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| 1 | Long-term safety follow-up of children from a randomized-controlled phase Ⅱb proof-of-concept efficacy study of the live,attenuated,tetravalent dengue vaccine (CYD-TDV) in Thailand显示文摘Objective:To investigate the long-term safety of a tetravalent dengue vaccine(CYD-TDV)in children in a phase Ⅱ b follow-up study in Thailand.Methods:In the phase Ⅱb study,children aged 4-11 years were randomized(2:1)to receive three injections of CYD-TDV or serve as control at 6-month intervals,with 25 months’ active follow-up(active phase).This study was an additional four-year passive surveillance for hospitalized virologically-confirmed dengue(VCD;hospital phase).Cases of hospitalized VCD,severe hospitalized VCD,vaccine-related serious adverse events,and deaths were reported for the total population,with post-hoc analyses by enrollment age(<9 and≥9 years).Results:Of 3 997 participants receiving≥1 injection,80.1% were recruited to the hospital phase[2 131(CYD-TDV);1 072(control)].Eighty-five hospitalized VCD cases were reported in the CYD-TDV group and 46 in the control group during the four-year hospital phase[relative risk(RR):0.93,95% confidence interval(Cl):0.64-1.36].The RR over six years of follow-up was 0.77(95% CI:0.57-1.05).In those aged≥9 years,the cumulative RRs in the active phase,hospital phase,and entire six years were 0.28(95% CI:0.08-0.81),0.51(95% CI:0.25-1.05),and 0.42(95% CI:0.24-0.75),respectively.In the overall population,there were ten severe hospitalized VCD cases in the CYD-TDV group and five in the control group over six years(RR:1.00,95% CI:0.31-3.75).Conclusions:Over six years of follow-up,in children aged ≥9 years,CYD-TDV administration is associated with a reduced risk of hospitalized VCD. | Kriengsak Limkittikul Weerawan Hattasingh Danaya Chansinghakul Arunee Sabchareon Wut Dulyachai Carina Frago T Anh Wartel Edith Langevin Sophia Gailhardou Alain Bouckenooghe | 2019 | Asian Pacific Journal of Tropical Medicine2019，12，9： | 1 |
| 2 | Is taurine a functional nutrient?显示文摘 | Bouckenooghe T Remacle C Reusens B | 2006 | Curr Opin Clin Nutr Metab Care2006，9，6： | 1 |
| 3 | Is taurine a functional nutrient显示文摘 | BOUCKENOOGHE T REMACLE C REUSENS B | 2006 | Curr Opin Clin Nutr Metab Care2006，9，6： | 1 |
| 4 | The human pancreatic islet transcriptomeexpression of candidate genes for type 1 diabetes and the impact of pro-inflammatory cytokines 显示文摘 | Eizirik D L Sammeth M Bouckenooghe T | 2012 | PLoS Genetics2012，8，10： | 1 |
| 5 | Immunogenicity, reactogcnicity and safety of the human rotavirus vaccine RIX4414 oral suspension ( liquid formulation ) in Finnish infants 显示文摘 | Vesikari T Karvonen A Bouckenooghe A | 2011 | Vaccine2011，29，11： | 1 |
| 6 | Is taurine a functional nutrient? 显示文摘 | Bouckenooghe T Remacle C Reusens B | 2006 | Curr Opin Clin Nutr Metab Care2006，9，6： | 1 |
| 7 | Is taurine a functional nutrient? 显示文摘 | Bouckenooghe T Remacle C Reusens B | 2006 | Curr Opin Clin Nutr Metab Care2006，9，6： | 1 |
| 8 | Is taurine a functional nutrient显示文摘 | Bouckenooghe T Remacle C Reusens B | | 0，，06： | 1 |
| 9 | Maternal malnutrition programs pancreatic islet mitochondrial dysfunction in the adult offspring显示文摘 | Theys N Ahn MT Bouckenooghe T | | 0，，10： | 1 |
| 10 | Modulation of specific beta cell gene (re)expression during in vitro expansion of human pancreatic islet cells 显示文摘 | Bouckenooghe T Vandewalle B Lukowiak B | 2003 | Cell Transplant2003，12，7： | 1 |
| 11 | Is taurine a functional nutrient显示文摘 | Bouckenooghe T Remacle C Reusens B | 2006 | Curr Opin Clin Nutr Metab Care2006，9，6： | 1 |
| 12 | Protective efficacy of the recombinant, live-attenuated, CYD tetravalent dengue vaccine in Thai schoolchildren: a randomised, controlled phase 2b trial显示文摘 | Arunee Sabchareon Derek Wallace Chukiat Sirivichayakul Kriengsak Limkittikul Pornthep Chanthavanich Saravudh Suvannadabba Vithaya Jiwariyavej Wut Dulyachai Krisana Pengsaa T Anh Wartel Annick Moureau Melanie Saville Alain Bouckenooghe Simonetta Viviani Na | 2012 | The Lancet . 2012 (9853)2012，，： | 1 |
| 13 | 人轮状病毒疫苗对欧洲2岁以下婴幼儿轮状病毒性胃肠炎的预防效应:一项随机、双盲、对照研究显示文摘背景该研究旨在评估1:2服轮状病毒减毒活疫苗Rotarix(RIX4414)对欧洲〈2岁婴幼儿轮状病毒性胃肠炎的预防效应。
方法选取来自欧洲6个国家的3994例〈2岁婴幼儿,随机分为1:2服RIX4414疫苗组(n=2646)及安慰剂组(n=1348),分别与特定的头2剂婴幼儿计划免疫疫苗联合接种。2周后观察其胃肠炎发病情况,并连续随访两个轮状病毒流行季节[即疫苗的联合效应随访期;平均持续17个月(s=1.6)]。该研究的主要终点是第一效应随访期内(即接种头2剂疫苗后2周至第一个轮状病毒流行季节结束)疫苗对所有轮状病毒性胃肠炎的预防效应。并于胃肠炎发病期采集粪便样品,应用ELISA法检测轮状病毒,然后通过RT-PCR进行分型。若终点事件的20分制Vesikari评分≥11分,则定义为重度胃肠炎。研究按照预设的协议进行分析,其在ClinicalTrials.gov网站上注册编码为NCT00140686(e-Track102247).
结果按照预设协议分析,研究共剔除了120例婴幼儿。在第一效应随访期[平均持续5、7个月(s=1.2)],2572例RIX4414疫苗组婴幼儿中有24例出现不同程度的轮状病毒性胃肠炎事件,而1302例安慰组中则有94例出现类似事件,因此该疫苗的预防效应为87.1%(95%CI79.6%~92.1%.P〈0.0001).在联合效应随访期,该疫苗对重度轮状病毒性胃肠炎的预防效应为90.4%(95%CI85.1%~94.1%.P〈0.0001),对需入院治疗的轮状病毒胃肠炎的预防效应为96.0%(95%CI83、8%~99.5%,P〈0.0001).对轮状病毒相关的医疗照顾的预防效应为83.8%(95%CI76.8%~88、9%,P〈0.0001),而对循环型G1、G2、G3、G4、G9轮状病毒引起的重度轮状病毒性胃肠炎也有显著的保护作用。
结论在欧洲,与儿童计划免疫疫苗联用的2剂RIX4414疫苗可对所有轮状病毒性胃肠炎产生较强的保护作用,因胃肠炎入院的病例数在连续两个轮状病毒流行季节亦呈整体下降趋势。 | T Vesikari A Karuonen R Prymula V Schuster J C Tejedor R Cohen F Meurice H H Han S Damaso A Bouckenooghe 王顺涛(译) | 2008 | 世界临床医学2008，2，2： | 0 |
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