Immunogenicity and Safety of Hepatitis A Among People Aged 18-50 Years Old

The Immunogenicity and Safety of Different Vaccination Interval of Inactivated Hepatitis A Vaccine in People Aged 18-50 Years, a Phase IV Clinical Trial

This study is conducted among people aged 18-50 in Dandong City, an area with a high incidence of hepatitis A in recent years. 1000 qualified pariticipants with signed informed consent will be screened for anti-HAV antibodies by collecting blood sample of 3ml. One dose of hepatitis A vaccine will be administrated to all the pariticipants. Negative anti-HAV antibodies-negative subjects will recieve the second dose of hepatitis A vaccination, and 400 of them will be randomly selected and assigned to 4 groups with different interval of vaccination(6 month, 18 months, 36 months and 60 months). Blood samples will be collected before vaccination of each dose and on 28 days after each dose of vaccination to anti-HAV antibody test. Safety data will be collected within 28 days after each vaccination with a smartphone mini-program.

Study Overview

• Status: Active, not recruiting
• Conditions: Hepatitis A
• Intervention / Treatment: Biological: Healive (hepatitis A vacine(human diploid cell), inactivated)

• Study Type: Interventional
• Enrollment (Actual): 1092
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Liaoning
    • Shenyang, Liaoning, China
      • Liaoning Center for Disease Control and Prevention

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Adults aged 18-50;
• Adults can understand and sign the informed consent form voluntarily;
• Adults can provide valid and legal identity certificate.

Exclusion Criteria:

• A history of hepatitis A infection;
• Previously vaccinated with inactivated hepatitis A vaccine, live attenuated hepatitis A vaccine, or hepatitis A and B combined vaccine;
• Allergic constitution or have severe allergic reaction to vaccines in the past (such as acute allergic reaction, angioedema, dyspnea, etc.);
• Pregnant women and lactating women;
• People suffering from uncontrolled epilepsy and other serious neurological diseases (such as transverse myelitis, Guillain-Barré syndrome, demyelinating diseases, etc.);
• Patients with fever during vaccination, or acute exacerbation of chronic diseases, or patients with uncontrolled severe chronic diseases, or suffering from acute diseases;
• Received other research drugs within 30 days before vaccination with the experimental vaccine;
• Have received a live attenuated vaccine within 14 days before vaccination with the experimental vaccine;
• Have received subunit or inactivated vaccine within 7 days before vaccination with experimental vaccine;
• Other conditions that are not suitable for vaccination judged by the researcher.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: immunogenicity group with vaccination interval of 6 month	Biological: Healive (hepatitis A vacine(human diploid cell), inactivated); The hepatitis A vaccine contains 500 SU inactivated hepatitis A virus per dose in 1mL of aluminum hydroxide solution. For anti-HAV antibody-negative participants, two dose of hepatitis A vaccine will be given with vaccination interval of 6 month, 18 months, 36 months, and 60 months, respectively.
Other: immunogenicity group with vaccination interval of 18 month	Biological: Healive (hepatitis A vacine(human diploid cell), inactivated); The hepatitis A vaccine contains 500 SU inactivated hepatitis A virus per dose in 1mL of aluminum hydroxide solution. For anti-HAV antibody-negative participants, two dose of hepatitis A vaccine will be given with vaccination interval of 6 month, 18 months, 36 months, and 60 months, respectively.
Other: immunogenicity group with vaccination interval of 36 month	Biological: Healive (hepatitis A vacine(human diploid cell), inactivated); The hepatitis A vaccine contains 500 SU inactivated hepatitis A virus per dose in 1mL of aluminum hydroxide solution. For anti-HAV antibody-negative participants, two dose of hepatitis A vaccine will be given with vaccination interval of 6 month, 18 months, 36 months, and 60 months, respectively.
Other: immunogenicity group with vaccination interval of 60 month	Biological: Healive (hepatitis A vacine(human diploid cell), inactivated); The hepatitis A vaccine contains 500 SU inactivated hepatitis A virus per dose in 1mL of aluminum hydroxide solution. For anti-HAV antibody-negative participants, two dose of hepatitis A vaccine will be given with vaccination interval of 6 month, 18 months, 36 months, and 60 months, respectively.
Other: safety observation group	Biological: Healive (hepatitis A vacine(human diploid cell), inactivated); The hepatitis A vaccine contains 500 SU inactivated hepatitis A virus per dose in 1mL of aluminum hydroxide solution. For anti-HAV antibody-negative participants, two dose of hepatitis A vaccine will be given with vaccination interval of 6 month, 18 months, 36 months, and 60 months, respectively.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The seroconversion rate of anti-HAV antibody 28 days after two dose of vaccination of hepatitis A vaccine with an interval of 6 month	28 days after two dose of vaccination of hepatitis A vaccine
Incidence of adverse reaction within 28 days after one dose of vaccination	28 days after one dose of vaccination

Secondary Outcome Measures

Outcome Measure	Time Frame
The seroconversion rate of anti-HAV antibody 28 days after two dose of vaccination of hepatitis A vaccine with an interval of 18 month, 36 months, and 60 months	28 days after two dose of vaccination
The seropositive rate, GMC and GMI of anti-HAV antibody 28 days after two dose of vaccination of hepatitis A vaccine with an interval of 6 months, 18 month, 36 months, and 60 months	28th day after two dose of vaccination
The seropositive rate, GMC and GMI of anti-HAV antibody 28 days after one dose of vaccination of hepatitis A vaccine with an interval of 6 months, 18 month, 36 months, and 60 months	28 days after one dose of vaccination
The seropositive rate, GMC and GMI of anti-HAV antibody 28 days after two dose of vaccination of hepatitis A vaccine with an interval of 6 months, 18 month, 36 months, and 60 months among people with underlying conditions	28 days after two dose of vaccination
The seropositive rate of anti-HAV antibody before vaccination	before vaccination
Incidence of adverse reaction within 7 days after one dose of vaccination	7 days after one dose of vaccination
Incidence of adverse reaction within 28 days after two dose of vaccination	28 days after two dose of vaccination
Incidence of adverse reaction within 28 days after one dose of vaccination among different group of people	28 days after one dose of vaccination among

Collaborators and Investigators

• Sponsor: Sinovac Biotech Co., Ltd
• Collaborators: Liaoning Center for Disease Control and Prevention

Publications and helpful links

General Publications

• Liu XE, Chen HY, Liao Z, Zhou Y, Wen H, Peng S, Liu Y, Li R, Li J, Zhuang H. Comparison of Immunogenicity Between Inactivated and Live Attenuated Hepatitis A Vaccines Among Young Adults: A 3-Year Follow-up Study. J Infect Dis. 2015 Oct 15;212(8):1232-6. doi: 10.1093/infdis/jiv213. Epub 2015 May 12.
• Iwarson S, Lindh M, Widerstrom L. Excellent booster response 4 to 8 years after a single primary dose of an inactivated hepatitis A vaccine. J Travel Med. 2004 Mar-Apr;11(2):120-1. doi: 10.2310/7060.2004.17079. No abstract available.

Helpful Links

• ACIP
• WHO position paper on hepatitis A vaccines-October2022

Study record dates

Study Major Dates

• Study Start (Actual): October 24, 2023
• Primary Completion (Estimated): March 17, 2028
• Study Completion (Estimated): December 31, 2029

Study Registration Dates

• First Submitted: September 21, 2023
• First Submitted That Met QC Criteria: September 21, 2023
• First Posted (Actual): September 28, 2023

Study Record Updates

• Last Update Posted (Actual): August 21, 2024
• Last Update Submitted That Met QC Criteria: August 20, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: hepatitis A vaccine; immunogenicity and safety of vaccine; vaccination schedule
• Additional Relevant MeSH Terms: Digestive System Diseases; RNA Virus Infections; Virus Diseases; Infections; Liver Diseases; Hepatitis, Viral, Human; Enterovirus Infections; Picornaviridae Infections; Hepatitis; Hepatitis A
• Other Study ID Numbers: PRO-HAV-MA4001-LN

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No