Yu-Feng Cao1, Hong Tao2, Yue-Mei Hu2, Cheng-Bo Shi3, Xing Wu4, Qi Liang2, Chun-Ping Chi3, Li Li3, Zheng-Lun Liang4, Ji-Hong Meng5, Feng-Cai Zhu6, Zhao-Hui Liu7, Xin-Ping Wang8. 1. College of Veterinary Medicine, Jilin University, 5333 Xian Road, Changchun 130062, Jilin, China; Changchun Institute of Biological Products Co. Ltd., 3456 Xian Road, Changchun 130062, Jilin, China. 2. Jiangsu Provincial Center for Disease Control and Prevention, Nanjing 210009, Jiangsu, China. 3. Changchun Institute of Biological Products Co. Ltd., 3456 Xian Road, Changchun 130062, Jilin, China. 4. National Institutes for Food and Drug Control, 100050 Beijing, China. 5. Department of Microbiology and Immunology, Southeast University School of Medicine, Nanjing 210009, Jiangsu, China. 6. Jiangsu Provincial Center for Disease Control and Prevention, Nanjing 210009, Jiangsu, China. Electronic address: jszfc@vip.sina.com. 7. Changchun Institute of Biological Products Co. Ltd., 3456 Xian Road, Changchun 130062, Jilin, China. Electronic address: lzh63@163.com. 8. College of Veterinary Medicine, Jilin University, 5333 Xian Road, Changchun 130062, Jilin, China; Key Laboratory for Zoonosis, Ministry of Education, and Institute for Zoonosis of Jilin University, Changchun 130062, Jilin, China. Electronic address: wangxp88@hotmail.com.
Abstract
BACKGROUND: This study aimed to evaluate the safety and tolerability for variable dosages of a novel hepatitis E vaccine p179. METHODS: The randomized open-label parallel control phase 1 clinical trial enrolled 120 eligible participants aged 16-65years in Jiangsu Province, China. The experimental groups were randomized to receive different dosages of 20μg, 30μg, and 40μg Hepatitis E Virus (HEV) p179 vaccines, with the 30μgHEV vaccine p239 Hecolin as control, and vaccinated at 0, 1 and 6month intervals. Participants were observed for solicited local and systemic adverse reactions (ARs) occurring within 7days after each vaccination, and any serious adverse events (SAEs) occurring within 6months post-vaccination. Blood samples were collected from participants 3days before and after each injection, to determine the blood routine and serum biochemical indexes. RESULTS: The solicited local ARs incidence in experimental groups were significantly lower than that of the control group (P=0.027). The difference between solicited total and systemic ARs incidence of experimental groups and the control group were not significant (P>0.05). Similar patterns were observed when the analyses were performed on the group having ARs of varying grades and symptoms. All changes in blood biochemical indexes and routine blood tests before and after different vaccinations were mild (grade 1) or moderate (grade 2), and the difference in experimental groups and the control group were not statistically significant. No vaccine related SAEs occurred in any of the subjects during the study. CONCLUSION: Three different dosages of HEV p179 vaccine were deemed safe and well tolerated. No vaccine-associated SAEs were identified, and the 30μg dosage formulation was selected for further investigation for efficacy. Clinical trials registration number: 2012L01657.
RCT Entities:
BACKGROUND: This study aimed to evaluate the safety and tolerability for variable dosages of a novel hepatitis E vaccine p179. METHODS: The randomized open-label parallel control phase 1 clinical trial enrolled 120 eligible participants aged 16-65years in Jiangsu Province, China. The experimental groups were randomized to receive different dosages of 20μg, 30μg, and 40μg Hepatitis E Virus (HEV) p179 vaccines, with the 30μgHEV vaccine p239 Hecolin as control, and vaccinated at 0, 1 and 6month intervals. Participants were observed for solicited local and systemic adverse reactions (ARs) occurring within 7days after each vaccination, and any serious adverse events (SAEs) occurring within 6months post-vaccination. Blood samples were collected from participants 3days before and after each injection, to determine the blood routine and serum biochemical indexes. RESULTS: The solicited local ARs incidence in experimental groups were significantly lower than that of the control group (P=0.027). The difference between solicited total and systemic ARs incidence of experimental groups and the control group were not significant (P>0.05). Similar patterns were observed when the analyses were performed on the group having ARs of varying grades and symptoms. All changes in blood biochemical indexes and routine blood tests before and after different vaccinations were mild (grade 1) or moderate (grade 2), and the difference in experimental groups and the control group were not statistically significant. No vaccine related SAEs occurred in any of the subjects during the study. CONCLUSION: Three different dosages of HEV p179 vaccine were deemed safe and well tolerated. No vaccine-associated SAEs were identified, and the 30μg dosage formulation was selected for further investigation for efficacy. Clinical trials registration number: 2012L01657.
Authors: Jodie Dionne-Odom; Gabriella D Cozzi; Ricardo A Franco; Basile Njei; Alan T N Tita Journal: Am J Obstet Gynecol Date: 2021-09-10 Impact factor: 8.661