Files and links (1)
Published VersionCC BY V4.0, Open Access
Journal article
10-Valent pneumococcal non-typeable H. influenzae protein D conjugate vaccine (PHiD-CV10) versus 13-valent pneumococcal conjugate vaccine (PCV13) as a booster dose to broaden and strengthen protection from otitis media (PREVIX_BOOST) in Australian Aboriginal children: study protocol for a randomised controlled trial
BMJ open, Vol.10(5), pp.1-11
2020
PMID: 32448790
Abstract
Introduction:
Streptococcus pneumoniae and non-typeable Haemophilus influenzae (NTHi) are major otitis media pathogens that densely co-colonise the nasopharynx and infect the middle ear of Australian Aboriginal infants from very early in life. Our co-primary hypotheses are that at 18 months of age infants receiving 10-valent pneumococcal Haemophilus influenzae protein D conjugate vaccine (PHiD-CV10) compared with those receiving 13-valent pneumococcal conjugate vaccine (PCV13) as a booster at 12 months of age will have higher antibody levels to Haemophilus influenzae protein D and that infants receiving PCV13 will have higher antibody levels to PCV13-only serotypes 3, 6A and 19A.
Methods and analyses:
Our randomised controlled trial will enrol 270 Aboriginal children at 12 months of age to a booster dose of either PHiD-CV10 or PCV13. Children who completed the three-dose primary course schedules of PHiD-CV10 at 2, 4, 6 months of age; PCV13 at 2, 4, 6 months of age; or a combination schedule of PHiD-CV10 at 1, 2, 4 months of age plus PCV13 at 6 months of age are eligible. The co-primary assessor-blinded outcomes when the infants are 18 months of age are as follows: (a) IgG geometric mean concentration (GMC) and proportion with IgG ≥100 EU/mL for protein D, and (b) IgG GMC and the proportion with IgG ≥0.35 µg/mL for pneumococcal serotypes 3, 6A and 19A. Secondary immunogenicity comparisons of six primary and booster dose schedules of 10 shared serotypes at 18 months of age, nasopharyngeal carriage, all forms of otitis media, hearing loss and developmental milestones at 18, 24, 30 and 36 months of age will be reported.
Ethics and dissemination:
Ethics committees of NT Department of Health, Menzies, WA Department of Health and WA Aboriginal Health approved the study. Results will be presented to communities, at conferences and published in peer-reviewed journals.
Trial registration number:
NCT01735084.
Details
- Title
- 10-Valent pneumococcal non-typeable H. influenzae protein D conjugate vaccine (PHiD-CV10) versus 13-valent pneumococcal conjugate vaccine (PCV13) as a booster dose to broaden and strengthen protection from otitis media (PREVIX_BOOST) in Australian Aboriginal children: study protocol for a randomised controlled trial
- Authors
- Victor Oguoma (Author) - Menzies School of Health ResearchNicole Wilson (Author) - Menzies School of Health ResearchKim Mulholland (Author) - Murdoch Children's Research InstituteMathuram Santosham (Author) - Johns Hopkins UniversityPaul J. Torzillo (Author) - Royal Prince Alfred HospitalPeter B McIntyre (Author) - National Centre for Immunisation Research & SurveillanceHeidi C Smith-Vaughan (Author) - Charles Darwin UniversityAnne Balloch (Author) - Murdoch Children's Research InstituteMark D Chatfield (Author) - The University of QueenslandDeborah Lehmann (Author) - The Kids Research Institute AustraliaMichael J. Binks (Author) - Charles Darwin UniversityAnne Chang (Author) - Charles Darwin UniversityJonathan Carapetis (Author) - The Kids Research Institute AustraliaVicki Krause (Author) - Northern Territory Health ServicesRoss Andrews (Author) - Charles Darwin UniversityTom Snelling (Author) - Princess Margaret Hospital for ChildrenPaul Licciardi (Author) - Murdoch Children's Research InstitutePeter Morris (Author) - Charles Darwin UniversityAmanda Jane Leach (Corresponding Author) - Menzies School of Health Research
- Publication details
- BMJ open, Vol.10(5), pp.1-11
- Publisher
- BMJ Group
- Date published
- 2020
- DOI
- 10.1136/bmjopen-2019-033511
- ISSN
- 2044-6055
- PMID
- 32448790
- Copyright note
- © Author(s) (or their employer(s)) Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. http://creativecommons.org/licenses/by-nc/4.0/ This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.
- Data Availability
- As previously described for the PREVIX_COMBO trial, this final trial dataset will be under the custody of the trial sponsor, the Menzies School of Health Research.
- Grants
- Organisation Unit
- Thompson Institute
- Language
- English
- Record Identifier
- 991121850802621
- Output Type
- Journal article
Metrics
13 Record Views
InCites Highlights
These are selected metrics from InCites Benchmarking & Analytics tool, related to this output
- Collaboration types
- Industry collaboration
- Domestic collaboration
- International collaboration
- Web Of Science research areas
- Immunology
UN Sustainable Development Goals (SDGs)
This output has contributed to the advancement of the following goals:
Source: InCites