Am J Trop Med Hyg. 2013 Dec;89(6):1058-1065. doi: 10.4269/ajtmh.13-0304. Epub 2013 Nov 4.
Immunogenicity and safety of a recombinant, live-attenuated, tetravalent dengue disease vaccine (CYD-TDV) was evaluated in children/adolescents in Brazil. In this observer-blind, placebo-controlled, phase II single-center study, children/adolescents (ages 9-16 years) were randomized to receive CYD-TDV or placebo at 0, 6, and 12 months. Immunogenicity was assessed using a 50% plaque neutralization test. Overall, 150 participants were enrolled (CYD-TDV: N = 100; placebo: N = 50). Injection site pain and headache were the most common solicited injection site and systemic reactions. Unsolicited adverse events (AEs) and serious AEs were similar between groups. No serious AEs were vaccine-related. Geometric mean titers against all dengue virus serotypes increased with CYD-TDV vaccination and were 267, 544, 741, and 432 1/dil for serotypes 1-4, respectively, after dose 3, representing a mean fold increase from baseline of 5, 6, 6, and 20, respectively. CYD-TDV vaccination elicited a neutralizing antibody response against serotypes 1-4 and was well-tolerated in children/adolescents in a dengue-endemic region.
在巴西，一项评估重组、减毒、四价登革热疫苗（CYD-TDV）在儿童和青少年中的免疫原性和安全性的观察者盲、安慰剂对照、II 期单中心研究中，将儿童和青少年（9-16 岁）随机分为 CYD-TDV 组或安慰剂组，分别于 0、6 和 12 个月进行接种。采用 50%蚀斑减少中和试验评估免疫原性。共纳入 150 名参与者（CYD-TDV：N=100；安慰剂：N=50）。最常见的局部和全身不良反应为注射部位疼痛和头痛。两组的不良事件（AE）和严重 AE 发生率相似。无严重 AE 与疫苗相关。接种 CYD-TDV 后，针对所有登革热病毒血清型的几何平均滴度均升高，第 3 剂后分别为 1、2、3 和 4 血清型的 267、544、741 和 432 1/稀释度，分别代表相对于基线的平均倍数增加为 5、6、6 和 20。CYD-TDV 疫苗接种可诱发针对血清型 1-4 的中和抗体应答，在登革热流行地区的儿童和青少年中具有良好的耐受性。
