{"title":"A reduced-dose recombinant pertussis vaccine booster in Thai adolescents: a phase 2/3, observer-blinded, randomised controlled, non-inferiority trial","authors":"Prof Thanyawee Puthanakit MD , Auchara Tangsathapornpong MD , Suvaporn Anugulruengkitt PhD , Rapisa Nantanee MD , Pornumpa Bunjoungmanee MD , Souad Mansouri PhD , Librada Fortuna MD , Wassana Wijagkanalan PhD , Terapong Tantawichien MD , TDA205 study team","doi":"10.1016/S2352-4642(24)00173-1","DOIUrl":"10.1016/S2352-4642(24)00173-1","url":null,"abstract":"<div><h3>Background</h3><div>A resurgence of pertussis has increased the demand for low-cost vaccines. The aim of this study was to test the immunogenicity of a booster acellular monovalent pertussis vaccine containing reduced-dose (2 μg) recombinant pertussis toxin (PT) and 5 μg filamentous haemagglutinin (FHA; ap<sub>gen</sub>) against a version of ap<sub>gen</sub> containing tetanus and reduced-dose diphtheria toxoids (Tdap<sub>gen</sub>) and a licensed vaccine containing chemically detoxified PT and FHA combined with tetanus toxoid and reduced-dose diphtheria toxoid (Tdap<sub>chem</sub>).</div></div><div><h3>Methods</h3><div>This phase 2/3, observer-blinded, randomised, controlled, non-inferiority trial was done in adolescents aged 9–17 years at two clinical research centres in Bangkok and Pathum Thani, Thailand. Eligible participants were screened and randomly assigned (1:1:1) to receive one booster dose of ap<sub>gen</sub>, Tdap<sub>gen</sub>, or Tdap<sub>chem</sub> vaccine. Participants were followed up until day 336 post-immunisation. The primary endpoint was non-inferior seroconversion rates in Tdap<sub>gen</sub> and Tdap<sub>chem</sub> vaccine groups, with seroconversion rate defined as the proportion of participants with at least a four-fold increase on day 28 post-immunisation relative to baseline of anti-PT and anti-FHA IgG. The non-inferiority for seroconversion rates of anti-PT and anti-FHA IgG was defined as the lower bound of the two-sided 95% CI of the seroconversion rate for Tdap<sub>gen</sub> compared with Tdap<sub>chem</sub> exceeding −10%. Immunogenicity was analysed in the per-protocol population. All safety data were collected, and the prevalence of adverse events was analysed in the intention-to-treat population. This trial was registered on the Thai Clinical Trial Registry (TCTR20181031001).</div></div><div><h3>Findings</h3><div>Between June 18, and Aug 3, 2019, 450 adolescents (mean age 12·1 years, SD 2·5) were enrolled and randomly assigned (150 participants in each group). Day 28 anti-PT IgG seroconversion rates were 141 (94%) of 150 participants who received Tdap<sub>gen</sub> (95% CI 88·8–97·0) and 105 (71%) of 149 participants who received Tdap<sub>chem</sub> (62·7–77·2; p<0·0001). Day 28 anti-FHA IgG seroconversion rates were 144 (96%) of 150 participants who received Tdap<sub>gen</sub> (91·4–98·3) and 124 (83%) of 149 participants who received Tdap<sub>chem</sub> (76·4–88·4; p<0·0001). The difference in seroconversion rates was 23·5% (95% CI 15·3–31·8) for anti-PT IgG and 12·8% (6·0–19·6) for anti-FHA IgG, when comparing the Tdap<sub>gen</sub> versus the Tdap<sub>chem</sub> vaccine group. No vaccine-related serious adverse events were reported.</div></div><div><h3>Interpretation</h3><div>Recombinant Tdap<sub>gen</sub> vaccine showed non-inferior immunogenicity compared with Tdap<sub>chem</sub> at day 28 in terms of seroconversion rate of anti-PT IgG and anti-FHA IgG relative to baseline. The reduced-dose ap","PeriodicalId":54238,"journal":{"name":"Lancet Child & Adolescent Health","volume":"8 12","pages":"Pages 900-909"},"PeriodicalIF":19.9,"publicationDate":"2024-11-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142690204","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Prof Akash Deep MD , Emma C Alexander MBBS , Joe Brierley MBChB , Mihaela Damian MD , Anish Gupta MBBS , Valerie McLin MD , Moinak Sen Sarma MBBS , James E Squires MD , Barbara E Wildhaber MD
