Browsing by Author "Carapetis J."
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Item Evaluation of safety and immunogenicity of a group a streptococcus vaccine candidate (mj8vax) in a randomized clinical trial.(2018-07-10) Sekuloski S.; Batzloff M.R.; Griffin P.; Parsonage W.; Elliott S.; Hartas J.; O'Rourke P.; Marquart L.; Pandey M.; Rubin F.A.; Carapetis J.; McCarthy J.; Good M.F.Background Group A streptococcus (GAS) is a serious human pathogen that affects people of different ages and socio-economic levels. Although vaccination is potentially one of the most effective methods to control GAS infection and its sequelae, few prototype vaccines have been investigated in humans. In this study, we report the safety and immunogenicity of a novel acetylated peptide-protein conjugate vaccine candidate MJ8VAX (J8-DT), when delivered intramuscularly to healthy adults. Methods A randomized, double-blinded, controlled Phase I clinical trial was conducted in 10 healthy adult participants. Participants were randomized 4:1 to receive the vaccine candidate (N = 8) or placebo (N = 2). A single dose of the vaccine candidate (MJ8VAX), contained 50 mug of peptide conjugate (J8-DT) adsorbed onto aluminium hydroxide and re-suspended in PBS in a total volume of 0.5 mL. Safety of the vaccine candidate was assessed by monitoring local and systemic adverse reactions following intramuscular administration. The immunogenicity of the vaccine was assessed by measuring the levels of peptide (anti-J8) and toxoid carrier (anti-DT)-specific antibodies in serum samples. Results No serious adverse events were reported over 12 months of study. A total of 13 adverse events (AEs) were recorded, two of which were assessed to be associated with the vaccine. Both were mild in severity. No local reactogenicity was recorded in any of the participants. MJ8VAX was shown to be immunogenic, with increase in vaccine-specific antibodies in the participants who received the vaccine. The maximum level of vaccine-specific antibodies was detected at 28 days post immunization. The level of these antibodies decreased with time during follow-up. Participants who received the vaccine also had a corresponding increase in anti-DT serum antibodies. Conclusions Intramuscular administration of MJ8VAX was demonstrated to be safe and immunogenic. The presence of DT in the vaccine formulation resulted in a boost in the level of anti-DT antibodies.Copyright © 2018 Sekuloski et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.Item High burden of infectious disease and antibiotic use in early life in Australian Aboriginal communities.(2019-02-14) Cuningham W.; McVernon J.; Lydeamore M.J.; Andrews R.M.; Carapetis J.; Kearns T.; Clucas D.; Dhurrkay R.G.; Tong S.Y.C.; Campbell P.T.Objective: To quantify the childhood infectious disease burden and antibiotic use in the Northern Territory's East Arnhem region through synthesis and analysis of historical data resources. Method(s): We combined primary health clinic data originally reported in three separate publications stemming from the East Arnhem Healthy Skin Project (Jan-01 to Sep-07). Common statistical techniques were used to explore the prevalence of infectious conditions and the seasonality of infections, and to measure rates of antibiotic use. Result(s): There was a high monthly prevalence of respiratory (mean: 32% [95% confidence interval (CI): 20%, 34%]) and skin (mean: 20% [95%CI: 19%, 22%]) infectious syndromes, with upper respiratory tract infections (mean: 29% [95%CI: 27%, 31%]) and skin sores (mean: 15% [95%CI: 14%, 17%]) the most common conditions. Antibiotics were frequently prescribed with 95% (95%CI: 91%, 97%) of children having received at least one antibiotic prescription by their first birthday, and 47% having received six antibiotic prescriptions; skin sores being a key driver. Conclusion(s): Early life infections drive high antibiotic prescribing rates in remote Aboriginal communities. Implications for public health: Eliminating skin disease could reduce antibiotic use by almost 20% in children under five years of age in this population. Copyright © 2019 The AuthorsItem Joining the dots: the links between education and health and implications for Indigenous children.(2010-02-01) Johnston V.; Lea T.; Carapetis J.This paper provides a general overview of the literature investigating the nexus between education and health; discussing the relationship between these domains at individual, family and community levels. We then briefly examine the programme and research implications of such a framework for interventions aimed at improving education and health, with specific reference to young Indigenous Australians. We find that while education and health are inextricably linked, throughout the life course and at different levels of influence, there is less empirical work exploring this relationship in an Indigenous context. Given the gravity of literacy and numeracy failure rates in school-based education and its potential impact on Indigenous health, we assert an urgent case for rigorous research into interventions that address the barriers to effectiveness in implementing quality educational experiences and opportunities for Indigenous children. © 2009 Paediatrics and Child Health Division (Royal Australasian College of Physicians).Item Scabies and risk of skin sores in remote Australian Aboriginal communities: a self-controlled case series study.(2018-08-20) Aung P.T.Z.; Cuningham W.; Hwang K.; Andrews R.M.; Carapetis J.; Kearns T.; Clucas D.; McVernon J.; Simpson J.A.; Tong S.; Campbell P.T.Background: Skin sores caused by Group A streptococcus (GAS) infection are a major public health problem in remote Aboriginal communities. Skin sores are often associated with scabies, which is evident in scabies intervention programs where a significant reduction of skin sores is seen after focusing solely on scabies control. Our study quantifies the strength of association between skin sores and scabies among Aboriginal children from the East Arnhem region in the Northern Territory. Methods and Results: Pre-existing datasets from three published studies, which were conducted as part of the East Arnhem Healthy Skin Project (EAHSP), were analysed. Aboriginal children were followed from birth up to 4.5 years of age. Self-controlled case series design was used to determine the risks, within individuals, of developing skin sores when infected with scabies versus when there was no scabies infection. Participants were 11.9 times more likely to develop skin sores when infected with scabies compared with times when no scabies infection was evident (Incidence Rate Ratio (IRR) 11.9; 95% CI 10.3-13.7; p<0.001), and this was similar across the five Aboriginal communities. Children had lower risk of developing skin sores at age <=1 year compared to at age >1 year (IRR 0.8; 95% CI 0.7-0.9). Conclusion(s): The association between scabies and skin sores is highly significant and indicates a causal relationship. The public health importance of scabies in northern Australia is underappreciated and a concerted approach is required to recognise and eliminate scabies as an important precursor of skin sores.Copyright © 2018 Aung et al. http://creativecommons.org/licenses/by/4.0/.