- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00435396
Study to Evaluate Safety and Immunogenicity of the GSK Bio CMV Vaccine in CMV-seronegative Healthy Male Adult Subjects
May 24, 2017 updated by: GlaxoSmithKline
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
40
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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La Louvière, Belgium, 7100
- GSK Investigational Site
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Wilrijk, Belgium, 2610
- GSK Investigational Site
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 38 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Group A
|
Intramuscular injection, 3 doses
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Occurrence, intensity and relationship to vaccination of solicited local and general AEs.
Time Frame: During a 7 days follow-up after each vaccination
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During a 7 days follow-up after each vaccination
|
Occurrence, intensity and relationship to vaccination of unsolicited AEs.
Time Frame: During a 31 days follow-up period after each vaccination
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During a 31 days follow-up period after each vaccination
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Occurrence and relationship to vaccination of any SAEs.
Time Frame: Throughout the study period
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Throughout the study period
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Haematological and biochemical parameters.
Time Frame: At months 0, 1, 2, 6, 7 12 and 24
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At months 0, 1, 2, 6, 7 12 and 24
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Anti-gB antibody avidity in all groups;
Time Frame: At months 0, 1, 2, 6, 7 12 and 24
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At months 0, 1, 2, 6, 7 12 and 24
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Neutralizing anti-cytomegalovirus (CMV) antibody response in all groups
Time Frame: At months 0, 1, 2, 6, 7, 12 and 24;
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At months 0, 1, 2, 6, 7, 12 and 24;
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Anti-CMV tegument proteins antibody response in all groups;
Time Frame: At months 0, 1, 2, 6, 7, 12 and 24;
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At months 0, 1, 2, 6, 7, 12 and 24;
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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
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At months 0, 1, 2, 6, 7, 12 and 24
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Anti-Herpes simplex virus (HSV) gD antibody response in all groups.
Time Frame: At months 0, 1, 2, 6, 7, 12 and 24
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At months 0, 1, 2, 6, 7, 12 and 24
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Anti-glycoprotein B (gB) antibody concentrations in all groups;
Time Frame: At months 0, 1, 2, 6, 7, 12 and 24;
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At months 0, 1, 2, 6, 7, 12 and 24;
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Anti-CMV Western Blot in all groups.
Time Frame: At months 0, 1, 2, 6, 7, 12 and 24
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At months 0, 1, 2, 6, 7, 12 and 24
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 22, 2007
Primary Completion (Actual)
August 27, 2008
Study Completion (Actual)
August 27, 2008
Study Registration Dates
First Submitted
February 14, 2007
First Submitted That Met QC Criteria
February 14, 2007
First Posted (Estimate)
February 15, 2007
Study Record Updates
Last Update Posted (Actual)
May 30, 2017
Last Update Submitted That Met QC Criteria
May 24, 2017
Last Verified
May 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 108890
- 109211 (Other Identifier: GSK)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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