{"title":"Paediatric acute liver failure: a multidisciplinary perspective on when a critically ill child is unsuitable for liver transplantation","authors":"Prof Akash Deep MD , Emma C Alexander MBBS , Joe Brierley MBChB , Mihaela Damian MD , Anish Gupta MBBS , Valerie McLin MD , Moinak Sen Sarma MBBS , James E Squires MD , Barbara E Wildhaber MD","doi":"10.1016/S2352-4642(24)00255-4","DOIUrl":"10.1016/S2352-4642(24)00255-4","url":null,"abstract":"<div><div>Paediatric acute liver failure is a devastating condition with high morbidity and mortality, which is challenging to manage for the hepatologist, intensivist, and associated specialists. Emergency liver transplantation is required for 10–20% of patients, but for 10% of critically ill children, liver transplantation is deemed unsuitable; the child might be too unwell, or the underlying cause might carry a poor prognosis. Other social, logistical, or ethical considerations are often relevant. Liver transplantation when a patient is too unwell creates perioperative risk to the child that could lead to morbidity, mortality, and potential graft wastage, which is detrimental for others on the waiting list. Donor liver scarcity should prompt an evaluation of whether a transplant is justified through a holistic multidisciplinary lens that considers medical, social, logistical, and ethical concerns. In this Review, we explore, from a multidisciplinary perspective, why a critically unwell child with paediatric acute liver failure might be unsuitable for liver transplantation.</div></div>","PeriodicalId":54238,"journal":{"name":"Lancet Child & Adolescent Health","volume":"8 12","pages":"Pages 921-932"},"PeriodicalIF":19.9,"publicationDate":"2024-11-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142690207","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"The pattern of childhood infections during and after the COVID-19 pandemic","authors":"Ulrikka Nygaard PhD , Mette Holm PhD , Prof Helena Rabie PhD , Maren Rytter PhD","doi":"10.1016/S2352-4642(24)00236-0","DOIUrl":"10.1016/S2352-4642(24)00236-0","url":null,"abstract":"<div><div>The rates of most paediatric infectious diseases declined during the initial phase of the COVID-19 pandemic due to the implementation of non-pharmaceutical interventions. However, after the gradual release of these interventions, resurgences of infections occurred with notable variations in incidence, clinical manifestations, pathogen strains, and age distribution. This Review seeks to explore these changes and the rare clinical manifestations that were made evident during the resurgence of known childhood infections. The magnitude of resurgences was possibly caused by a profound population immunity debt to specific pathogens in combination with the coinciding reappearance of viral and bacterial infections, rather than novel pathogen variants, increased antimicrobial resistance, or altered childhood immune function. As the usual patterns of paediatric infectious diseases were disrupted during the COVID-19 pandemic, the consequences of a population immunity debt were unravelled, and new insights into pathogen transmissibility, disease pathogenesis, and rare clinical manifestations were revealed.</div></div>","PeriodicalId":54238,"journal":{"name":"Lancet Child & Adolescent Health","volume":"8 12","pages":"Pages 910-920"},"PeriodicalIF":19.9,"publicationDate":"2024-11-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142690208","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"The world in 2024 was not all right for children","authors":"The Lancet Child & Adolescent Health","doi":"10.1016/S2352-4642(24)00308-0","DOIUrl":"10.1016/S2352-4642(24)00308-0","url":null,"abstract":"","PeriodicalId":54238,"journal":{"name":"Lancet Child & Adolescent Health","volume":"8 12","pages":"Page 843"},"PeriodicalIF":19.9,"publicationDate":"2024-11-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142690209","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Fernanda Bruzadelli Paulino da Costa PhD , Prof Mark P Nicol PhD , Maresa Botha MBChB , Lesley Workman MPH , Prof Ricardo Alexandre Arcêncio PhD , Prof Heather J Zar PhD , Leonardo Martinez PhD
