122 research outputs found
Human papillomavirus vaccine safety in Australia: experience to date and issues for surveillance
No full textAustralia was one of the first countries to licence a quadrivalent human papillomavirus (HPV) vaccine, rapidly followed by a federally funded program of universal vaccination of a broad age group of females through schools (12 to 18 years) and primary care (19 to 26 years). As of August 2009, more than 5.8 million doses of Gardasil® (quadrivalent; Merck, New Jersey, USA) have been distributed in Australia and a total of 1394 suspected adverse events following immunisation (AEFI) have been reported to the passive surveillance system. Most reports are of common and expected reactions. Case series of more uncommon and serious AEFI, both known to be potentially vaccine related (anaphylaxis, conversion disorders and lipoatrophy) and otherwise (multiple sclerosis and pancreatitis) have been published.Michael S. Gold, Jim Buttery and Peter McIntyr
Febrile seizures following measles and varicella vaccines in young children in Australia
No full textAbstract not availableKristine K. Macartney, Heather F. Gidding, Lieu Trinh, Han Wang, Jocelynne McRae, Nigel Crawford, Michael Gold, Anne Kynaston, Christopher Blyth, Zurynski Yvonne, Elizabeth Elliott, Robert Booy, Jim Buttery, Helen Marshall, Michael Nissen, Peter Richmond, Peter B. McInytre, Nicholas Woo
Comparative effectiveness of lung volume reduction surgery for emphysema and bronchoscopic lung volume reduction with valve placement: a randomised controlled trial
No full textBackground: lung volume reduction surgery (LVRS) and bronchoscopic lung volume reduction (BLVR) with endobronchial valves (EBVs) can improve lung function, exercise capacity and quality of life in appropriately selected patients with emphysema. However, no direct comparison data exists to inform clinical decision-making in people who appear suitable for both procedures. Our aim was to investigate whether LVRS produces superior health outcomes when compared to BLVR at 12 months.Methods: the CELEB study was a multi-centre, single-blind parallel-group trial randomising patients from five UK hospitals, who were suitable for a targeted lung volume reduction procedure, to either LVRS or BLVR, and comparing outcomes at one year using the i-BODE score. This composite disease severity measure includes body mass index, airflow obstruction, dyspnoea and exercise capacity (incremental shuttle walk test). The researchers responsible for collecting outcomes were masked to treatment allocation. All outcomes were assessed in the intention-to-treat population.Findings: between 16 th September 2016 and 22 nd July 2019, 88 participants (48% female, mean (±SD) age 64.6±7.7, FEV 1 %predicted 31.0±7.9) were recruited at five specialist centres across the UK and randomised to either LVRS(n=41) or BLVR(n=47). At 12 months follow up, the complete i-BODE was available in 49 participants (21 LVRS/ 28 BLVR). Neither improvement in the i-BODE composite score (LVRS: -1.10 (1.44), BLVR: -0.82 (1.61) p=0.54) nor its individual components differed between treatment arms. Both treatments produced similar improvements in gas trapping; RV% predicted (LVRS -36.1 (-54.1, -10), BLVR: -30.1 (-53.7, -9) p=0.81). There was one death in each treatment arm.Interpretation: our findings do not support the hypothesis that LVRS is a substantially superior treatment to BLVR in individuals who are suitable for both treatments.Trial Registration Details: the trial was registered prospectively; ISRCTN19684749.Funding Information: this project was funded by the National Institute for Health Research (NIHR) under its Research for Patient Benefit (RfPB) Programme (Grant Reference Number PB-PG-1014-35051). The views expressed are those of the author(s) and not necessarily those of the NIHR or the Department of Health and Social Care. Imperial College, London will support the reporting of this manuscript. Trial sponsor representative: Patrik Pettersson, Royal Brompton and Harefield NHS Foundation Trust (RB&HFT), Royal Brompton Hospital.Declaration of Interests: PLS and DW have received payment from PulmonX for educational lectures. NG has received grants to institution from GSK and Genentech and grants for lectures and travel from AZ and Chiesi. RL is a member of the British Thoracic Society COPD Specialist Advisory group, a member of South Yorkshire Clinical Senate and a member of South Yorkshire and Bassetlaw Respiratory Clinical Network. All other authors have nothing to declare.Ethics Approval Statement: ethical approval was obtained from Fulham Research Ethics Committee, London, UK (REC reference: 16/LO/0286). The trial protocol has been published previously (20). A trial steering committee with an independent chair met quarterly to review progress, conduct and safety throughout the course of the trial
Information systems for vaccine safety surveillance
No full textImmunization implementation in the community relies upon post-licensure vaccine safety surveillance to maintain safe vaccination programs and to detect rare AEFI not observed in clinical trials. The increasing availability of electronic health-care related data and correspondence from both health-related providers and internet-based media has revolutionized health-care information. Many and varied forms of health information related to adverse event following immunization (AEFI) are potentially suitable for vaccine safety surveillance. The utilization of these media ranges from more efficient use of electronic spontaneous reporting, automated solicited surveillance methods, screening various electronic health record types, and the utilization of natural language processing techniques to scan enormous amounts of internet-based data for AEFI mentions. Each of these surveillance types have advantages and disadvantages and are often complementary to each other. Most are “hypothesis generating,” detecting potential safety signals, where some, such as vaccine safety datalinking, may also serve as “hypothesis testing” to help verify and investigate those potential signals
Recurrence of extensive injection site reactions following DTPa or dTpa vaccine in children 4-6 years old
No full textObjectivesThe aim of this study was to compare the immunogenicity and reactogenicity of a lower dose diphtheria, tetanus and pertussis vaccine (dTpa) with the recommended vaccine (DTPa) given as a fifth dose to 4-6-year old children who previously experienced an extensive injection site reaction (ISR).Material and methodsChildren aged 4-6 years who had experienced an extensive ISR following a 4th dose of DTPa were recruited and randomly assigned to receive either the recommended DTPa or the lower dose dTpa vaccine. Parents recorded local reactions and systemic events for 15 days following vaccination. Immunogenicity was assessed pre and post vaccination by ELISA for diphtheria (D), tetanus (T), pertussis toxin (PT), filamentous haemagglutinin (FHA), and pertactin (PRN).ResultsA total of 53 participants were vaccinated. There was a 72% recurrence rate of ISR, with a trend (p=0.055) towards fewer ISR in the dTpa (61.5%) compared with the DTPa group (85.2%). There was no difference in reports of pain or irritability between groups. All participants had seroprotective levels of antibody to D and T and seroresponse to each of the 3 pertussis antigens following vaccination with higher GMCs in DTPa vs dTpa group. There was no increase in antibody avidity observed post vaccination, regardless of vaccine given.ConclusionRecurrence of ISR with the 5th dose of diphtheria, tetanus and pertussis vaccination in children who have previously experienced an extensive ISR is high. Vaccination with a dTpa vaccine may reduce the risk of fifth dose ISR.Patrick Quinn, Michael Gold, Jenny Royle, Jim Buttery, Peter Richmond, Peter McIntyre, Nick Wood, Su-san Lee, Helen Marshal
Clinical update: Rotavirus gastroenteritis and its prevention
No full textThe licensing of oral rotavirus vaccines in many countries has refocused attention on the epidemiology and disease burden of rotaviruses. Rotaviruses infect nearly all children by age 5 years, and are the most common cause of severe gastroenteritis during childhood. Every year, rotaviruses cause 114 million diarrhoea episodes, 2·4 million hospital admissions, and 600 000 deaths in children younger than 5 years worldwide. 98% of rotavirus-related deaths occur in developing countries, whereas in developed countries 220 000 children are admitted to hospital every year, and about one in 50 children are admitted to hospital by age 5 years. Rotavirus epidemics that arise every winter and spring coincide with peak activity of respiratory viruses and place extra demands on primary and hospital care. Rotavirus vaccines could reduce child mortality from all causes by 5% and admission to hospital for gastroenteritis by 40% or more worldwide. However, these reductions will take at least several years and will vary by setting. In the USA, where vaccine coverage is 90%, rotavirus vaccination should prevent about 80% of the 40 deaths and 60 000 rotavirus-associated hospital admissions annually. By contrast, modelling has found that 6000 deaths and 235 000 severe rotavirus episodes could be avoided annually in Nigeria. However, because of only 22% vaccine coverage in the Expanded Program on Immunisation (EPI), these figures are only 15% of the estimated disease burden. Therefore efforts to ensure that rotavirus vaccines are safe and efficacious must be matched by those making EPI vaccines available for all infants
