Challenge Dose of Hepatitis B Vaccine in Subjects Who Previously Received Engerix™-B Vaccine

NCT00524576 | Completed Phase 4 Results

• 1 other identifier: 108988
• Study Type: interventional
• Target: 144
• Locations: 2 countries
• Sites: 3

Brief Summary

To evaluate the response to an additional dose (challenge dose) of hepatitis B vaccine, when given to subjects who had received primary vaccination of Engerix™-B vaccine approximately 72-78 months ago. This protocol posting deals with objectives \& outcome measures of the challenge phase. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Conditions

Hepatitis B

Keywords

Hepatitis B; Persistence; Challenge dose

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Immunological Response to Challenge Dose in Terms of Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentration

  Immune response defined as: * For initially seronegative subjects (anti-HBs antibody concentration \<3.3 milli-international unit per milliliter \[mIU/mL\] before vaccination) antibody concentration ≥ 10mIU/mL at post booster. * For initially seropositive subjects: antibody concentration at post booster ≥ 4-fold the pre-vaccination antibody concentration.

  30 days post-challenge dose

Secondary Outcomes (6)

• Number of Participants With Anti-HBs Antibody Concentrations Above the Cut-off Value

  30 days post-challenge dose

• Concentration of Anti-HBs Antibodies

  30 days post-challenge dose

• Number of Participants Reporting Solicited Local Symptoms

  During the 4-day follow-up period (Day 0-3) after the challenge dose

• Number of Participants Reporting Solicited General Symptoms

  During the 4-day follow-up period (Day 0-3) after the challenge dose

• Number of Participants Reporting Unsolicited Adverse Events (AE)

  During the 31-day follow-up period (Day 0-30) after the challenge dose

Study Arms (2)

Engerix 2 Doses + Challenge Dose

EXPERIMENTAL

Subjects received 2 doses of Engerix™-B (Month 0 and 6) in the primary study and a single dose of Engerix™-B during the booster study.

Biological: Engerix™-B

Engerix 3 Doses + Challenge Dose

EXPERIMENTAL

Subjects received 3 doses of Engerix™-B (Month 0, 1 and 6) in the primary study and a single dose of Engerix™-B during the booster study.

Biological: Engerix™-B

Interventions

Engerix™-B BIOLOGICAL

One dose (10µg Hepatitis B surface antigen (HBsAg))

Also known as: Hepatitis B vaccine

Engerix 2 Doses + Challenge Dose; Engerix 3 Doses + Challenge Dose

Eligibility Criteria

• Age: 17 Years - 22 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Subjects who the investigator believes that they can and will comply with the requirements of the protocol.
• A male or female who had received complete primary vaccination course of hepatitis B vaccine in the primary study
• Written informed consent obtained from the subject and/or parent/guardian of 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 the hepatitis B challenge dose.

You may not qualify if:

• Use of any investigational/non-registered drug or vaccine other than the study vaccine within 30 days preceding the hepatitis B vaccine challenge dose or planned use during the study period.
• Chronic administration (more than 14 days) of immunosuppressants 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 an additional dose of hepatitis B vaccine outside the context of the study between the primary vaccination course and the hepatitis B challenge vaccination 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, based on medical history and physical examination.
• Acute disease at the time of enrolment.
• Acute or chronic, clinically significant 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 (one month).
• Pregnant or lactating female.
• Female planning to become pregnant or planning to discontinue contraceptive precautions.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (3)

GSK Investigational Site

Westmead, New South Wales, 2145, Australia

Location

GSK Investigational Site

Brussels, 1200, Belgium

Location

GSK Investigational Site

Wilrijk, 2610, Belgium

Location

Related Publications (1)

• Van Damme P, Moiseeva A, Marichev I, Kervyn AD, Booy R, Kuriyakose S, Brockway A, Ng SP, Leyssen M, Jacquet JM. Five years follow-up following two or three doses of a hepatitis B vaccine in adolescents aged 11-15 years: a randomised controlled study. BMC Infect Dis. 2010 Dec 20;10:357. doi: 10.1186/1471-2334-10-357.

  PMID: 21171982 BACKGROUND

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

Interventions

Hepatitis B Vaccines

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Viral Hepatitis Vaccines; Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

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: August 31, 2007
• First Posted: September 3, 2007
• Study Start: November 28, 2007
• Primary Completion: May 14, 2008
• Study Completion: May 14, 2008
• Last Updated: September 7, 2018
• Results First Posted: July 8, 2009

Record last verified: 2016-11

Data Sharing

• IPD Sharing: Will share

Locations

AU (1); BE (2)