PneuMum: Impact from a randomised controlled trial of maternal 23-valent pneumococcal polysaccharide vaccination on middle ear disease amongst Indigenous infants, Northern Territory, Australia

Binks, Michael J.; Moberley, Sarah; Balloch, Anne; Leach, Amanda J.; Nelson, Sandra; Hare, Kim M.; Wilson, Cate; Morris, Peter S.; Nelson, Jane; Chatfield, Mark D.; Tang, Mimi L.K.; Torzillo, Paul J.; Carapetis, Jonathan R.; Mulholland, E. Kim; Andrews, Ross M.

doi:10.1016/j.vaccine.2015.10.101

Cited by 28 publications

(48 citation statements)

References 20 publications

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“…Finally, an association has also been demonstrated, in indigenous Australian infants, between the nasopharyngeal pneumococcal carriage and the occurrence of chronic suppurative ear infections [10]; a condition which is also reported with variable prevalence in sub-Saharan Africa and South and East Asia [15]. Once established, as early as the first two or three months of life in this indigenous infant population, the infection is associated with prolonged morbidity, including educational disadvantage, throughout childhood [10,16,17]. Of note, there are currently limited data on the overall burden of disease from countries such as China and India which have large populations under five years of age; much less on the burden of disease in early infancy in these countries.…”

Section: Pneumococcal Carriage and Disease In Early Infancymentioning

confidence: 85%

“…The vaccine efficacy against this exploratory, derived endpoint was 51% (-2% to 76%) in the maternal vaccination group. In contrast, there was no evidence of comparable efficacy when looking at the association between ear disease and carriage of other pneumococcal serotypes or other bacteria (non-typeable Haemophilus influenzae or Moraxella catarrhalis) suggesting a genuine, albeit only borderline significant result [16].…”

Section: Maternal Vaccinationmentioning

confidence: 86%

“…In each case, the level of polysaccharide-specific IgA was higher in the breast milk in vaccinated compared to control mothers. Levels returned towards baseline by around six months in each case although with some variation in the exact time of sampling [16,43,47,50]. Given the primary site of pneumococcal colonization in the nasopharynx, antibodies delivered in this way may reasonably be expected to provide local protection although there are no data to examine this directly.…”

Section: Maternal Vaccinationmentioning

confidence: 99%

“…Finally, the PneuMum trial group has recently reported the results of a randomized controlled trial examining the impact of maternal 23-valent pneumococcal polysaccharide vaccination on middle ear disease amongst indigenous infants in the Northern Territory of Australia [16]. The trial enrolled a total of 227 eligible women who were randomized, in equal number into one of three groups.…”

Section: Maternal Vaccinationmentioning

confidence: 99%

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Maternal and neonatal pneumococcal vaccination - where are we now?

Clarke

Kampmann

2016

Expert Review of Vaccines

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Pneumococcus is a significant pathogen in neonates and in early infancy, particularly as a cause of invasive disease in sub-Saharan Africa where nasopharyngeal carriage rates are also exceptionally high. The pneumococcal-conjugate vaccines have now been rolled out in many high income settings and an increasing number of low and middle income countries. They have been highly effective at preventing vaccine serotype disease in infants. However, a window of susceptibility remains prior to the first vaccination at around six weeks of age. This paper summarizes the data available on both maternal and neonatal vaccination to prevent disease in newborns and early infancy and considers the key challenges and next steps for research in the field

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Section: Pneumococcal Carriage and Disease In Early Infancymentioning

confidence: 85%

Section: Maternal Vaccinationmentioning

confidence: 86%

Section: Maternal Vaccinationmentioning

confidence: 99%

Section: Maternal Vaccinationmentioning

confidence: 99%

See 2 more Smart Citations

Maternal and neonatal pneumococcal vaccination - where are we now?

Clarke

Kampmann

2016

Expert Review of Vaccines

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“…Aboriginal mother–infant pairs were recruited from urban and remote communities in the NT of Australia between August 2006 and January 2011. Inclusion criteria, eligibility and randomisation methods have been published . Participants were excluded if they had received 23vPPV within the previous three years, intended to leave the study area during the follow‐up period, were carrying a multiparous pregnancy, had a known congenital anomaly or were considered high risk (described in Appendix ).…”

Section: Methodsmentioning

confidence: 99%

Birth outcomes in Aboriginal mother–infant pairs from the Northern Territory, Australia, who received 23‐valent polysaccharide pneumococcal vaccination during pregnancy, 2006–2011: The PneuMum randomised controlled trial

McHugh

Binks

Ware

et al. 2019

Aust NZ J Obst Gynaeco

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Background Pregnant women and infants <6 months old have a high baseline risk for pneumococcal disease compared to the general population, particularly among Indigenous populations living in poverty and low‐resource settings. Efficacy trials of pneumococcal vaccination in pregnancy examining adverse birth outcomes are lacking. Aims We report adverse birth events as secondary outcomes from the ‘PneuMum’ randomised controlled trial of 23‐valent pneumococcal polysaccharide vaccination (23vPPV) in pregnancy (August 2006–January 2011). Materials and methods Australian Aboriginal women aged 17–39 years with singleton uncomplicated pregnancies were randomised (1:2 ratio) to receive 23vPPV or no 23vPPV in pregnancy at 30–36 weeks gestation. We compared risks of stillbirth, preterm birth, low birthweight (LBW), and small for gestational age (SGA) between vaccinated and unvaccinated pregnant women. Cox proportional hazard ratios (HRs) were calculated on an intention‐to‐treat basis. Results Among 227 enrolled participants, 75 (33%) received 23vPPV in pregnancy. Risk differences in adverse birth outcomes between 23vPPV vaccinated and unvaccinated pregnant women were; preterm birth 9% vs 4% (HR 2.79; 95% CI 0.94–8.32) P = 0.07; LBW 9% vs 5% (HR 2.09; 95% CI 0.76–5.78) P = 0.15; and SGA 15% vs 17% (HR 1.02; 95% CI 0.50–2.06) P = 0.96. There were no stillbirths. Conclusions We found a numerically higher rate of preterm births among women who received 23vPPV in pregnancy compared to unvaccinated pregnant women. Although further investigation with larger participant numbers is needed to better evaluate this safety signal, the contribution of safety results from smaller studies using appropriate data analysis methodologies is critical, particularly as more clinical trials in pneumococcal vaccination in pregnancy are progressing.

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Transplacental transfer of RSV antibody in Australian First Nations infants

Homaira

Binks

Walker

et al. 2021

Journal of Medical Virology

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Respiratory syncytial virus (RSV) is the leading cause of acute lower respiratory infection hospitalisations in Aboriginal infants specifically those aged <6 months.Maternally derived RSV antibody (Ab) can protect against severe RSV disease in infancy. However, the efficiency of transplacental transfer of maternal anti-RSV Ab remains unknown in Aboriginal infants. We characterised RSV Ab in Australian First Nations mother-infant pairs (n = 78). We investigated impact of covariates including low birthweight, gestational age (GA), sex of the baby, maternal age and multiparity of the mother on cord to maternal anti-RSV Ab titre ratio (CMTR) using multivariable logistic regression model. All (n = 78) but one infant was born full term (median GA: 39 weeks, interquartile range: 38-40 weeks) and 56% were males. The mean log 2 RSV Ab titre was 10.7 (SD± 1.3) in maternal serum and 11.0 (SD ± 1.3) in cord serum at birth; a ratio of 1.02 (SD ± 0.06). One-third of the pairs had a CMTR of <1 indicating impaired transfer. Almost 9% (7/78) of the term infants had cord RSV Ab

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PneuMum: Impact from a randomised controlled trial of maternal 23-valent pneumococcal polysaccharide vaccination on middle ear disease amongst Indigenous infants, Northern Territory, Australia

Cited by 28 publications

References 20 publications

Maternal and neonatal pneumococcal vaccination - where are we now?

Maternal and neonatal pneumococcal vaccination - where are we now?

Birth outcomes in Aboriginal mother–infant pairs from the Northern Territory, Australia, who received 23‐valent polysaccharide pneumococcal vaccination during pregnancy, 2006–2011: The PneuMum randomised controlled trial

Transplacental transfer of RSV antibody in Australian First Nations infants

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