Hepatitis B Clinical Trial
Official title:
Study to Evaluate the Immune Response of Healthy Subjects Who Received Neonatal Vaccination Course With GSK Biologicals' Engerix™-B Vaccine, Approximately 20 Years Ago.
Verified date | July 2011 |
Source | GlaxoSmithKline |
Contact | n/a |
Is FDA regulated | No |
Health authority | Thailand: Ministry of Public Health |
Study type | Interventional |
This study will evaluate the immune response of healthy subjects who received neonatal
vaccination course with GSK Biologicals' Engerix™-B vaccine, approximately 20 years ago. The
presence of immune memory against hepatitis B surface antigen (HBsAg) in these subjects will
be investigated by the administration of a challenge dose of hepatitis B vaccine and the
comparison of their antibody concentration before and one month after vaccination.
This protocol posting deals with objectives & outcome measures of the booster phase. No new
subjects will be recruited during this booster phase of the study.
Status | Completed |
Enrollment | 49 |
Est. completion date | June 2010 |
Est. primary completion date | June 2010 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 19 Years to 22 Years |
Eligibility |
Inclusion Criteria: - 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 who received the complete neonatal primary vaccination course of Engerix™-B in the 103860/273 primary study approximately 20 years earlier. - Anti-HBs antibody concentrations less than the specified value at the last available follow-up time-point. - 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 vaccination. Exclusion Criteria: - Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the Engerix™-B challenge dose, or planned use during the study period. - Chronic administration (defined as more than 14 days) of immunosuppressant or other immune-modifying drugs within six months prior to challenge dose administration. - Planned administration/ administration of a vaccine not foreseen by the study protocol starting from 30 days before the challenge dose and ending 30 days after. - Administration of a hepatitis B vaccine outside the context of this study between the follow-up time-point at which anti-HBs antibody concentrations was less than the specified value 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. - Acute disease at the time of enrolment. - Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection. - 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 challenge dose visit or planned administration during the study period. - Pregnant or lactating female. - Female planning to become pregnant or planning to discontinue contraceptive precautions. |
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Thailand | GSK Investigational Site | Bangkok |
Lead Sponsor | Collaborator |
---|---|
GlaxoSmithKline |
Thailand,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Subjects With an Anamnestic Response to a Challenge Dose of Hepatitis B Virus (HBV) Vaccine as Measured by Enzyme-Linked Immunosorbent Assay (ELISA). | Anamnestic response to the challenge dose is defined as: - At least (i.e. greater than or equal to) a 4-fold rise in post-challenge anti-HBsAg antibody concentrations in subjects seropositive at the last available follow-up time-point. -Post-challenge dose anti-HBsAg antibody concentrations >= 10 mIU/mL in subjects seronegative at the last available follow-up time-point. | One month after the hepatitis B vaccine challenge dose. | No |
Primary | Number of Subjects With an Anamnestic Response to a Challenge Dose of Hepatitis B Virus (HBV) Vaccine as Measured by ChemiLuminescence ImmunoAssay (CLIA). | Anamnestic response to the challenge dose is defined as: - At least (i.e. greater than or equal to) a 4-fold rise in post-challenge anti-HBsAg antibody concentrations in subjects seropositive at the last available follow-up time-point. -Post-challenge dose anti-HBsAg antibody concentrations >= 10 mIU/mL in subjects seronegative at the last available follow-up time-point. | One month after the hepatitis B vaccine challenge dose. | No |
Secondary | Number of Subjects With Anti-Hepatitis B Surface (HBs) Antibody Concentrations Above Cut-off Values as Measured by ELISA. | Cut-off values assessed were as follows: =3.3 milli-international units/milliliter (mIU/mL), =10 mIU/mL, =100 mIU/mL | One month after the hepatitis B vaccine challenge dose. | No |
Secondary | Number of Subjects With Anti-Hepatitis B Surface (HBs) Antibody Concentrations Above Cut-off Values as Measured by CLIA. | Cut-off values assessed were as follows: =6.2 milli-international units/milliliter (mIU/mL), =10 mIU/mL, =100 mIU/mL | One month after the hepatitis B vaccine challenge dose. | No |
Secondary | Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentration as Measured by ELISA. | Concentrations given as GMC expressed as milli-international unit per millilitre (mIU/mL). | One month after the hepatitis B vaccine challenge dose. | No |
Secondary | Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentration as Measured by CLIA. | Concentrations given as GMC expressed as milli-international unit per millilitre (mIU/mL). | One month after the hepatitis B vaccine challenge dose. | No |
Secondary | Number of Subjects Experiencing Any, Grade 3 and Related to Vaccination Unsolicited Symptoms. | Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Grade 3 symptom is any event that prevented normal activities. Related symptom is an event that was considered by investigator as causally related to the study vaccination. | During the 31-day follow-up period after the hepatitis B vaccine challenge dose. | No |
Secondary | Number of Subjects That Experienced Serious Adverse Events (SAEs) | SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. | During the entire study period after the challenge dose (1 month). | No |
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