Clinical trial NCT06058416: Immunogenicity and Safety of Hepatitis A Among People Aged 18-50 Years Old
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE4
Conditions: Hepatitis A
Keywords: immunogenicity and safety of vaccine
hepatitis A vaccine
vaccination schedule
Lead sponsor: Sinovac Biotech Co., Ltd
Sponsor class: INDUSTRY
Collaborators: name: Liaoning Center for Disease Control and Prevention
First posted: 2023-09-28
Enrollment: 1092
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: PREVENTION

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.


Eligibility 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:

* 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.

Primary outcomes:
measure: The seroconversion rate of anti-HAV antibody 28 days after two dose of vaccination of hepatitis A vaccine with an interval of 6 month
timeFrame: 28 days after two dose of vaccination of hepatitis A vaccine
measure: Incidence of adverse reaction within 28 days after one dose of vaccination
timeFrame: 28 days after one dose of vaccination
Secondary outcomes:
measure: 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
timeFrame: 28 days after two dose of vaccination
measure: 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
timeFrame: 28th day after two dose of vaccination
measure: 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
timeFrame: 28 days after one dose of vaccination
measure: 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
timeFrame: 28 days after two dose of vaccination
measure: The seropositive rate of anti-HAV antibody before vaccination
timeFrame: before vaccination
measure: Incidence of adverse reaction within 7 days after one dose of vaccination
timeFrame: 7 days after one dose of vaccination
measure: Incidence of adverse reaction within 28 days after two dose of vaccination
timeFrame: 28 days after two dose of vaccination
measure: Incidence of adverse reaction within 28 days after one dose of vaccination among different group of people
timeFrame: 28 days after one dose of vaccination among
Other outcomes:
Locations:
city: Shenyang
country: China
facility: Liaoning Center for Disease Control and Prevention
state: Liaoning
Study officials:
References:
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.
citation: 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.