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Valent Pneumococcal Conjugate Vaccine Open access Protocol BMJ Open: first published as 10.1136/bmjopen-2019-033511 on 24 May 2020. Downloaded from 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 Victor M Oguoma ,1 Nicole Wilson,1 Kim Mulholland,2 Mathuram Santosham,3 Paul Torzillo,4 Peter McIntyre,5 Heidi Smith- Vaughan,1 Anne Balloch,6 Mark Chatfield,7 Deborah Lehmann,8 Michael J Binks,1 Anne Chang,1 To cite: Oguoma VM, Wilson N, Jonathan Carapetis,9 Vicki Krause,10 Ross Andrews,1 Tom Snelling,11,12 Mulholland K, et al. 10- Valent 13,14 1 1 pneumococcal non- typeable H. Paul Licciardi, Peter Morris, Amanda Jane Leach influenzae protein D conjugate vaccine (PHiD- CV10) versus 13- valent pneumococcal conjugate vaccine (PCV13) as ABSTRACT a booster dose to broaden and Strengths and limitation of this study Introduction Streptococcus pneumoniae and non- strengthen protection from typeable Haemophilus influenzae (NTHi) are major http://bmjopen.bmj.com/ otitis media (PREVIX_BOOST) in ► This study addresses an important health and so- Australian Aboriginal children: otitis media pathogens that densely co- colonise the cial issue for Australian Aboriginal and Torres Strait study protocol for a randomised nasopharynx and infect the middle ear of Australian Islander children. controlled trial. Aboriginal infants from very early in life. Our co- BMJ Open ► This study is a randomised controlled trial of two 2020;10:e033511. doi:10.1136/ primary hypotheses are that at 18 months of age licensed pneumococcal conjugate vaccines (PCVs) bmjopen-2019-033511 infants receiving 10- valent pneumococcal Haemophilus given as a booster dose at 12 months of age to chil- ► Prepublication history for influenzae protein D conjugate vaccine (PHiD- CV10) dren who completed primary course schedules. this paper is available online. compared with those receiving 13- valent pneumococcal ► Primary outcomes at 18 months of age are accept- To view these files, please visit conjugate vaccine (PCV13) as a booster at 12 months ed global immunogenicity criteria for licensing and on September 25, 2021 by guest. Protected copyright. the journal online (http:// dx. doi. of age will have higher antibody levels to Haemophilus varying PCV schedules. org/ 10. 1136/ bmjopen- 2019- influenzae protein D and that infants receiving PCV13 ► Secondary outcomes include 6 monthly nasopha- 033511). will have higher antibody levels to PCV13- only serotypes ryngeal carriage, standardised assessments of Received 09 August 2019 3, 6A and 19A. middle ear status, hearing status, developmental Revised 06 March 2020 Methods and analyses Our randomised controlled trial milestones and rates of respiratory illness. Accepted 20 April 2020 will enrol 270 Aboriginal children at 12 months of age to ► Limitations of the study include limited power for a booster dose of either PHiD- CV10 or PCV13. Children secondary outcomes. who completed the three- dose primary course schedules © Author(s) (or their 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 employer(s)) 2020. Re- use carriage, all forms of otitis media, hearing loss and permitted under CC BY-NC. No at 1, 2, 4 months of age plus PCV13 at 6 months of age developmental milestones at 18, 24, 30 and 36 months of commercial re- use. See rights are eligible. The co- primary assessor- blinded outcomes age will be reported. and permissions. Published by when the infants are 18 months of age are as follows: (a) Ethics and dissemination Ethics committees of NT BMJ. IgG geometric mean concentration (GMC) and proportion Department of Health, Menzies, WA Department of Health For numbered affiliations see with IgG ≥100 EU/mL for protein D, and (b) IgG GMC and and WA Aboriginal Health approved the study. Results end of article. the proportion with IgG ≥0.35 µg/mL for pneumococcal will be presented to communities, at conferences and serotypes 3, 6A and 19A. Secondary immunogenicity Correspondence to published in peer-reviewed journals. comparisons of six primary and booster dose schedules of Professor Amanda Jane Leach; Trial registration number NCT01735084. amanda. leach@ menzies. edu. au 10 shared serotypes at 18 months of age, nasopharyngeal Oguoma VM, et al. BMJ Open 2020;10:e033511. doi:10.1136/bmjopen-2019-033511 1 Open access BMJ Open: first published as 10.1136/bmjopen-2019-033511 on 24 May 2020. Downloaded from INTRODUCTION These data provide a strong rationale for rigorous eval- Background and rationale uation of these vaccines (PHiD- CV10 vs PCV13) on Otitis media (OM) is one of the most common childhood outcomes during the second and third year of life. infectious diseases of children living in the Northern In the present study, eligible participants had been Territory (NT) of Australia with very high rates reported previously enrolled in a trial of pneumococcal conjugate in infancy.1 Our