Clinical trial NCT00524576: Challenge Dose of Hepatitis B Vaccine in Subjects Who Previously Received Engerix™-B Vaccine
Official title: Administration of a Challenge Dose of Hepatitis B Vaccine in Subjects Who Previously Received Engerix™-B Vaccine.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hepatitis B
Keywords: Hepatitis B
Persistence
Challenge dose
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2007-09-03
Enrollment: 144
Sex: ALL
Minimum age (years): 17
Maximum age (years): 22
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Number of Participants With Immunological Response to Challenge Dose in Terms of Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentration
timeFrame: 30 days post-challenge dose
Secondary outcomes:
measure: Number of Participants With Anti-HBs Antibody Concentrations Above the Cut-off Value
timeFrame: 30 days post-challenge dose
measure: Concentration of Anti-HBs Antibodies
timeFrame: 30 days post-challenge dose
measure: Number of Participants Reporting Solicited Local Symptoms
timeFrame: During the 4-day follow-up period (Day 0-3) after the challenge dose
measure: Number of Participants Reporting Solicited General Symptoms
timeFrame: During the 4-day follow-up period (Day 0-3) after the challenge dose
measure: Number of Participants Reporting Unsolicited Adverse Events (AE)
timeFrame: During the 31-day follow-up period (Day 0-30) after the challenge dose
measure: Number of Participants Reporting Serious Adverse Events (SAE)
timeFrame: During the 31-day follow-up period (Day 0-30) after the challenge dose
Other outcomes:
Locations:
city: Westmead
country: Australia
facility: GSK Investigational Site
state: New South Wales
city: Bruxelles
country: Belgium
facility: GSK Investigational Site
city: Wilrijk
country: Belgium
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: 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.