Last updated: 11/03/2018 10:11:40
Immune response to hepatitis B vaccine challenge dose in subjects who received a primary neonatal hepatitis B vaccine.
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: To Evaluate Immune Response to a Hepatitis B Vaccine (Engerix™-B ) Challenge Dose in Healthy Subjects Who Received GSK Biologicals' Hepatitis B Vaccine (Engerix™-B ) Approximately 20 Years Ago as Primary Vaccination at 0, 1, 2 and 12 Months.
Trial description: The current study will evaluate immunological memory to hepatitis B antigen in subjects who received primary neonatal vaccination of hepatitis B vaccine (Engerix™-B ), 20 years ago in the primary study and who have anti-HBs antibody concentrations < pre-defined cut-off values at the previous long-term time point. All participating subjects will receive a challenge dose of hepatitis B vaccine. Subjects will be aged approximately 20-21 years at the time of this study. No new subjects will be recruited in this long-term follow-up study. Blood sampling will be done one month after the administration of the challenge dose. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Primary purpose:
Prevention
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Not applicable
Primary outcomes:
Number of participants with anti-hepatitis B surface antigen (anti-HBs) antibody concentrations above specific cut-off values
Timeframe: One month after the hepatitis B vaccine challenge dose
Secondary outcomes:
Occurrence, intensity and relationship to vaccination of unsolicited adverse events (AEs)
Timeframe: During the 31-day follow-up period after the challenge dose of hepatitis B vaccine.
Number of participants reporting any serious adverse events (SAEs).
Timeframe: Up to 1 month after the challenge dose.
Interventions:
Biological/vaccine: Engerix™-B
Enrollment:
76
Observational study model:
Not applicable
Primary completion date:
2008-28-01
Time perspective:
Not applicable
Clinical publications:
Poovorawan Y et al. (2010) Persistence of antibodies and immune memory to hepatitis B vaccine 20 years after infant vaccination in Thailand. Vaccine. 28(3): 730-736.
Poovorawan Y et al. (2011) Evidence of protection against clinical disease and chronic hepatitis B infection 20 years after infant hepatitis B vaccination in a high endemicity region. J Viral Hepat. 18(5):369-375.
Poovorawan Y et al. 20-year follow-up of immunogenicity and efficacy of infant hepatitis B vaccination. Abstract presented at the 6th World Congress of the World Society for Pediatric Infectious Diseases (WSPID). Buenos Aires, Argentina, 18-22 November 2009.
Poovorawan Y et al. 20-year persistence of immune response to infant hepatitis B vaccination in a high endemicity region. Abstract presented at the 13th International Symposium on Viral Hepatitis and Liver Disease (ISVHLD), Washington DC, US, 20-24 March 2009.
Medical condition
Hepatitis B
Product
SKF103860
Collaborators
Not applicable
Study date(s)
April 2007 to January 2008
Type
Interventional
Phase
4
Participation criteria
Sex
Female & Male
Age
20 - 21 years
Accepts healthy volunteers
Yes
- 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 in primary study approximately 20 years earlier.
- 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.
- Administration of a vaccine not foreseen by the study protocol during the study period.
Inclusion and exclusion criteria
Inclusion criteria:
- A male or female adult who received the complete neonatal primary vaccination course of hepatitis B vaccine in primary study approximately 20 years earlier.
- Documented level of anti-HBs antibody concentrations < specified concentration 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.
Subjects who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study.
Exclusion criteria:
- Administration of a vaccine not foreseen by the study protocol during the study period.
- Administration of immunoglobulins and/or any blood products during the study period.
- Drug and/or alcohol abuse.
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.
Trial location(s)
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Completed
Actual primary completion date
2008-28-01
Actual study completion date
2008-28-01
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
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