NCT00984139

Persistence of Immunity Against Hepatitis B in 12-13 Year Old Adolescents After Infant Hepatitis B Vaccination

Completed Phase 4 Results posted Last updated 20 August 2018

What this trial tests

Phase 4 trial testing Engerix™-B Kinder in Hepatitis B in 306 participants. Completed in 7 April 2010.

Timeline

12 October 2009

Primary endpoint
7 April 2010

7 April 2010

Quick facts

Lead sponsor	GlaxoSmithKline
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	prevention
Enrollment	306
Start date	12 October 2009
Primary completion	7 April 2010
Estimated completion	7 April 2010
Sites	24 locations across Germany

Drugs / interventions tested

• Engerix™-B Kinder

Conditions studied

• Hepatitis B — all drugs for Hepatitis B →

Sponsor

GlaxoSmithKline — full company profile →

Who can join

Adults 12 to 13, any sex, with Hepatitis B. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations as Measured by ELISA Equal to or Above Cut-off Value Primary · One month after the challenge dose (Month 1)

The cut-off value was defined as 100 milli-international units per milliliter (mIU/mL).

Group	Value	95% CI
Engerix-B Group	266

Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations as Measured by ChemiLuminescence ImmunoAssay (CLIA) Equal to or Above Cut-off Value. Primary · One month after the challenge dose (Month 1)

The cut-off value was defined as 100 milli-international units per milliliter (mIU/mL).

Group	Value	95% CI
Engerix-B Group	257

Number of Subjects With Anti-HBs Antibody Concentrations as Measured by ELISA Equal to or Above Cut-off Values Secondary · Before (Day 0) and one month (Month 1) after the challenge dose

The cut-off values were defined as 3.3 mIU/mL, 10 mIU/mL and 100 mIU/mL. Note: the number of subjects with anti-HBs antibody concentrations equal to or above 100 mIU/mL on month post-challenge dose data are presented as a primary outcome measure.

pre challenge dose 3.3 mIU/mL

Group	Value	95% CI
Engerix-B Group	259

post challenge dose 3.3 mIU/mL

Group	Value	95% CI
Engerix-B Group	283

pre challenge dose 10 mIU/mL

Group	Value	95% CI
Engerix-B Group	220

post challenge dose 10 mIU/mL

Group	Value	95% CI
Engerix-B Group	281

pre challenge dose 100 mIU/mL

Group	Value	95% CI
Engerix-B Group	70

Number of Subjects With Anti-HBs Antibody Concentrations as Measured by CLIA Equal to or Above Cut-off Values Secondary · Before (Day 0) and one month (Month 1) after the challenge dose

The cut-off values were defined as 6.2 mIU/mL, 10 mIU/mL and 100 mIU/mL. Note: the number of subjects with anti-HBs antibody concentrations equal to or above 100 mIU/mL on month post-challenge dose data are presented as a primary outcome measure.

pre challenge dose 6.2 mIU/mL

Group	Value	95% CI
Engerix-B Group	201

post challenge dose 6.2 mIU/mL

Group	Value	95% CI
Engerix-B Group	271

pre challenge dose 10 mIU/mL

Group	Value	95% CI
Engerix-B Group	181

post challenge dose 10 mIU/mL

Group	Value	95% CI
Engerix-B Group	271

pre challenge dose 100 mIU/mL

Group	Value	95% CI
Engerix-B Group	67

Number of Subjects With Solicited Local and General Symptoms Secondary · During the 4-day (Day 0-3) follow-up period following the challenge dose vaccination

Solicited local symptoms were pain, redness and swelling. Solicited general symptoms were fatigue, gastrointestinal symptoms, headache and fever. Fever was defined as axillary temperature greater than or equal to 37.5 degrees Celsius.

pain

Group	Value	95% CI
Engerix-B Group	104

redness

Group	Value	95% CI
Engerix-B Group	56

swelling

Group	Value	95% CI
Engerix-B Group	26

fatigue

Group	Value	95% CI
Engerix-B Group	63

gastrointestinal symptoms

Group	Value	95% CI
Engerix-B Group	14

headache

Group	Value	95% CI
Engerix-B Group	56

fever

Group	Value	95% CI
Engerix-B Group	9

Number of Subjects With Unsolicited Adverse Events (AEs) Secondary · During the 31-day (Day 0-30) follow-up period following the challenge dose vaccination

Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.

Group	Value	95% CI
Engerix-B Group	64

Number of Subjects With Serious Adverse Events (SAEs) Secondary · After the challenge dose of the vaccine (Day 0) up to the study end (Month 1)

SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.

Group	Value	95% CI
Engerix-B Group	0

Number of Subjects With Anamnestic Response to the Challenge Dose as Measured by ELISA. Secondary · One month after the challenge dose (Month 1)

Anamnestic response was defined as: - At least (i.e. greater than or equal to) a 4-fold rise in post-challenge vaccine dose anti-HBs antibody concentrations in subjects seropositive (i.e. with anti-HBs antibody concentration equal to or greater than 3.3 mIU/mL) at the pre-challenge dose time point. - Post-challenge dose anti-HBs antibody concentrations equal to or greater than 10 mIU/mL in subjects seronegative (i.e. with anti-HBs antibody concentrations less than 3.3 mIU/mL) at the pre-challenge dose time point.

Group	Value	95% CI
Engerix-B Group	274

Number of Subjects With Anamnestic Response to the Challenge Dose as Measured by CLIA. Secondary · One month after the challenge dose (Month 1)

Anamnestic response was defined as: - At least (i.e. greater than or equal to) a 4-fold rise in post-challenge vaccine dose anti-HBs antibody concentrations in subjects seropositive (i.e. with anti-HBs antibody concentration ≥ 6.2 mIU/mL) at the pre-challenge dose time point. - Post-challenge dose anti-HBs antibody concentrations equal to or greater than 10 mIU/mL in subjects seronegative (i.e. with anti-HBs antibody concentrations \< 6.2 mIU/mL) at the pre-challenge dose time point.

Group	Value	95% CI
Engerix-B Group	267

Adverse events — posted to ClinicalTrials.gov

Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Engerix-B Group

Serious: 0/306 (0%)

Deaths: —

Other adverse events (5 terms — click to expand)

Reaction	System	Engerix-B Group
Pain	General disorders	—
Fatigue	General disorders	—
Redness	General disorders	—
Headache	General disorders	—
Swelling	General disorders	—

Data from ClinicalTrials.gov NCT00984139 adverse events section.

Sponsor's own description

This phase IV open study will evaluate the persistence of humoral antibodies against hepatitis B as well as the immune response to a challenge dose of hepatitis B vaccine in adolescents aged 12-13 years, who received three consecutive doses of GSK Biologicals' recombinant hepatitis B vaccine (Engerix™-B) in infancy.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Platforms, advances, and technical challenges in virus-like particles-based vaccines.
   Gupta R, Arora K, Roy SS, Joseph A, et al · · 2023 · cited 80× · PMID 36845125 · DOI 10.3389/fimmu.2023.1123805
2. Long-term anti-HBs antibody persistence and immune memory in children and adolescents who received routine childhood hepatitis B vaccination.
   Behre U, Bleckmann G, Crasta PD, Leyssen M, et al · · 2012 · cited 22× · PMID 22508412 · DOI 10.4161/hv.19898