Study to Evaluate Safety and Immunogenicity of the GSK Bio CMV Vaccine in CMV-seronegative Healthy Male Adult Subjects

NCT ID: NCT00435396

Last Updated: 2017-05-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-02-22
• Study Completion Date: 2008-08-27

Brief 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.

Detailed Description

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.

Conditions

Infections, Cytomegalovirus

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Group A

Group Type: EXPERIMENTAL

GSK Biologicals' Recombinant CMV gB Vaccine GSK1492903A

Intervention Type: BIOLOGICAL

Intramuscular injection, 3 doses

Interventions

GSK Biologicals' Recombinant CMV gB Vaccine GSK1492903A

Intramuscular injection, 3 doses

Intervention Type: BIOLOGICAL

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

La Louvière, , Belgium

GSK Investigational Site

Wilrijk, , Belgium

Countries

Belgium

Other Identifiers

109211

Identifier Type: OTHER

Identifier Source: secondary_id

108890

Identifier Type: -

Identifier Source: org_study_id