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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00524576
First received: August 31, 2007
Last updated: November 2, 2016
Last verified: November 2016
  Purpose

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.


Condition Intervention Phase
Hepatitis B
Biological: Engerix™-B
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Administration of a Challenge Dose of Hepatitis B Vaccine in Subjects Who Previously Received Engerix™-B Vaccine.

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Number of Participants With Immunological Response to Challenge Dose in Terms of Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentration [ Time Frame: 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.


Secondary Outcome Measures:
  • Number of Participants With Anti-HBs Antibody Concentrations Above the Cut-off Value [ Time Frame: 30 days post-challenge dose ]
    Anti-HBs antibody cut-off values assessed include 3.3, 10 and 100 mIU/mL.

  • Concentration of Anti-HBs Antibodies [ Time Frame: 30 days post-challenge dose ]
    Concentrations given as geometric mean concentration (GMC) and expressed in mIU/mL.

  • Number of Participants Reporting Solicited Local Symptoms [ Time Frame: During the 4-day follow-up period (Day 0-3) after the challenge dose ]
    Solicited local symptoms assessed include pain, redness and swelling.

  • Number of Participants Reporting Solicited General Symptoms [ Time Frame: 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.

  • Number of Participants Reporting Unsolicited Adverse Events (AE) [ Time Frame: 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.

  • Number of Participants Reporting Serious Adverse Events (SAE) [ Time Frame: 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.


Enrollment: 144
Study Start Date: November 2007
Study Completion Date: May 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
One dose (10µg Hepatitis B surface antigen (HBsAg))
Other Name: Hepatitis B vaccine
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
One dose (10µg Hepatitis B surface antigen (HBsAg))
Other Name: Hepatitis B vaccine

  Eligibility

Ages Eligible for Study:   17 Years to 22 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00524576

Locations
Australia, New South Wales
GSK Investigational Site
Westmead, New South Wales, Australia, 2145
Belgium
GSK Investigational Site
Bruxelles, Belgium, 1200
GSK Investigational Site
Wilrijk, Belgium, 2610
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Additional Information:
Publications:
Study Data/Documents: Informed Consent Form  This link exits the ClinicalTrials.gov site
Identifier: 108988
For additional information about this study please refer to the GSK Clinical Study Register
Dataset Specification  This link exits the ClinicalTrials.gov site
Identifier: 108988
For additional information about this study please refer to the GSK Clinical Study Register
Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: 108988
For additional information about this study please refer to the GSK Clinical Study Register
Individual Participant Data Set  This link exits the ClinicalTrials.gov site
Identifier: 108988
For additional information about this study please refer to the GSK Clinical Study Register
Clinical Study Report  This link exits the ClinicalTrials.gov site
Identifier: 108988
For additional information about this study please refer to the GSK Clinical Study Register

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00524576     History of Changes
Other Study ID Numbers: 108988
Study First Received: August 31, 2007
Results First Received: May 14, 2009
Last Updated: November 2, 2016
Individual Participant Data  
Plan to Share IPD: Yes
Plan Description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Keywords provided by GlaxoSmithKline:
Hepatitis B
Persistence
Challenge dose

Additional relevant MeSH terms:
Hepatitis B
Hepatitis
Hepatitis A
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Vaccines
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on March 27, 2017