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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
49
Intramuscular injection, one dose.
GSK Investigational Site
Bangkok, Thailand
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.
Time frame: One month after the hepatitis B vaccine challenge dose.
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.
Time frame: One month after the hepatitis B vaccine challenge dose.
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
Time frame: One month after the hepatitis B vaccine challenge dose.
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
Time frame: One month after the hepatitis B vaccine challenge dose.
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).
Time frame: One month after the hepatitis B vaccine challenge dose.
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).
Time frame: One month after the hepatitis B vaccine challenge dose.
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.
Time frame: During the 31-day follow-up period after the hepatitis B vaccine challenge dose.
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.
Time frame: During the entire study period after the challenge dose (1 month).
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.