PDF(Pubmed)
Abstract：
UNASSIGNED: Emergence of antimalarial drugs and insecticides resistance alarms scientists to develop a safe and effective malaria vaccine. A pre-erythrocytic malaria vaccine called RTS,S has made great strides.
UNASSIGNED: The review was aimed to assess the safety of the candidate malaria vaccine RTS,S with AS01 and AS02 adjuvants using data from Phase I-III randomized controlled clinical trials (RCTs).
UNASSIGNED: This systematic review was conducted based on PRISMA 2020. Regardless of time of publication year, all articles related with safety of RTS,S, RCTs published in the English language were included in the study. The last search of databases, and registry was conducted on 30 May, 2022. Pubmed, Google Scholar, Cochrane Library, Wiley Online Library, and Clinical trials.gov were thoroughly searched for accessible RCTs on the safety of RTS,S malaria vaccine. The studies were screened in three steps: duplicate removal, title and abstract screening, and full-text review. The included studies\' bias risk was assessed using the Cochrane risk of bias tool for RCTs. This systematic review is registered at Prospero (registration number: CRD42021285888). The qualitative descriptive findings from the included published studies were reported stratified by clinical trial phases.
UNASSIGNED: A total of thirty-five eligible safety studies were identified. Injection site pain and swelling, febrile convulsion, fever, headache, meningitis, fatigue, gastroenteritis, myalgia, pneumonia, reactogenicity, and anemia were the most commonly reported adverse events. Despite few clinical trials reported serious adverse events, none of them were related to vaccination.
UNASSIGNED: Most of the adverse events observed from RTS,S/AS01 and RTS,S/AS02 malaria vaccines were reported in the control group and shared by other vaccines. Hence, the authors concluded that both RTS,S/AS01 and RTS,S/AS02 malaria vaccines are safe.
UNASSIGNED: The review was aimed to assess the safety of the candidate malaria vaccine RTS,S with AS01 and AS02 adjuvants using data from Phase I-III randomized controlled clinical trials (RCTs).
UNASSIGNED: This systematic review was conducted based on PRISMA 2020. Regardless of time of publication year, all articles related with safety of RTS,S, RCTs published in the English language were included in the study. The last search of databases, and registry was conducted on 30 May, 2022. Pubmed, Google Scholar, Cochrane Library, Wiley Online Library, and Clinical trials.gov were thoroughly searched for accessible RCTs on the safety of RTS,S malaria vaccine. The studies were screened in three steps: duplicate removal, title and abstract screening, and full-text review. The included studies\' bias risk was assessed using the Cochrane risk of bias tool for RCTs. This systematic review is registered at Prospero (registration number: CRD42021285888). The qualitative descriptive findings from the included published studies were reported stratified by clinical trial phases.
UNASSIGNED: A total of thirty-five eligible safety studies were identified. Injection site pain and swelling, febrile convulsion, fever, headache, meningitis, fatigue, gastroenteritis, myalgia, pneumonia, reactogenicity, and anemia were the most commonly reported adverse events. Despite few clinical trials reported serious adverse events, none of them were related to vaccination.
UNASSIGNED: Most of the adverse events observed from RTS,S/AS01 and RTS,S/AS02 malaria vaccines were reported in the control group and shared by other vaccines. Hence, the authors concluded that both RTS,S/AS01 and RTS,S/AS02 malaria vaccines are safe.
摘要：
UNASSIGNED：抗疟药和杀虫剂耐药性的出现提醒科学家们开发一种安全有效的疟疾疫苗。一种叫做RTS的前红细胞疟疾疫苗，S取得了长足的进步。
UNASSIGNED：该审查旨在评估候选疟疾疫苗RTS的安全性，S与AS01和AS02佐剂使用来自I-III期随机对照临床试验(RCTs)的数据。
UNASSIGNED：本系统评价是基于PRISMA2020进行的。无论出版年份的时间，所有与RTS安全相关的文章，S,该研究包括以英语发表的RCT。最后一次搜索数据库，并于5月30日进行了登记，2022年。Pubmed,谷歌学者，科克伦图书馆,Wiley在线图书馆,和临床试验。gov彻底搜索了关于RTS安全性的可访问RCT，S疟疾疫苗。这些研究分三个步骤进行了筛选：重复去除，标题和摘要筛选，和全文回顾。使用Cochrane偏倚风险工具评估纳入的研究的偏倚风险。该系统评价在Prospero注册(注册号:CRD42021285888)。纳入的已发表研究的定性描述性结果按临床试验阶段进行了分层报告。
UNASSIGNED：总共确定了35项合格的安全性研究。注射部位疼痛和肿胀，高热惊厥,发烧,头痛,脑膜炎,疲劳,胃肠炎,肌痛，肺炎,反应原性,贫血是最常见的不良事件.尽管很少有临床试验报道严重的不良事件，他们都没有与疫苗接种有关。
未经评估：从RTS观察到的大多数不良事件，S/AS01和RTS，在对照组中报告了S/AS02疟疾疫苗，并由其他疫苗共享。因此，作者得出结论，两个RTS，S/AS01和RTS，S/AS02疟疾疫苗是安全的。
UNASSIGNED：该审查旨在评估候选疟疾疫苗RTS的安全性，S与AS01和AS02佐剂使用来自I-III期随机对照临床试验(RCTs)的数据。
UNASSIGNED：本系统评价是基于PRISMA2020进行的。无论出版年份的时间，所有与RTS安全相关的文章，S,该研究包括以英语发表的RCT。最后一次搜索数据库，并于5月30日进行了登记，2022年。Pubmed,谷歌学者，科克伦图书馆,Wiley在线图书馆,和临床试验。gov彻底搜索了关于RTS安全性的可访问RCT，S疟疾疫苗。这些研究分三个步骤进行了筛选：重复去除，标题和摘要筛选，和全文回顾。使用Cochrane偏倚风险工具评估纳入的研究的偏倚风险。该系统评价在Prospero注册(注册号:CRD42021285888)。纳入的已发表研究的定性描述性结果按临床试验阶段进行了分层报告。
UNASSIGNED：总共确定了35项合格的安全性研究。注射部位疼痛和肿胀，高热惊厥,发烧,头痛,脑膜炎,疲劳,胃肠炎,肌痛，肺炎,反应原性,贫血是最常见的不良事件.尽管很少有临床试验报道严重的不良事件，他们都没有与疫苗接种有关。
未经评估：从RTS观察到的大多数不良事件，S/AS01和RTS，在对照组中报告了S/AS02疟疾疫苗，并由其他疫苗共享。因此，作者得出结论，两个RTS，S/AS01和RTS，S/AS02疟疾疫苗是安全的。
