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Immune Response to Hepatitis B Vaccine Challenge Dose in Subjects Who Received a Primary Neonatal Hepatitis B Vaccine.

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00456625
First Posted: April 5, 2007
Last Update Posted: December 16, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
GlaxoSmithKline
  Purpose
The current study will evaluate immunological memory to hepatitis B antigen in subjects who received primary neonatal vaccination of hepatitis B vaccine (Engerix™-B ), 20 years ago in the primary study and who have anti-HBs antibody concentrations < pre-defined cut-off values at the previous long-term time point. All participating subjects will receive a challenge dose of hepatitis B vaccine. Subjects will be aged approximately 20-21 years at the time of this study. No new subjects will be recruited in this long-term follow-up study. Blood sampling will be done one month after the administration of the challenge dose. 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: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: To Evaluate Immune Response to a Hepatitis B Vaccine (Engerix™-B ) Challenge Dose in Healthy Subjects Who Received GSK Biologicals' Hepatitis B Vaccine (Engerix™-B ) Approximately 20 Years Ago as Primary Vaccination at 0, 1, 2 and 12 Months.

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Number of Participants With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Above Specific Cut-off Values [ Time Frame: One month after the hepatitis B vaccine challenge dose ]
    The cut-off values assessed include: ≥ 3.3 Milli International Units per Milliliter (mIU/mL), ≥ 10 mIU/mL, and ≥ 100 mIU/mL.


Secondary Outcome Measures:
  • Occurrence, Intensity and Relationship to Vaccination of Unsolicited Adverse Events (AEs) [ Time Frame: During the 31-day follow-up period after the challenge dose of hepatitis B vaccine. ]

    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.

    An AE is considered severe if it prevents normal, everyday activities.


  • Number of Participants Reporting Any Serious Adverse Events (SAEs). [ Time Frame: Up to 1 month 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: 76
Study Start Date: April 2007
Study Completion Date: January 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group Engerix™-B
Subjects received a dose of Hepatitis B vaccine approximately 20 years after the primary neonatal vaccination
Biological: Engerix™-B
Intramuscular injection, 1 dose
Other Name: Hepatitis B vaccine

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   20 Years to 21 Years   (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 should be enrolled in the study.
  • A male or female adult who received the complete neonatal primary vaccination course of hepatitis B vaccine in primary study approximately 20 years earlier.
  • Documented level of anti-HBs antibody concentrations < specified concentration at the previous long-term time point for which serological results are available for that subject.
  • Written informed consent obtained from 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 completion of the hepatitis B challenge dose.

Exclusion Criteria:

  • Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the hepatitis B vaccine challenge dose.
  • Administration of a vaccine not foreseen by the study protocol during the study period.
  • Administration of immunoglobulins and/or any blood products during the study period.
  • Drug and/or alcohol abuse.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00456625


Locations
Thailand
GSK Investigational Site
Bangkok, Thailand, 10330
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Additional Information:
Publications:
Poovorawan Y et al. 20-year follow-up of immunogenicity and efficacy of infant hepatitis B vaccination. Abstract presented at the 6th World Congress of the World Society for Pediatric Infectious Diseases (WSPID). Buenos Aires, Argentina, 18-22 November 2009.
Poovorawan Y et al. 20-year persistence of immune response to infant hepatitis B vaccination in a high endemicity region. Abstract presented at the 13th International Symposium on Viral Hepatitis and Liver Disease (ISVHLD), Washington DC, US, 20-24 March 2009.

Study Data/Documents: Informed Consent Form  This link exits the ClinicalTrials.gov site
Identifier: 108984
For additional information about this study please refer to the GSK Clinical Study Register
Annotated Case Report Form  This link exits the ClinicalTrials.gov site
Identifier: 108984
For additional information about this study please refer to the GSK Clinical Study Register
Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: 108984
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: 108984
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: 108984
For additional information about this study please refer to the GSK Clinical Study Register
Dataset Specification  This link exits the ClinicalTrials.gov site
Identifier: 108984
For additional information about this study please refer to the GSK Clinical Study Register
Statistical Analysis Plan  This link exits the ClinicalTrials.gov site
Identifier: 108984
For additional information about this study please refer to the GSK Clinical Study Register

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00456625     History of Changes
Other Study ID Numbers: 108984
First Submitted: April 4, 2007
First Posted: April 5, 2007
Results First Submitted: January 15, 2009
Results First Posted: May 15, 2009
Last Update Posted: December 16, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
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 vaccine
Challenge dose

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis B
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