Trial Outcomes & Findings for Hepatitis B Booster Study in Adolescence (NCT NCT02169674)

NCT ID: NCT02169674

Last Updated: 2019-03-21

Results Overview

The primary outcome measure is the number of participants who have residual HB immunity 10 or 15 years after infant HB immunization, defined by a persistent anti-HBs titer \>12 IU/L.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 359 participants
• Primary outcome timeframe: 10 or more years after infant HB immunization
• Results posted on: 2019-03-21

Participant Flow

Screening for eligibility will be part of volunteer identification, with confirmation of eligibility to follow at the first in-person visit. A component of volunteer screening will be initiating a review of individual HBV immunization records.

Initially, 359 volunteers who met inclusion criteria where recruited, of whom 6 were deemed ineligible due to late disclosure of neonatal HBV vaccination (n=3), ineligible medical condition (n=2) or additional doses of HBV vaccine (n=1). Three early consent withdrawals resulted in 350 participants who underwent baseline testing.

Participant milestones

Measure	10-11 Year-olds Single challenge dose of HBV vaccine (10 mcg, Engerix B, GSK)	15-16 Year-olds Single challenge dose of HBV vaccine (10 mcg, Engerix B, GSK)
Overall Study STARTED	137	213
Overall Study COMPLETED	105	135
Overall Study NOT COMPLETED	32	78

Reasons for withdrawal

Measure	10-11 Year-olds Single challenge dose of HBV vaccine (10 mcg, Engerix B, GSK)	15-16 Year-olds Single challenge dose of HBV vaccine (10 mcg, Engerix B, GSK)
Overall Study Withdrawal by Subject	2	1
Overall Study Seroprotected	30	76
Overall Study Lost to Follow-up	0	1

Baseline Characteristics

Hepatitis B Booster Study in Adolescence

Baseline characteristics by cohort

Measure	10-11 Year-olds n=137 Participants Single challenge dose of HBV vaccine (10 mcg, Engerix B, GSK)	15-16 Year-olds n=213 Participants Single challenge dose of HBV vaccine (10 mcg, Engerix B, GSK)	Total n=350 Participants Total of all reporting groups
Age, Categorical <=18 years	137 Participants n=5 Participants	213 Participants n=7 Participants	350 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	10.6 years STANDARD_DEVIATION 0.50 • n=5 Participants	16.0 years STANDARD_DEVIATION 0.18 • n=7 Participants	13.9 years STANDARD_DEVIATION 2.66 • n=5 Participants
Sex: Female, Male Female	69 Participants n=5 Participants	87 Participants n=7 Participants	156 Participants n=5 Participants
Sex: Female, Male Male	68 Participants n=5 Participants	126 Participants n=7 Participants	194 Participants n=5 Participants
Race/Ethnicity, Customized White/Caucasian	78 Participants n=5 Participants	99 Participants n=7 Participants	177 Participants n=5 Participants
Race/Ethnicity, Customized Chinese	18 Participants n=5 Participants	55 Participants n=7 Participants	73 Participants n=5 Participants
Race/Ethnicity, Customized South Asian	6 Participants n=5 Participants	6 Participants n=7 Participants	12 Participants n=5 Participants
Race/Ethnicity, Customized Mixed	29 Participants n=5 Participants	35 Participants n=7 Participants	64 Participants n=5 Participants
Race/Ethnicity, Customized Other	6 Participants n=5 Participants	18 Participants n=7 Participants	24 Participants n=5 Participants
Region of Enrollment Canada	137 participants n=5 Participants	213 participants n=7 Participants	350 participants n=5 Participants

PRIMARY outcome

Timeframe: 10 or more years after infant HB immunization

The primary outcome measure is the number of participants who have residual HB immunity 10 or 15 years after infant HB immunization, defined by a persistent anti-HBs titer >12 IU/L.

Outcome measures

Measure	10-11 Year-olds n=137 Participants Single challenge dose of HBV vaccine (10 mcg, Engerix B, GSK)	15-16 Year-olds n=213 Participants Single challenge dose of HBV vaccine (10 mcg, Engerix B, GSK)
Serum Anti-HBs Concentration 12 IU/L or Greater	30 Participants	76 Participants

PRIMARY outcome

Timeframe: 28 days after HB booster

The primary outcome measure is the number of participants who have capacity to recall anti-HBs titer >12 IU/L after HB booster vaccination.

Outcome measures

Measure	10-11 Year-olds n=105 Participants Single challenge dose of HBV vaccine (10 mcg, Engerix B, GSK)	15-16 Year-olds n=135 Participants Single challenge dose of HBV vaccine (10 mcg, Engerix B, GSK)
Recollection of Anti-HBs Titer >12 IU/L After Booster	102 Participants	123 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Before and after booster immunization

Population: Post challenge number analyzed are those nonseroprotected at baseline minus two withdrawals in the 10-11 year-old group and one withdrawal and one loss to follow-up in the 15-16 year-old group.

The geometric mean concentration of anti-HBs antibodies before and after booster vaccination, in both age groups

Outcome measures

Measure	10-11 Year-olds n=137 Participants Single challenge dose of HBV vaccine (10 mcg, Engerix B, GSK)	15-16 Year-olds n=213 Participants Single challenge dose of HBV vaccine (10 mcg, Engerix B, GSK)
Geometric Mean Concentration of Anti-HBs Before booster	4.2 mIU/ml Interval 3.38 to 5.22	7.98 mIU/ml Interval 6.37 to 9.99
Geometric Mean Concentration of Anti-HBs After booster	590.6 mIU/ml Interval 473.0 to 737.0	319.3 mIU/ml Interval 229.0 to 445.0

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline sample

The number of baseline serum samples that contain anti-HBc antibodies, as a function of time since immunization

Outcome measures

Measure	10-11 Year-olds n=137 Participants Single challenge dose of HBV vaccine (10 mcg, Engerix B, GSK)	15-16 Year-olds n=213 Participants Single challenge dose of HBV vaccine (10 mcg, Engerix B, GSK)
Anti-HBc (Hepatitis B Core Antigen) Antibody	0 Participants	0 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline

The number of baseline serum samples that contain HBs antigen, as a function of time since immunization.

Outcome measures

Measure	10-11 Year-olds n=137 Participants Single challenge dose of HBV vaccine (10 mcg, Engerix B, GSK)	15-16 Year-olds n=213 Participants Single challenge dose of HBV vaccine (10 mcg, Engerix B, GSK)
HBs Antigenemia	0 Participants	0 Participants

Adverse Events

10-11 Year-olds

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

15-16 Year-olds

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

Director of Vaccine Evaluation Center

Vaccine Evaluation Center

Phone: 604-845-2422

Results disclosure agreements

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