Safety, Immunogenicity, and Immune Persistence Study of an Inactivated Hepatitis A Vaccine

August 29, 2019 updated by: Sinovac Biotech Co., Ltd

The Phase Ⅳ Clinical Trial to Evaluate the Safety, Immunogenicity, and Immune Persistence of Three Consecutive Lots of an Inactivated Hepatitis A Vaccine in Healthy Children

A double-blind, randomized and controlled clinical trial was conducted in healthy children aged from 1 to 8 years to evaluate the immunogenicity and safety of three consecutive lots of a preservative-free inactivated hepatitis A vaccine (Healive®).

Participants who completed their primary vaccination were invited to participate in the follow-up phase. Written informed consents were obtained from them. The follow-up study was open-label. These subjects were visited in the next 11 years for blood sampling and assessment of immune persistence induced by vaccination.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The investigated vaccine is an inactivated, adjuvanted and preservative-free hepatitis A vaccine. Each dose contained 250 U HAV antigen in 0.5 milliliter.

Total 400 subjects were enrolled and assigned into four groups, each receiving one of the three lots of Healive® or an established control vaccine at month 0 and 6. Anti-HAV titers were determined at month 1, 6 and 7. Anti-HAV titer over 20 mIU/ml is defined as seroprotection.

After the full immunization schedule, written informed consents were obtained from subjects who would like to participate in the follow-up study. Blood samples of these subjects were collected at month 18, 30, 42, 54, 66, 112,138 after the first injection to evaluate the seroconversion rates (SCRs) and geometric mean concentrations (GMCs) of antibody against hepatitis A virus. Serological results of the follow-up study were then used to explore suitable statistical model for predicting the persistence of hepatitis A vaccine-induced antibodies.

Study Type

Interventional

Enrollment (Actual)

400

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Jiangsu
      • Changzhou, Jiangsu, China, 213003
        • Changzhou City Center for Disease Control and Prevention

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 6 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Health children from 1 to 10 years
  • Not participate in any other trial during the course of the trial
  • Informed consent

Exclusion Criteria:

  • Any history of allergic reactions or convulsions following vaccination
  • Other known or planned vaccination within 1 month prior to the study and during the study period
  • Any chronic illness/disease including virus hepatitis, tuberculosis and epilepsy
  • Presence of any congenital abnormality, upgrowth obstacle
  • Any history/suspicion/presence of neurology and Lunacy
  • Any current or foreseeable use of immunosuppressors (i.e. corticosteroids , immunoglobulins) within 1 month prior to the vaccination and during the period of the study
  • Contraindication to intramuscularly injection due to thrombocytopenia or other bleeding disorders
  • Abnormal ALT
  • Positive markers for anti-HAV and HBV（HBsAg）infection
  • Presence of fever at the time of vaccination, i.e. body temperature (by mouth) > 37.0 centigrade.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1: Healive® Lot 1
Biological: Healive® Lot 1
Inactivated hepatitis A vaccine manufactured by Sinovac Biotech Co., Ltd.; two-dose regimen with 6 months apart
Experimental: 2: Healive® Lot 2
Biological: Healive® Lot 2
Inactivated hepatitis A vaccine manufactured by Sinovac Biotech Co., Ltd.; two-dose regimen with 6 months apart
Experimental: 3: Healive® Lot 3
Biological: Healive® Lot 3
Inactivated hepatitis A vaccine manufactured by Sinovac Biotech Co., Ltd.; two-dose regimen with 6 months apart
Active Comparator: 4: control vaccine (Havrix)
Biological: Havrix
Inactivated hepatitis A vaccine manufactured by GlaxoSmithKline Biologicals; two-dose regimen with 6 months apart

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anti-HAV titer
Time Frame: 7 months after the first dose
To evaluate the immune responses to the inactivated hepatitis A vaccine by detecting the anti-HAV titer using microparticle enzyme immunoassay (MEIA) assay.
7 months after the first dose

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Solicited adverse reactions (AE): local reactions and systematic reactions
Time Frame: 72 hours after each injection
Solicited AEs were recorded until 72 hours after each injection
72 hours after each injection
Unsolicited adverse reactions (AE)
Time Frame: 7 months after the first dose
Unsolicited AEs were recorded until month 7
7 months after the first dose
Change of anti-HAV titer: geometry mean titer(GMT) and seroconversion rate
Time Frame: baseline (day 0), month 1, 6, 7, 18, 30, 42, 54, 66,112,138 after the first dose
Blood samples were collected at day 0, month 1, 6, 7, 18, 30, 42, 54, 66,112, 138 after the first dose to assess the change of long-term immune response. Anti-HAV antibodies were assessed by microparticle enzyme immunoassay (MEIA) assay (cut off: 20 mIU/ml)
baseline (day 0), month 1, 6, 7, 18, 30, 42, 54, 66,112,138 after the first dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sinovac Biotech Co., Ltd

Investigators

  • Principal Investigator: Wen-Yu Chen, Changzhou City Centre for Diseases Control and Prevention

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2006

Primary Completion (Actual)

October 1, 2017

Study Completion (Actual)

October 1, 2017

Study Registration Dates

First Submitted

September 24, 2007

First Submitted That Met QC Criteria

September 24, 2007

First Posted (Estimate)

September 26, 2007

Study Record Updates

Last Update Posted (Actual)

September 4, 2019

Last Update Submitted That Met QC Criteria

August 29, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRO-HA-4006
  • PRO-HA-4008 (11 Y follow-up) (Other Identifier: Sinovac Biotech Co., Ltd)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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