Abstract：
Meningococcal disease is caused by Neisseria meningitidis or meningococcus. Every year globally around 1.2 million people are affected and approximately 120,000 deaths occur due to meningitis. The disease can be prevented by a single dose of meningococcal vaccine. We carried out a randomized observer-blinded non-inferiority trial to evaluate and compare the immunogenicity and safety of a local meningococcal polysaccharide vaccine \'Ingovax ACWY\' (test) with Quadri MeningoTM (comparator), an approved meningococcal polysaccharide vaccine in India. A total of 88 healthy adults (18-45 years old) were randomized at a 1:1 ratio in two vaccine groups receiving a single dose vaccine subcutaneously. All participants were followed until three months post-vaccination. Blood for clinical parameters (hematology and biochemistry) and serum bactericidal assay (SBA) was collected prior to vaccination and one-month post-vaccination. Solicited adverse events (AEs) were assessed up to 6 days following vaccination and unsolicited AEs were monitored throughout the follow-up period. There was no significant difference in rates of AE between the two groups. The commonest solicited AE was injection site pain. No serious AEs were reported. There was no significant difference (p<0.05) in seroconversion rate as well as pre and post-vaccination SBA geometric mean titers (GMT)between test and comparator vaccine. The post-vaccination GMT ratio (GMR) of the test and comparator vaccine was found to be 0.9, 1, 1.29, and 0.85 for serogroup A, C, W135, and Y respectively. For all the serogroups, lower limit of 95% CI of the GMR was found to be greater than the pre-defined 0.5 non-inferiority margin suggesting that Ingovax ACWY is similar to Quadri MeningoTM vaccine. We observed the immunogenicity and safety of Ingovax ACWY is non-inferior to comparator vaccine. The development of facilities for manufacturing polysaccharide ACWY vaccines locally will further lead to capacity building in the field of vaccines for Bangladesh.
摘要：
脑膜炎球菌病由脑膜炎奈瑟菌或脑膜炎球菌引起。每年，全球约有120万人受到脑膜炎的影响，约有12万人死亡。该疾病可以通过单剂量的脑膜炎球菌疫苗来预防。我们进行了一项随机观察者盲非劣性试验，以评估和比较局部脑膜炎球菌多糖疫苗“IngovaxACWY”（测试）与QuadriMeningoTM（比较器）的免疫原性和安全性，印度批准的脑膜炎球菌多糖疫苗。总共88名健康成人（18-45岁）以1：1的比例随机分为两个疫苗组，皮下接受单剂量疫苗。对所有参与者进行随访，直到疫苗接种后三个月。在疫苗接种前和疫苗接种后一个月收集用于临床参数(血液学和生物化学)和血清杀菌测定(SBA)的血液。在疫苗接种后长达6天评估诱发的不良事件(AE),并且在整个随访期间监测未经请求的AE。两组之间的AE发生率没有显着差异。最常见的诱发不良事件是注射部位疼痛。未报告严重的AE。测试疫苗和比较疫苗之间的血清转化率以及接种前和接种后SBA几何平均滴度(GMT)没有显著差异(p<0.05)。对于血清群A，测试疫苗和比较疫苗的疫苗接种后GMT比率（GMR）为0.9、1、1.29和0.85，C,分别为W135和Y。对于所有的血清群，发现GMR的95%CI下限大于预定义的0.5非劣效性界限,提示IngovaxACWY与QuadriMeningoTM疫苗相似.我们观察到IngovaxACWY的免疫原性和安全性不劣于比较疫苗。在当地开发生产多糖ACWY疫苗的设施将进一步促进孟加拉国疫苗领域的能力建设。
