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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00524576




Registration number
NCT00524576
Ethics application status
Date submitted
31/08/2007
Date registered
3/09/2007
Date last updated
7/09/2018

Titles & IDs
Public title
Challenge Dose of Hepatitis B Vaccine in Subjects Who Previously Received Engerix™-B Vaccine
Scientific title
Administration of a Challenge Dose of Hepatitis B Vaccine in Subjects Who Previously Received Engerix™-B Vaccine.
Secondary ID [1] 0 0
108988
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hepatitis B 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Engerix™-B

Experimental: Engerix 2 Doses + Challenge Dose - 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.

Experimental: Engerix 3 Doses + Challenge Dose - 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.


Other interventions: Engerix™-B
One dose (10µg Hepatitis B surface antigen (HBsAg))

Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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.
Timepoint [1] 0 0
30 days post-challenge dose
Secondary outcome [1] 0 0
Number of Participants With Anti-HBs Antibody Concentrations Above the Cut-off Value - Anti-HBs antibody cut-off values assessed include 3.3, 10 and 100 mIU/mL.
Timepoint [1] 0 0
30 days post-challenge dose
Secondary outcome [2] 0 0
Concentration of Anti-HBs Antibodies - Concentrations given as geometric mean concentration (GMC) and expressed in mIU/mL.
Timepoint [2] 0 0
30 days post-challenge dose
Secondary outcome [3] 0 0
Number of Participants Reporting Solicited Local Symptoms - Solicited local symptoms assessed include pain, redness and swelling.
Timepoint [3] 0 0
During the 4-day follow-up period (Day 0-3) after the challenge dose
Secondary outcome [4] 0 0
Number of Participants Reporting Solicited General Symptoms - Solicited general symptoms assessed include fatigue, fever, gastrointestinal symptoms, and headache.
Timepoint [4] 0 0
During the 4-day follow-up period (Day 0-3) after the challenge dose
Secondary outcome [5] 0 0
Number of Participants Reporting Unsolicited Adverse Events (AE) - An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Timepoint [5] 0 0
During the 31-day follow-up period (Day 0-30) after the challenge dose
Secondary outcome [6] 0 0
Number of Participants Reporting Serious Adverse Events (SAE) - An SAE is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above.
Timepoint [6] 0 0
During the 31-day follow-up period (Day 0-30) after the challenge dose

Eligibility
Key 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.
Minimum age
17 Years
Maximum age
22 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key 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.

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 4
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
GSK Investigational Site - Westmead
Recruitment postcode(s) [1] 0 0
2145 - Westmead
Recruitment outside Australia
Country [1] 0 0
Belgium
State/province [1] 0 0
Bruxelles
Country [2] 0 0
Belgium
State/province [2] 0 0
Wilrijk

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
GlaxoSmithKline
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT00524576
Trial related presentations / publications
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.
Public notes

Contacts
Principal investigator
Name 0 0
GSK Clinical Trials
Address 0 0
GlaxoSmithKline
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications