Phase Ⅳ Clinical Trial of Recombinant Hepatitis E Vaccine（Hecolin®）

Hepatitis E Clinical Trial

Official title:

Evaluation of Safety and Immunogenicity of Recombinant (E. Coli) Hepatitis E Vaccine（Hecolin®） in Seniors Aged Over 65 Years

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02189603
• Other study ID #: PRO-HE-05
• Status: Completed
• Phase: Phase 4
• Start date: June 2014
• Est. completion date: December 7, 2015

Study information

• Verified date: August 2018
• Source: Xiamen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine the safety and immunogenicity of the recombinant hepatitis E vaccine in people older than 65 years, and evaluate the efficacy of hepatitis E vaccine in this population.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 601
• Est. completion date: December 7, 2015
• Est. primary completion date: December 7, 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 16 Years and older

Eligibility

Inclusion Criteria:

• Healthy people aged over 16 years old at the time of the first vaccination, normal intelligence and agree to sign the informed consent form.

• Healthy subjects as established by medical history and history-oriented clinical examination before entering into the study.

• Subjects will reside in the study region in the next 7 months.

• Free of history of hepatitis E.

• Can comply with the request of study.

• Axillary temperature is below 37 degree centigrade.

Exclusion Criteria:

For dose 1:

• receiving other vaccine or immunoglobulin within two weeks;

• Having serious 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, genetic defect, HIV or other factors;

• Congenital malformation, eccyliosis or severe chronic 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.

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis E

Intervention

Biological:
• Recombinant (E. Coli) Hepatitis E Vaccine

Locations

Country	Name	City	State
China	Center for disease control and prevention in Xiamen haicang district	Xiamen	Fujian

Sponsors (3)

Lead Sponsor	Collaborator
Jun Zhang	Xiamen Center for Disease Control and Prevention, Xiamen Innovax Biotech Co., Ltd

Country where clinical trial is conducted

China, 

References & Publications (1)

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 adults: a large-scale, randomised, double-blind placebo-controlled, phase 3 trial. Lancet. 2010 Sep 11;376(9744):895-902. doi: 10.1016/S0140-6736(10)61030-6. Epub 2010 Aug 20. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants with Serious and Non-Serious Adverse Events	Any adverse events reported within one month post each vaccination would be recorded, any serious adverse events reported throughout the study would be recorded.	From month 0-7
Secondary	anti-HEV IgG seropositive rate		at month 7
Secondary	GMT of anti-HEV IgG	Serum sample would be collected at month 7, and geometric mean titer of anti-HEV IgG would be tested	7 month after first vaccination