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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00435396
First received: February 14, 2007
Last updated: June 14, 2012
Last verified: June 2012
  Purpose

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 Intervention Phase
Cytomegalovirus
Biological: GSK Biologicals' Recombinant CMV gB Vaccine GSK1492903A
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Occurrence, intensity and relationship to vaccination of solicited local and general AEs. [ Time Frame: During a 7 days follow-up after each vaccination ] [ Designated as safety issue: No ]
  • Occurrence, intensity and relationship to vaccination of unsolicited AEs. [ Time Frame: During a 31 days follow-up period after each vaccination ] [ Designated as safety issue: No ]
  • Occurrence and relationship to vaccination of any SAEs. [ Time Frame: Throughout the study period ] [ Designated as safety issue: No ]
  • Haematological and biochemical parameters. [ Time Frame: At months 0, 1, 2, 6, 7 12 and 24 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Anti-gB antibody avidity in all groups; [ Time Frame: At months 0, 1, 2, 6, 7 12 and 24 ] [ Designated as safety issue: No ]
  • Neutralizing anti-cytomegalovirus (CMV) antibody response in all groups [ Time Frame: At months 0, 1, 2, 6, 7, 12 and 24; ] [ Designated as safety issue: No ]
  • Anti-CMV tegument proteins antibody response in all groups; [ Time Frame: At months 0, 1, 2, 6, 7, 12 and 24; ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Anti-Herpes simplex virus (HSV) gD antibody response in all groups. [ Time Frame: At months 0, 1, 2, 6, 7, 12 and 24 ] [ Designated as safety issue: No ]
  • Anti-glycoprotein B (gB) antibody concentrations in all groups; [ Time Frame: At months 0, 1, 2, 6, 7, 12 and 24; ] [ Designated as safety issue: No ]
  • Anti-CMV Western Blot in all groups. [ Time Frame: At months 0, 1, 2, 6, 7, 12 and 24 ] [ Designated as safety issue: No ]

Enrollment: 40
Study Start Date: February 2007
Study Completion Date: September 2009
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group A Biological: GSK Biologicals' Recombinant CMV gB Vaccine GSK1492903A
Intramuscular injection, 3 doses

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.

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00435396

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

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00435396     History of Changes
Other Study ID Numbers: 108890, 109211
Study First Received: February 14, 2007
Last Updated: June 14, 2012
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products

ClinicalTrials.gov processed this record on July 31, 2014