Trial Outcomes & Findings for Safety and Immunogenicity of a Booster Dose of GlaxoSmithKline (GSK) Biologicals' Hepatitis B Vaccine (NCT NCT00657657)

Results Overview

Immune response to a challenge dose of hepatitis B vaccine is defined as * at least a 4-fold rise in post-challenge dose anti-HBs antibody concentrations in subjects seropositive (≥ 3.3 mIU/mL) at the previous available long-term time point, or * a post-challenge dose anti-HBs antibody concentrations ≥ 10 mIU/mL in subjects seronegative (\<3.3 mIU/mL) at the previous available long-term time point.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

29 participants

Primary outcome timeframe

One month after the hepatitis B vaccine challenge dose

Results posted on

2016-12-21

Participant Flow

Subjects who received primary neonatal Engerix™-B vaccination 20 years ago in the 103860/272 primary study and who had anti-hepatitis B surface antigen (HBs) antibody concentrations \< 100 milli-international units per milliliter (mIU/ml) at the previous available long-term time-point (NCT00240539), were invited to participate in the current study.

Participant milestones

Participant milestones
Measure	Engerix Group Subjects received a challenge dose of hepatitis B vaccine (Engerix™-B).
Overall Study STARTED	29
Overall Study COMPLETED	29
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Safety and Immunogenicity of a Booster Dose of GlaxoSmithKline (GSK) Biologicals' Hepatitis B Vaccine

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Engerix Group n=29 Participants Subjects received a challenge dose of hepatitis B vaccine (Engerix™-B).
Age, Continuous	19.9 years STANDARD_DEVIATION 0.35 • n=5 Participants
Gender Female	19 Participants n=5 Participants
Gender Male	10 Participants n=5 Participants

PRIMARY outcome

Timeframe: One month after the hepatitis B vaccine challenge dose

Immune response to a challenge dose of hepatitis B vaccine is defined as * at least a 4-fold rise in post-challenge dose anti-HBs antibody concentrations in subjects seropositive (≥ 3.3 mIU/mL) at the previous available long-term time point, or * a post-challenge dose anti-HBs antibody concentrations ≥ 10 mIU/mL in subjects seronegative (\<3.3 mIU/mL) at the previous available long-term time point.

Outcome measures

Outcome measures
Measure	Engerix Group n=29 Participants Subjects received a challenge dose of hepatitis B vaccine (Engerix™-B).
Number of Subjects With an Immune Response to a Challenge Dose of Hepatitis B Vaccine	28 subjects

SECONDARY outcome

Timeframe: One month after the hepatitis B vaccine challenge dose

Anti-hepatitis B surface antigen (anti-HBs) antibody cut-off values assessed include 3.3, 10 and 100 mIU/mL.

Outcome measures

Outcome measures
Measure	Engerix Group n=29 Participants Subjects received a challenge dose of hepatitis B vaccine (Engerix™-B).
Number of Subjects With Anti-HBs Antibody Concentrations Above Pre-defined Cut-off Values ≥100 mIU/mL	27 subjects
Number of Subjects With Anti-HBs Antibody Concentrations Above Pre-defined Cut-off Values ≥3.3 mIU/mL	29 subjects
Number of Subjects With Anti-HBs Antibody Concentrations Above Pre-defined Cut-off Values ≥10 mIU/mL	28 subjects

SECONDARY outcome

Timeframe: One month after the hepatitis B vaccine challenge dose

Concentrations are given as Geometric Mean Concentrations (GMCs), calculated on subjects seropositive (subjects with anti-HBs antibody concentrations ≥ 3.3 mIU/mL) post-challenge dose.

Outcome measures

Outcome measures
Measure	Engerix Group n=29 Participants Subjects received a challenge dose of hepatitis B vaccine (Engerix™-B).
Concentration of Anti-HBs Antibodies	1082.4 mIU/mL Interval 561.0 to 2088.6

SECONDARY outcome

Timeframe: During the 31-day follow-up period after the challenge dose of hepatitis B vaccine

An adverse event is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.

Outcome measures

Outcome measures
Measure	Engerix Group n=29 Participants Subjects received a challenge dose of hepatitis B vaccine (Engerix™-B).
Number of Subjects Reporting Unsolicited Adverse Events	0 subjects

SECONDARY outcome

Timeframe: During the 31-day follow-up period after the challenge dose of hepatitis B vaccine

A serious adverse event is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above.

Outcome measures

Outcome measures
Measure	Engerix Group n=29 Participants Subjects received a challenge dose of hepatitis B vaccine (Engerix™-B).
Number of Subjects Reporting Serious Adverse Events	0 subjects

Adverse Events

Engerix Group

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

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

Results disclosure agreements

Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Publication restrictions are in place

Restriction type: OTHER