A Study to Evaluate the 17-Year Immune Persistence of a Single Dose of Inactivated Hepatitis A Vaccine

NCT07855705 | Completed

• 1 other identifier: PRO-HAV-4013-01
• Study Type: observational
• Target: 105
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this follow-up study is to evaluate the seventeen-year immune persistence of a single dose of inactivated or attenuated alive hepatitis A vaccine in healthy participants.

Conditions

Hepatitis A

Keywords

Hepatitis A; immune persistence; inactivated hepatitis A vaccine

Outcome Measures

Primary Outcomes (2)

• Seropositivity rate of anti-hepatitis A virus (HAV) antibodies in serum at year 17 after vaccination

  Evaluate the immune persistence of anti-HAV antibodies in serum 17 years after a single dose of inactivated or attenuated alive hepatitis A vaccine. Seropositivity is defined as anti-HAV antibody concentration ≥ 20 mIU/mL.

  17 years after vaccination

• Geometric mean concentration (GMC) of anti-hepatitis A virus (HAV) antibodies in serum at year 17 after vaccination

  Evaluate the immune persistence of anti-HAV antibodies in serum 17 years after a single dose of inactivated or attenuated alive hepatitis A vaccine.

  17 years after vaccination

Study Arms (2)

Inactivated HAV vaccine group

Participants who received a single dose of inactivated hepatitis A vaccine in the PRO-HA-4013 trial.

Biological: Inactivated HAV vaccine

Attenuated alive HAV vaccine group

Participants who received a single dose of freeze-dried attenuated alive hepatitis A vaccine in the PRO-HA-4013 trial.

Biological: Attenuated live HAV vaccine

Interventions

Inactivated HAV vaccine BIOLOGICAL

Inactivated hepatitis A vaccine developed by Sinovac Biotech Co., Ltd, per dose containing 250 u antigen, one dose administered in the prior trial.

Inactivated HAV vaccine group

Attenuated live HAV vaccine BIOLOGICAL

Attenuated alive hepatitis A vaccine, per dose containing 6.50 lgCCID50 alive virus, one dose administered in the prior trial.

Attenuated alive HAV vaccine group

Eligibility Criteria

• Age: 18 Years - 22 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Healthy participants who received a single dose of inactivated or live attenuated hepatitis A vaccine in the PRO-HA-4013 trial and were included in the study, aged 18 to 22 years at enrollment.

You may qualify if:

• Participants who were included in the Full Analysis Set (FAS) of the PRO-HA-4013 trial;
• Able to understand and voluntarily sign the informed consent form;
• Able to provide legal identification.

You may not qualify if:

• History of hepatitis A virus infection;
• Receipt of any vaccine containing hepatitis A antigen since participation in the PRO-HA-4013 trial;
• Autoimmune disease or immunodeficiency/immunosuppression;
• Coagulation abnormality (e.g., coagulation factor deficiency, platelet abnormality), or obvious bleeding, hematoma or ecchymosis after prior intramuscular injection or venipuncture;
• Any other condition judged by the investigator to be unsuitable for participation.

Sponsors & Collaborators

• Sinovac Biotech Co., Ltd: lead

Study Sites (1)

Tianjin Center for Disease Control and Prevention

Tianjin, China

Location

MeSH Terms

Conditions

Hepatitis A

Condition Hierarchy (Ancestors)

Hepatitis, Viral, Human; Virus Diseases; Infections; Enterovirus Infections; Picornaviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Study Officials

• Li Lin

  Tianjin Center for Disease Control and Prevention

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 28, 2026
• First Posted: October 2, 2026
• Study Start: January 13, 2026
• Primary Completion: March 9, 2026
• Study Completion: March 9, 2026
• Last Updated: October 2, 2026

Record last verified: 2026-09

Locations

CN (1)