Trial Outcomes & Findings for Hepatitis B Vaccine in Chronic Hepatitis B Patients With Low Serum HBsAg (NCT NCT01817725)

NCT ID: NCT01817725

Last Updated: 2017-05-02

Results Overview

The difference of HBsAg levels at the end of follow up (2 years) and baseline

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 20 participants
• Primary outcome timeframe: 2 years
• Results posted on: 2017-05-02

Participant Flow

Participant milestones

Measure	Engerix-B Engerix-B (20 μg/ml, GlaxoSmithKline) was administered at 0-2-4-6-8-10-12 months in dosage of 40μg for \>20 years old and 20μg for \< or =20 years old HBV vaccine (Engerix B): Engerix-B (20μg/ml, GlaxoSmithKline Biologicals) is administered intramuscularly at 0, 2, 4, 6, 8, 10, 12 months. The dosage is 20μg in those \<= 20 years old and 40μg in those \> 20 years old.
Overall Study STARTED	20
Overall Study COMPLETED	19
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Measure	Engerix-B Engerix-B (20 μg/ml, GlaxoSmithKline) was administered at 0-2-4-6-8-10-12 months in dosage of 40μg for \>20 years old and 20μg for \< or =20 years old HBV vaccine (Engerix B): Engerix-B (20μg/ml, GlaxoSmithKline Biologicals) is administered intramuscularly at 0, 2, 4, 6, 8, 10, 12 months. The dosage is 20μg in those \<= 20 years old and 40μg in those \> 20 years old.
Overall Study Withdrawal by Subject	1

Baseline Characteristics

Hepatitis B Vaccine in Chronic Hepatitis B Patients With Low Serum HBsAg

Baseline characteristics by cohort

Measure	Engerix-B n=20 Participants Engerix-B (20 μg/ml, GlaxoSmithKline) was administered at 0-2-4-6-8-10-12 months in dosage of 40μg for \>20 years old and 20μg for \< or =20 years old HBV vaccine (Engerix B): Engerix-B (20μg/ml, GlaxoSmithKline Biologicals) is administered intramuscularly at 0, 2, 4, 6, 8, 10, 12 months. The dosage will be 20μg in those \<= 20 years old and 40μg in those \> 20 years old.
Age, Continuous	43.3 years STANDARD_DEVIATION 12.1 • n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants
Sex: Female, Male Male	16 Participants n=5 Participants
Region of Enrollment Taiwan	20 participants n=5 Participants

PRIMARY outcome

Timeframe: 2 years

The difference of HBsAg levels at the end of follow up (2 years) and baseline

Outcome measures

Measure	Engerix-B n=19 Participants Engerix-B (20 μg/ml, GlaxoSmithKline) was administered at 0-2-4-6-8-10-12 months in dosage of 40μg for \>20 years old and 20μg for \< or =20 years old HBV vaccine (Engerix B): Engerix-B (20μg/ml, GlaxoSmithKline Biologicals) is administered intramuscularly at 0, 2, 4, 6, 8, 10, 12 months. The dosage is 20μg in those \<= 20 years old and 40μg in those \> 20 years old.
Change in HBsAg Levels From Baseline to 2 Years	-0.27 log IU/ml Standard Deviation 0.48

SECONDARY outcome

Timeframe: 2 years

Outcome measures

Measure	Engerix-B n=19 Participants Engerix-B (20 μg/ml, GlaxoSmithKline) was administered at 0-2-4-6-8-10-12 months in dosage of 40μg for \>20 years old and 20μg for \< or =20 years old HBV vaccine (Engerix B): Engerix-B (20μg/ml, GlaxoSmithKline Biologicals) is administered intramuscularly at 0, 2, 4, 6, 8, 10, 12 months. The dosage is 20μg in those \<= 20 years old and 40μg in those \> 20 years old.
Anti-HBs Seropositivity	2 Participants

Adverse Events

Engerix-B

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

Dr. Ming-Wei Lai

Chang Gung Memorial Hospital, Linkou Branch

Phone: 886-3-3281200

Email: a22141@adm.cgmh.org.tw

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place