Clinical trial NCT01949857: The Immunogenicity and Safety of Inactivated and Live Attenuated Hepatitis A Vaccines
Official title: Phase 4 Clinical Trial to Assess the Safety, Immunogenicity,Three-year Immune Persistence of Inactivated Hepatitis A Vaccine (HAV) and Live Attenuated HAV Vaccine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hepatitis A
Keywords: Hepatitis A
Vaccine
Safety
efficacy
Lead sponsor: Institute of Medical Biology, Chinese Academy of Medical Sciences
Sponsor class: OTHER
Collaborators: name: Jiangsu Province Centers for Disease Control and Prevention
First posted: 2013-09-25
Enrollment: 35000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this Phase 4 trial is to assess the safety, immunogenicity, three-year immune persistence of inactivated hepatitis A vaccine (HAV) and live attenuated HAV vaccine.

Detailed description: Hepatitis A refers to liver inflammation caused by infection with the hepatitis A virus. HAV is is one of the most common hepatitis viruses that can cause hepatitis in China. The data from the phase 1, 2 and 3 trials suggested that both inactivated hepatitis A vaccine and live attenuated hepatitis A vaccine had a clinically acceptable safety and good immunogenicity for healthy Chinese people.

Eligibility criteria: Inclusion Criteria:

* Only subjects fulfilling all of the following criteria will be eligible for the study:

  * People aged from 18 months to 65 years old.
  * The subjects or subjects' guardians are able to understand and sign the informed consent
  * The subjects or subjects' guardians allow to comply with the requirements of the protocol
  * Subjects with temperature \<=37.0°C on axillary setting
  * The subjects have signed informed consent already

Exclusion Criteria:

* Subjects will not be eligible for the study if any of the following criteria is met:

  * Subject who has a medical history of serious disease including Tumor, autoimmune disease, progressive atherosclerosis diseases or complications of diabetes, chronic obstructive pulmonary disease (copd), kidney disease, congestive heart failure etc.
  * Have a history of neurological symptoms or signs
  * Have medical history or family history relating to allergies, seizures, epilepsy, brain and spirit etc.
  * Suffering from serious chronic diseases
  * Suffering from known or suspected of diseases including respiratory diseases, acute infection , mothers have HIV infection, cardiovascular disease, severe hypertension, skin diseases, malignant tumor
  * Allergic to any ingredient in research, history of allergies to any vaccination (always), especially for people allergic to high protein food like eggs and milk
  * Any prior known or suspected damage or abnormal immune function. As for patients who are treated with immune inhibitors or immune enhancer medicine, accept with immunoglobin, blood products and plasma extraction within 3 months
  * Any prior diseases including human immunodeficiency virus infection or related
  * Bleeding constitution or prolong bleeding time situation
  * Accept hepatitis A vaccination within a month
  * Received vaccines, other immune globulin, any research drug injections in the past 4 weeks
  * People who had any acute illness, needed systemic antibiotics or antiviral treatment in the past 7 days
  * Caught a fever with axillary temperature 38°C or higher in past 3 days
  * Take part in another clinical researchers
  * Any medical, psychiatric, social condition, occupational reason or other responsibility that, in the judgment of the investigator, is a contraindication to protocol participation or impairs a volunteer's ability to give informed consent
  * Pregnancy test result is positive

Primary outcomes:
measure: changes of hepatitis A antibody concentration
timeFrame: up to 43 months
Secondary outcomes:
measure: The frequency of all the adverse events in vaccine group and placebo group
timeFrame: up to 43 months
Other outcomes:
Locations:
city: Kunming
country: China
facility: Institute of Medical Biology -Chinese Academy of Medical Sciences
state: Yunnan
Study officials:
affiliation: Institude of Medical Biology, Chinese Academy of Medical Sciences
name: Qihan Li, Ph.D.
role: STUDY_CHAIR
affiliation: Institude of Medical Biology, Chinese Academy of Medical Sciences
name: Jingsi Yang
role: STUDY_CHAIR
affiliation: Institude of Medical Biology, Chinese Academy of Medical Sciences
name: Qiangming Sun, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Jiangsu Provincial Center for Disease Control and Prevention
name: Fubao Ma
role: STUDY_DIRECTOR
References: