Please use this identifier to cite or link to this item:
https://hdl.handle.net/2440/134504
Citations | ||
Scopus | Web of Science® | Altmetric |
---|---|---|
?
|
?
|
Type: | Journal article |
Title: | Study protocol for preventing early-onset pneumonia in young children through maternal immunisation: a multi-centre randomised controlled trial (PneuMatters) |
Author: | Chang, A.B. Toombs, M. Chatfield, M.D. Mitchell, R. Fong, S.M. Binks, M.J. Smith-Vaughan, H. Pizzutto, S.J. Lust, K. Morris, P.S. Marchant, J.M. Yerkovich, S.T. O'Farrell, H. Torzillo, P.J. Maclennan, C. Simon, D. Unger, H.W. Ellepola, H. Odendahl, J. Marshall, H.S. et al. |
Citation: | Frontiers in Pediatrics, 2022; 9:781168-1-781168-12 |
Publisher: | Frontiers Media |
Issue Date: | 2022 |
ISSN: | 2296-2360 2296-2360 |
Statement of Responsibility: | Anne B. Chang, Maree Toombs, Mark D. Chatfield, Remai Mitchell, Siew M. Fong, Michael J. Binks ... at al. |
Abstract: | Background: Preventing and/or reducing acute lower respiratory infections (ALRIs) in young children will lead to substantial short and long-term clinical benefits. While immunisation with pneumococcal conjugate vaccines (PCV) reduces paediatric ALRIs, its efficacy for reducing infant ALRIs following maternal immunisation has not been studied. Compared to other PCVs, the 10-valent pneumococcal-<i>Haemophilus influenzae</i> Protein D conjugate vaccine (PHiD-CV) is unique as it includes target antigens from two common lower airway pathogens, pneumococcal capsular polysaccharides and protein D, which is a conserved <i>H. influenzae</i> outer membrane lipoprotein. Aims: The primary aim of this randomised controlled trial (RCT) is to determine whether vaccinating pregnant women with PHiD-CV (compared to controls) reduces ALRIs in their infants' first year of life. Our secondary aims are to evaluate the impact of maternal PHiD-CV vaccination on different ALRI definitions and, in a subgroup, the infants' nasopharyngeal carriage of pneumococci and <i>H. influenzae</i>, and their immune responses to pneumococcal vaccine type serotypes and protein D. Methods: We are undertaking a parallel, multicentre, superiority RCT (1:1 allocation) at four sites across two countries (Australia, Malaysia). Healthy pregnant Australian First Nation or Malaysian women aged 17-40 years with singleton pregnancies between 27<sup>+6</sup> and 34<sup>+6</sup> weeks gestation are randomly assigned to receive either a single dose of PHiD-CV or usual care. Treatment allocation is concealed. Study outcome assessors are blinded to treatment arms. Our primary outcome is the rate of medically attended ALRIs by 12-months of age. Blood and nasopharyngeal swabs are collected from infants at birth, and at ages 6- and 12-months (in a subset). Our planned sample size (<i>n</i> = 292) provides 88% power (includes 10% anticipated loss to follow-up). Discussion: Results from this RCT potentially leads to prevention of early and recurrent ALRIs and thus preservation of lung health during the infant's vulnerable period when lung growth is maximum. The multicentre nature of our study increases the generalisability of its future findings and is complemented by assessing the microbiological and immunological outcomes in a subset of infants. Clinical Trial Registration: https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=374381, identifier: ACTRN12618000150246. |
Keywords: | children maternal immunisation pneumonia protocol randomised controlled trial |
Rights: | © 2022 Chang, Toombs, Chatfield,Mitchell, Fong, Binks, Smith-Vaughan, Pizzutto, Lust,Morris,Marchant, Yerkovich, O’Farrell, Torzillo,Maclennan, Simon, Unger, Ellepola, Odendahl, Marshall, Swamy and Grimwood. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms. |
DOI: | 10.3389/fped.2021.781168 |
Grant ID: | http://purl.org/au-research/grants/nhmrc/1138555 http://purl.org/au-research/grants/nhmrc/1170958 http://purl.org/au-research/grants/nhmrc/1154302 http://purl.org/au-research/grants/nhmrc/1155066 |
Published version: | http://dx.doi.org/10.3389/fped.2021.781168 |
Appears in Collections: | Obstetrics and Gynaecology publications |
Files in This Item:
File | Description | Size | Format | |
---|---|---|---|---|
hdl_134504.pdf | Published version | 501.41 kB | Adobe PDF | View/Open |
Items in DSpace are protected by copyright, with all rights reserved, unless otherwise indicated.