Safety and Immunogenicity of a Booster Dose of GlaxoSmithKline (GSK) Biologicals' Hepatitis B Vaccine

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00657657
First received: April 8, 2008
Last updated: August 6, 2009
Last verified: August 2009
  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 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: 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.

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Number of Subjects With an Immune Response to a Challenge Dose of Hepatitis B Vaccine [ Time Frame: One month after the hepatitis B vaccine challenge dose ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of Subjects With Anti-HBs Antibody Concentrations Above Pre-defined Cut-off Values [ Time Frame: One month after the hepatitis B vaccine challenge dose ] [ Designated as safety issue: No ]
  • Concentration of Anti-HBs Antibodies [ Time Frame: One month after the hepatitis B vaccine challenge dose ] [ Designated as safety issue: No ]
  • Number of Subjects Reporting Unsolicited Adverse Events [ Time Frame: During the 31-day follow-up period after the challenge dose of hepatitis B vaccine ] [ Designated as safety issue: No ]
  • Number of Subjects Reporting Serious Adverse Events [ Time Frame: During the 31-day follow-up period after the challenge dose of hepatitis B vaccine ] [ Designated as safety issue: No ]

Enrollment: 29
Study Start Date: April 2008
Study Completion Date: August 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Engerix Group
Subjects received a challenge dose of hepatitis B vaccine (Engerix™-B).
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 < 100 milli-international units per milliliter (mIU/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
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: NCT00657657

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: Study Director, GSK
ClinicalTrials.gov Identifier: NCT00657657     History of Changes
Other Study ID Numbers: 110071
Study First Received: April 8, 2008
Results First Received: August 6, 2009
Last Updated: August 6, 2009
Health Authority: Thailand: NA

Keywords provided by GlaxoSmithKline:
Hepatitis
vaccine

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

ClinicalTrials.gov processed this record on July 31, 2014