{"title":"Mycobacterium tuberculosis infection and tuberculosis disease in the first decade of life: a South African birth cohort study","authors":"Fernanda Bruzadelli Paulino da Costa PhD , Prof Mark P Nicol PhD , Maresa Botha MBChB , Lesley Workman MPH , Prof Ricardo Alexandre Arcêncio PhD , Prof Heather J Zar PhD , Leonardo Martinez PhD","doi":"10.1016/S2352-4642(24)00256-6","DOIUrl":"10.1016/S2352-4642(24)00256-6","url":null,"abstract":"<div><h3>Background</h3><div>Paediatric tuberculosis leads to more than 200 000 deaths annually. We aimed to investigate the incidence of <em>Mycobacterium tuberculosis</em> infection and tuberculosis disease in the first decade of life in the Drakenstein Child Health Study (DCHS), a South African cohort in a community with high tuberculosis and HIV incidence.</div></div><div><h3>Methods</h3><div>In this prospective birth cohort study, we enrolled pregnant women aged 18 years or older who were between 20 and 28 weeks’ of gestation in a peri-urban setting outside of Cape Town, South Africa. We followed up their children for tuberculosis until age 10 years. To measure <em>M tuberculosis</em> infection tuberculin skin tests were administered to children at age 6 months, 12 months, and then annually in children with a negative test, and at the time of a lower respiratory tract infection. Tuberculin skin test conversion was defined by an induration reaction of 10 mm or more. To measure tuberculosis disease, active surveillance was done throughout follow-up. Each episode of presumed tuberculosis disease was investigated using sputum induction, tested with Xpert MTB/RIF and liquid culture for <em>M tuberculosis</em>. Survival analyses were performed and multivariable Cox regression was used to measure factors associated with <em>M tuberculosis</em> infection or disease.</div></div><div><h3>Findings</h3><div>Between March 5, 2012, and March 31, 2015, 1137 women and their 1143 children (248 [21·7%] of 1143 children were HIV-exposed, two [0·2%] children with HIV) were included in the analysis. Children were followed up for 8870 person-years (median follow-up 9·1 years [IQR 8·2–10·2]). The annual risk of tuberculin conversion during follow-up was 6·6 infections per 100 person-years (95% CI 5·8–7·3) but ranged from 4–9 infections per 100 person-years over the follow-up period. 98 children developed tuberculosis (1105 cases per 100 000 person-years; 95% CI 906–1347). The cumulative hazard of tuberculin conversion was 36% (95% CI 32–41) at age 8 years and the cumulative hazard of tuberculosis disease was 10% (8–12) at age 10 years. Preventive treatment was associated with a reduction in tuberculosis disease among children who had tuberculin conversion (adjusted hazard ratio 0·23 [95% CI 0·12–0·47]). Most cases of tuberculosis disease (78 [79%; 95% CI 69–86] of 98 children) occurred among children who had tuberculin skin test conversion but were not administered preventive treatment.</div></div><div><h3>Interpretation</h3><div>In this prospective South African birth cohort, <em>M tuberculosis</em> transmission was consistently high throughout the first decade of life leading to approximately 10% of children developing tuberculosis disease. A multipronged approach to decrease paediatric tuberculosis is needed that combines preventive treatment for children at risk, reducing community <em>M tuberculosis</em> transmission, and active case finding.</div></div><div>","PeriodicalId":54238,"journal":{"name":"Lancet Child & Adolescent Health","volume":"8 12","pages":"Pages 891-899"},"PeriodicalIF":19.9,"publicationDate":"2024-11-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11579303/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142607822","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Jiali Zhou MPH , Jing Wu MPH , Denan Jiang MPH , Shan Cai MPH , Chenhao Zhang MS , Jiayao Ying MPH , Jin Cao MPH , Prof Yi Song PhD , Peige Song PhD
