PO: Experimental
Primary vaccination: Placebo ID/BCG PO (Danish); secondary vaccination (1 year later): Placebo ID/BCG (Danish) PO.
|
Biological: BCG (PO)
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).
Drug: Placebo (ID)
Sauton medium for intradermal administration.
|
Group G: Connaught strain BCG ID; Connaught strain BCG ID: Experimental
Primary vaccination: Connaught strain BCG ID; secondary vaccination (1 year later); Connaught strain BCG ID.
|
Biological: Connaught strain BCG
Connaught strain Bacillus Calmette-Guerin (BCG), 8-32 x 10^5 CFU vaccine for intradermal administration.
|
Group F: BCG ID/BCG PO; BCG ID/BCG PO: Experimental
Primary vaccination: BCG ID/BCG PO (Danish); secondary vaccination (1 year later): BCG ID (Danish)/BCG PO (Danish).
|
Biological: BCG (ID)
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..
Biological: BCG (PO)
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).
|
Group E: BCG ID/BCG PO; Placebo ID/Placebo PO: Experimental
Primary vaccination: BCG ID (Danish)/BCG PO (Danish); secondary vaccination (1 year later): Placebo ID/Placebo PO.
|
Biological: BCG (ID)
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..
Biological: BCG (PO)
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).
Drug: Placebo (ID)
Sauton medium for intradermal administration.
Drug: Placebo (PO)
Phosphate buffered saline (PBS) for oral administration.
|
The purpose of this phase I, single-center, double-blind, randomized, placebo-controlled vaccine trial is to investigate the safety and immunogenicity of primary and secondary Bacillus Calmette-Guérin (BCG) vaccination delivered intradermally, orally, and by combined routes of administration in healthy and previously immunologically naïve volunteers. Seventy healthy male and female subjects, 18-40 years old, inclusive, who are negative for QuantiFERON®-TB Gold and human immunodeficiency virus will participate in this study conducted at Saint Louis University for Vaccine Development. Volunteers will be enrolled into 7 groups of 10 subjects to receive 1 or 2 BCG vaccinations intradermally, orally, or by both routes combined. Volunteers will be randomized in a double-blind fashion to groups A-F to receive intradermal (ID) BCG vaccination plus oral (PO) placebo, ID placebo plus PO BCG vaccination, or a combination of ID and PO BCG vaccination, or to the open-label Group G to receive ID BCG vaccination only. One year later, Groups A, C and E will receive both ID and PO placebos, while Groups B, D and F will receive the same combinations of vaccinations that they received 1 year earlier for primary vaccination. Group G will receive ID BCG (Connaught strain, all other BCG vaccinations are Danish BCG) vaccination again 12 months after the primary vaccination. Groups A-F will be followed in a double blind fashion until the end of the study. Group G will be followed in an open-label fashion throughout the study. The placebo will be injectable Sauton medium for ID administration and phosphate buffered saline (PBS) for oral administration. Each volunteer will participate in the study for up to 26 months, which includes the 60-day screening period. The primary study objectives are assessment of the safety of combined and individual ID and PO vaccination with BCG in healthy, immunologically naïve volunteers; comparisons of mycobacteria-specific interferon-gamma responses, mucosal immunoglobulin-A, and intracellular killing activity induced by BCG vaccination given intradermally, orally, and by both routes combined; and comparison of safety and immunogenicity BCG given intradermally. The secondary study objectives are assessment of purified protein derivative skin test responses as an indication of cutaneous T-cell trafficking after vaccination with BCG; characterization of mycobacteria-specific T cells induced intradermally, orally, or both routes by vaccination with BCG using dendritic cells as antigen-presenting cells and stored peripheral blood mononuclear cells as a source for matched T cells collected before and after vaccination; and quantitation of BCG replication in ID BCG ulcerative lesions after primary and secondary ID BCG vaccination. Safety is one of the primary endpoints of this Phase I trial.
Ages Eligible for Study: | 18 Years to 40 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Note: Systemic symptoms occurring prior to secondary vaccination will result in the secondary vaccination being delayed until at least 72 hours after resolution of any of these symptoms that were not considered indicative of active Tuberculosis (TB).
Note: Self-limited ulceration at Intradermal (ID) vaccination site healing within 3 months or other mild to moderate complaints lasting less than 1-2 weeks, as documented in the memory aids (used for 2 weeks after each vaccination) or other source documents used to capture results of clinical assessments at any time point during the trial, will not be reasons to exclude a volunteer from receiving the secondary vaccination.
Contact: Daniel F Hoft | (314) 577-8648 | hoftdf@slu.edu |
United States, Missouri | |
Saint Louis University | Recruiting |
St. Louis, Missouri, United States, 63104 |
Responsible Party: | HHS/NIAID/DMID ( Robert Johnson ) |
Study ID Numbers: | 01-351, Concept 904-004 |
Study First Received: | November 3, 2006 |
Last Updated: | January 8, 2009 |
ClinicalTrials.gov Identifier: | NCT00396370 |
Health Authority: | United States: Federal Government; United States: Food and Drug Administration; United States: Institutional Review Board |
tuberculosis, Bacillus Calmette-Guérin |
BCG Vaccine Bacterial Infections Gram-Positive Bacterial Infections Neoplasm Metastasis |
Mycobacterium Infections Tuberculosis Healthy |
Immunologic Factors Physiological Effects of Drugs Adjuvants, Immunologic Pharmacologic Actions Actinomycetales Infections |