immunogenicity and persistence of glaxosmithkline (gsk) biologicals' havrix® in healthy adult subjects vaccinated at infancy under the hepatitis a universal mass vaccination (umv) program in israel

Conditions: Hepatitis A

Summary: this study will evaluate the persistence, immunogenicity and safety of havrix® (hepatitis a vaccine) in adults primed in infancy. the enrolled subjects will be assessed for circulating antibodies against hepatitis a and will also receive a challenge dose of havrix adult vaccine. in the present study, the anamnestic response will be assessed 30 days after the challenge dose.


Eligibility criteria:
inclusion criteria: * subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol * written informed consent obtained from the subject prior to performing any study specific procedure * a male or female subject aged 18 to 19 years at the time of enrolment (up to but excluding the 20th birthday) * documented administration of 2 doses of havrix® junior in the second year of life * healthy subjects as established by medical history and clinical examination before entering into the study * female subjects of childbearing potential may be enrolled in the study, if the subject: has practiced adequate contraception for 30 days prior to study vaccine administration, and has a negative pregnancy test on the day of vaccine administration, and has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the study vaccine administration exclusion criteria: * use of any investigational or non-registered product other than the study vaccine during the period starting 30 days before the dose of study vaccine (day 29 to day1), or planned use during the study period * any medical condition that in the judgment of the investigator would make intramuscular injection unsafe * chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs during the period starting six months prior to the vaccine dose. for corticosteroids, this will mean prednisone ≥ 20 mg/day, or equivalent. inhaled and topical steroids are allowed * administration of long-acting immune-modifying drugs at any time during the study entry * 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 vaccine/product * administration of any hepatitis a vaccine dose, with the exception of the two doses of routine toddler vaccination for the subjects * any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination * history of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine * planned enrolment in the israel defense forces within 30 days of study enrolment or activity that would prohibit the subject to return for visit 2 * acute disease and/or fever at the time of enrolment fever is defined as temperature ≥38.0°c / 100.4°f. the preferred location for measuring temperature in this study will be the oral cavity subjects with a minor illness without fever may be enrolled at the discretion of the investigator * pregnant or lactating female * female planning to become pregnant or planning to discontinue contraceptive precautions

Keywords: israel universal mass vaccination havrix® hepatitis a healthy adults long term persistence toddlers