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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT06058416
Recruitment Status : Active, not recruiting
First Posted : September 28, 2023
Last Update Posted : November 28, 2023
Sponsor:
Collaborator:
Liaoning Center for Disease Control and Prevention
Information provided by (Responsible Party):
Sinovac Biotech Co., Ltd

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Hepatitis A Biological: Healive (hepatitis A vacine(human diploid cell), inactivated) Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1092 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official 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
Actual Study Start Date : October 24, 2023
Estimated Primary Completion Date : March 17, 2024
Estimated Study Completion Date : December 31, 2029

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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.
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.
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.
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.
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.


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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:

  • Have suffered from hepatitis A;
  • 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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06058416


Locations
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China, Liaoning
Liaoning Center for Disease Control and Prevention
Shenyang, Liaoning, China
Sponsors and Collaborators
Sinovac Biotech Co., Ltd
Liaoning Center for Disease Control and Prevention
More Information
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Additional Information:
ACIP  This link exits the ClinicalTrials.gov site

Publications:

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Responsible Party: Sinovac Biotech Co., Ltd
ClinicalTrials.gov Identifier: NCT06058416    
Other Study ID Numbers: PRO-HAV-MA4001-LN
First Posted: September 28, 2023    Key Record Dates
Last Update Posted: November 28, 2023
Last Verified: November 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sinovac Biotech Co., Ltd:
immunogenicity and safety of vaccine
hepatitis A vaccine
vaccination schedule
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
 Virus Diseases
Infections
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections