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

Hepatitis A Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00534885
• Other study ID #: PRO-HA-4006
• Secondary ID: PRO-HA-4008 (11
• Status: Completed
• Phase: Phase 4
• Start date: March 2006
• Est. completion date: October 2017

Study information

• Verified date: August 2019
• Source: Sinovac Biotech Co., Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: October 2017
• Est. primary completion date: October 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Months to 10 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A

Intervention

Biological:
• Healive® Lot 1
Inactivated hepatitis A vaccine manufactured by Sinovac Biotech Co., Ltd.; two-dose regimen with 6 months apart
• Healive® Lot 2
Inactivated hepatitis A vaccine manufactured by Sinovac Biotech Co., Ltd.; two-dose regimen with 6 months apart
• Healive® Lot 3
Inactivated hepatitis A vaccine manufactured by Sinovac Biotech Co., Ltd.; two-dose regimen with 6 months apart
• Havrix
Inactivated hepatitis A vaccine manufactured by GlaxoSmithKline Biologicals; two-dose regimen with 6 months apart

Locations

Country	Name	City	State
China	Changzhou City Center for Disease Control and Prevention	Changzhou	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Sinovac Biotech Co., Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anti-HAV titer	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	Solicited adverse reactions (AE): local reactions and systematic reactions	Solicited AEs were recorded until 72 hours after each injection	72 hours after each injection
Secondary	Unsolicited adverse reactions (AE)	Unsolicited AEs were recorded until month 7	7 months after the first dose
Secondary	Change of anti-HAV titer: geometry mean titer(GMT) and seroconversion rate	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