Immunogenicity and safety of orally administered killed whole cell non-typeable Haemophilus influenzae (Study HI-H003)
Phase 1
Completed
- Conditions
- Smokers at risk of recurrent bronchitisRespiratory - Other respiratory disorders / diseases
- Registration Number
- ACTRN12607000271404
- Lead Sponsor
- The University of Newcastle Research Associates (TUNRA) Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 64
Inclusion Criteria
Smokers who had smoked at least 10 cigarettes per day for the past 2 years (1 pack year), with no medical or social reason for being unable to comply with requirements of the study, and willingness and ability to give signed informed consent.
Exclusion Criteria
Known current chronic infection (except episodes of acute bronchitis with or without chronic bronchitis); participation in a clinical trial in the past 3 months; pregnant, breast-feeding, or women with child-bearing potential without an effective method of contraception, any patient likely to withdraw or not comply with the study protocol; any other medical reason that the medical advisor feels that a patient should not be included.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To compare surrogate markers of mucosal protection (NTHi-specific antibody in saliva and serum, NTHi-specific T cells in blood) and non-specific parameters (INF-gamma, lysozyme, lactoferrin and nitric oxide in saliva) between vaccine and placebo groups. NTHi-specific antibody, IFNg, lysozyme and lactoferrin were measured by ELISA assays. NTHi-specific lymphocytes were measured by in vitro proliferation of blood lymphocytes in response to antigen stimulation. Nitric oxide was measured by chemical assay.[Measured at baseline, at weeks 2,4,6 and 8 during intervention and at weeks 10 and 12 post-intervention. ]
- Secondary Outcome Measures
Name Time Method