surveillance of OM in remote Australian vaccines PHiD- CV10 and PCV13 in sequence or alone trial Aboriginal communities shows high rates of disease from (PREVIX_COMBO).10 The trial compared three primary weeks after birth throughout early childhood, particularly course schedules of PHiD- CV10 at 2, 4, 6 months of age; tympanic membrane perforations (TMPs) in the second PCV13 at 2, 4, 6 months of age; or an investigational year of life.2 The mean age of any TMP was 18 months combination schedule of PHiD- CV10 at 1, 2, 4 months and that of acute otitis media with perforation (AOMwiP) of age plus PCV13 at 6 months. The NT childhood was 8 to <18 months and 21 months for chronic suppu- immunisation schedule recommended a booster dose at rative otitis media (CSOM). The impact of chronic OM 18 months of age. However, our surveillance suggested in early childhood on hearing loss, developmental mile- that the booster should perhaps be given earlier, prior stones, school readiness and academic performance of to peak incidence of pneumococcal infections at 18 NT Aboriginal children is not known. months of age. Our co-primar y study hypotheses are that The introduction of 7-valent pneumococcal conju- at 18 months of age (a) infants receiving PHiD-CV10 as gate vaccine (PCV7) in the NT in 2001 had high uptake a booster at 12 months of age will have higher protein D (>90%) during infancy3 and resulted in the near elimina- antibody levels compared with those receiving PCV13 as a tion of PCV7 types in both nasopharyngeal (NP) carriage booster and (b) infants receiving PCV13 as a booster at 12 and middle ear discharge (ED) among infants.4 However, months of age compared with those receiving PHiD- CV10 analysis of middle ED from cases of AOMwiP in recipi- as a booster will have higher antibody levels to serotypes ents of PCV7 showed that almost 60% of ED specimens 3, 6A and 19A. were associated with culture of non-typeable Haemophilus Our secondary study hypotheses focus on vaccine- influenzae (NTHi), while ~40% were culture-positive for related differences in additional immunogenicity Streptococcus pneumoniae (pneumococcus), including 3% outcomes at 18 months of age, and NP carriage, OM, having serotypes 3, 6A or 19A.5 6 Ten- valent pneumo- respiratory illness, hearing loss and developmental delay coccal Haemophilus influenzae protein D conjugate vaccine at 18, 24, 30 and 36 months of age. First, we hypothesise (PHiD- CV10) and 13- valent pneumococcal conjugate that infants receiving PHiD-CV10 compared with those vaccine (PCV13) were licensed in Australia for use in receiving PCV13 as a booster at 12 months of age will large- scale immunisation programmes in 2009 and 2011, have (i) superior immunogenicity at 18 months of age respectively. The NT was the only jurisdiction to include for common serotypes (1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F http://bmjopen.bmj.com/ PHiD- CV10 in the childhood immunisation schedule as and 23F). Second, at each time point 18, 24, 30 and 36 a 3+1 (2, 4, 6, +18 month) schedule for Aboriginal and months of age, infants receiving PHiD-CV10 compared Torres Strait Islander children from October 2009 to with those receiving PCV13 as a booster at 12 months of October 2011, when it was replaced by PCV13. PHiD- age will have (ii) less NP carriage of NTHi; (iii) more NP CV10 has protein D of NTHi (HiD) as the carrier for carriage of serotypes 3, 6A and 19A; (iv) less NP carriage some serotypes while PCV13 is conjugated to Cross- of common serotypes (1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F Reacting Material (CRM197)—a variant of diphtheria and 23F); (v) less NP carriage of vaccine-related or non- toxin, and has three additional serotypes (3, 6A and vaccine (replacement) serotypes; (vi) less OM; (vii) less on September 25, 2021 by guest. Protected copyright. 19A), but not protein D. Evidence of carrier protein D respiratory illness; (viii) less hearing loss and (ix) less having efficacy for AOM prevention was initially reported developmental delay. Finally, we hypothesise that infants from a single randomised control trial (RCT) in which receiving PHiD- CV10 compared with those receiving OM was a primary outcome. In that trial of an earlier PCV13 as a booster at 12 months of age will have (x) lower 11- valent formulation (11PnPD), there was ~55% efficacy rates of any AOM, any respiratory illness and antibiotic for culture- positive pneumococcal vaccine type AOM and prescription documented in medical records between 12 35% efficacy for NTHi AOM following a 3+1 schedule.7 and 36 months of age. This trial also demonstrated a 43% (95% CI: −17 to 72) reduction in the NP carriage of pneumococcal vaccine Explanation for choice of comparators serotypes and a 43% (95% CI: 1 to 67) reduction in the The WHO recommended the use of either PHiD-CV10 carriage of H.
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