Original Article
Evaluation of safety and immune efficacy of domestic lyophilized live attenuated varicella vaccine in children aged 1-12 years
Gao Zhao, Wu Zhiwei, Ye Xiangzhong, Li Minjie, Xin Yantao, Li Shengjun, Shen Zhengjun, Su Yupo, Jin Fei, Song Qiaoqiao, Zhao Yuliang, Ma Jingchen
Published 2021-08-25
Cite as Inter J Epidemiol Infect Dis, 2021, 48(4): 296-301. DOI: 10.3760/cma.j.cn331340-20210429-00090
Abstract
ObjectiveTo evaluate the safety and immune efficacy of 1-dose domestic lyophilized live attenuated varicella vaccine in children aged 1-12 years.
MethodsA randomized, double-blind, positive-controlled, non-inferiority clinical trial was conducted in Hebei vaccine clinical research base from October 2018 to December 2020. The subjects were 1 080 children aged 1-12 years, who were assigned in a 1∶1 ratio to receive the test vaccine (Beijing Wantai Biological Pharmacy Enterprise Co., Ltd) and control vaccine (Shanghai Institute of Biological Products Co., Ltd). Adverse reactions within 30 days after vaccination were observed. Before and 30 days after vaccination, 2.5-3.0 mL of venous blood was collected, respectively. The anti-varicella virus antibody was detected by fluorescent antibody to membrane antigen(FAMA), and the positive conversion rate and geometric average titer(GMT) of the antibody were calculated.
ResultsThe antibody positive conversion rate in the experimental group was 96.00%(240/250), which was higher than that of 88.74% in the control group( χ2=9.128, P<0.01). The positive conversion rate(4 times increase) in the experimental group was 92.95%(501/539), which was higher than that of 78.52% in the control group (χ2=45.915, P<0.01). The GMT in the experimental group was 192.42 (167.92-220.50), which was higher than that of 85.65 (73.29-100.09) in the control group(t=7.683, P < 0.01). The proportion of antibody GMT ≥ 1:128 in the experimental group was 61.97%, which was higher than that of 38.33% in the control group( χ2=60.266, P<0.01). The incidence rates of overall adverse reactions were 24.12%(130/539) in experimental group and 26.48%(143/540) in control group, and the difference was not statistically significant(P>0.05). The common local adverse reactions were redness, swelling and pain. No severe adverse reaction happened in both groups.
ConclusionsThe immunogenicity and safety of 1-dose domestic lyophilized live attenuated varicella vaccine in children aged 1-12 years are all good.
Key words:
Chickenpox vaccine; Safety; Immunogenicity; Adverse reaction
Contributor Information
Gao Zhao
Insititute of Vaccine Clinical Research, Hebei Province Center for Disease Control and Prevention, Shijiazhuang 050021, China
Wu Zhiwei
Insititute of Vaccine Clinical Research, Hebei Province Center for Disease Control and Prevention, Shijiazhuang 050021, China
Ye Xiangzhong
Beijing Wantai Biological Pharmacy Enterprise Co., Ltd., Beijing 102206, China
Li Minjie
Insititute of Vaccine Clinical Research, Hebei Province Center for Disease Control and Prevention, Shijiazhuang 050021, China
Xin Yantao
Office of Vaccine Clinical Research, Daming County Center for Disease Control and Prevention, Handan 056900, Hebei, China
Li Shengjun
Beijing Wantai Biological Pharmacy Enterprise Co., Ltd., Beijing 102206, China
Shen Zhengjun
School of Public Health, North China University of Science and Technology, Tangshan 063000, Hebei, China
Su Yupo
Beijing Wantai Biological Pharmacy Enterprise Co., Ltd., Beijing 102206, China
Jin Fei
Insititute of Vaccine Clinical Research, Hebei Province Center for Disease Control and Prevention, Shijiazhuang 050021, China
Song Qiaoqiao
Beijing Wantai Biological Pharmacy Enterprise Co., Ltd., Beijing 102206, China
Zhao Yuliang
Insititute of Vaccine Clinical Research, Hebei Province Center for Disease Control and Prevention, Shijiazhuang 050021, China
Ma Jingchen
Insititute of Vaccine Clinical Research, Hebei Province Center for Disease Control and Prevention, Shijiazhuang 050021, China
