Hepatitis B Clinical Trial
— IRHBRVDOfficial title:
The Immune Responses After Hepatitis B Revaccination Doses in a Young Cohort
This prospective cohort study aims to provide the evidence-based clinical guide to help decide the revaccination doses of hepatitis B vaccine that the high-risk young adults without hepatitis B seroprotective antibodies (anti-HBs titer<10 mIU/mL) need to take.
Status | Recruiting |
Enrollment | 240 |
Est. completion date | December 31, 2024 |
Est. primary completion date | July 31, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 20 Years to 36 Years |
Eligibility | Inclusion Criteria: 1. The actual age at the time of admission was higher than 20 years old and birth year after 1987 2. Born in Taiwan and had received a full course of hepatitis B vaccines at least three doses at infant period. 3. Those who have tested negative for hepatitis B surface antibody and surface antigen at baseline 4. Have never been vaccinated against hepatitis B in childhood and adolescence by questionnaire 5. Consent to administer 1-2 doses of hepatitis B vaccine according to the assigned group after sharing decision making process 6. In good health Exclusion Criteria: 1. Those who were previously allergic to hepatitis B vaccine or its components (such as yeast) 2. Those who have been vaccinated against hepatitis B during childhood and adolescence 3. Those who have a positive test for hepatitis B surface antibody or a positive test for hepatitis B surface antigen |
Country | Name | City | State |
---|---|---|---|
Taiwan | Family Medicine, NTUH | Taipei |
Lead Sponsor | Collaborator |
---|---|
National Taiwan University Hospital | Academia Sinica, Taiwan, Ministry of Science and Technology, Taiwan |
Taiwan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | anti-HBs titer response rate at 7-10 days | the anti-HBs titer response rate after 1-2 doses of hepatitis B vaccine(s) | 7-10 days | |
Primary | anti-HBs titer response rate at one month | the anti-HBs titer response rate after 1-2 doses of hepatitis B vaccine(s) | 28 days | |
Primary | anti-HBs titer response rate at 6 months | the anti-HBs titer response rate after 1-2 doses of hepatitis B vaccine(s) | 24-28 weeks | |
Primary | anti-HBs titer response rate at 12 months | the anti-HBs titer response rate after 1-2 doses of hepatitis B vaccine(s) | 48-52 weeks | |
Primary | anti-HBs titer immune response change at 12 months | anti-HBs titer immune response change at 12 months after 1-2 doses of hepatitis B vaccine(s) | 48-52 weeks |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT01182311 -
Duration of Long-term Immunity After Hepatitis B Virus Immunization
|
||
Completed |
NCT04971928 -
Phase 1 Study of GSK3228836 Pharmacokinetics in Participants With Hepatic Impairment
|
Phase 1 | |
Completed |
NCT03285620 -
A Study of AL-034 to Evaluate the Safety, Tolerability and Pharmacokinetics of Single and Multiple Doses in Healthy Participants
|
Phase 1 | |
Completed |
NCT01884415 -
Phase III, Study to Evaluate the Efficacy of Two Different HBV Vaccination Schemes in Patients With Hepatic Cirrhosis
|
Phase 3 | |
Recruiting |
NCT05404919 -
Utilization of Hepatitis B Virus NAT+ Donors for Hepatitis B Vaccinated Lung Transplant Candidates
|
Phase 2 | |
Completed |
NCT02153320 -
Study to Evaluate the Persistence of the Cellular and Humoral Immune Response Following Vaccinations With GlaxoSmithKline (GSK) Biologicals' Candidate Vaccines Containing HBsAg and Different Adjuvants in Healthy Adult Volunteers
|
Phase 1 | |
Completed |
NCT00352963 -
Immunogenicity & Safety Study of Combined/Separate Vaccine(s) Against Common Diseases in Infants (2,4,6 Months of Age).
|
Phase 3 | |
Completed |
NCT03567382 -
Arresting Vertical Transmission of Hepatitis B Virus
|
Phase 4 | |
Not yet recruiting |
NCT04056728 -
A Phase IV Study to Assess the Safety of EupentaTM Inj
|
Phase 4 | |
Not yet recruiting |
NCT03604016 -
Study to Assess Efficacy of Besifovir and L-carnitine in Chronic Hepatitis B Patients With Nonalcoholic Fatty Liver
|
Phase 4 | |
Completed |
NCT00753649 -
Immunogenicity and Safety of GSK Biologicals' Infanrix Hexa in Infants
|
Phase 4 | |
Recruiting |
NCT03027258 -
Point-of-Delivery Prenatal Test Results Through mHealth to Improve Birth Outcome
|
N/A | |
Terminated |
NCT02604199 -
A Multi-dose Study of ARC-520 in Patients With Hepatitis B 'e' Antigen (HBeAg) Negative, Chronic Hepatitis B Virus (HBV) Infection
|
Phase 2 | |
Completed |
NCT02540538 -
Safety and Immunogenicity of HBAI20 Hepatitis B Vaccine in Naive Adults and Non-responders
|
Phase 1 | |
Completed |
NCT02421666 -
A Comparative Trial of Improving Care for Underserved Asian Americans Infected With HBV
|
N/A | |
Completed |
NCT02169674 -
Hepatitis B Booster Study in Adolescence
|
Phase 4 | |
Completed |
NCT01917357 -
A Comparison of the Immunogenicity and Safety of Quinvaxem in Mono-dose Vials and Uniject
|
Phase 3 | |
Completed |
NCT01732354 -
Study for Consolidation Period of Chronic Hepatitis B
|
||
Completed |
NCT01368497 -
Entecavir/Pegylated Interferon in Immune Tolerant Children With Chronic Hepatitis B Virus (HBV) Infection
|
Phase 3 | |
Recruiting |
NCT01462981 -
Cohort of Hepatitis B Research of Amsterdam
|
N/A |