Trial Outcomes & Findings for The Hepatitis B Vaccine Booster Response Among the Youth Who Had Completed Neonatal Hepatitis B Vaccines (NCT NCT00792610)

Last Updated: 2009-10-06

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

127 participants

Primary outcome timeframe

7 months

Results posted on

2009-10-06

Participant Flow

This cohort study was conducted between October 2007 and Jan 2009. The participants were recruited through a Student's Health Center Clinic referral, Bulletin Board System posts, and Web-broadcast invitation. They received intervention and blood exam in the hospital.

Initially, 150 seronegative subjects for the three hepatitis B viral markers (HBsAg, anti-HBs, and anti-HBc) were invited to participate in the study. Among them, five subjects were excluded because of seropositive results upon recheck or drop-out. History of complete neonatal HB vaccination could not be confirmed in 18 cases.

Participant milestones

Participant milestones
Measure	Hepatitis B Booster 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.
Overall Study STARTED	127
Overall Study Youths	127
Overall Study COMPLETED	127
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Hepatitis B Booster n=127 Participants 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.
Age, Customized < 20 years old	54 participants n=5 Participants
Age, Customized >= 20 years old	73 participants n=5 Participants
Sex: Female, Male Female	61 Participants n=5 Participants
Sex: Female, Male Male	66 Participants n=5 Participants
Blood type A	28 participants n=5 Participants
Blood type B	31 participants n=5 Participants
Blood type AB	8 participants n=5 Participants
Blood type O	53 participants n=5 Participants
Blood type unknown	7 participants n=5 Participants
Body Mass Index(BMI) category BMI< 18.5	21 participants n=5 Participants
Body Mass Index(BMI) category 18.5<= BMI < 24	94 participants n=5 Participants
Body Mass Index(BMI) category BMI >= 24	12 participants n=5 Participants
Family history of hepatitis B carrier Yes	18 participants n=5 Participants
Family history of hepatitis B carrier NO	71 participants n=5 Participants
Family history of hepatitis B carrier Unknown	38 participants n=5 Participants

PRIMARY outcome

Timeframe: 7 months

Outcome measures

Outcome measures
Measure	Hepatitis B Booster n=127 Participants 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.
Hepatitis B Surface Antibody Seroprotective Rate(Seroprotective: for Those Who Had Anti-HBs(Surface Antibody Against Hepatitis B) Titer Higher Than 10 mIU/mL) seroprotective rate of HB vaccine at 7 months	126 participants
Hepatitis B Surface Antibody Seroprotective Rate(Seroprotective: for Those Who Had Anti-HBs(Surface Antibody Against Hepatitis B) Titer Higher Than 10 mIU/mL) seroprotective rate of HB vaccine at 7-10 days	26 participants
Hepatitis B Surface Antibody Seroprotective Rate(Seroprotective: for Those Who Had Anti-HBs(Surface Antibody Against Hepatitis B) Titer Higher Than 10 mIU/mL) seroprotective rate of HB vaccine at one month	96 participants
Hepatitis B Surface Antibody Seroprotective Rate(Seroprotective: for Those Who Had Anti-HBs(Surface Antibody Against Hepatitis B) Titer Higher Than 10 mIU/mL) seroprotective rate of HB vaccine at 6 months	120 participants

Adverse Events

Hepatitis B Booster

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Jan, Chyi-Feng

National Taiwan University Hospital

Phone: 886-2-23562147

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place