Yihunie Wubetu, Kebede Bekalu, Tegegne Bantayehu Addis, Getachew Melese, Abebe Dehnnet, Aschale Yibeltal, Belew Habtamu, Bahiru Bereket
Department of Pharmacy, College of Health Sciences, Debre Markos University, Debre Markos, Ethiopia.
Department of Medical Laboratory Science, College of Health Sciences, Debre Markos University, Debre Markos, Ethiopia.
Clin Pharmacol. 2023 Mar 14;15:21-32. doi: 10.2147/CPAA.S400155. eCollection 2023.
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.
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).
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.
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.
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.
抗疟药物和杀虫剂耐药性的出现警示科学家们要研发一种安全有效的疟疾疫苗。一种名为RTS,S的红细胞前期疟疾疫苗已取得了重大进展。
本综述旨在利用I-III期随机对照临床试验（RCT）的数据，评估候选疟疾疫苗RTS,S与AS01和AS02佐剂联合使用时的安全性。
本系统评价依据PRISMA 2020进行。无论发表年份，所有与RTS,S安全性相关的英文发表的RCT文章均纳入研究。最后一次数据库检索和登记于2022年5月30日进行。全面检索了PubMed、谷歌学术、考克兰图书馆、威利在线图书馆和临床试验.gov，以获取关于RTS,S疟疾疫苗安全性的可获取RCT。研究分三个步骤进行筛选：去除重复项、标题和摘要筛选以及全文审查。使用考克兰RCT偏倚风险工具评估纳入研究的偏倚风险。本系统评价已在国际系统评价注册库（注册号：CRD42021285888）登记。纳入的已发表研究的定性描述性结果按临床试验阶段分层报告。
共确定了35项符合条件的安全性研究。注射部位疼痛和肿胀、热性惊厥、发热、头痛、脑膜炎、疲劳、胃肠炎、肌痛、肺炎、反应原性和贫血是最常报告的不良事件。尽管很少有临床试验报告严重不良事件，但均与疫苗接种无关。
RTS,S/AS01和RTS,S/AS02疟疾疫苗观察到的大多数不良事件在对照组中也有报告，且其他疫苗也有类似情况。因此，作者得出结论，RTS,S/AS01和RTS,S/AS02疟疾疫苗均是安全的。
