International Centre for Diarrhoeal Disease Research Bangladesh (icddr,b), Dhaka, Bangladesh; Department of Health Research Methods, Evidence and Impact, Faculty of Health Sciences, McMaster University, Hamilton, Canada.
International Centre for Diarrhoeal Disease Research Bangladesh (icddr,b), Dhaka, Bangladesh.
Vaccine. 2024 Oct 3;42(23):126063. doi: 10.1016/j.vaccine.2024.06.030. Epub 2024 Jun 18.
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 Meningo (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 Meningo 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.
脑膜炎球菌病是由脑膜炎奈瑟菌或脑膜炎球菌引起的。 每年，全球约有 120 万人受到影响，约有 12 万人死于脑膜炎。 该疾病可以通过一剂脑膜炎球菌疫苗来预防。 我们进行了一项随机、观察者设盲、非劣效性试验，以评估和比较局部脑膜炎球菌多糖疫苗'Ingovax ACWY'（试验）与印度批准的脑膜炎球菌多糖疫苗 Quadri Meningo（对照）的免疫原性和安全性。 共有 88 名健康成年人（18-45 岁）以 1:1 的比例随机分为两组，每组接受一剂皮下疫苗。 所有参与者均随访至接种后三个月。 在接种前和接种后一个月采集血液用于临床参数（血液学和生物化学）和血清杀菌试验（SBA）。 在接种后 6 天内评估有症状的不良事件（AE），并在整个随访期间监测无症状的 AE。 两组之间的 AE 发生率没有显著差异。 最常见的有症状 AE 是注射部位疼痛。 未报告严重 AE。 试验疫苗和对照疫苗的血清转化率以及接种前后 SBA 几何平均滴度（GMT）均无显著差异（p<0.05）。 试验疫苗和对照疫苗的接种后 GMT 比值（GMR）分别为血清组 A、C、W135 和 Y 的 0.9、1、1.29 和 0.85。 对于所有血清组，GMR 的 95%CI 下限均大于预先设定的 0.5 非劣效性边界，表明 Ingovax ACWY 与 Quadri Meningo 疫苗相似。 我们观察到 Ingovax ACWY 的免疫原性和安全性不劣于对照疫苗。 在当地生产多糖 ACWY 疫苗的能力将进一步为孟加拉国的疫苗领域建立能力。
