study to evaluate safety and immunogenicity of the gsk bio cmv vaccine in cmv-seronegative healthy male adult subjects

Conditions: Infections, Cytomegalovirus

Summary: this will be the first time in humans (ftih) study with the gsk bio recombinant gb antigen to evaluate safety and immunogenicity of this cmv candidate vaccine with a proprietary gsk adjuvant system. the vaccine will be administered to young male healthy subjects at 0, 1 and 6 months. the trial will assess the safety and immunogenicity of the candidate cmv vaccine. an additional secondary objective of this trial is to identify and validate a test which will be able to differentiate between previous cmv infection and cmv vaccination. subjects will be followed for a total of 2 years.

the protocol posting has been amended to reflect changes as a consequence of an amendment to the protocol. the section impacted by the change is key inclusion \& exclusion criteria. the protocol posting has been updated in order to comply with the fda amendment act, sep 2007.

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. * male between, and including, 18 and 40 years of age at the time of the first vaccination. * written informed consent obtained from the subject. * the subject consents to being informed of his cmv and hsv serostatus. * healthy subjects as established by medical history and clinical examination before entering into the study. * seronegative for cmv. * previously completed routine childhood vaccinations to the best of his knowledge. exclusion criteria: * the hsv serologic status. * 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 first vaccine dose. * any chronic drug therapy to be continued during the study period. * receipt of live attenuated vaccines within 30 days of study vaccine administration. * receipt of medically indicated subunit or killed vaccines (e.g., influenza, pneumococcal) or allergy treatment with antigen injections within 14 days of study vaccine administration. * prior receipt of the adjuvant or any of its components being used in this study. * previous vaccination against cmv. * history of recurrent herpes simplex infection (more than 1 episode per year). * any confirmed or suspected immunosuppressive or immunodeficient condition * hepatitis b infection or hepatitis c infection. * a family history of congenital or hereditary immunodeficiency. * history of allergic disease or reactions likely to be exacerbated by any component of the vaccine. * major congenital defects or serious chronic illness including but not limited to diabetes mellitus and thyroid disease * history of any neurologic disorders or seizures except people with febrile convulsions before the age of 5. * history of malignancy * acute disease at the time of enrollment. * acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests. * hepatomegaly, right upper quadrant abdominal pain or tenderness. * decreased renal function * administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine or planned administration during the study period. * history of chronic alcohol consumption and/or drug abuse.