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CompletedNCT00524576Updated Sep 7, 2018Results posted

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

A Phase 4 interventional study of Engerix™-B in Hepatitis B, sponsored by GlaxoSmithKline. Completed at 3 sites in 2 countries. Open to participants aged 17 Years to 22 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-09-07.

Sponsored by GlaxoSmithKline · Phase 4, Interventional, and Prevention

Phase
Phase 4
Study type
Interventional
Enrollment
144
Allocation
Non-randomized
Ages
17 Years to 22 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Hepatitis B

Keywords

  • Hepatitis B
  • Persistence
  • Challenge dose
03

In context

Hepatitis A

2,710 studies on the registry are indexed under Hepatitis A; 142 are open to participants now.

This study's enrollment of 144 is above the median of 100 across 1,887 interventional studies indexed under Hepatitis A.

Browse Hepatitis A studies →

Lead sponsor

GlaxoSmithKline is the lead sponsor of 3,562 studies on the registry; 117 are open to participants now.

Of its 258 completed or terminated interventional studies of FDA-regulated products, 232 (90%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
17 Years to 22 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Subjects who the investigator believes that they can and will comply with the requirements of the protocol.
  • A male or female who had received complete primary vaccination course of hepatitis B vaccine in the primary study
  • Written informed consent obtained from the subject and/or parent/guardian of the subject.
  • Healthy subjects as established by medical history and clinical examination before entering into the study.
  • If the subject is female, she must be of non-childbearing potential or if she is of childbearing potential, she must practice adequate contraception for 30 days prior to vaccination, have a negative pregnancy test and continue such precautions for 2 months after the hepatitis B challenge dose.

Exclusion criteria

Exclusion Criteria:

  • Use of any investigational/non-registered drug or vaccine other than the study vaccine within 30 days preceding the hepatitis B vaccine challenge dose or planned use during the study period.
  • Chronic administration (more than 14 days) of immunosuppressants other immune-modifying drugs within six months prior to the hepatitis B vaccine challenge dose.
  • Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting from 30 days before the hepatitis B vaccine challenge dose and ending 30 days after.
  • Subjects who received an additional dose of hepatitis B vaccine outside the context of the study between the primary vaccination course and the hepatitis B challenge vaccination visit.
  • Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product.
  • History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
  • Acute disease at the time of enrolment.
  • Acute or chronic, clinically significant hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
  • Administration of immunoglobulins and/or any blood products within the three months preceding the hepatitis B vaccine challenge dose or planned administration during the study period (one month).
  • Pregnant or lactating female.
  • Female planning to become pregnant or planning to discontinue contraceptive precautions.
05

Study design

Phase
Phase 4
Primary purpose
Prevention
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
144 participants (actual)

Study arms

  • Experimental
    Engerix 2 Doses + Challenge Dose

    Subjects received 2 doses of Engerix™-B (Month 0 and 6) in the primary study and a single dose of Engerix™-B during the booster study.

    Biological: Engerix™-B

  • Experimental
    Engerix 3 Doses + Challenge Dose

    Subjects received 3 doses of Engerix™-B (Month 0, 1 and 6) in the primary study and a single dose of Engerix™-B during the booster study.

    Biological: Engerix™-B

Interventions

  • BiologicalEngerix™-B

    One dose (10µg Hepatitis B surface antigen (HBsAg))

    Also known as: Hepatitis B vaccine

06

What researchers measure

Primary outcomes

  1. Number of Participants With Immunological Response to Challenge Dose in Terms of Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentration

    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.

    Time frame: 30 days post-challenge dose

Secondary outcomes

  1. Number of Participants With Anti-HBs Antibody Concentrations Above the Cut-off Value

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

    Time frame: 30 days post-challenge dose

  2. Concentration of Anti-HBs Antibodies

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

    Time frame: 30 days post-challenge dose

  3. Number of Participants Reporting Solicited Local Symptoms

    Solicited local symptoms assessed include pain, redness and swelling.

    Time frame: During the 4-day follow-up period (Day 0-3) after the challenge dose

  4. Number of Participants Reporting Solicited General Symptoms

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

    Time frame: During the 4-day follow-up period (Day 0-3) after the challenge dose

  5. Number of Participants Reporting Unsolicited Adverse Events (AE)

    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.

    Time frame: During the 31-day follow-up period (Day 0-30) after the challenge dose

  6. Number of Participants Reporting Serious Adverse Events (SAE)

    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.

    Time frame: During the 31-day follow-up period (Day 0-30) after the challenge dose

07

Results

Posted Jul 8, 2009

Participant flow

Participant flow — Overall Study
MilestoneEngerix 2 Doses + Challenge DoseEngerix 3 Doses + Challenge Dose
Started9747
Completed9747
Not completed00

Outcome measures

PrimaryNumber of Participants With Immunological Response to Challenge Dose in Terms of Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentration

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.

