The Immune Responses After Hepatitis B Revaccination Doses in a Young Cohort
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20-36
SponsorNational Taiwan University Hospital
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
The actual age at the time of admission was higher than 20 years old and birth year after 1987
Born in Taiwan and had received a full course of hepatitis B vaccines at least three doses at infant period.
Those who have tested negative for hepatitis B surface antibody and surface antigen at baseline
Have never been vaccinated against hepatitis B in childhood and adolescence by questionnaire
Disqualifiers
Those who were previously allergic to hepatitis B vaccine or its components (such as yeast)
Those who have been vaccinated against hepatitis B during childhood and adolescence
Those who have a positive test for hepatitis B surface antibody or a positive test for hepatitis B surface antigen
Trial design
Design model
Parallel
Treatments tested in this trial
recombinant hepatitis B vaccine
Biological/VaccineHepatitis B vaccine (Engerix-B) will be administered to the eligible participants by 4 groups. Each case will be tracked for 12 months, at 0, 7-10 days, 28 days, 24-28 weeks, 48-52 weeks anti-HBs titer concentration and 4 follow-up questionnaires.
Treatment groups
240 Participants
are divided into 4 treatment groupsGroup A: Low titer with two doses of HB VaccinesExperimental treatment 1 intervention
Group B: Low titer with one dose of HB VaccineActive comparator 1 intervention
Group C: Extremely low titer with two doses of HB VaccinesActive comparator 1 intervention
Group D: Extremely low titer with one dose of HB VaccineActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
anti-HBs titer response rate at 7-10 days
the anti-HBs titer response rate after 1-2 doses of hepatitis B vaccine(s)
Time frame
7-10 days2
anti-HBs titer response rate at one month
the anti-HBs titer response rate after 1-2 doses of hepatitis B vaccine(s)
Time frame
28 days3
anti-HBs titer response rate at 6 months
the anti-HBs titer response rate after 1-2 doses of hepatitis B vaccine(s)
Time frame
24-28 weeks4
anti-HBs titer response rate at 12 months
the anti-HBs titer response rate after 1-2 doses of hepatitis B vaccine(s)
Time frame
48-52 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
National Taiwan University Hospital
Lead sponsor
Academia Sinica, Taiwan
Collaborator
Ministry of Science and Technology, Taiwan
Collaborator
Source ClinicalTrials.gov