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

Hepatitis B Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00657657
• Other study ID #: 110071
• Status: Completed
• Phase: Phase 4
• First received: April 8, 2008
• Last updated: August 6, 2009
• Start date: April 2008
• Est. completion date: August 2008

Study information

• Verified date: August 2009
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: NA
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: August 2008
• Est. primary completion date: August 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis B

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Subjects With an Immune Response to a Challenge Dose of Hepatitis B Vaccine		One month after the hepatitis B vaccine challenge dose	No
Secondary	Number of Subjects With Anti-HBs Antibody Concentrations Above Pre-defined Cut-off Values		One month after the hepatitis B vaccine challenge dose	No
Secondary	Concentration of Anti-HBs Antibodies		One month after the hepatitis B vaccine challenge dose	No
Secondary	Number of Subjects Reporting Unsolicited Adverse Events		During the 31-day follow-up period after the challenge dose of hepatitis B vaccine	No
Secondary	Number of Subjects Reporting Serious Adverse Events		During the 31-day follow-up period after the challenge dose of hepatitis B vaccine	No