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

Hepatitis A Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06058416
• Other study ID #: PRO-HAV-MA4001-LN
• Status: Active, not recruiting
• Phase: Phase 4
• 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
• 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.

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A

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

External Links

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