Hepatitis E Clinical Trial
Official title:
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.
Status | Completed |
Enrollment | 60 |
Est. completion date | August 2016 |
Est. primary completion date | April 2016 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 16 Years to 65 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
China | Jiangsu Provincial Center for Diseases Control and Prevention | Nanjing | Jiangsu |
Lead Sponsor | Collaborator |
---|---|
Jiangsu Province Centers for Disease Control and Prevention | Changchun Institute of Biological Products Co., Ltd. |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Occurrence of adverse reactions after vaccination | Occurrence of adverse reactions within 7 days after each vaccination with the Recombinant Hepatitis E vaccine. | within 7 days after each vaccination | Yes |
Primary | The geometric mean concentration of antibody against Hepatitis E responses to the Hepatitis E vaccine | Antibody against Hepatitis E responses to the Hepatitis E vaccine at 7 months after the first vaccination | 7 months after the first vaccination | No |
Secondary | Occurrence of adverse events after each vaccination | Occurrence of adverse events within 28 days after each vaccination with the Hepatitis E vaccine. | within 28 days after each vaccination | Yes |
Secondary | Occurrence of serious adverse events after the 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 | Yes |
Secondary | The positive rates of antibody against Hepatitis E responses to the Hepatitis E vaccine. | 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 | No |
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