Impact of the 23-valent pneumococcal polysaccharide vaccination in pregnancy against infant acute lower respiratory infections in the Northern Territory of Australia

Michael J Binks, Sarah A Moberley, Anne Balloch, Amanda J Leach, Sandra Nelson, Kim M Hare, Cate Wilson, Jane Nelson, Peter S Morris, Robert S Ware, Mimi L K Tang, Paul J Torzillo, Jonathan R Carapetis, Kim Mulholland, Ross M Andrews, Michael J Binks, Sarah A Moberley, Anne Balloch, Amanda J Leach, Sandra Nelson, Kim M Hare, Cate Wilson, Jane Nelson, Peter S Morris, Robert S Ware, Mimi L K Tang, Paul J Torzillo, Jonathan R Carapetis, Kim Mulholland, Ross M Andrews

Abstract

Background: Indigenous children in Australia's Northern Territory are densely colonised with the pneumococcus within weeks of birth antecedent to a high prevalence of acute lower respiratory infection (ALRI). We assessed the impact of the 23-valent pneumococcal polysaccharide vaccine (23vPPV) in pregnancy against infant ALRI in this setting.

Methods: In an open label, allocation concealed, outcome-assessor blinded, randomised controlled trial conducted in the Northern Territory of Australia, healthy Indigenous women aged 17-39 years were randomised to receive the 23vPPV during pregnancy (n = 75; 30-36 weeks gestation), at birth (n = 75), or at 7 months post-partum (n = 77). Randomisation was stratified by community of residence. In a secondary analysis, we compared the incidence of ALRI hospitalisations and ALRI clinic presentations (ascertained from electronic medical records) among infants of pregnancy vaccinees versus infants of mothers not vaccinated in pregnancy (controls) in the first year of life.

Results: ALRI hospitalisation incidence was 12.3 per 100 child-years among infants of pregnancy vaccinees compared with 15.8 per 100 child-years among controls (hazard ratio (HR) 0.77, 95%CI 0.29-2.03). ALRI hospitalisations were more common among remote compared to urban infants (27.7 versus 8.6 per 100 child-years). Stratification by dwelling highlighted a differential antenatal vaccine effect against ALRI hospitalisations (urban HR 2.45, 95%CI 0.60-9.99; remote HR 0.21, 95%CI 0.04-1.08). ALRI clinic presentation incidence was similar among infants of pregnancy vaccinees and controls.

Conclusions: In this small study, antenatal 23vPPV vaccination was not associated with a reduced incidence of infant ALRI hospitalisations or ALRI clinic presentations during the first year of life. A potential differential effect between urban and remote settings warrants further investigation.

Trial registration: PneuMum; ClinicalTrials.gov NCT00714064.

Keywords: 23-valent pneumococcal polysaccharide vaccine; Acute lower respiratory infection; Australia; Indigenous; Pregnancy.

Conflict of interest statement

The study was approved by the Human Research Ethics Committee of the Northern Territory Department of Health and Menzies School of Health Research (HREC 05/52). Written consent was obtained for access to each child’s medical records to complete all of the described outcomes of the study including publication of non-identifiable data.No individually identifiable data were included in this publication.AJL has received research and conference support from GlaxoSmithKline (GSK) and Pfizer. PSM and EKM have received research funding from GSK. EKM has served on Advisory Boards for GSK and Pfizer. Other authors declare no competing interests.Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Study participant flow diagram. Hospital records were investigated for all 225 infants born during the study. Clinic presentations were investigated among the 70 infants from remote communities for whom electronic medical records were available
Fig. 2
Fig. 2
Time to first ALRI episodes. Cumulative proportion of first hospitalisations between birth and 12 months of age for infants of pregnancy vaccinees (dashes) compared to controls (solid lines). Any and ALRI hospitalisation (A1; overall) (A2; by dwelling). Any and ALRI clinic presentations (B; data available for the 70 remote participants only). The logrank test was used to indicate the equality of the Kaplan-Meier failure functions

References

    1. Binks MJ, Moberley SA, Balloch A, Leach AJ, Nelson S, Hare KM, et al. PneuMum: impact from a randomised controlled trial of maternal 23-valent pneumococcal polysaccharide vaccination on middle ear disease amongst indigenous infants, Northern Territory. Australia Vaccine. 2015;33:6579–6587. doi: 10.1016/j.vaccine.2015.10.101.
    1. Stubbs E, Hare K, Wilson C, Morris P, Leach AJ. Streptococcus pneumoniae and noncapsular Haemophilus influenzae nasal carriage and hand contamination in children: a comparison of two populations at risk of otitis media. Pediatr Infect Dis J. 2005;24:423–428. doi: 10.1097/.
    1. O'Grady KA, Torzillo PJ, Chang AB. Hospitalisation of indigenous children in the Northern Territory for lower respiratory illness in the first year of life. Med J Aust. 2010;192:586–590.
    1. Kearns T, Clucas D, Connors C, Currie BJ, Carapetis JR, Andrews RM. Clinic attendances during the first 12 months of life for aboriginal children in five remote communities of northern Australia. PLoS One. 2013;8:e58231. doi: 10.1371/journal.pone.0058231.
    1. O'Grady KA, Taylor-Thomson DM, Chang AB, Torzillo PJ, Morris PS, Mackenzie GA, et al. Rates of radiologically confirmed pneumonia as defined by the World Health Organization in Northern Territory indigenous children. Med J Aust. 2010;192:592–595.
    1. Leach AJ, Boswell JB, Asche V, Nienhuys TG, Mathews JD. Bacterial colonization of the nasopharynx predicts very early onset and persistence of otitis media in Australian aboriginal infants. Pediatr Infect Dis J. 1994;13:983–989. doi: 10.1097/00006454-199411000-00009.
    1. Leach AJ, Wigger C, Beissbarth J, Woltring D, Andrews R, Chatfield MD, et al. General health, otitis media, nasopharyngeal carriage and middle ear microbiology in Northern Territory aboriginal children vaccinated during consecutive periods of 10-valent or 13-valent pneumococcal conjugate vaccines. Int J Pediatr Otorhinolaryngol. 2016;86:224–232. doi: 10.1016/j.ijporl.2016.05.011.
    1. Hare KM, Grimwood K, Leach AJ, Smith-Vaughan H, Torzillo PJ, Morris PS, et al. Respiratory Bacterial Pathogens in the Nasopharynx and Lower Airways of Australian Indigenous Children with Bronchiectasis. J Pediatr. 2010.
    1. Omer SB, Clark DR, Aqil AR, Tapia MD, Nunes MC, Kozuki N, et al. Maternal influenza immunization and prevention of severe clinical pneumonia in young infants: analysis of randomized controlled trials conducted in Nepal, Mali and South Africa. Pediatr Infect Dis J. 2018;37:436–440. doi: 10.1097/INF.0000000000001914.
    1. Riley ID, Tarr PI, Andrews M, Pfeiffer M, Howard R, Challands P, et al. Immunisation with a polyvalent pneumococcal vaccine. Reduction of adult respiratory mortality in a New Guinea highlands community. Lancet. 1977;1:1338–1341. doi: 10.1016/S0140-6736(77)92552-1.
    1. O'Dempsey TJ, McArdle T, Ceesay SJ, Banya WA, Demba E, Secka O, et al. Immunization with a pneumococcal capsular polysaccharide vaccine during pregnancy. Vaccine. 1996;14:963–970. doi: 10.1016/0264-410X(96)00009-6.
    1. Lopes CR, Berezin EN, Ching TH, Canuto Jde S, Costa VO, Klering EM. Ineffectiveness for infants of immunization of mothers with pneumococcal capsular polysaccharide vaccine during pregnancy. Braz J Infect Dis. 2009;13:104–106. doi: 10.1590/S1413-86702009000200006.
    1. Chaithongwongwatthana S, Yamasmit W, Limpongsanurak S, Lumbiganon P, DeSimone JA, Baxter JK, et al. Pneumococcal vaccination during pregnancy for preventing infant infection. Cochrane Database Syst Rev. 2012;7:CD004903.
    1. Binks MJ, Moberley SA, Balloch A, Leach AJ, Nelson S, Hare KM, et al. The PneuMum Trial Protocol: . Menzies School of Health Research. 2010 (last update).
    1. National Centre for Classification in Health. The International Statistical Classification of Diseases and Related Health Problems, 10th Revision, Australian Modification (ICD-10-AM), 6th edition. National Centre for Classification in Health, Faculty of Health Sciences, The University of Sydney. 2009.
    1. Valery PC, Morris PS, Byrnes CA, Grimwood K, Torzillo PJ, Bauert PA, et al. Long-term azithromycin for indigenous children with non-cystic-fibrosis bronchiectasis or chronic suppurative lung disease (bronchiectasis intervention study): a multicentre, double-blind, randomised controlled trial. Lancet Respir Med. 2013;1:610–620. doi: 10.1016/S2213-2600(13)70185-1.
    1. Binks MJ, Cheng AC, Smith-Vaughan H, Sloots T, Nissen M, Whiley D, et al. Viral-bacterial co-infection in Australian indigenous children with acute otitis media. BMC Infect Dis. 2011;11:161. doi: 10.1186/1471-2334-11-161.
    1. Dunbar M, Moberley S, Nelson S, Leach AJ, Andrews R. Clear not simple: an approach to community consultation for a maternal pneumococcal vaccine trial among indigenous women in the Northern Territory of Australia. Vaccine. 2007;25:2385–2388. doi: 10.1016/j.vaccine.2006.09.005.
    1. Lehmann D, Pomat WS, Combs B, Dyke T, Alpers MP. Maternal immunization with pneumococcal polysaccharide vaccine in the highlands of Papua New Guinea. Vaccine. 2002;20:1837–1845. doi: 10.1016/S0264-410X(02)00040-3.
    1. Munoz FM, Englund JA, Cheesman CC, Maccato ML, Pinell PM, Nahm MH, et al. Maternal immunization with pneumococcal polysaccharide vaccine in the third trimester of gestation. Vaccine. 2001;20:826–837. doi: 10.1016/S0264-410X(01)00397-8.
    1. Krause V, Cook H. Downs and ups of invasive pneumococcal disease (IPD) amid vaccine introductions in the Indigenous population of the Northern Territory (NT), Australia. 8th International Symposium on Pneumococci and Pneumococcal Diseases. Iguacu Falls, Brazil2012.

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