Anna Calvert, Nick Andrews, Sheula Barlow, Ray Borrow, Charlotte Black, Barbara Bromage, Jeremy Carr, Paul Clarke, Andrew C Collinson, Karen Few, Naomi Hayward, Christine E Jones, Kirsty Le Doare, Shamez N Ladhani, Jennifer Louth, Georgia Papadopoulou, Michelle Pople, Tim Scorrer, Matthew D Snape, Paul T Heath
{"title":"英国早产儿接种四价脑膜炎球菌 B 型疫苗两种接种方案的开放标签 IV 期随机对照试验。","authors":"Anna Calvert, Nick Andrews, Sheula Barlow, Ray Borrow, Charlotte Black, Barbara Bromage, Jeremy Carr, Paul Clarke, Andrew C Collinson, Karen Few, Naomi Hayward, Christine E Jones, Kirsty Le Doare, Shamez N Ladhani, Jennifer Louth, Georgia Papadopoulou, Michelle Pople, Tim Scorrer, Matthew D Snape, Paul T Heath","doi":"10.1136/archdischild-2024-327040","DOIUrl":null,"url":null,"abstract":"<p><strong>Objective: </strong>To compare immunological responses of preterm infants to a four-component meningococcal B vaccine (4CMenB; Bexsero) following a 2+1 vs a 3+1 schedule, and to describe reactogenicity of routine vaccines.</p><p><strong>Design: </strong>An open-label, phase IV randomised study conducted across six UK sites.</p><p><strong>Setting: </strong>Neonatal units, postnatal wards, community recruitment following discharge.</p><p><strong>Participants: </strong>129 preterm infants born at a gestation of <35 weeks (64 in group 1 (2+1), 65 in group 2 (3+1)) were included in the analysis. Analysis was completed for postprimary samples from 125 participants (59 in group 1, 66 in group 2) and for postbooster samples from 118 participants (59 in both groups).</p><p><strong>Interventions: </strong>Infants randomised to 4CMenB according to a 2+1 or a 3+1 schedule, alongside routine vaccines.</p><p><strong>Main outcome measures: </strong>Serum bactericidal antibody (SBA) assays performed at 5, 12 and 13 months of age: geometric mean titres (GMTs) and proportions of infants achieving titres ≥4 compared between groups.</p><p><strong>Results: </strong>There were no significant differences in SBA GMTs between infants receiving a 2+1 compared with a 3+1 schedule following primary or booster vaccination, but a significantly higher proportion of infants had an SBA titre ≥4 against strain NZ98/254 (porin A) at 1 month after primary vaccination using a 3+1 compared with a 2+1 schedule (3+1: 87% (95% CI 76 to 94%), 2+1: 70% (95% CI 56 to 81%), p=0.03).At 12 weeks of age those in the 3+1 group, who received a dose of 4CMenB, had significantly more episodes of fever >38.0°C than those in the 2+1 group who did not (group 2+1: 2% (n=1); 3+1: 14% (n=9); p=0.02).</p><p><strong>Conclusions: </strong>Both schedules were immunogenic in preterm infants, although a lower response against strain NZ98/254 was seen in the 2+1 schedule; ongoing disease surveillance is important in understanding the clinical significance of this difference.</p><p><strong>Trial registration number: </strong>NCT03125616.</p>","PeriodicalId":8150,"journal":{"name":"Archives of Disease in Childhood","volume":" ","pages":"898-904"},"PeriodicalIF":4.3000,"publicationDate":"2024-10-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11503106/pdf/","citationCount":"0","resultStr":"{\"title\":\"An open-label, phase IV randomised controlled trial of two schedules of a four-component meningococcal B vaccine in UK preterm infants.\",\"authors\":\"Anna Calvert, Nick Andrews, Sheula Barlow, Ray Borrow, Charlotte Black, Barbara Bromage, Jeremy Carr, Paul Clarke, Andrew C Collinson, Karen Few, Naomi Hayward, Christine E Jones, Kirsty Le Doare, Shamez N Ladhani, Jennifer Louth, Georgia Papadopoulou, Michelle Pople, Tim Scorrer, Matthew D Snape, Paul T Heath\",\"doi\":\"10.1136/archdischild-2024-327040\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Objective: </strong>To compare immunological responses of preterm infants to a four-component meningococcal B vaccine (4CMenB; Bexsero) following a 2+1 vs a 3+1 schedule, and to describe reactogenicity of routine vaccines.</p><p><strong>Design: </strong>An open-label, phase IV randomised study conducted across six UK sites.</p><p><strong>Setting: </strong>Neonatal units, postnatal wards, community recruitment following discharge.</p><p><strong>Participants: </strong>129 preterm infants born at a gestation of <35 weeks (64 in group 1 (2+1), 65 in group 2 (3+1)) were included in the analysis. Analysis was completed for postprimary samples from 125 participants (59 in group 1, 66 in group 2) and for postbooster samples from 118 participants (59 in both groups).</p><p><strong>Interventions: </strong>Infants randomised to 4CMenB according to a 2+1 or a 3+1 schedule, alongside routine vaccines.</p><p><strong>Main outcome measures: </strong>Serum bactericidal antibody (SBA) assays performed at 5, 12 and 13 months of age: geometric mean titres (GMTs) and proportions of infants achieving titres ≥4 compared between groups.</p><p><strong>Results: </strong>There were no significant differences in SBA GMTs between infants receiving a 2+1 compared with a 3+1 schedule following primary or booster vaccination, but a significantly higher proportion of infants had an SBA titre ≥4 against strain NZ98/254 (porin A) at 1 month after primary vaccination using a 3+1 compared with a 2+1 schedule (3+1: 87% (95% CI 76 to 94%), 2+1: 70% (95% CI 56 to 81%), p=0.03).At 12 weeks of age those in the 3+1 group, who received a dose of 4CMenB, had significantly more episodes of fever >38.0°C than those in the 2+1 group who did not (group 2+1: 2% (n=1); 3+1: 14% (n=9); p=0.02).</p><p><strong>Conclusions: </strong>Both schedules were immunogenic in preterm infants, although a lower response against strain NZ98/254 was seen in the 2+1 schedule; ongoing disease surveillance is important in understanding the clinical significance of this difference.</p><p><strong>Trial registration number: </strong>NCT03125616.</p>\",\"PeriodicalId\":8150,\"journal\":{\"name\":\"Archives of Disease in Childhood\",\"volume\":\" \",\"pages\":\"898-904\"},\"PeriodicalIF\":4.3000,\"publicationDate\":\"2024-10-18\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11503106/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Archives of Disease in Childhood\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1136/archdischild-2024-327040\",\"RegionNum\":3,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"PEDIATRICS\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Archives of Disease in Childhood","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1136/archdischild-2024-327040","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"PEDIATRICS","Score":null,"Total":0}
An open-label, phase IV randomised controlled trial of two schedules of a four-component meningococcal B vaccine in UK preterm infants.
Objective: To compare immunological responses of preterm infants to a four-component meningococcal B vaccine (4CMenB; Bexsero) following a 2+1 vs a 3+1 schedule, and to describe reactogenicity of routine vaccines.
Design: An open-label, phase IV randomised study conducted across six UK sites.
Setting: Neonatal units, postnatal wards, community recruitment following discharge.
Participants: 129 preterm infants born at a gestation of <35 weeks (64 in group 1 (2+1), 65 in group 2 (3+1)) were included in the analysis. Analysis was completed for postprimary samples from 125 participants (59 in group 1, 66 in group 2) and for postbooster samples from 118 participants (59 in both groups).
Interventions: Infants randomised to 4CMenB according to a 2+1 or a 3+1 schedule, alongside routine vaccines.
Main outcome measures: Serum bactericidal antibody (SBA) assays performed at 5, 12 and 13 months of age: geometric mean titres (GMTs) and proportions of infants achieving titres ≥4 compared between groups.
Results: There were no significant differences in SBA GMTs between infants receiving a 2+1 compared with a 3+1 schedule following primary or booster vaccination, but a significantly higher proportion of infants had an SBA titre ≥4 against strain NZ98/254 (porin A) at 1 month after primary vaccination using a 3+1 compared with a 2+1 schedule (3+1: 87% (95% CI 76 to 94%), 2+1: 70% (95% CI 56 to 81%), p=0.03).At 12 weeks of age those in the 3+1 group, who received a dose of 4CMenB, had significantly more episodes of fever >38.0°C than those in the 2+1 group who did not (group 2+1: 2% (n=1); 3+1: 14% (n=9); p=0.02).
Conclusions: Both schedules were immunogenic in preterm infants, although a lower response against strain NZ98/254 was seen in the 2+1 schedule; ongoing disease surveillance is important in understanding the clinical significance of this difference.
期刊介绍：
Archives of Disease in Childhood is an international peer review journal that aims to keep paediatricians and others up to date with advances in the diagnosis and treatment of childhood diseases as well as advocacy issues such as child protection. It focuses on all aspects of child health and disease from the perinatal period (in the Fetal and Neonatal edition) through to adolescence. ADC includes original research reports, commentaries, reviews of clinical and policy issues, and evidence reports. Areas covered include: community child health, public health, epidemiology, acute paediatrics, advocacy, and ethics.
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