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.
Original language | English |
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Article number | 282 |
Pages (from-to) | 1-11 |
Number of pages | 11 |
Journal | Trials |
Volume | 14 |
DOIs |
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Publication status | Published - 5 Sept 2013 |