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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sinovac Biotech Co., Ltd
ClinicalTrials.gov Identifier:
NCT00534885
First received: September 24, 2007
Last updated: April 25, 2016
Last verified: November 2015
  Purpose

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 annually in the next 5 years for blood sampling and assessment of immune persistence induced by vaccination.


Condition Intervention Phase
Hepatitis A
Biological: Healive® Lot 1
Biological: Healive® Lot 2
Biological: Healive® Lot 3
Biological: Havrix
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Sinovac Biotech Co., Ltd:

Primary Outcome Measures:
  • Anti-HAV titer [ Time Frame: 7 months after the first dose ] [ Designated as safety issue: No ]
    To evaluate the immune responses to the inactivated hepatitis A vaccine by detecting the anti-HAV titer using microparticle enzyme immunoassay (MEIA) assay.


Secondary Outcome Measures:
  • Solicited adverse reactions (AE): local reactions and systematic reactions [ Time Frame: 72 hours after each injection ] [ Designated as safety issue: Yes ]
    Solicited AEs were recorded until 72 hours after each injection

  • Unsolicited adverse reactions (AE) [ Time Frame: 7 months after the first dose ] [ Designated as safety issue: Yes ]
    Unsolicited AEs were recorded until month 7

  • 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 after the first dose ] [ Designated as safety issue: No ]
    Blood samples were collected at day 0, month 1, 6, 7, 18, 30, 42, 54, 66 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)


Enrollment: 400
Study Start Date: March 2006
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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 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.

  Eligibility

Ages Eligible for Study:   12 Months to 10 Years   (Child)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00534885

Locations
China, Jiangsu
Changzhou City Center for Disease Control and Prevention
Changzhou, Jiangsu, China, 213003
Sponsors and Collaborators
Sinovac Biotech Co., Ltd
Investigators
Principal Investigator: Wen-Yu Chen Changzhou City Centre for Diseases Control and Prevention
  More Information

Responsible Party: Sinovac Biotech Co., Ltd
ClinicalTrials.gov Identifier: NCT00534885     History of Changes
Other Study ID Numbers: PRO-HA-4006  PRO-HA-4008 (5Y follow-up) 
Study First Received: September 24, 2007
Last Updated: April 25, 2016
Health Authority: China: Food and Drug Administration

Keywords provided by Sinovac Biotech Co., Ltd:
inactivated hepatitis A vaccine
Healive
safety
immunogenicity
immune persistence

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Vaccines
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 27, 2016