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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

601 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-06-30

Study Completion Date

2015-12-07

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Study on the Recombinant Hepatitis E Vaccine (Escherichia Coli) (Accelerated Vaccination Schedule)

NCT03168412

Hepatitis E

COMPLETED PHASE4

Clinical Trial of Recombinant Hepatitis E Vaccine

NCT01014845

Hepatitis E

COMPLETED PHASE3

Safety and Immunogenicity Study of Thiomersal-free Hepatitis E Vaccine in People Ages 16 Years and Above

NCT06564116

Hepatitis E

COMPLETED PHASE4

Immunogenicity and Safety of Co-immunization With Cecolin and Hecolin

NCT05415345

Human Papilloma Virus Infection Type 16 Human Papilloma Virus Infection Type 18 Hepatitis E Virus Infection

UNKNOWN PHASE4

An Immuno-bridging Study of a Nonavalent HPV Vaccine (E.Coli) in Healthy Population Aged 9-17 vs Aged 18-26 Years Old

NCT05056402

Cervical Cancer Condylomata Acuminata

ACTIVE_NOT_RECRUITING PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hepatitis E

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Recombinant (E. Coli) Hepatitis E Vaccine

Intervention Type BIOLOGICAL

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.

Group Type ACTIVE_COMPARATOR

Recombinant (E. Coli) Hepatitis E Vaccine

Intervention Type BIOLOGICAL

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Recombinant (E. Coli) Hepatitis E Vaccine

Intervention Type BIOLOGICAL

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Hecolin®

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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;

Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes