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

NCT00657657 | Completed Phase 4 Results

• 1 other identifier: 110071
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hepatitis B

Keywords

Hepatitis; vaccine

Outcome Measures

Primary Outcomes (1)

• Number of Subjects With an Immune Response to a Challenge Dose of Hepatitis B Vaccine

  Immune response to a challenge dose of hepatitis B vaccine is defined as * at least a 4-fold rise in post-challenge dose anti-HBs antibody concentrations in subjects seropositive (≥ 3.3 mIU/mL) at the previous available long-term time point, or * a post-challenge dose anti-HBs antibody concentrations ≥ 10 mIU/mL in subjects seronegative (\<3.3 mIU/mL) at the previous available long-term time point.

  One month after the hepatitis B vaccine challenge dose

Secondary Outcomes (4)

• Number of Subjects With Anti-HBs Antibody Concentrations Above Pre-defined Cut-off Values

  One month after the hepatitis B vaccine challenge dose

• Concentration of Anti-HBs Antibodies

  One month after the hepatitis B vaccine challenge dose

• Number of Subjects Reporting Unsolicited Adverse Events

  During the 31-day follow-up period after the challenge dose of hepatitis B vaccine

• Number of Subjects Reporting Serious Adverse Events

  During the 31-day follow-up period after the challenge dose of hepatitis B vaccine

Study Arms (4)

Group 1

EXPERIMENTAL

Neonates from mother HBsAg (+) and HBeAg (+) had received HBV vaccine at Month 0, 1, 2, 12, 60 (5 doses)

Biological: Engerix™-B

Group 2

EXPERIMENTAL

Neonates from mother HBsAg (+) and HBeAg (+) had received HBV vaccine at Month 0, 1, 2, 12 (4 doses)

Biological: Engerix™-B

Group 4

EXPERIMENTAL

Neonates from mother HBsAg (+) and HBeAg (-) had received HBV vaccine at Month 0, 1, 2, 12 (4 doses)

Biological: Engerix™-B

Group 6

EXPERIMENTAL

Neonates from mother HBsAg (-) and HBeAg (-) had received HBV vaccine at Month 0, 1, 2, 12 (4 doses)

Biological: Engerix™-B

Interventions

Engerix™-B BIOLOGICAL

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.

Group 1; Group 2; Group 4; Group 6

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Bangkok, 10330, Thailand

Location

Related Publications (2)

• Poovorawan Y et al. Persistence of anti-HBs antibodies and immune memory 20-years after hepatitis B vaccination among children in Thailand. Abstract presented at the 9th International Congress of Tropical Pediatrics (ICTP). Bangkok, Thailand. 18-20 October 2011.

  BACKGROUND

• Poovorawan Y, Chongsrisawat V, Theamboonlers A, Crasta PD, Messier M, Hardt K. Long-term anti-HBs antibody persistence following infant vaccination against hepatitis B and evaluation of anamnestic response: a 20-year follow-up study in Thailand. Hum Vaccin Immunother. 2013 Aug;9(8):1679-84. doi: 10.4161/hv.24844. Epub 2013 May 31.

  PMID: 23732904 DERIVED

Related Links

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

MeSH Terms

Conditions

Hepatitis B; Hepatitis

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Liver Diseases; Digestive System Diseases

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2008
• First Posted: April 14, 2008
• Study Start: April 1, 2008
• Primary Completion: August 1, 2008
• Study Completion: August 1, 2008
• Last Updated: December 21, 2016
• Results First Posted: September 14, 2009

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will share

Locations

TH (1)