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Safety and Immunogenicity of a Booster Dose of GlaxoSmithKline (GSK) Biologicals' Hepatitis B Vaccine.
This study has been completed.
Sponsored by: GlaxoSmithKline
Information provided by: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00657657
  Purpose

In this study, subjects who received primary neonatal vaccination with hepatitis B vaccine at 0, 1, 2, 12 months, 20 years ago in the 103860/272 primary study will be evaluated for immunological memory to hepatitis B vaccine via assessment of the response to a vaccine challenge dose.


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

MedlinePlus related topics: Hepatitis Hepatitis B
Drug Information available for: Hepatitis B Vaccines
U.S. FDA Resources
Study Type: Interventional
Study Design: Prevention, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title: Immune Response to a Hepatitis B Vaccine Challenge Dose in Healthy Subjects Who Received Primary Vaccination of GlaxoSmithKline Biologicals' Hepatitis B Vaccine, Approximately 20 Years Ago.

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Immune response to a challenge dose of hepatitis B vaccine [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Anti-HBs antibody concentrations [ Time Frame: One month after the hepatitis B vaccine challenge dose ] [ Designated as safety issue: No ]
  • Occurrence, intensity and relationship to vaccination of unsolicited symptoms [ Time Frame: During the 31-day follow-up period after the challenge dose of hepatitis B vaccine. ] [ Designated as safety issue: Yes ]
  • Occurrence of serious adverse events (SAEs) reported [ Time Frame: During the entire study period after the challenge dose ] [ Designated as safety issue: Yes ]

Enrollment: 29
Study Start Date: April 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
A: Experimental Biological: Engerix™-B
A challenge dose of hepatitis B vaccine will be administered to all subjects as a deep intramuscular injection in the deltoid region of the non-dominant arm.

  Eligibility

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 should be enrolled in the study.
  • A male or female adult who received the complete neonatal primary vaccination course of hepatitis B vaccine (Engerix™-B), in the 103860/272 primary study approximately 20 years earlier.
  • Documented level of anti-HBs antibody concentrations < 100mIU/ml 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:

  • Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
  • 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.
  • 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 a booster dose of hepatitis B vaccine outside the context of this study between the long-term time-point at the documented level of anti-HBs antibody concentrations and the current challenge dose study 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, including human immunodeficiency virus (HIV) infection.
  • Acute disease at the time of enrolment.
  • Acute or chronic, clinically significant pulmonary, cardiovascular, 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.
  • 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: NCT00657657

Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Responsible Party: GSK ( Study Director )
Study ID Numbers: 110071
Study First Received: April 8, 2008
Last Updated: October 30, 2008
ClinicalTrials.gov Identifier: NCT00657657  
Health Authority: Thailand: NA

Keywords provided by GlaxoSmithKline:
Hepatitis
vaccine

Study placed in the following topic categories:
Virus Diseases
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis B
Hepatitis, Viral, Human
DNA Virus Infections
Healthy

Additional relevant MeSH terms:
Hepadnaviridae Infections

ClinicalTrials.gov processed this record on January 16, 2009