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Trial registered on ANZCTR


Registration number
ACTRN12606000074594
Ethics application status
Approved
Date submitted
21/02/2006
Date registered
22/02/2006
Date last updated
2/06/2009
Type of registration
Prospectively registered

Titles & IDs
Public title
An oral killed Non-typeable Haemophilus influenzae vaccine for preventing episodes of acute bronchitis in patients with moderate to severe airways disease: Safety and efficacy study
Scientific title
A multi-centre, double blind, placebo controlled, prospective study to assess safety and efficacy of orally administered killed whole cell nontypeable Haemophilus influenzae (NTHi) HI-1-164 in preventing episodes of acute bronchitis in patients with moderate to severe airway disease
Secondary ID [1] 242 0
Hunter Immunology Ltd Protocol HI-H002
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute bronchitis in moderate to severe airway disease 1038 0
Condition category
Condition code
Respiratory 1115 1115 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Subjects will be randomly allocated to active tablets each containing 45mg HI-1-164-AS (inactivated non-typeable Haemophilus influenzae). Study medication (2 tablets) will be taken on days 1,2,3, 29,30,31, 57, 58,59. The live phase of the study will be of 8 months duration (March-October).
Intervention code [1] 911 0
Prevention
Comparator / control treatment
Placebo tablets containing excipients only. Placebo (2 tablets) will be taken on days 1,2,3, 29,30,31, 57, 58,59. The live phase of the study will be of 8 months duration (March-October).
Control group
Placebo

Outcomes
Primary outcome [1] 1485 0
Number of episodes of acute bronchitis during the study
Timepoint [1] 1485 0
During the study
Primary outcome [2] 1486 0
Proportion of subjects experiencing an episode of acute bronchitis during the study
Timepoint [2] 1486 0
During the study
Primary outcome [3] 1487 0
The duration of episodes of acute bronchitis during the study
Timepoint [3] 1487 0
During the study
Primary outcome [4] 1488 0
The number of courses of antibiotics taken for treatment of acute episodes of bronchitis during the study
Timepoint [4] 1488 0
During the study
Secondary outcome [1] 2673 0
NTHi-specific antibody
Timepoint [1] 2673 0
At beginning and end of study
Secondary outcome [2] 2674 0
Pharyngeal colonisation with H. influenzae
Timepoint [2] 2674 0
Gargles collected at each of the monthly visits (7-9 visits depending on date of registration).
Secondary outcome [3] 2675 0
Presence of H. influenzae, M. catarrhalis, S. pneumoniae and Pseudomonas spp in sputum
Timepoint [3] 2675 0
Sputum collected at each of the monthly visits (7-9 visits depending on date of registration), and also at times of acute excerbations.
Secondary outcome [4] 2676 0
Severity of episodes of acute bronchitis. It was planned that the analysis of the severity of episodes of acute bronchitis was to be based on the respiratory questionnaires completed by the patients at the time of each episode. However, insufficient respiratory questionnaires were completed during the study to allow for analysis of the data collected. In accordance with recent draft guidance for industry for developing drugs for treatment of COPD issued by FDA in November 2007, assessment of modification or prevention of exacerbations of disease can include severity of exacerbations as a primary efficacy endpoint. This can be based on worsening in symptoms requiring changes in treatment or requiring urgent treatment or hospitalisation. On a post hoc basis, rates of hospitalisation, corticosteroid use and a review of the medications used to treat the episodes of acute bronchitis were all analysed as measures of severity of episodes.
Timepoint [4] 2676 0
Severity of episodes was measured at each of the monthly visits (7-9 visits depending on time of registration).
Secondary outcome [5] 7853 0
Safety parameters. This outcome was measured by biochemistry and haematology profiling on bloods collected at visits 1, 3 and final visit, and also via adverse event data collected by patient verbatim at each visit. Examples of adverse events include cough, hypertension, headache (these events were not related to investigational product).
Timepoint [5] 7853 0
Bloods for safety profiling were collected at visits 1, 3 and final visit; adverse event data was collected at every visit.

Eligibility
Key inclusion criteria
Moderate to severe airway disease (FEV1 less than or equal to 50% of predicted value); at least two episodes of acute bronchitis in each of the past two years; no medical or social reason for being unable to comply with study requirements; willingness and availability to give informed consent.
Minimum age
18 Years
Maximum age
Not stated
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Known current infection (except bronchitis); taking of antibiotics within 4 weeks prior to visit 1; participation in a clinical trial of any vaccine or immune stimulating product (except probiotics) in the past 12 months (unless known to have received placebo treatment only); participation in a clinical trial apart from that described above, in the past 3 months); pregnant, breast-feeding, or women with child-bearing potential without an effective form of contraception; any significant medical disorder which would preclude evaluation of the patient's condition (except COPD); any subject likely to withdraw or not comply with the study protocol; any other medical reason for which the investigator feels a patient should not be included.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Interested persons were provided with an Information Statement and Consent Form to read. An appointment was then made for the first visit where an informed consent discussion occurred and consent was obtained. Participants were allocated a Subject number & Randomisation number. The randomisation code was held in a sealed envelope at each study site - only randomisation code envelopes specific to that site was forwarded to the site.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation code was generated using MS Excel. Restriction method: block randomisation, issued in blocks of six to ensure equal distribution between groups if maximum number of participants were recruited.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 1043 0
2300
Recruitment postcode(s) [2] 200 0
6009

Funding & Sponsors
Funding source category [1] 1219 0
Commercial sector/Industry
Name [1] 1219 0
Hunter Immunology Ltd
Address [1] 1219 0
Suite 209-210, 18 Rodborough Road,
Frenchs Forest NSW 2086
Country [1] 1219 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Hunter Immunology Ltd
Address
Suite 209-210, 18 Rodborough Road,
Frenchs Forest NSW 2086
Country
Australia
Secondary sponsor category [1] 1077 0
None
Name [1] 1077 0
None
Address [1] 1077 0
Country [1] 1077 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2552 0
Hollywood Private Hospital
Ethics committee address [1] 2552 0
Monash Avenue,
Nedlands, Western Australia
Ethics committee country [1] 2552 0
Australia
Date submitted for ethics approval [1] 2552 0
01/11/2005
Approval date [1] 2552 0
22/12/2005
Ethics approval number [1] 2552 0
HPH206

Summary
Brief summary
This aim of this study is to determine whether an oral vaccine against non-typeable Haemophilus influenzae will reduce the number of episodes of acute bronchitis experienced by people with moderate to severe airway disease
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35793 0
Address 35793 0
Country 35793 0
Phone 35793 0
Fax 35793 0
Email 35793 0
Contact person for public queries
Name 10100 0
Emeritus Professor Robert Clancy
Address 10100 0
Hunter Immnology Ltd,
David Maddison Building Level 4,
Cnr King and Watt Sts,
Newcastle NSW 2300
Country 10100 0
Australia
Phone 10100 0
+61 2 4913 8135
Fax 10100 0
+61 2 4913 8998
Email 10100 0
Robert.Clancy@newcastle.edu.au
Contact person for scientific queries
Name 1028 0
Emeritus Professor Robert Clancy
Address 1028 0
Hunter Immnology Ltd,
David Maddison Building Level 4,
Cnr King and Watt Sts,
Newcastle NSW 2300
Country 1028 0
Australia
Phone 1028 0
+61 2 4913 8135
Fax 1028 0
+61 2 4913 8998
Email 1028 0
Robert.Clancy@newcastle.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary