Javadekar Bakul, Ghosh Apurba, Kompithra Rajeev Zachariah, Awasthi Shally, Perminova Olga, Romanenko Viktor, Rodnikova Vera, Kharit Susanna, Thollot Yael, Bosch-Castells Valerie, Goldstein Alexander, Dubey Himanshu
Department of Pediatrics, Medical College and SSG Hospital, Baroda, SSG Hospital Campus, Raopura, Vadodara, Gujarat, India.
Institute of Child Health, Kolkata, West Bengal, India.
Indian Pediatr. 2018 Dec 15;55(12):1050-1055.
Evaluation of tolerability, safety and immunogenicity of a two-dose series of a quadrivalent meningococcal polysaccharide diptheria toxoid conjugate (ACYW-D) vaccine in Indian and Russian infants/toddlers.
Open-label, single-arm, phase III multi-national trial.
300 children aged 9-17 months, previously unvaccinated against meningococcal disease from four sites each in India (n=200) and the Russian Federation (n=100).
Two 0.5 mL doses of ACYW-D by intramuscular injection, 3-6 months apart.
Meningococcal antibody titers to serogroups A, C, W-135 and Y, determined using a serum bactericidal assay in the presence of human complement before vaccination and 28 days after the second vaccination. Titers ≥1:8 against either/all of the A, C, W-135 or Y were considered sero-protective.
After dose 2, 95.7-99.5% and 92.9-99.0% of infants/toddlers achieved seroprotection across the four serogroups in India and the Russian Federation, respectively. No immediate adverse events were reported after any dose of ACYW-D. Solicited reactions were reported in 49.2% of participants, and were mainly of Grade 1 severity, and resolved within three days. Unsolicited adverse events were reported in 19.1% of infants: one event (Grade 3 diarrhea, resolving within one day) was considered related to study vaccine. No non-serious adverse events led to premature withdrawal from the study. Four serious adverse events were reported; none were considered related to study vaccine. No deaths occurred during the study.
A two-dose series of ACYW-D vaccine in Indian and Russian children (9-17 month) was well-tolerated with no safety concerns, and induced robust bactericidal antibody responses against the meningococcal serogroups contained in the vaccine.
评估一剂次四价脑膜炎球菌多糖白喉类毒素结合疫苗（ACYW-D）在印度和俄罗斯婴幼儿中的耐受性、安全性和免疫原性。
开放标签、单臂、III期多国试验。
300名9至17个月大的儿童，此前未接种过脑膜炎球菌疫苗，分别来自印度的4个地点（n = 200）和俄罗斯联邦（n = 100）。
通过肌肉注射接种两剂0.5mL的ACYW-D，间隔3至6个月。
在接种疫苗前和第二次接种后28天，使用人补体存在下的血清杀菌试验测定针对A、C、W-135和Y血清群的脑膜炎球菌抗体滴度。针对A、C、W-135或Y中任何一个/所有血清群的滴度≥1:8被认为具有血清保护作用。
在印度和俄罗斯联邦，分别有95.7-99.5%和92.9-99.0%的婴幼儿在接种第2剂疫苗后对4个血清群实现了血清保护。在接种任何一剂ACYW-D后均未报告立即发生的不良事件。49.2%的参与者报告了预期反应，主要为1级严重程度，并在三天内缓解。19.1%的婴幼儿报告了非预期不良事件：1例事件（3级腹泻，一天内缓解）被认为与研究疫苗有关。没有非严重不良事件导致过早退出研究。报告了4例严重不良事件；均不被认为与研究疫苗有关。研究期间未发生死亡。
在印度和俄罗斯9至17个月大的儿童中，一剂次ACYW-D疫苗耐受性良好，无安全问题，并诱导了针对疫苗中所含脑膜炎球菌血清群的强烈杀菌抗体反应。
