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

Study Description

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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.

Condition or disease	Intervention/treatment	Phase
Infections, Cytomegalovirus	Biological: GSK Biologicals' Recombinant CMV gB Vaccine GSK1492903A	Phase 1

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	40 participants
Allocation:	Non-Randomized
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Prevention
Official Title:	A Phase I, Open-label, Vaccination Study to Evaluate the Safety and Immunogenicity of the GSK Biologicals Recombinant CMV gB Sub-unit Vaccine GSK1492903A in CMV-seronegative Healthy Male Adult Subjects
Actual Study Start Date :	February 22, 2007
Actual Primary Completion Date :	August 27, 2008
Actual Study Completion Date :	August 27, 2008

Arms and Interventions

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Arm	Intervention/treatment
Experimental: Group A	Biological: GSK Biologicals' Recombinant CMV gB Vaccine GSK1492903A; Intramuscular injection, 3 doses

Outcome Measures

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Primary Outcome Measures :

1. Occurrence, intensity and relationship to vaccination of solicited local and general AEs. [ Time Frame: During a 7 days follow-up after each vaccination ]
2. Occurrence, intensity and relationship to vaccination of unsolicited AEs. [ Time Frame: During a 31 days follow-up period after each vaccination ]
3. Occurrence and relationship to vaccination of any SAEs. [ Time Frame: Throughout the study period ]
4. Haematological and biochemical parameters. [ Time Frame: At months 0, 1, 2, 6, 7 12 and 24 ]

Secondary Outcome Measures :

1. Anti-gB antibody avidity in all groups; [ Time Frame: At months 0, 1, 2, 6, 7 12 and 24 ]
2. Neutralizing anti-cytomegalovirus (CMV) antibody response in all groups [ Time Frame: At months 0, 1, 2, 6, 7, 12 and 24; ]
3. Anti-CMV tegument proteins antibody response in all groups; [ Time Frame: At months 0, 1, 2, 6, 7, 12 and 24; ]
4. Frequencies of CD4/CD8 T-cells with antigen-specific IFN-g, IL-2, TNF-a and/or CD40L secretion/expression to gB as determined by ICS in all groups; [ Time Frame: At months 0, 1, 2, 6, 7, 12 and 24 ]
5. Anti-Herpes simplex virus (HSV) gD antibody response in all groups. [ Time Frame: At months 0, 1, 2, 6, 7, 12 and 24 ]
6. Anti-glycoprotein B (gB) antibody concentrations in all groups; [ Time Frame: At months 0, 1, 2, 6, 7, 12 and 24; ]
7. Anti-CMV Western Blot in all groups. [ Time Frame: At months 0, 1, 2, 6, 7, 12 and 24 ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 40 Years (Adult)
Sexes Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes

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.

Contacts and Locations

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Locations

Belgium
GSK Investigational Site
La Louvière, Belgium, 7100
GSK Investigational Site
Wilrijk, Belgium, 2610

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:	GSK Clinical Trials	GlaxoSmithKline

More Information

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Additional Information:

Results for study 108890 can be found on the GSK Clinical Study Register 

Responsible Party:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00435396 History of Changes
Other Study ID Numbers:	108890; 109211 ( Other Identifier: GSK )
First Posted:	February 15, 2007
Last Update Posted:	May 30, 2017
Last Verified:	May 2017

Additional relevant MeSH terms:

Cytomegalovirus Infections; Herpesviridae Infections; DNA Virus Infections; Virus Diseases	Vaccines; Immunologic Factors; Physiological Effects of Drugs