Trial record 9 of 820 for:    "Hepatitis B"

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

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00524576
First received: August 31, 2007
Last updated: March 17, 2011
Last verified: March 2011
  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
Hepatitis B Vaccine
Biological: Engerix™-B
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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
Genders Eligible for Study:   Both
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
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
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided by GlaxoSmithKline

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
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: March 17, 2011
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration

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

ClinicalTrials.gov processed this record on April 16, 2014