NCT00524576

Challenge Dose of Hepatitis B Vaccine in Subjects Who Previously Received Engerix™-B Vaccine

Completed Phase 4 Results posted Last updated 7 September 2018

What this trial tests

Phase 4 trial testing Engerix™-B in Hepatitis B in 144 participants. Completed in 14 May 2008.

Timeline

28 November 2007

Primary endpoint
14 May 2008

14 May 2008

Quick facts

Lead sponsor	GlaxoSmithKline
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	single group
Masking	none
Primary purpose	prevention
Enrollment	144
Start date	28 November 2007
Primary completion	14 May 2008
Estimated completion	14 May 2008
Sites	3 locations across Belgium, Australia

Drugs / interventions tested

• Engerix™-B

Conditions studied

• Hepatitis B — all drugs for Hepatitis B →

Sponsor

GlaxoSmithKline — full company profile →

Who can join

Adults 17 to 22, 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 Participants With Immunological Response to Challenge Dose in Terms of Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentration Primary · 30 days post-challenge dose

Immune response defined as: * For initially seronegative subjects (anti-HBs antibody concentration \<3.3 milli-international unit per milliliter \[mIU/mL\] before vaccination) antibody concentration ≥ 10mIU/mL at post booster. * For initially seropositive subjects: antibody concentration at post booster ≥ 4-fold the pre-vaccination antibody concentration.

Group	Value	95% CI
Engerix 2 Doses + Challenge Dose	53
Engerix 3 Doses + Challenge Dose	21

Number of Participants With Anti-HBs Antibody Concentrations Above the Cut-off Value Secondary · 30 days post-challenge dose

Anti-HBs antibody cut-off values assessed include 3.3, 10 and 100 mIU/mL.

≥ 3.3 mIU/mL

Group	Value	95% CI
Engerix 2 Doses + Challenge Dose	53
Engerix 3 Doses + Challenge Dose	21

≥ 10 mIU/mL

Group	Value	95% CI
Engerix 2 Doses + Challenge Dose	53
Engerix 3 Doses + Challenge Dose	21

≥ 100 mIU/mL

Group	Value	95% CI
Engerix 2 Doses + Challenge Dose	50
Engerix 3 Doses + Challenge Dose	20

Concentration of Anti-HBs Antibodies Secondary · 30 days post-challenge dose

Concentrations given as geometric mean concentration (GMC) and expressed in mIU/mL.

Group	Value	95% CI
Engerix 2 Doses + Challenge Dose	6214.1	3213.1 – 12018.0
Engerix 3 Doses + Challenge Dose	16564.3	6394.9 – 42905.6

Number of Participants Reporting Solicited Local Symptoms Secondary · During the 4-day follow-up period (Day 0-3) after the challenge dose

Solicited local symptoms assessed include pain, redness and swelling.

Pain

Group	Value	95% CI
Engerix 2 Doses + Challenge Dose	22
Engerix 3 Doses + Challenge Dose	4

Redness

Group	Value	95% CI
Engerix 2 Doses + Challenge Dose	11
Engerix 3 Doses + Challenge Dose	1

Swelling

Group	Value	95% CI
Engerix 2 Doses + Challenge Dose	9
Engerix 3 Doses + Challenge Dose	0

Number of Participants Reporting Solicited General Symptoms Secondary · During the 4-day follow-up period (Day 0-3) after the challenge dose

Solicited general symptoms assessed include fatigue, fever, gastrointestinal symptoms, and headache.

Fatigue

Group	Value	95% CI
Engerix 2 Doses + Challenge Dose	19
Engerix 3 Doses + Challenge Dose	7

Fever ≥ 37.5 degree Celsius

Group	Value	95% CI
Engerix 2 Doses + Challenge Dose	1
Engerix 3 Doses + Challenge Dose	0

Gastrointestinal disorder

Group	Value	95% CI
Engerix 2 Doses + Challenge Dose	7
Engerix 3 Doses + Challenge Dose	4

Headache

Group	Value	95% CI
Engerix 2 Doses + Challenge Dose	14
Engerix 3 Doses + Challenge Dose	4

Number of Participants Reporting Unsolicited Adverse Events (AE) Secondary · During the 31-day follow-up period (Day 0-30) after the challenge dose

An AE 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.

Group	Value	95% CI
Engerix 2 Doses + Challenge Dose	19
Engerix 3 Doses + Challenge Dose	5

Number of Participants Reporting Serious Adverse Events (SAE) Secondary · During the 31-day follow-up period (Day 0-30) after the challenge dose

An SAE 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.

Group	Value	95% CI
Engerix 2 Doses + Challenge Dose	0
Engerix 3 Doses + Challenge Dose	0

Adverse events — posted to ClinicalTrials.gov

Time frame: Solicited local and general symptoms: during the 4-day follow-up period (Day 0-3) after the challenge dose. Unsolicited AEs and serious AEs (SAEs): during the 31-day follow-up period (Day 0-30) after the challenge dose.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Engerix 2 Doses + Challenge Dose

Serious: 0/55 (0%)

Deaths: 0/55

Engerix 3 Doses + Challenge Dose

Serious: 0/22 (0%)

Deaths: 0/22

Other adverse events (6 terms — click to expand)

Reaction	System	Engerix 2 Doses + Challeng…	Engerix 3 Doses + Challeng…
Pain	General disorders	—	—
Fatigue	General disorders	—	—
Headache	Nervous system disorders	—	—
Redness	General disorders	—	—
Swelling	General disorders	—	—
Gastrointestinal disorder	General disorders	—	—

Data from ClinicalTrials.gov NCT00524576 adverse events section.

Sponsor's own description

To evaluate the response to an additional dose (challenge dose) of hepatitis B vaccine, when given to subjects who had received primary vaccination of Engerix™-B vaccine approximately 72-78 months ago.

This protocol posting deals with objectives \& outcome measures of the challenge phase. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Five years follow-up following two or three doses of a hepatitis B vaccine in adolescents aged 11-15 years: a randomised controlled study.
   Van Damme P, Moiseeva A, Marichev I, Kervyn AD, et al · · 2010 · cited 16× · PMID 21171982 · DOI 10.1186/1471-2334-10-357