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

Phase 4

Completed

• Conditions: Hepatitis A
• Interventions: Biological: Inactivated HAV vaccine; Biological: Live attenuated HAV vaccine

• Registration Number: NCT01865968
• Lead Sponsor: Sinovac Biotech Co., Ltd

Brief Summary

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

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.

Study Timeline

• Study Start: 2008-10
• Primary Completion: 2011-12
• Study Completion: 2012-09
• Status Verified: 2013-05
• Study First Submitted: 2013-05-28
• Study First Submitted QC: 2013-05-28
• Study First Posted: 2013-05-31
• Last Update Submitted: 2015-05-13
• Last Update Posted: 2015-05-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 239

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Two-dose inactivated HAV vaccine	Inactivated HAV vaccine	Healthy undergraduate students aged 16 to 25 years with anti-HAV negative received inactivated HAV vaccine containing 500u/vial with two-dose regimen.
Inactivated HAV vaccine	Inactivated HAV vaccine	Healthy undergraduate students aged 16 to 25 years with anti-HAV negative received inactivated HAV vaccine containing 500u/vial with one-dose regimen.
Live attenuated HAV vaccine	Live attenuated HAV vaccine	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.

Primary Outcome Measures

Name	Time	Method
concentration of antibody to hepatitis A virus	37 months	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Nanchang Center for Disease prevention and Control; 🇨🇳 Nanchang, Jiangxi, China