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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT06058416
Other study ID # PRO-HAV-MA4001-LN
Secondary ID
Status Active, not recruiting
Phase Phase 4
First received
Last updated
Start date October 24, 2023
Est. completion date December 31, 2029

Study information

Verified date November 2023
Source Sinovac Biotech Co., Ltd
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 1092
Est. completion date December 31, 2029
Est. primary completion date March 17, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 50 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
China Liaoning Center for Disease Control and Prevention Shenyang Liaoning

Sponsors (2)

Lead Sponsor Collaborator
Sinovac Biotech Co., Ltd Liaoning Center for Disease Control and Prevention

Country where clinical trial is conducted

China, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary Incidence of adverse reaction within 28 days after one dose of vaccination 28 days after one dose of vaccination
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary The seropositive rate of anti-HAV antibody before vaccination before vaccination
Secondary Incidence of adverse reaction within 7 days after one dose of vaccination 7 days after one dose of vaccination
Secondary Incidence of adverse reaction within 28 days after two dose of vaccination 28 days after two dose of vaccination
Secondary 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
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