Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT06058416

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

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

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Liaoning Center for Disease Control and Prevention

Shenyang, Liaoning, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Healive (hepatitis A vacine(human diploid cell), inactivated)

Biological

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.

Primary outcomes

  1. The seroconversion rate of anti-HAV antibody 28 days after two dose of vaccination of hepatitis A vaccine with an interval of 6 month

    Time frame: 28 days after two dose of vaccination of hepatitis A vaccine

  2. Incidence of adverse reaction within 28 days after one dose of vaccination

    Time frame: 28 days after one dose of vaccination

Secondary outcomes

  1. 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

    Time frame: 28 days after two dose of vaccination

  2. 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

    Time frame: 28th day after two dose of vaccination

  3. 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

    Time frame: 28 days after one dose of vaccination

  4. 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

    Time frame: 28 days after two dose of vaccination

  5. The seropositive rate of anti-HAV antibody before vaccination

    Time frame: before vaccination

  6. Incidence of adverse reaction within 7 days after one dose of vaccination

    Time frame: 7 days after one dose of vaccination

  7. Incidence of adverse reaction within 28 days after two dose of vaccination

    Time frame: 28 days after two dose of vaccination

  8. Incidence of adverse reaction within 28 days after one dose of vaccination among different group of people

    Time frame: 28 days after one dose of vaccination among

Sponsors and collaborators

Lead sponsor

Sinovac Biotech Co., Ltd

Industry

Collaborators

  • Liaoning Center for Disease Control and Prevention

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2028
Study completion
2029
First posted
Sep 28, 2023
Registry last updated
Aug 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.