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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12606000074594

Enrollment

124

Registered

2006-02-22

Start date

2006-03-07

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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

Interventions

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

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Prevention

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

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.

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.

Outcome results