Choi Ui Yoon, Kim Ki Hwan, Cho Hye-Kyung, Kim Dong Ho, Ma Sang Hyuk, Choi Young Youn, Kim Chun Soo, Capeding Maria Rosario, Kobashi Ilya Angelica Rochin, Kim Hun, Ryu Ji Hwa, Lee Su Jeen, Park Ho Keun, Kim Jong-Hyun
Department of Pediatrics, Eunpyeong St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul 03312, Republic of Korea.
Department of Pediatrics, Incheon St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul 21431, Republic of Korea.
Vaccines (Basel). 2023 Aug 24;11(9):1416. doi: 10.3390/vaccines11091416.
Korean manufacturers have developed a new varicella vaccine, NBP608. This phase 3, randomized, double-blind, multicenter study aimed to compare the immunogenicity and safety of NBP608 in healthy children to those of Varivax (control). Children aged 12 months to 12 years were randomized in a ratio of 1:1 to receive either NBP608 or the control vaccine. Serum samples were obtained before vaccination and within six to eight weeks after vaccination. In total, 499 participants (NBP608, n = 251; control, n = 248) were enrolled. The seroconversion rate (SCR) measured using a FAMA assay was 99.53% in the NBP608 group, and the lower limit of the 95% confidence interval (95% LCL) for the SCR difference (NBP608 minus the control) was 0.52%. This 95% LCL for the difference was higher than the specified non-inferiority margin of -15%. In an assessment using gpELISA, the SCR was 99.53% in the NBP608 group, and the 95% LCL for the SCR difference was 6.5%, which was higher than the specified non-inferiority margin of -15%. There were no significant differences between the NBP608 and control group with respect to the proportions of participants who demonstrated local and systemic solicited AEs. This study indicated that NBP608 had a clinically acceptable safety profile and was not immunologically inferior to Varivax.
韩国制造商研发了一种新的水痘疫苗NBP608。这项3期随机双盲多中心研究旨在比较NBP608在健康儿童中的免疫原性和安全性与Varivax（对照）的免疫原性和安全性。12个月至12岁的儿童按1:1的比例随机分组，分别接受NBP608或对照疫苗。在接种疫苗前以及接种后6至8周采集血清样本。总共招募了499名参与者（NBP608组，n = 251；对照组，n = 248）。使用FAMA检测法测得的NBP608组血清转化率（SCR）为99.53%，SCR差异（NBP608减去对照组）的95%置信区间下限（95% LCL）为0.52%。该差异的95% LCL高于规定的非劣效性界值-15%。在使用gpELISA进行的评估中，NBP608组的SCR为99.53%，SCR差异的95% LCL为6.5%，高于规定的非劣效性界值-15%。在出现局部和全身预期不良事件的参与者比例方面，NBP608组和对照组之间没有显著差异。这项研究表明，NBP608具有临床上可接受的安全性，并且在免疫方面不劣于Varivax。
