Ignite Creation Date:
2024-05-05 @ 5:07 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00396370
Status:
COMPLETED
Last Update Posted:
2019-11-12
First Post:
2006-11-03
Brief Title:
BCG Vaccination Delivered Intradermally Orally and by Combined Routes
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2012-10-26
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 andor placebo substance containing no medication will be given by mouth andor 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
Detailed Description:
Vaccination with Bacillus Calmette-Guérin BCG is used as part of tuberculosis TB control strategies in most of the world outside of the United States and constitutes the most widely implemented vaccination strategy worldwide However despite widespread use of BCG TB remains a leading infectious cause of death worldwide and it is estimated that one-third of the worlds population is chronically and asymptomatically latently infected with Mycobacterium tuberculosis Mtb the causative agent of TB This is a phase I single-center randomized vaccine trial including six double-blind placebo-controlled groups and one open-label group Approximately 68 up to 80 healthy male and female subjects 18-40 years old inclusive who are negative for QuantiFERON-TB Gold and human immunodeficiency virus will be enrolled The expected total duration of the volunteer enrollment vaccination and follow-up volunteer participation for this study is 30 months All volunteers are expected to be enrolled over a period of 9 months and on study for 24 months Detailed immune studies with frozen samples will be expected to continue after collection of all samples and after the protocol has been completed Eligibility will be determined by volunteers health at prescreening and eligible subjects will give study specific main study informed consent for enrollment in the study Subjects randomized to Groups A-F will receive at Day 0 and 1 year later BCG intradermally orally or by both routes PBS PO and Sauton medium injectable placebo will be used to blind the study Subjects randomized to Group G will receive BCG intradermally at Day 0 only The primary study objectives are the assessment of the safety of combined and individual intradermal ID and oral PO vaccination with Statens Serum Institut SSI BCG in healthy immunologically naïve volunteers comparisons of mycobacteria-specific interferon-gamma responses and mucosal immunoglobulin-A induced by SSI BCG vaccination given intradermally orally and by both routes combined and comparison of safety and immunogenicity of Danish and Connaught BCG given intradermally The secondary study objectives are the assessment of purified protein derivative skin test responses as an indication of cutaneous T cell trafficking after vaccination with SSI BCG and quantitation of BCG replication in Sanofi Pasteur ID BCG ulcerative lesions after ID BCG vaccination The exploratory study objectives are comparisons of intracellular killing activity induced by SSI BCG vaccination given intradermally orally and by both routes combined and characterization of mycobacteria-specific T cells induced intradermally orally or both routes by vaccination with SSI 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 Parent protocol to sub-study 12-0110 and 10-0026
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None