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

Primary Purpose

Hepatitis A

Status

Completed

Phase

Phase 4

Locations

China

Study Type

Interventional

Intervention

Inactivated HAV vaccine

Live attenuated HAV vaccine

About this trial

This is an interventional prevention trial for Hepatitis A focused on measuring inactivated HAV vaccine; live attenuated HAV vaccine; immunogenicity; safety

Eligibility Criteria

16 Years - 25 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Nanchang Center for Disease prevention and Control

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Experimental

Arm Label

Inactivated HAV vaccine

Live attenuated HAV vaccine

Two-dose inactivated HAV vaccine

Arm Description

Healthy undergraduate students aged 16 to 25 years with anti-HAV negative received inactivated HAV vaccine containing 500u/vial with one-dose regimen.

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.

Healthy undergraduate students aged 16 to 25 years with anti-HAV negative received inactivated HAV vaccine containing 500u/vial with two-dose regimen.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT01865968

First Posted

May 28, 2013

Last Updated

May 13, 2015

Sponsor

Sinovac Biotech Co., Ltd

1. Study Identification

Unique Protocol Identification Number

NCT01865968

Brief Title

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

Official Title

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.

Study Type

Interventional

2. Study Status

Record Verification Date

May 2013

Overall Recruitment Status

Completed

Study Start Date

October 2008 (undefined)

Primary Completion Date

December 2011 (Actual)

Study Completion Date

September 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Sinovac Biotech Co., Ltd

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hepatitis A

Keywords

inactivated HAV vaccine; live attenuated HAV vaccine; immunogenicity; safety

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

239 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Inactivated HAV vaccine

Arm Type

Experimental

Arm Description

Healthy undergraduate students aged 16 to 25 years with anti-HAV negative received inactivated HAV vaccine containing 500u/vial with one-dose regimen.

Arm Title

Live attenuated HAV vaccine

Arm Type

Active Comparator

Arm Description

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.

Arm Title

Two-dose inactivated HAV vaccine

Arm Type

Experimental

Arm Description

Healthy undergraduate students aged 16 to 25 years with anti-HAV negative received inactivated HAV vaccine containing 500u/vial with two-dose regimen.

Intervention Type

Biological

Intervention Name(s)

Inactivated HAV vaccine

Other Intervention Name(s)

Inactivated hepatitis A vaccines

Intervention Description

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

Intervention Name(s)

Live attenuated HAV vaccine

Other Intervention Name(s)

Live attenuated hepatitis A vaccines

Intervention Description

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.

Primary Outcome Measure Information:

Title

concentration of antibody to hepatitis A virus

Description

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.

Time Frame

37 months

Secondary Outcome Measure Information:

Title

reported side effects and adverse events

Description

After each dose, solicited injection-site and general adverse events (AEs) were recorded for 7 days and unsolicited AEs were recorded for 28 days.

Time Frame

37 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

16 Years

Maximum Age & Unit of Time

25 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Hui Zhuang, Ph.D, MD

Organizational Affiliation

Medical school of Peking University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Nanchang Center for Disease prevention and Control

City

Nanchang

State/Province

Jiangxi

ZIP/Postal Code

330000

Country

China

12. IPD Sharing Statement

Citations:

PubMed Identifier

25969561

Citation

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.

Results Reference

derived

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

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