safety and immunogenicity of a booster dose of glaxosmithkline (gsk) biologicals' hepatitis b vaccine

Conditions: Hepatitis B

Summary: in this study, subjects who received primary neonatal vaccination with hepatitis b vaccine at 0, 1, 2, 12 months, 20 years ago in the 103860/272 primary study will be evaluated for immunological memory to hepatitis b vaccine via assessment of the response to a vaccine challenge dose.


Eligibility criteria:
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 adult who received the complete neonatal primary vaccination course of hepatitis b vaccine (engerix™-b), in the 103860/272 primary study approximately 20 years earlier. * documented level of anti-hbs antibody concentrations \< 100 milli-international units per milliliter (miu/ml) 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. exclusion criteria: * use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period. * 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. * 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 a booster dose of hepatitis b vaccine outside the context of this study between the long-term time-point at the documented level of anti-hbs antibody concentrations 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. * any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (hiv) infection. * acute disease at the time of enrolment. * 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 hepatitis b vaccine challenge dose or planned administration during the study period. * pregnant or lactating female. * female planning to become pregnant or planning to discontinue contraceptive precautions.

Keywords: hepatitis vaccine