a Department of Acute Infectious Disease , Sichuan Center for Disease Control and Prevention , Chengdu City , Sichuan , P.R. China.
b Department of Arbovirus Vaccine , National Institutes for Food and Drug Control , Beijing , P.R. China.
Hum Vaccin Immunother. 2019;15(4):828-833. doi: 10.1080/21645515.2018.1549450. Epub 2018 Dec 10.
The large-scale production of a human diploid cell (HDC) vaccine (HDCV) for rabies is limited by several technical challenges. Kanghua Biological Products Co., Ltd., has successfully used microcarrier technology for the large-scale culture of HDCs in bioreactors to develop a lyophilized and purified HDCV. In this blinded, randomized, parallel-group study conducted between July and October 2014 in Mianzhu, Sichuan Province, China, we monitored the safety and immunogenicity of this vaccine in a healthy population vaccinated according to the Essen post-exposure immunization schedule. A hamster kidney cell vaccine was used as the control. Adverse reactions were monitored 0.5, 6, 24, 48, and 72 h post vaccination to assess safety. Neutralizing antibodies in venous blood were measured on day 7, 14, and 72 to evaluate the immunogenicity of the vaccine while follow-up monitoring continued for 1 month. No serious adverse reactions were observed in any volunteer. The incidence rates of systemic and local adverse reactions were, respectively, 10.6% and 2.9% in the test group and 20.0% and 13.6% in the control group. After the third injection, the positive conversion rates of antibodies in the test and control groups were 100% and 98.82%, respectively. In addition, the average antibody titers on day 7, 14, and 42, were respectively, 1.71, 2.72, and 1.29 times higher than those in the control group. These results indicate that HDCV had a better safety profile and higher immunogenicity than the hamster kidney cell rabies vaccine. Trial registration number: 20130602.
狂犬病人类二倍体细胞（HDC）疫苗（HDCV）的大规模生产受到若干技术挑战的限制。康华生物制品有限公司已成功使用微载体技术在生物反应器中大规模培养 HDC，开发出冻干和纯化的 HDCV。在 2014 年 7 月至 10 月期间于中国四川省绵竹市进行的这项盲法、随机、平行组研究中，我们按照 Essen 暴露后免疫程序对健康人群进行疫苗接种，监测了该疫苗的安全性和免疫原性。使用仓鼠肾细胞疫苗作为对照。接种后 0.5、6、24、48 和 72 小时监测不良反应以评估安全性。接种后第 7、14 和 72 天测量静脉血中的中和抗体以评估疫苗的免疫原性，同时继续随访监测 1 个月。任何志愿者均未观察到严重不良反应。实验组全身和局部不良反应的发生率分别为 10.6%和 2.9%，对照组分别为 20.0%和 13.6%。在第三次注射后，实验组和对照组的抗体阳性转化率分别为 100%和 98.82%。此外，实验组抗体滴度在第 7、14 和 42 天的平均值分别比对照组高 1.71、2.72 和 1.29 倍。这些结果表明，HDCV 比仓鼠肾细胞狂犬病疫苗具有更好的安全性和更高的免疫原性。试验注册号：20130602。
