Back to resultsImmunogenicity and Safety of Hepatitis A Among People Aged 18-50 Years Old
Primary Purpose
Hepatitis A
Status
Not yet recruiting
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Healive (hepatitis A vacine(human diploid cell), inactivated)
Sponsored by
About this trial
This is an interventional prevention trial for Hepatitis A focused on measuring immunogenicity and safety of vaccine, hepatitis A vaccine, vaccination schedule
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: 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Other
Other
Other
Other
Other
Arm Label
immunogenicity group with vaccination interval of 6 month
immunogenicity group with vaccination interval of 18 month
immunogenicity group with vaccination interval of 36 month
immunogenicity group with vaccination interval of 60 month
safety observation group
Arm Description
Outcomes
Primary Outcome Measures
The seroconversion rate of anti-HAV antibody 28 days after two dose of vaccination of hepatitis A vaccine with an interval of 6 month
Incidence of adverse reaction within 28 days after one dose of vaccination
Secondary Outcome Measures
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
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
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
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
The seropositive rate of anti-HAV antibody before vaccination
Incidence of adverse reaction within 7 days after one dose of vaccination
Incidence of adverse reaction within 28 days after two dose of vaccination
Incidence of adverse reaction within 28 days after one dose of vaccination among different group of people
Full Information
NCT ID
NCT06058416
First Posted
September 21, 2023
Last Updated
September 21, 2023
Sponsor
Sinovac Biotech Co., Ltd
Collaborators
Liaoning Center for Disease Control and Prevention
1. Study Identification
Unique Protocol Identification Number
NCT06058416
Brief Title
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
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 11, 2023 (Anticipated)
Primary Completion Date
October 17, 2023 (Anticipated)
Study Completion Date
December 31, 2029 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sinovac Biotech Co., Ltd
Collaborators
Liaoning Center for Disease Control and Prevention
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis A
Keywords
immunogenicity and safety of vaccine, hepatitis A vaccine, vaccination schedule
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1000 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
immunogenicity group with vaccination interval of 6 month
Arm Type
Other
Arm Title
immunogenicity group with vaccination interval of 18 month
Arm Type
Other
Arm Title
immunogenicity group with vaccination interval of 36 month
Arm Type
Other
Arm Title
immunogenicity group with vaccination interval of 60 month
Arm Type
Other
Arm Title
safety observation group
Arm Type
Other
Intervention Type
Biological
Intervention Name(s)
Healive (hepatitis A vacine(human diploid cell), inactivated)
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
Title
Incidence of adverse reaction within 28 days after one dose of vaccination
Time Frame
28 days after one dose of vaccination
Secondary Outcome Measure Information:
Title
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
Title
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
Title
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
Title
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
Title
The seropositive rate of anti-HAV antibody before vaccination
Time Frame
before vaccination
Title
Incidence of adverse reaction within 7 days after one dose of vaccination
Time Frame
7 days after one dose of vaccination
Title
Incidence of adverse reaction within 28 days after two dose of vaccination
Time Frame
28 days after two dose of vaccination
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhen LI
Phone
15810282173
Email
liz5469@sinovac.com
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
25969561
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.
Results Reference
background
PubMed Identifier
15109480
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.
Results Reference
background
Links:
URL
https://www.cdc.gov/mmwr/preview/mmwrhtml/rr5507a1.htm#tab2
Description
ACIP
URL
https://www.who.int/publications/i/item/who-wer9740-493-512
Description
WHO position paper on hepatitis A vaccines-October2022
Learn more about this trial
Immunogenicity and Safety of Hepatitis A Among People Aged 18-50 Years Old
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