Kim Dong Soo, Jang Gwang Cheon, Cha Sung-Ho, Choi Soo-Han, Kim Hwang Min, Kim Ji Hong, Kang Jin Han, Kim Jong-Hyun, Kim Ki Hwan, Bang Joon, Naimi Zulaikha, Bouckenooghe Alain, Bosch-Castells Valérie, Houillon Guy
From the *Yonsei University College of Medicine, Severance Children's Hospital, Seoul, Korea; †National Health Insurance Service Ilsan Hospital, Gyeonggi-do, Korea; ‡KyungHee University Hospital, Seoul, Korea; §Hallym University Dongtan Sacred Heart Hospital, Gyeonggi-do, Korea; ¶Wonju Severance Christian Hospital, Gangwon-do, Korea; ‖Gangnam Severance Hospital, Seoul, Korea; **The Catholic University of Korea Seoul St. Mary's Hospital, Seoul, Korea; ††The Catholic University of Korea St. Vincent's Hospital, Gyeonggi-do, Korea; ‡‡Medical Department, Sanofi Pasteur, Seoul, Korea; §§Global Pharmacovigilance Department and ¶¶Global Medical Affairs, Sanofi Pasteur, Lyon, France; ‖Clinical Department, Sanofi Pasteur, Singapore; and ***Clinical Department, Sanofi Pasteur, Marcy l'Etoile, France.
Pediatr Infect Dis J. 2016 Feb;35(2):e60-4. doi: 10.1097/INF.0000000000000967.
This study evaluated the effect of a booster vaccination of a new, live attenuated, Japanese encephalitis chimeric vaccine (JE-CV). Previously this vaccine has been used as a booster 12 months after priming with an inactivated vaccine and at >24 months after priming with the same JE-CV. This study evaluates the immunogenicity and safety of the JE-CV given at 12-24 months after JE-CV priming.
Phase III, open-label study in the Republic of Korea in which 119 children previously vaccinated with JE-CV at 12-24 months of age received a JE-CV booster at 12-24 months after primary vaccination. JE neutralizing antibody titers were measured using >50% plaque reduction neutralization test prebooster and 1 month postbooster vaccination. Seroprotection (SP) was defined as ≥10 (1/dil). Safety was assessed for 28 days postvaccination by parental reports. Serious adverse events were monitored for 6 months postvaccination.
Antibody persistence was high prebooster (SP rate 93.5%). There was a strong anamnestic response postbooster vaccination, with an SP rate of 100% and a >50-fold increase in geometric mean titer from the prebooster level. Both antibody persistence and the booster response were independent of whether the booster was given at 12-17 or 18-24 months. The safety profile was good and comparable with the primary vaccination; there were no vaccine-related serious adverse events and no deaths.
This study confirms the suitability of a JE-CV booster vaccination at 12-24 months after a primary dose of the same vaccine given at 12-24 months of age in children in the Republic of Korea.
本研究评估了一种新型减毒活日本脑炎嵌合疫苗（JE-CV）加强免疫的效果。此前，该疫苗已在灭活疫苗初免后12个月以及相同JE-CV初免后超过24个月用作加强疫苗。本研究评估了在JE-CV初免后12 - 24个月接种JE-CV的免疫原性和安全性。
在韩国进行的一项III期开放标签研究，119名在12 - 24月龄时曾接种过JE-CV的儿童在初次接种后12 - 24个月接受JE-CV加强免疫。在加强免疫前和加强免疫后1个月使用>50%蚀斑减少中和试验测量JE中和抗体滴度。血清保护（SP）定义为≥10（1/稀释度）。通过家长报告评估接种后28天的安全性。接种后6个月监测严重不良事件。
加强免疫前抗体持久性较高（SP率93.5%）。加强免疫后有强烈的回忆反应，SP率为100%，几何平均滴度较加强免疫前水平增加>50倍。抗体持久性和加强免疫反应均与加强免疫是在12 - 17个月还是18 - 24个月进行无关。安全性良好，与初次接种相当；未出现与疫苗相关的严重不良事件，也无死亡病例。
本研究证实，在韩国儿童中，在12 - 24月龄时初次接种相同疫苗后12 - 24个月进行JE-CV加强免疫是合适的。
