Phase Ⅳ Clinical Trial of Recombinant Hepatitis E Vaccine(Hecolin®)
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ClinicalTrials.gov Identifier: NCT02189603 |
Recruitment Status :
Completed
First Posted : July 14, 2014
Last Update Posted : August 17, 2018
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Condition or disease | Intervention/treatment | Phase |
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Hepatitis E | Biological: Recombinant (E. Coli) Hepatitis E Vaccine | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 601 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Prevention |
Official Title: | Evaluation of Safety and Immunogenicity of Recombinant (E. Coli) Hepatitis E Vaccine(Hecolin®) in Seniors Aged Over 65 Years |
Study Start Date : | June 2014 |
Actual Primary Completion Date : | December 7, 2015 |
Actual Study Completion Date : | December 7, 2015 |

Arm | Intervention/treatment |
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Experimental: Senior group(over 65 years old)-HE
Anti-HEV IgG seronegative participants over 65 years old were enrolled. Hepatitis E vaccine, containing 30mcg of HEV239 recombinant antigen adsorbed to alum adjuvant suspended in 0.5ml phosphate buffer, was given at 0, 1, 6m for three doses.
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Biological: Recombinant (E. Coli) Hepatitis E Vaccine
Other Name: Hecolin® |
Active Comparator: Younger groups(16-65 years old)
Participants aged 16-65 years old were enrolled. Hepatitis E vaccine, containing 30mcg of HEV239 recombinant antigen adsorbed to alum adjuvant suspended in 0.5ml phosphate buffer, was given at 0, 1, 6m for three doses.
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Biological: Recombinant (E. Coli) Hepatitis E Vaccine
Other Name: Hecolin® |
No Intervention: Senior group(over 65 years old)-Cont
Anti-HEV IgG seropositive participants over 65 years old were enrolled. This is the safety control group, without any intervention.
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- Number of Participants with Serious and Non-Serious Adverse Events [ Time Frame: From month 0-7 ]Any adverse events reported within one month post each vaccination would be recorded, any serious adverse events reported throughout the study would be recorded.
- anti-HEV IgG seropositive rate [ Time Frame: at month 7 ]
- GMT of anti-HEV IgG [ Time Frame: 7 month after first vaccination ]Serum sample would be collected at month 7, and geometric mean titer of anti-HEV IgG would be tested

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Ages Eligible for Study: | 16 Years and older (Child, Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02189603
China, Fujian | |
Center for disease control and prevention in Xiamen haicang district | |
Xiamen, Fujian, China, 361000 |
Responsible Party: | Jun Zhang, professor,Xiamen University, Xiamen University |
ClinicalTrials.gov Identifier: | NCT02189603 |
Other Study ID Numbers: |
PRO-HE-05 |
First Posted: | July 14, 2014 Key Record Dates |
Last Update Posted: | August 17, 2018 |
Last Verified: | August 2018 |
hepatitis E Immunogenicity vaccine safety |
Hepatitis A Hepatitis E Hepatitis Liver Diseases Digestive System Diseases Hepatitis, Viral, Human |
Virus Diseases Infections Enterovirus Infections Picornaviridae Infections RNA Virus Infections |