Time frame:
30 days post-challenge dose
Reported as:
Number · participants
Number of Participants With Immunological Response to Challenge Dose in Terms of Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentration
participantsEngerix 2 Doses + Challenge DoseEngerix 3 Doses + Challenge Dose
Number of Participants With Immunological Response to Challenge Dose in Terms of Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentration5321
SecondaryNumber of Participants With Anti-HBs Antibody Concentrations Above the Cut-off Value

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

Time frame:
30 days post-challenge dose
Reported as:
Number · participants
Number of Participants With Anti-HBs Antibody Concentrations Above the Cut-off Value
participantsEngerix 2 Doses + Challenge DoseEngerix 3 Doses + Challenge Dose
≥ 3.3 mIU/mL5321
≥ 10 mIU/mL5321
≥ 100 mIU/mL5020
SecondaryConcentration of Anti-HBs Antibodies

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

Time frame:
30 days post-challenge dose
Reported as:
Geometric mean · mIU/mL
Concentration of Anti-HBs Antibodies
mIU/mLEngerix 2 Doses + Challenge DoseEngerix 3 Doses + Challenge Dose
Concentration of Anti-HBs Antibodies6214.1 (3213.1 to 12018.0)16564.3 (6394.9 to 42905.6)
SecondaryNumber of Participants Reporting Solicited Local Symptoms

Solicited local symptoms assessed include pain, redness and swelling.

Time frame:
During the 4-day follow-up period (Day 0-3) after the challenge dose
Reported as:
Number · participants
Number of Participants Reporting Solicited Local Symptoms
participantsEngerix 2 Doses + Challenge DoseEngerix 3 Doses + Challenge Dose
Pain224
Redness111
Swelling90
SecondaryNumber of Participants Reporting Solicited General Symptoms

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

Time frame:
During the 4-day follow-up period (Day 0-3) after the challenge dose
Reported as:
Number · participants
Number of Participants Reporting Solicited General Symptoms
participantsEngerix 2 Doses + Challenge DoseEngerix 3 Doses + Challenge Dose
Fatigue197
Fever ≥ 37.5 degree Celsius10
Gastrointestinal disorder74
Headache144
SecondaryNumber of Participants Reporting Unsolicited Adverse Events (AE)

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.

Time frame:
During the 31-day follow-up period (Day 0-30) after the challenge dose
Reported as:
Number · participants
Number of Participants Reporting Unsolicited Adverse Events (AE)
participantsEngerix 2 Doses + Challenge DoseEngerix 3 Doses + Challenge Dose
Number of Participants Reporting Unsolicited Adverse Events (AE)195
SecondaryNumber of Participants Reporting Serious Adverse Events (SAE)

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.

Time frame:
During the 31-day follow-up period (Day 0-30) after the challenge dose
Reported as:
Number · participants
Number of Participants Reporting Serious Adverse Events (SAE)
participantsEngerix 2 Doses + Challenge DoseEngerix 3 Doses + Challenge Dose
Number of Participants Reporting Serious Adverse Events (SAE)00

Adverse events

Collected over 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.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Engerix 2 Doses + Challenge Dose0/55 (0%)0/55 (0%)39/55 (70.9%)
Engerix 3 Doses + Challenge Dose0/22 (0%)0/22 (0%)14/22 (63.6%)
Most frequent other events
Most frequent other events
EventEngerix 2 Doses + Challenge DoseEngerix 3 Doses + Challenge Dose
PainGeneral disorders22/554/22
FatigueGeneral disorders19/557/22
HeadacheNervous system disorders17/556/22
RednessGeneral disorders11/551/22
Gastrointestinal disorderGeneral disorders7/554/22
SwellingGeneral disorders9/550/22

Baseline characteristics

Age, Continuous
Age, Continuous(years)Engerix 2 Doses + Challenge DoseEngerix 3 Doses + Challenge DoseTotal
Mean19.5 ± 1.2219.3 ± 1.4619.4 ± 1.30
Sex: Female, Male
Sex: Female, Male(Participants)Engerix 2 Doses + Challenge DoseEngerix 3 Doses + Challenge DoseTotal
Female502373
Male472471
08

Study locations

3 sites
  • GSK Investigational Site
    Westmead, New South Wales 2145, Australia
  • GSK Investigational Site
    Bruxelles, 1200, Belgium
  • GSK Investigational Site
    Wilrijk, 2610, Belgium
09

References and documents

Publications

  • Van Damme P, Moiseeva A, Marichev I, Kervyn AD, Booy R, Kuriyakose S, Brockway A, Ng SP, Leyssen M, Jacquet JM. Five years follow-up following two or three doses of a hepatitis B vaccine in adolescents aged 11-15 years: a randomised controlled study. BMC Infect Dis. 2010 Dec 20;10:357. doi: 10.1186/1471-2334-10-357. PubMed 21171982 ↗

Individual participant data

Plan to share: Yes — Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 7, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00524576
Lead sponsor
GlaxoSmithKline
Responsible party
Sponsor
First posted
Sep 3, 2007
Start date
Nov 28, 2007
Primary completion
May 14, 2008
Completion
May 14, 2008
Results posted
Jul 8, 2009
Last update
Sep 7, 2018

Study contacts

GSK Clinical Trials
study director · GlaxoSmithKline
View the source record on ClinicalTrials.gov ↗

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