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

NCT ID: NCT01865968

Last Updated: 2015-05-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 239 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-10-31
• Study Completion Date: 2012-09-30

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.

Conditions

Hepatitis A

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Inactivated HAV vaccine

Intervention Type: BIOLOGICAL

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.

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.

Group Type: ACTIVE_COMPARATOR

Live attenuated HAV vaccine

Intervention Type: BIOLOGICAL

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.

Two-dose 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.

Group Type: EXPERIMENTAL

Inactivated HAV vaccine

Intervention Type: BIOLOGICAL

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.

Interventions

Inactivated HAV vaccine

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.

Intervention Type: BIOLOGICAL

Live attenuated HAV vaccine

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.

Intervention Type: BIOLOGICAL

Other Intervention Names

Inactivated hepatitis A vaccines; Live attenuated hepatitis A vaccines

Eligibility Criteria

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

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 25 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sinovac Biotech Co., Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hui Zhuang, Ph.D, MD

Role: PRINCIPAL_INVESTIGATOR

Medical school of Peking University

Locations

Nanchang Center for Disease prevention and Control

Nanchang, Jiangxi, China

Countries

China

References

Liu XE, Chen HY, Liao Z, Zhou Y, Wen H, Peng S, Liu Y, Li R, Li J, Zhuang H. Comparison of Immunogenicity Between Inactivated and Live Attenuated Hepatitis A Vaccines Among Young Adults: A 3-Year Follow-up Study. J Infect Dis. 2015 Oct 15;212(8):1232-6. doi: 10.1093/infdis/jiv213. Epub 2015 May 12.

Reference Type: DERIVED

PMID: 25969561 (View on PubMed)

Other Identifiers

PRO-HA-4009

Identifier Type: -

Identifier Source: org_study_id