Immunogenicity and safety of orally administered killed whole cell non-typeable Haemophilus influenzae (Study HI-H003)

A single centre, double blind, placebo controlled, prospective study to assess the immunogenicity and safety of orally administered killed whole cell non-typeable Haemophilus influenzae (NTHi) HI-1-164 in smokers at risk of recurrent bronchitis (Study HI-H003)

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12607000271404

Enrollment

Registered

2007-05-18

Start date

2005-07-25

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 study monitored safety and measured specific and non-specific immunological parameters in smokers, who are a group at risk of recurrent bronchitis. This group was chosen rather than healthy non-smoking volunteers for this safety/pharmacokinetic study as it was thought possible that the immune parameters may differ in smokers to that in healthy non-smokers. This safety and immunogenicity study has been completed. It was not registered prior to initiation due to our unawareness of the registration system at that time. As it is a Phase I study and is not required to be registered it is being registered for the purpose of public information as we are now aware that post-initiation registration is possible

Interventions

The test product was formalin-inactivated whole cell non-typeable Haemophilus influenzae formulated in enteric-coated tablets to be taken orally. Each tablet contained 45mg of active ingredient plus excipients. Three courses of tablets were taken by each participant at monthly intervals. Each course consisted of 2 tablets per day for three consecutive days. Thus treatment took place over a period of 60 days. Participants attended visits at 2-week intervals for 3 months.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Healthy volunteers

Yes

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.

Outcome results