The Immunogenicity and Safety of Inactivated and Live Attenuated Hepatitis A Vaccines

Condition(s) targeted: Hepatitis A

Intervention: Attenuated HAV Vaccine, H2 Strain (Biological); Attenuated HAV Vaccine, L-A-1 Strain (Biological); Inactivated HAV Vaccine, Lu8 Strain (Biological); Inactivated HAV Vaccine, TZ84 Strain (Biological)

Phase: Phase 4

Status: Active, not recruiting

Sponsored by: Chinese Academy of Medical Sciences

Official(s) and/or principal investigator(s):
Qihan Li, Ph.D., Study Chair, Affiliation: Institude of Medical Biology, Chinese Academy of Medical Sciences
Jingsi Yang, Study Chair, Affiliation: Institude of Medical Biology, Chinese Academy of Medical Sciences
Qiangming Sun, Ph.D., Principal Investigator, Affiliation: Institude of Medical Biology, Chinese Academy of Medical Sciences
Fubao Ma, Study Director, Affiliation: Jiangsu Provincial Center for Disease Control and Prevention

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.

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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention

Primary outcome: changes of hepatitis A antibody concentration

Secondary outcome: The frequency of all the adverse events in vaccine group and placebo group

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.

Minimum age: 18 Months. Maximum age: 65 Years. Gender(s): Both.

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

Institute of Medical Biology -Chinese Academy of Medical Sciences, Kunming, Yunnan 650118, China

Starting date: September 2013
Last updated: February 4, 2015