Changes in patterns of hospitalized children with varicella and of associated varicella genotypes after introduction of varicella vaccine in Australia
No full textBACKGROUND: Varicella in children, although usually mild, can cause hospitalization and rarely death. This study examined patterns of hospitalized children with varicella, and associated varicella genotypes, in 4 tertiary children’s hospitals throughout Australia before and after varicella vaccine was introduced. METHODS: We obtained coded data on discharge diagnoses from each hospital before (1999 to 2001) and after (2007 to 2010) varicella vaccine introduction in 2005, adding active surveillance to capture clinical features, complications and immunization history in the latter period. Varicella vesicles were swabbed, and genotyping of varicella strains was performed by real-time polymerase chain reaction amplification. RESULTS: Overall, a 68% reduction in coded hospitalizations (varicella, 73.2% [P < 0.001]; zoster, 40% [P = 0.002]) occurred post-vaccine introduction. Of children with detailed clinical data (97 varicella and 18 zoster cases), 46 (40%) were immunocompromised. Only 6 of 32 (19%) age-eligible immunocompetent children were immunized. Complications, most commonly secondary skin infections (n = 25) and neurologic conditions (n = 14), occurred in 44% of children. There were no deaths; but 3 immunocompetent unimmunized children had severe multiple complications requiring intensive care. All strains genotyped were “wild-type” varicella, with Clade 1 (European origin) predominating. CONCLUSIONS: After the introduction of varicella vaccine, coverage of greater than 80% at 2 years of age was achieved, with varicella hospitalizations reduced by almost 70%. Of hospitalized children age-eligible for varicella vaccine, 80% were unimmunized, including all cases requiring intensive care.Helen S. Marshall, Peter McIntyre, Peter Richmond, Jim P. Buttery, Jenny A. Royle, Michael S. Gold, Nicholas Wood, Elizabeth J. Elliott, Yvonne Zurynski, Cheryl S. Toi, Dominic E. Dwyer, and Robert Boo
Predictors of disease severity in children hospitalized for pertussis during an epidemic
No full textAustralia recently experienced its worst pertussis epidemic since introduction of pertussis vaccine into the National Immunisation Program. This study aimed to determine factors associated with severe pertussis in hospitalized children during an epidemic using a novel pertussis severity scoring (PSS) system. This prospective, observational, multicenter study enrolled children hospitalized with laboratory confirmed pertussis from 8 tertiary pediatric hospitals during a 12 month period (May 2009-April 2010). Variables assessed included demographics, clinical symptoms and relevant medical and immunization history. Cases were scored using objective clinical findings with cases classified as either severe (PSS > 5) or not severe (PSS ≤ 5). Logistic regression models were used to predict variables associated with severe disease. One hundred twenty hospitalized children 0-17 years of age were enrolled with a median PSS of 5 (interquartile range 3-7). Most (61.7%) were classified as not severe with 38.3% (46/120) severe. Most severe cases (54.3%) were 37.5°C (OR: 5.97, CI: 1.19-29.96) and history of prematurity (OR: 5.00, CI: 1.27-19.71) were independently associated with severe disease. A total of 70 cases in children ≥2 months of age, almost a third (n = 23) had not received pertussis vaccine. Most severe pertussis occurred in young, unimmunized infants, although severe disease was also observed in children >12 months of age and previously vaccinated children. Children admitted with pertussis with evidence of coinfection, history of prematurity or fever on presentation need close monitoring.Helen Marshall, Michelle Clarke, Kavita Rasiah, Peter Richmond, Jim Buttery, Graham Reynolds, Ross Andrews, Michael Nissen, Nick Wood and Peter McIntyr
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