Clinical trial NCT02603055: A Clinical Trial to Evaluate a Recombinant Hepatitis E Vaccine in Healthy Adults
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hepatitis E
Keywords: Safety
immunogenicity
Hepatitis E
Lead sponsor: Jiangsu Province Centers for Disease Control and Prevention
Sponsor class: NETWORK
Collaborators: name: Changchun Institute of Biological Products Co., Ltd.
First posted: 2015-11-11
Enrollment: 60
Sex: ALL
Minimum age (years): 16
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Occurrence of adverse reactions after vaccination
timeFrame: within 7 days after each vaccination
measure: The geometric mean concentration of antibody against Hepatitis E responses to the Hepatitis E vaccine
timeFrame: 7 months after the first vaccination
Secondary outcomes:
measure: Occurrence of adverse events after each vaccination
timeFrame: within 28 days after each vaccination
measure: Occurrence of serious adverse events after the vaccination.
timeFrame: within 12 months after the first vaccination
measure: The positive rates of antibody against Hepatitis E responses to the Hepatitis E vaccine.
timeFrame: 7 months after the first vaccination
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Jiangsu Provincial Center for Diseases Control and Prevention
state: Jiangsu
Study officials:
References: