The Hepatitis B Vaccine Booster Response Among the Youth Who Had Completed Neonatal Hepatitis B Vaccines

Not Applicable

Completed

• Conditions: Hepatitis B
• Interventions: Biological: hepatitis B vaccine

• Registration Number: NCT00792610
• Lead Sponsor: National Taiwan University Hospital

Brief Summary

At the time of the present study, the necessity for booster vaccinations for the prevention of hepatitis B(HB) 15 years post-vaccination in the group of young adults who have become seronegative for HB markers after complete neonatal HB vaccination was in question. A booster vaccination strategy may lead to a significant economic impact on national health care resources, and the costs/benefits must therefore be carefully evaluated. Unfortunately, the data to support such analyses are lacking. Because an increased risk of HB infection is anticipated when adolescents enter into young adulthood through becoming sexual active, breakthrough infections such as fulminant HB might be the main concern instead of the risk of chronic HB carriage. To address this issue, this study aimed to measure the booster responses after HB vaccination in seronegative young adults who had completed neonatal HB vaccines in Taiwan before.

Detailed Description

This cohort study was conducted between October 2007 and Jan 2009. The target population was subjects aged 18-23 years who were born after 1984 when the Taiwanese national HB vaccination program was launched. Their vaccination records must have shown a completed neonatal HB vaccination, and they were seronegative for all three HB viral markers including HBsAg(Hepatitis B surface antigen), anti-HBc(core antibody against Hepatitis B), and anti-HBs(Surface antibody against Hepatitis B) within 2 years of entry into the study and at study entry. They were recruited through a Student's Health Center Clinic referral, Bulletin Board System posts, and Web-broadcast invitation. The neonatal HB vaccination records were verified through linkage to the Taiwan Center for Disease Control databank. Signed informed consent was obtained from all the participants and their parents or guardians. Pregnant females, persons with a previous history of allergy to HB vaccines, or allergy to yeast were excluded. First 3 months are screen phase to recruit college students for assay of hepatitis B viral markers. Seronegative subjects were approached for enrollment into receiving hepatitis B vaccine booster afterwards.

All participants were tested for HB markers at enrollment, even if they had been tested in the previous months, to confirm their status. A questionnaire was completed at enrolment to record sociodemographic factors including age, gender, self reported family history of hepatitis B carriers, self reported blood type, and so on. The participants then received three intramuscular doses of HB vaccine (Engerix-B, recombinant hepatitis B surface antigen, 20 microgram/ml/vial, GlaxoSmithKline, Belgium) at baseline and at the 1st and 6th month follow-up visits. Their anti-HBs status was checked at baseline, 7-10 days, 1 month, 6 months, and 7 months following the first dose of HB vaccine. Adverse effects associated with the vaccine were also reported within one week after each Engerix-B injection.

Study Timeline

• Study Start: 2007-08
• Study First Submitted: 2008-11-16
• Study First Submitted QC: 2008-11-17
• Study First Posted: 2008-11-18
• Primary Completion: 2009-01
• Study Completion: 2009-02
• Status Verified: 2009-08
• Results First Submitted: 2009-08-16
• Results First Submitted QC: 2009-08-16
• Results First Posted: 2009-09-24
• Last Update Submitted: 2009-10-05
• Last Update Posted: 2009-10-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 127

Inclusion Criteria

1. aged 18-23 years
2. the youth born after July 1984 who have received a hepatitis B virus markers checkup within 2 years including HBsAg, core antibody against hepatitis B(anti-HBc), and surface antibody against hepatitis B (anti-HBs) and the results are all negative for these 3 viral markers.
3. Participants should agree to sign inform consent. For younger than 20 years old subjects, one of their parents also help the participate review and sign the inform consent.
4. Participants are willing to receive 3 doses of Hepatitis B vaccines without payment.
5. General condition is in good health judged by the doctor

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Exclusion Criteria

1. Allergy to Hepatitis B vaccines or yeast
2. pregnancy

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Hepatitis B booster	hepatitis B vaccine	They receive 3 doses of hepatitis B vaccine (Engerix-B Injection, recombinant HBsAg, 20mcg/ml/vial, GSK) at 0, 1st, 6th month during follow-up. Their anti-HBs status were checked at baseline, one week, one month, sixth month, and seven months later after the first dose of hepatitis B vaccine.

Primary Outcome Measures

Name	Time	Method
Hepatitis B Surface Antibody Seroprotective Rate(Seroprotective: for Those Who Had Anti-HBs(Surface Antibody Against Hepatitis B) Titer Higher Than 10 mIU/mL)	7 months	The anti-HBs(Surface antibody against Hepatitis B) status was checked at baseline, 7-10 days, 1 month, 6 months, and 7 months following the first dose of hepatitis B vaccine. And then the seroprotective rate for anti-HBs(numbers of those who had anti-HBs titer higher than 10 mIU/mL/all participants numbers) was calculated respectively.

Trial Locations

Locations (1)

National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan