Comparison of Immunogenicity and Safety of Inactivated and Live Attenuated Hepatitis A Vaccines in Young Adults

Study Overview
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Brief Summary
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A phase IV, randomization, single center, controlled clinical trial to compare the safety, immunogenicity,three-year immune persistence of inactivated hepatitis A vaccine (HAV) with one- or two-dose regimen and live attenuated HAV with one-dose regimen in Chinese young adults, and to evaluate the immunogenicity of a booster dose.

Detailed Description
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Healthy undergraduate students aged 16 to 25 years with anti-HAV negative were randomly divided into three groups. Group A and B were administrated with one-dose inactivated and live attenuated hepatitis A vaccines respectively; Group C was immunized with two doses of an inactivated vaccine with 6 months apart. Blood samples were collected at month 1, and 12, 24 and 36 for anti-HAV titers determination. Safety observation in 30 minutes' duration after vaccinations and injection-site reactions and systemic reactions for three consecutive days were recorded to assess the safety of investigational vaccines. At Month 36, subjects who received one dose of inactivated or live attenuated HAV were administrated a booster dose and then were taken blood samples one month later for anti-HAV titers determination.

Official Title
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Phase IV Trial to Compare the Safety, Immunogenicity,Three-year Immune Persistence of Inactivated Hepatitis A Vaccine (HAV) With One- or Two-dose Regimen and Live Attenuated HAV With One-dose Regimen in Chinese Young Adults, and to Evaluate the Immunogenicity of a Booster Dose.

Conditions
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Hepatitis A

Intervention / Treatment
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* Biological: Inactivated HAV vaccine
* Biological: Live attenuated HAV vaccine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy undergraduate students aged 16 to 25 years Sign the informed consent Provide ID Exclusion Criteria: Axillary temperature > 37.0 centigrade at the time of dosing Subject that has a medical history of any of the following: allergic history, or allergic to any ingredient of vaccine Serious adverse reactions to vaccines such as anaphylaxis, hives, respiratory difficulty, angioedema, or abdominal pain Autoimmune disease or immunodeficiency Congenital malformation, developmental disorders or serious chronic diseases (such as Down's syndrome, diabetes, sickle cell anemia or neurological disorders) Bleeding disorder diagnosed by a doctor (e.g. factor deficiency, coagulopathy, or platelet disorder requiring special precautions) or significant bruising or bleeding difficulties with IM injections or blood draws History or family history of convulsions, epilepsy, brain disease and psychiatric History of any blood products within 3 months Administration of any other investigational research agents within 30 days Administration of any live attenuated vaccine within 30 days Administration of subunit or inactivated vaccines within 14 days 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 anti-HBsAg positive anti-HAV positive Pregnancy test result is positive

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 25 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Inactivated HAV vaccine<br>Healthy undergraduate students aged 16 to 25 years with anti-HAV negative received inactivated HAV vaccine containing 500u/vial with one-dose regimen. | Biological: Inactivated HAV vaccine<br>* Hepatitis A vaccine (Healive), 500 u per dose per 0.5 millilitre. Vaccines will be administered with one-dose or two-dose regimen of the arm 6 months apart in the deltoid muscle.<br>* Other names: Inactivated hepatitis A vaccines;|
| Active Comparator: Live attenuated HAV vaccine<br>Healthy undergraduate students aged 16 to 25 years with anti-HAV negative received live attenuated HAV vaccine containing 6.50 lgCCID50/vial with one-dose regimen. | Biological: Live attenuated HAV vaccine<br>* Live attenuated hepatitis A vaccine, 6.50 lgCCID50 per dose per 0.5 millilitre. Vaccines will be administered with one-dose regimen in the deltoid muscle.<br>* Other names: Live attenuated hepatitis A vaccines;|
| Experimental: Two-dose inactivated HAV vaccine<br>Healthy undergraduate students aged 16 to 25 years with anti-HAV negative received inactivated HAV vaccine containing 500u/vial with two-dose regimen. | Biological: Inactivated HAV vaccine<br>* Hepatitis A vaccine (Healive), 500 u per dose per 0.5 millilitre. Vaccines will be administered with one-dose or two-dose regimen of the arm 6 months apart in the deltoid muscle.<br>* Other names: Inactivated hepatitis A vaccines;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| concentration of antibody to hepatitis A virus | Anti-HAV antibody geometric mean concentrations pre-vaccination, and at month 1, and 12, 24 and 36, and 1 months (month 37) after the booster vaccination. | 37 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| reported side effects and adverse events | After each dose, solicited injection-site and general adverse events (AEs) were recorded for 7 days and unsolicited AEs were recorded for 28 days. | 37 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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inactivated HAV vaccine; live attenuated HAV vaccine; immunogenicity; safety