CompletedPhase 2ACTRN12606000076572

An oral killed non-typeable Haemophilus influenzae vaccine for preventing episodes of acute bronchitis in patients with mild to moderate airways disease: Safety and efficacy study

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 mild to moderate airway disease


Sponsor

Hunter Immunology Ltd

Enrollment

124 participants

Start Date

Mar 7, 2006

Study Type

Interventional

Conditions

Summary

The 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 mild to moderate airway disease.


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Inclusion Criteria1

  • Mild to moderate airway disease (FEV1 greater than 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 the study requirements; willingness and availability to give informed consent.

Exclusion Criteria1

  • Known current chronic 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.

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Interventions

Subjects will be randomly allocated to treatment group: active tablets containing 45mg HI-1-164-AS (inactivated non-typeable Haemophilus influenzae),

Subjects will be randomly allocated to treatment group: active tablets 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).


Locations(1)

Australia

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ACTRN12606000076572