Study on the Long-Term Persistence of Immunity Induced by Inactivated Hepatitis A Vaccine

A 20-Year Study of the Persistence of Immunity in Healthy Children Aged 1-8 Years Induced by Inactivated Hepatitis A Vaccine

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07889219

Enrollment

106

Registered

2026-10-22

Start date

2026-08-02

Completion date

2026-11-30

Last updated

2026-10-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatitis A

Keywords

Hepatitis A, Inactivated hepatitis A vaccine, Immune persistence

Brief summary

This study is a single-center, open-label, controlled study. Its primary objective is to evaluate the 20-year persistence of immunity induced by the inactivated hepatitis A vaccine. At least 106 healthy participants aged 21-28 years will be enrolled. Participants will be selected from individuals who completed the full vaccination course in the PRO-HA-4006 clinical study (Three-Batch Consistency Study of Healive® in Healthy Children Aged 1-8 Years in Changzhou) . After voluntarily providing informed consent, each participant will undergo one venous blood collection of approximately 3.0 mL for hepatitis A antibody testing to assess the persistence of immunity induced by the hepatitis A vaccine.

Interventions

BIOLOGICALHealive®

Healive® developed by Sinovac Biotech Co., Ltd, per dose containing 250 u antigen, two doses administered in the prior trial.

BIOLOGICALHavrix®

The control vaccine (0.5 mL/dose) contained 720 ELISA units (El.U) antigen and 0.25 mg alum with 2-phenoxyethanol as preservative.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

21 Years to 28 Years

Healthy volunteers

Yes

Inclusion criteria

Participants must meet all of the following criteria to be eligible for this study: 1. Healthy participants aged 21-28 years who previously participated in PRO-HA-4006 and completed the full vaccination course; 2. Participants who are able to understand and voluntarily sign the informed consent form; 3. Provision of valid legal identification.

Exclusion criteria

Individuals meeting any of the following criteria will be excluded from this study: 1. History of hepatitis A virus infection; 2. Receipt of any vaccine containing hepatitis A antigen since participation in the PRO-HA-4006 clinical study; 3. Autoimmune disease or immunodeficiency/immunosuppression; 4. Coagulation abnormalities, such as coagulation factor deficiency or platelet abnormalities, or a history of significant bleeding, hematoma, or ecchymosis following intramuscular injection or venipuncture; 5. In the investigator's judgment, any other factor that makes the participant unsuitable for participation in the clinical study.

Design outcomes

Primary

Measure	Time frame	Description
Seropositivity rate and geometric mean concentration (GMC) of hepatitis A antibodies at Year 20 after vaccination.	20 years after vaccination	Evaluate the immune persistence of anti-HAV antibodies in serum 20 years after two doses of inactivated hepatitis A vaccine. Seropositivity is defined as anti-HAV antibody concentration ≥ 20 mIU/mL.

Countries

China

Contacts

CONTACTWenguo Xu

853574402@qq.com+86 18912330198

PRINCIPAL_INVESTIGATORWenguo Xu

Changzhou City Center for Disease Control and Prevention

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Oct 23, 2026