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

Sponsor
Sinovac Biotech Co., Ltd (Industry)
Overall Status
Completed
CT.gov ID
NCT00534885
Collaborator
(none)
400
1
4
139
2.9

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Biological: Healive® Lot 1
  • Biological: Healive® Lot 2
  • Biological: Healive® Lot 3
  • Biological: Havrix
Phase 4

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 Design

Study Type:
Interventional
Actual Enrollment :
400 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, 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
Study Start Date :
Mar 1, 2006
Actual Primary Completion Date :
Oct 1, 2017
Actual Study Completion Date :
Oct 1, 2017

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Anti-HAV titer [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.

Secondary Outcome Measures

  1. Solicited adverse reactions (AE): local reactions and systematic reactions [72 hours after each injection]

    Solicited AEs were recorded until 72 hours after each injection

  2. Unsolicited adverse reactions (AE) [7 months after the first dose]

    Unsolicited AEs were recorded until month 7

  3. Change of anti-HAV titer: geometry mean titer(GMT) and seroconversion rate [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)

Eligibility Criteria

Criteria

Ages Eligible for Study:
12 Months to 10 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Locations

Site City State Country Postal Code
1 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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Sinovac Biotech Co., Ltd
ClinicalTrials.gov Identifier:
NCT00534885
Other Study ID Numbers:
  • PRO-HA-4006
  • PRO-HA-4008 (11 Y follow-up)
First Posted:
Sep 26, 2007
Last Update Posted:
Sep 4, 2019
Last Verified:
Aug 1, 2019
Keywords provided by Sinovac Biotech Co., Ltd
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 4, 2019