Charles Darwin University

CDU eSpace
Institutional Repository

 
CDU Staff and Student only
 

Does a 10-valent pneumococcal-Haemophilus influenzae protein D conjugate vaccine prevent respiratory exacerbations in children with recurrent protracted bacterial bronchitis, chronic suppurative lung disease and bronchiectasis: protocol for a randomised c

O'Grady, Kerry-Ann F., Grimwood, Keith, Cripps, Allan, Mulholland, E. Kim, Morris, Peter S., Torzillo, Paul J., Wood, Nicholas A., Smith-Vaughan, Heidi C., Revell, Amber, Wilson, Andrew, van Asperen, Peter, Richmond, Peter, Thornton, Ruth, Rablin, Sheree and Chang, Anne B. (2013). Does a 10-valent pneumococcal-Haemophilus influenzae protein D conjugate vaccine prevent respiratory exacerbations in children with recurrent protracted bacterial bronchitis, chronic suppurative lung disease and bronchiectasis: protocol for a randomised controlled trial. Trials,14(282):1-11.

Document type: Journal Article
Citation counts: Altmetric Score Altmetric Score is 1
Google Scholar Search Google Scholar
Attached Files (Some files may be inaccessible until you login with your CDU eSpace credentials)
Name Description MIMEType Size Downloads
Download this reading Mulholland_40744.pdf Published version application/pdf 568.92KB 47
Reading the attached file works best in Firefox, Chrome and IE 9 or later.

ARC Grant No. 545216
IRMA ID bsmithxPUB208
NHMRC Grant No. 1019904
1045157
1024175
Title Does a 10-valent pneumococcal-Haemophilus influenzae protein D conjugate vaccine prevent respiratory exacerbations in children with recurrent protracted bacterial bronchitis, chronic suppurative lung disease and bronchiectasis: protocol for a randomised controlled trial
Author O'Grady, Kerry-Ann F.
Grimwood, Keith
Cripps, Allan
Mulholland, E. Kim
Morris, Peter S.
Torzillo, Paul J.
Wood, Nicholas A.
Smith-Vaughan, Heidi C.
Revell, Amber
Wilson, Andrew
van Asperen, Peter
Richmond, Peter
Thornton, Ruth
Rablin, Sheree
Chang, Anne B.
Journal Name Trials
Publication Date 2013
Volume Number 14
Issue Number 282
eISSN 1745-6215
Scopus ID 2-s2.0-84883800016
Start Page 1
End Page 11
Total Pages 11
Place of Publication United Kingdom
Publisher BioMed Central Ltd.
HERDC Category C2 - Journal Article - Other contributions to refereed journal (internal)
Abstract Background
Recurrent protracted bacterial bronchitis (PBB), chronic suppurative lung disease (CSLD) and bronchiectasis are characterised by a chronic wet cough and are important causes of childhood respiratory morbidity globally. Haemophilus influenzae and Streptococcus pneumoniae are the most commonly associated pathogens. As respiratory exacerbations impair quality of life and may be associated with disease progression, we will determine if the novel 10-valent pneumococcal-Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) reduces exacerbations in these children.

Methods
A multi-centre, parallel group, double-blind, randomised controlled trial in tertiary paediatric centres from three Australian cities is planned. Two hundred six children aged 18 months to 14 years with recurrent PBB, CSLD or bronchiectasis will be randomised to receive either two doses of PHiD-CV or control meningococcal (ACYW135) conjugate vaccine 2 months apart and followed for 12 months after the second vaccine dose. Randomisation will be stratified by site, age (<6 years and ≥6 years) and aetiology (recurrent PBB or CSLD/bronchiectasis). Clinical histories, respiratory status (including spirometry in children aged ≥6 years), nasopharyngeal and saliva swabs, and serum will be collected at baseline and at 2, 3, 8 and 14 months post-enrolment. Local and systemic reactions will be recorded on daily diaries for 7 and 30 days, respectively, following each vaccine dose and serious adverse events monitored throughout the trial. Fortnightly, parental contact will help record respiratory exacerbations. The primary outcome is the incidence of respiratory exacerbations in the 12 months following the second vaccine dose. Secondary outcomes include: nasopharyngeal carriage of H. influenzae and S. pneumoniae vaccine and vaccine- related serotypes; systemic and mucosal immune responses to H. influenzae proteins and S. pneumoniae vaccine and vaccine-related serotypes; impact upon lung function in children aged ≥6 years; and vaccine safety.

Discussion
As H. influenzae is the most common bacterial pathogen associated with these chronic respiratory diseases in children, a novel pneumococcal conjugate vaccine that also impacts upon H. influenzae and helps prevent respiratory exacerbations would assist clinical management with potential short- and long-term health benefits. Our study will be the first to assess vaccine efficacy targeting H. influenzae in children with recurrent PBB, CSLD and bronchiectasis.
Keywords Bronchiectasis
Child
Chronic suppurative lung disease
Non-typeable Haemophilus influenzae
Pneumococcal conjugate vaccines
Protracted bacterial bronchitis
Randomised controlled trial
Respiratory exacerbations
Streptococcus pneumoniae
DOI http://dx.doi.org/10.1186/1745-6215-14-282   (check subscription with CDU E-Gateway service for CDU Staff and Students  check subscription with CDU E-Gateway in new window)
Additional Notes This is an Open Access article distributed under the terms of the Creative Commons Attribution License 2.0, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
Description for Link Link to CC Attribution 2.0 License
URL https://creativecommons.org/licenses/by/2.0/au/legalcode


© copyright

Every reasonable effort has been made to ensure that permission has been obtained for items included in CDU eSpace. If you believe that your rights have been infringed by this repository, please contact digitisation@cdu.edu.au.

 
Versions
Version Filter Type
Access Statistics: 63 Abstract Views, 47 File Downloads  -  Detailed Statistics
Created: Thu, 07 Aug 2014, 17:24:45 CST