{"title":"National, regional and provincial prevalence of childhood hypertension in China in 2020: a systematic review and modelling study","authors":"Jiali Zhou MPH , Jing Wu MPH , Denan Jiang MPH , Shan Cai MPH , Chenhao Zhang MS , Jiayao Ying MPH , Jin Cao MPH , Prof Yi Song PhD , Peige Song PhD","doi":"10.1016/S2352-4642(24)00260-8","DOIUrl":"10.1016/S2352-4642(24)00260-8","url":null,"abstract":"<div><h3>Background</h3><div>Childhood hypertension is a growing health concern in China. Accurate estimation of prevalence is essential but challenging due to the variability of blood pressure and the need for multiple occasions for confirmation. This study aimed to estimate the national, regional, and provincial prevalence of childhood hypertension in China in 2020.</div></div><div><h3>Methods</h3><div>For this systematic review and modelling study, we did a comprehensive literature search of epidemiological studies reporting the prevalence of elevated blood pressure (EBP) or hypertension among Chinese children (aged 18 years or younger) that were published between Jan 1, 1990 and June 20, 2024 in PubMed, Embase, MEDLINE, China National Knowledge Infrastructure, Wanfang Data, and Chinese Science and Technology Journal Database. EBP was defined as blood pressure greater than or equal to the 95th percentile on a single occasion, and childhood hypertension as blood pressure greater than or equal to the 95th percentile consistently across three occasions. First, we estimated the prevalence of childhood EBP using a multi-level mixed-effects meta-regression and the pooled odds ratios (ORs) for factors associated with childhood EBP through random-effects meta-analysis. Second, the ratio of childhood EBP to childhood hypertension was calculated via random-effects meta-analysis, based on which the national and regional prevalence of childhood hypertension was imputed. Finally, we derived the provincial prevalence of childhood hypertension using an associated factor-based model. The review protocol was registered in PROSPERO (CRD42024537570).</div></div><div><h3>Findings</h3><div>We identified 8872 records, of which 134 articles covering 22 431 861 children were included. In 2020, the overall prevalence of hypertension among Chinese children aged 6–18 years was 3·11% (95% CI 2·35–4·04), equivalent to 6·80 million (5·13–8·83) affected children. The prevalence of childhood hypertension ranged from 2·25% (1·54–2·75) for children aged 6 years to 2·01% (1·36–3·37) for those aged 18 years, peaking at 3·84% (2·97–4·94) for those aged 14 years. The overall prevalence was higher in boys (3·34% [2·53–4·35]) than in girls (2·85% [2·13–3·69]). Associations between four factors (overweight, obesity, salted food intake, and family history of hypertension) and childhood EBP were graded as highly suggestive evidence.</div></div><div><h3>Interpretation</h3><div>This study reveals substantial regional and provincial variations in the prevalence of childhood hypertension in China. Our findings could inform targeted public health initiatives and optimise resource allocation to address this public health concern.</div></div><div><h3>Funding</h3><div>This study was supported by the National Natural Science Foundation of China (72104211 and 82273654) and the Chao Kuang Piu High-tech Development Fund (2022RC019).</div></div><div><h3>Translation</h3><div>For the Chinese translat","PeriodicalId":54238,"journal":{"name":"Lancet Child & Adolescent Health","volume":"8 12","pages":"Pages 872-881"},"PeriodicalIF":19.9,"publicationDate":"2024-10-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142565289","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Nuria Sanchez Clemente , Kirsty Le Doare , Ezekiel Mupere , Jean B Nachega , Stephen Rulisa , Boghuma Titanji
{"title":"Hidden in plain sight: the threat of mpox to children and adolescents","authors":"Nuria Sanchez Clemente , Kirsty Le Doare , Ezekiel Mupere , Jean B Nachega , Stephen Rulisa , Boghuma Titanji","doi":"10.1016/S2352-4642(24)00298-0","DOIUrl":"10.1016/S2352-4642(24)00298-0","url":null,"abstract":"","PeriodicalId":54238,"journal":{"name":"Lancet Child & Adolescent Health","volume":"8 12","pages":"Pages 849-851"},"PeriodicalIF":19.9,"publicationDate":"2024-10-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142565283","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}