NCT06058416

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,092

participants targeted

Target at P75+ for phase_4

Timeline
44mo left

Started Oct 2023

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress41%
Oct 2023Dec 2029

First Submitted

Initial submission to the registry

September 21, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 28, 2023

Completed
26 days until next milestone

Study Start

First participant enrolled

October 24, 2023

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 17, 2028

Expected
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2029

Last Updated

August 21, 2024

Status Verified

August 1, 2024

Enrollment Period

4.4 years

First QC Date

September 21, 2023

Last Update Submit

August 20, 2024

Conditions

Hepatitis A

Keywords

immunogenicity and safety of vaccinehepatitis A vaccinevaccination schedule

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (8)

  • 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

  • +3 more secondary outcomes

Study Arms (5)

immunogenicity group with vaccination interval of 6 month

OTHER
Biological: Healive (hepatitis A vacine(human diploid cell), inactivated)

immunogenicity group with vaccination interval of 18 month

OTHER
Biological: Healive (hepatitis A vacine(human diploid cell), inactivated)

immunogenicity group with vaccination interval of 36 month

OTHER
Biological: Healive (hepatitis A vacine(human diploid cell), inactivated)

immunogenicity group with vaccination interval of 60 month

OTHER
Biological: Healive (hepatitis A vacine(human diploid cell), inactivated)

safety observation group

OTHER
Biological: Healive (hepatitis A vacine(human diploid cell), inactivated)

Interventions

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.

immunogenicity group with vaccination interval of 18 monthimmunogenicity group with vaccination interval of 36 monthimmunogenicity group with vaccination interval of 6 monthimmunogenicity group with vaccination interval of 60 monthsafety observation group

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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-BarrĂ© 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Liaoning Center for Disease Control and Prevention

Shenyang, Liaoning, China

Location

Related Publications (2)

  • 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.

    PMID: 25969561BACKGROUND

  • 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.

    PMID: 15109480BACKGROUND

Related Links

MeSH Terms

Conditions

Hepatitis AHepatitis

Condition Hierarchy (Ancestors)

Hepatitis, Viral, HumanVirus DiseasesInfectionsEnterovirus InfectionsPicornaviridae InfectionsRNA Virus InfectionsLiver DiseasesDigestive System Diseases

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 21, 2023

First Posted

September 28, 2023

Study Start

October 24, 2023

Primary Completion (Estimated)

March 17, 2028

Study Completion (Estimated)

December 31, 2029

Last Updated

August 21, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)