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

Jun Zhang

Status and phase: Completed; Phase 4

Conditions: Hepatitis E

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

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02189603

PRO-HE-05

Details and patient eligibility

About

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.

Enrollment: 601 patients

Sex: All

Ages: 16+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

---

601 participants in 3 patient groups

Senior group(over 65 years old)-HE

Experimental group

Description:

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.

Treatment:

Biological: Recombinant (E. Coli) Hepatitis E Vaccine

Younger groups(16-65 years old)

Active Comparator group

Description:

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.

Treatment:

Biological: Recombinant (E. Coli) Hepatitis E Vaccine

Senior group(over 65 years old)-Cont

No Intervention group

Description:

Anti-HEV IgG seropositive participants over 65 years old were enrolled. This is the safety control group, without any intervention.