Hepatitis E Clinical Trial
Official title:
A Phase 3, Randomized, Double-blind, Placebo (Hepatitis B Vaccine) Controlled Clinical Trial of Recombinant (E. Coli) Hepatitis E Vaccine
Verified date | July 2020 |
Source | Xiamen University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The primary purpose of this study is to determine whether the preventive hepatitis E are
effective in the prevention of hepatitis E occurring at least 30 days after the
administration of the third dose of vaccine.
The secondary purpose of this study is to to evaluate the safety and immunogenicity and
immunopersistence of the study vaccine.
The initial study is planed to be ended on month 19 and the results were analysed and used
for registration purpose. The extended study will be continued to assess the long-term
efficacy, immunogenicity and safety.
Status | Completed |
Enrollment | 112604 |
Est. completion date | October 2017 |
Est. primary completion date | October 2017 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 16 Years to 65 Years |
Eligibility |
Inclusion Criteria: - Healthy people aged from 16 years to 65 years old at the time of the first vaccination, normal intelligence and agree to sign the informed consent form. - Subjects will reside in the study region in the next 19 months. - Free of history of hepatitis B or hepatitis E. - Can comply with the request of study. - Axillary temperature is below 37 degree centigrade. Exclusion Criteria: For dose 1: - Having other vaccine or immunoglobulin within two weeks; - Having allergic history to vaccine and medicine - Eclampsia, epilepsy, encephalopathy and history of mental disease or family; - Thrombocytopenia or other disturbance of blood coagulation which would lead to muscle injection taboo; - Fixed or suspected deficiency of immunologic function, containing immunosuppressant treatment(radiation therapy, chemical treatment, steroid hormone, antimetabolites, cytotoxic drugs), genetic defect(e.g. fabism), HIV or other factors; - congenital malformation, eccyliosis or severe chronic disease(e.g. Down Syndrome, diabetes, sickle cell anemia or mental disease); - fixed or suspected other disease including fever, active infection, liver and kidney disease, angiocardiopathy, malignancy, acute and chronic disease; - joining other clinical study undergoing; - women pregnant or in lactation. For dose 2 or 3: - Severe allergy for dose 1 or 2; - Severe adverse reaction associated with last vaccination; - New occurrence of symptoms meet dose 1 exclusion criteria after the first dose. |
Country | Name | City | State |
---|---|---|---|
China | Dongtai Center for Disease Control and Prevention | Dongtai | Jiangsu |
Lead Sponsor | Collaborator |
---|---|
Xiamen University | Beijing Wantai Biological Pharmacy Enterprise Co., Ltd., Jiangsu Provincial Center for Disease Control and Prevention, National Institute of Diagnostics and Vaccine Development in infectious disease, Xiamen Innovax Biotech Co., Ltd |
China,
He S, Miao J, Zheng Z, Wu T, Xie M, Tang M, Zhang J, Ng MH, Xia N. Putative receptor-binding sites of hepatitis E virus. J Gen Virol. 2008 Jan;89(Pt 1):245-249. doi: 10.1099/vir.0.83308-0. — View Citation
Li S, Tang X, Seetharaman J, Yang C, Gu Y, Zhang J, Du H, Shih JW, Hew CL, Sivaraman J, Xia N. Dimerization of hepatitis E virus capsid protein E2s domain is essential for virus-host interaction. PLoS Pathog. 2009 Aug;5(8):e1000537. doi: 10.1371/journal.ppat.1000537. Epub 2009 Aug 7. — View Citation
Li SW, Zhang J, He ZQ, Gu Y, Liu RS, Lin J, Chen YX, Ng MH, Xia NS. Mutational analysis of essential interactions involved in the assembly of hepatitis E virus capsid. J Biol Chem. 2005 Feb 4;280(5):3400-6. Epub 2004 Nov 22. — View Citation
Li SW, Zhang J, Li YM, Ou SH, Huang GY, He ZQ, Ge SX, Xian YL, Pang SQ, Ng MH, Xia NS. A bacterially expressed particulate hepatitis E vaccine: antigenicity, immunogenicity and protectivity on primates. Vaccine. 2005 Apr 22;23(22):2893-901. — View Citation
Wu T, Huang SJ, Zhu FC, Zhang XF, Ai X, Yan Q, Wang ZZ, Yang CL, Jiang HM, Liu XH, Guo M, Du HL, Ng MH, Zhang J, Xia NS. Immunogenicity and safety of hepatitis E vaccine in healthy hepatitis B surface antigen positive adults. Hum Vaccin Immunother. 2013 N — View Citation
Wu T, Zhu FC, Huang SJ, Zhang XF, Wang ZZ, Zhang J, Xia NS. Safety of the hepatitis E vaccine for pregnant women: a preliminary analysis. Hepatology. 2012 Jun;55(6):2038. doi: 10.1002/hep.25522. — View Citation
Zhang J, Gu Y, Ge SX, Li SW, He ZQ, Huang GY, Zhuang H, Ng MH, Xia NS. Analysis of hepatitis E virus neutralization sites using monoclonal antibodies directed against a virus capsid protein. Vaccine. 2005 Apr 22;23(22):2881-92. — View Citation
Zhang J, Liu CB, Li RC, Li YM, Zheng YJ, Li YP, Luo D, Pan BB, Nong Y, Ge SX, Xiong JH, Shih JW, Ng MH, Xia NS. Randomized-controlled phase II clinical trial of a bacterially expressed recombinant hepatitis E vaccine. Vaccine. 2009 Mar 13;27(12):1869-74. doi: 10.1016/j.vaccine.2008.12.061. Epub 2009 Jan 23. — View Citation
Zhang J, Zhang XF, Zhou C, Wang ZZ, Huang SJ, Yao X, Liang ZL, Wu T, Li JX, Yan Q, Yang CL, Jiang HM, Huang HJ, Xian YL, Shih JW, Ng MH, Li YM, Wang JZ, Zhu FC, Xia NS. Protection against hepatitis E virus infection by naturally acquired and vaccine-induc — View Citation
Zhu FC, Huang SJ, Wu T, Zhang XF, Wang ZZ, Ai X, Yan Q, Yang CL, Cai JP, Jiang HM, Wang YJ, Ng MH, Zhang J, Xia NS. Epidemiology of zoonotic hepatitis E: a community-based surveillance study in a rural population in China. PLoS One. 2014 Jan 31;9(1):e8715 — View Citation
Zhu FC, Zhang J, Zhang XF, Zhou C, Wang ZZ, Huang SJ, Wang H, Yang CL, Jiang HM, Cai JP, Wang YJ, Ai X, Hu YM, Tang Q, Yao X, Yan Q, Xian YL, Wu T, Li YM, Miao J, Ng MH, Shih JW, Xia NS. Efficacy and safety of a recombinant hepatitis E vaccine in healthy — View Citation
* Note: There are 11 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Rate of confirmed hepatitis E cases | One year since one month post the third injection | ||
Secondary | IgG anti-HEV seroconversion rate | On one month post the third injection | ||
Secondary | Persistency of IgG anti-HEV | One year |
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