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

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ClinicalTrials.gov Identifier: NCT00435396
Recruitment Status : Completed
First Posted : February 15, 2007
Last Update Posted : May 30, 2017
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

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

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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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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00435396


Locations
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Belgium
GSK Investigational Site
La Louvière, Belgium, 7100
GSK Investigational Site
Wilrijk, Belgium, 2610
Sponsors and Collaborators
GlaxoSmithKline
Investigators
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Study Director: GSK Clinical Trials GlaxoSmithKline
More Information
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Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00435396    
Other Study ID Numbers: 108890
109211 ( Other Identifier: GSK )
First Posted: February 15, 2007    Key Record Dates
Last Update Posted: May 30, 2017
Last Verified: May 2017
Additional relevant MeSH terms:
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Cytomegalovirus Infections
Herpesviridae Infections
DNA Virus Infections
Virus Diseases