Immunogenicity and Safety of Hepatitis A Among People Aged 18-50 Years Old

Study Overview
=================
Brief Summary
-----------------
This study is conducted among people aged 18-50 in Dandong City, an area with a high incidence of hepatitis A in recent years. 1000 qualified pariticipants with signed informed consent will be screened for anti-HAV antibodies by collecting blood sample of 3ml. One dose of hepatitis A vaccine will be administrated to all the pariticipants. Negative anti-HAV antibodies-negative subjects will recieve the second dose of hepatitis A vaccination, and 400 of them will be randomly selected and assigned to 4 groups with different interval of vaccination(6 month, 18 months, 36 months and 60 months). Blood samples will be collected before vaccination of each dose and on 28 days after each dose of vaccination to anti-HAV antibody test. Safety data will be collected within 28 days after each vaccination with a smartphone mini-program.

Official Title
-----------------
The Immunogenicity and Safety of Different Vaccination Interval of Inactivated Hepatitis A Vaccine in People Aged 18-50 Years, a Phase IV Clinical Trial

Conditions
-----------------
Hepatitis A

Intervention / Treatment
-----------------
* Biological: Healive (hepatitis A vacine(human diploid cell), inactivated)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults aged 18-50; Adults can understand and sign the informed consent form voluntarily; Adults can provide valid and legal identity certificate. Exclusion Criteria: Have suffered from hepatitis A; Previously vaccinated with inactivated hepatitis A vaccine, live attenuated hepatitis A vaccine, or hepatitis A and B combined vaccine; Allergic constitution or have severe allergic reaction to vaccines in the past (such as acute allergic reaction, angioedema, dyspnea, etc.); Pregnant women and lactating women; People suffering from uncontrolled epilepsy and other serious neurological diseases (such as transverse myelitis, Guillain-Barré syndrome, demyelinating diseases, etc.); Patients with fever during vaccination, or acute exacerbation of chronic diseases, or patients with uncontrolled severe chronic diseases, or suffering from acute diseases; Received other research drugs within 30 days before vaccination with the experimental vaccine; Have received a live attenuated vaccine within 14 days before vaccination with the experimental vaccine; Have received subunit or inactivated vaccine within 7 days before vaccination with experimental vaccine; Other conditions that are not suitable for vaccination judged by the researcher.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: immunogenicity group with vaccination interval of 6 month<br> | Biological: Healive (hepatitis A vacine(human diploid cell), inactivated)<br>* The hepatitis A vaccine contains 500 SU inactivated hepatitis A virus per dose in 1mL of aluminum hydroxide solution. For anti-HAV antibody-negative participants, two dose of hepatitis A vaccine will be given with vaccination interval of 6 month, 18 months, 36 months, and 60 months, respectively.<br>|
| Other: immunogenicity group with vaccination interval of 18 month<br> | Biological: Healive (hepatitis A vacine(human diploid cell), inactivated)<br>* The hepatitis A vaccine contains 500 SU inactivated hepatitis A virus per dose in 1mL of aluminum hydroxide solution. For anti-HAV antibody-negative participants, two dose of hepatitis A vaccine will be given with vaccination interval of 6 month, 18 months, 36 months, and 60 months, respectively.<br>|
| Other: immunogenicity group with vaccination interval of 36 month<br> | Biological: Healive (hepatitis A vacine(human diploid cell), inactivated)<br>* The hepatitis A vaccine contains 500 SU inactivated hepatitis A virus per dose in 1mL of aluminum hydroxide solution. For anti-HAV antibody-negative participants, two dose of hepatitis A vaccine will be given with vaccination interval of 6 month, 18 months, 36 months, and 60 months, respectively.<br>|
| Other: immunogenicity group with vaccination interval of 60 month<br> | Biological: Healive (hepatitis A vacine(human diploid cell), inactivated)<br>* The hepatitis A vaccine contains 500 SU inactivated hepatitis A virus per dose in 1mL of aluminum hydroxide solution. For anti-HAV antibody-negative participants, two dose of hepatitis A vaccine will be given with vaccination interval of 6 month, 18 months, 36 months, and 60 months, respectively.<br>|
| Other: safety observation group<br> | Biological: Healive (hepatitis A vacine(human diploid cell), inactivated)<br>* The hepatitis A vaccine contains 500 SU inactivated hepatitis A virus per dose in 1mL of aluminum hydroxide solution. For anti-HAV antibody-negative participants, two dose of hepatitis A vaccine will be given with vaccination interval of 6 month, 18 months, 36 months, and 60 months, respectively.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The seroconversion rate of anti-HAV antibody 28 days after two dose of vaccination of hepatitis A vaccine with an interval of 6 month |  | 28 days after two dose of vaccination of hepatitis A vaccine | 
| Incidence of adverse reaction within 28 days after one dose of vaccination |  | 28 days after one dose of vaccination | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The seroconversion rate of anti-HAV antibody 28 days after two dose of vaccination of hepatitis A vaccine with an interval of 18 month, 36 months, and 60 months |  | 28 days after two dose of vaccination | 
| The seropositive rate, GMC and GMI of anti-HAV antibody 28 days after two dose of vaccination of hepatitis A vaccine with an interval of 6 months, 18 month, 36 months, and 60 months |  | 28th day after two dose of vaccination | 
| The seropositive rate, GMC and GMI of anti-HAV antibody 28 days after one dose of vaccination of hepatitis A vaccine with an interval of 6 months, 18 month, 36 months, and 60 months |  | 28 days after one dose of vaccination | 
| The seropositive rate, GMC and GMI of anti-HAV antibody 28 days after two dose of vaccination of hepatitis A vaccine with an interval of 6 months, 18 month, 36 months, and 60 months among people with underlying conditions |  | 28 days after two dose of vaccination | 
| The seropositive rate of anti-HAV antibody before vaccination |  | before vaccination | 
| Incidence of adverse reaction within 7 days after one dose of vaccination |  | 7 days after one dose of vaccination | 
| Incidence of adverse reaction within 28 days after two dose of vaccination |  | 28 days after two dose of vaccination | 
| Incidence of adverse reaction within 28 days after one dose of vaccination among different group of people |  | 28 days after one dose of vaccination among | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
immunogenicity and safety of vaccine, hepatitis A vaccine, vaccination schedule