A Clinical Trial to Evaluate a Recombinant Hepatitis E Vaccine in Healthy Adults

August 30, 2016 updated by: Jiangsu Province Centers for Disease Control and Prevention

A Phase Ib Single Center, Randomized, Blinding, Parallel-controlled Clinical Trial to Evaluate the Safety and Immunogenicity of a Recombinant Hepatitis E Vaccine in Healthy Adults Aged 16 to 65 Years Old in China

Hepatitis E is characteristic by sporadic and local epidemic around the world, and mainly infects adults aged 15 to 40 years old, resulting in the infection rate ranged from 1% to 15%. The investigational hepatitis E vaccine is a recombinant aluminium-adjuvant hepatitis E vaccine.

This is a single center, randomized, blinding, parallel-controlled phase Ib clinical trial. This study will determine the safety and immunogenicity of the investigational recombinant hepatitis E vaccine in healthy adults between 16 and 65 years.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China, 210009
        • Jiangsu Provincial Center for Diseases Control and Prevention

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 65 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Aged between 16 and 65 years with normal intelligence.
  • Negative in antibody against hepatitis E test.
  • No plan to go out for a long time within 9 months.
  • Able to understand the content of informed consent and willing to sign the informed consent
  • General good health as established by medical history and physical examination.
  • Able and willing to complete all the secluded study process during the whole study follow-up period.
  • No history of hepatitis B, hepatitis C and hepatitis E(Patients diagnosed as hepatitis B, hepatitis C and hepatitis E by town or above)
  • Axillary temperature ≤37.0°C on the day of enrollment

Exclusion Criteria:

  • Woman who is pregnant, breast-feeding or planning to be pregnant during the study period
  • Allergic history of any vaccination or drugs, or allergic to any ingredient of the Hepatitis E vaccine
  • History of serious adverse reactions after vaccination, such as allergies, urticaria, breathing difficulties, angioneurotic oedema or abdominal pain
  • Autoimmune disease or immunodeficiency
  • Asthma that was unstable and need emergency treatment, hospitalization, oral or intravenous corticosteroid within two years
  • Type I or II diabetes, not including gestational diabetes
  • History of thyroidectomy, or need treatment for thyroid disease in the past 12 months
  • History of serious angioneurotic edema in the past 3 years, or need treatment for it in the past 2 years
  • Severe hypertension, with the blood pressure still more than 150/100 mmHg after drug maintenance treatment
  • Abnormal coagulation function (such as coagulation factor deficiency, coagulation disorders, platelet abnormalities) or coagulation disorders diagnosed by the doctor.
  • Patients who are active or not have a definite cure of malignant tumors, or who may recur in the study period.
  • Epilepsy, not including alcohol epilepsy in the first 3 years abstinence or simple epilepsy without the need of treatment in the past 3 years
  • Asplenia or functional asplenia, or asplenia and splenectomy under any circumstances
  • Guillain Barre Syndrome
  • Prior administration of immunodepressant, cytotoxic or corticosteroids (not including corticosteroid therapy for allergic rhinitis and acute non concurrent dermatitis )treatment in last 6 months
  • Prior administration of immune globulin in last 3 months
  • Prior administration of other research medicines in last 1 month
  • Prior administration of attenuated vaccine in last 1 month
  • Prior administration of subunit or inactivated vaccine in last 14 days, such as pneumococcal Vaccine
  • Current anti-tuberculosis prophylaxis or therapy
  • Fever (axillary temperature 38.0℃) in 3 days before vaccination or any acute disease, systemic application of antibiotics or antiviral therapy in the past five days
  • Unable to comply with the study requirements due to the psychological situation, a past or present history of mental disease, two-stage affective psychosis which were not well controlled in the past two years; mental disease need medical treatment, and have suicidal tendency over the past five years
  • Any condition that in the opinion of the investigators may interfere with the evaluation of study objectives

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 30μg/0.5ml Hepatitis E vaccine
three doses, 30μg/0.5ml per dose
Biological: 30μg/0.5ml Hepatitis E vaccine
three doses, 30μg/0.5ml per dose
Active Comparator: 30μg/0.5ml Recombinant Hepatitis E vaccine
30μg/0.5ml Hepatitis E vaccine developed by Xiamen innovax biotech Co., Ltd. three doses, 30μg/0.5ml per dose
Biological: 30μg/0.5ml Recombinant Hepatitis E vaccine
30μg/0.5ml Hepatitis E vaccine developed by Xiamen innovax biotech Co.,Ltd.,three doses, 30μg/0.5ml per dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Occurrence of adverse reactions after vaccination
Time Frame: within 7 days after each vaccination
Occurrence of adverse reactions within 7 days after each vaccination with the Recombinant Hepatitis E vaccine.
within 7 days after each vaccination
The geometric mean concentration of antibody against Hepatitis E responses to the Hepatitis E vaccine
Time Frame: 7 months after the first vaccination
Antibody against Hepatitis E responses to the Hepatitis E vaccine at 7 months after the first vaccination
7 months after the first vaccination

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Occurrence of adverse events after each vaccination
Time Frame: within 28 days after each vaccination
Occurrence of adverse events within 28 days after each vaccination with the Hepatitis E vaccine.
within 28 days after each vaccination
Occurrence of serious adverse events after the vaccination.
Time Frame: within 12 months after the first vaccination
Occurrence of serious adverse events within 12 months after the first vaccination with the Hepatitis E vaccine.
within 12 months after the first vaccination
The positive rates of antibody against Hepatitis E responses to the Hepatitis E vaccine.
Time Frame: 7 months after the first vaccination
The positive rates of antibody against Hepatitis E responses to the Hepatitis E vaccine at 7 months after the first vaccination.
7 months after the first vaccination

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jiangsu Province Centers for Disease Control and Prevention

Collaborators

Changchun Institute of Biological Products Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2015

Primary Completion (Actual)

April 1, 2016

Study Completion (Actual)

August 1, 2016

Study Registration Dates

First Submitted

November 10, 2015

First Submitted That Met QC Criteria

November 10, 2015

First Posted (Estimate)

November 11, 2015

Study Record Updates

Last Update Posted (Estimate)

September 1, 2016

Last Update Submitted That Met QC Criteria

August 30, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JSVCT025

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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