Clinical trial NCT00435396: Study to Evaluate Safety and Immunogenicity of the GSK Bio CMV Vaccine in CMV-seronegative Healthy Male Adult Subjects
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Infections, Cytomegalovirus
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2007-02-15
Enrollment: 40
Sex: MALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Occurrence, intensity and relationship to vaccination of solicited local and general AEs.
timeFrame: During a 7 days follow-up after each vaccination
measure: Occurrence, intensity and relationship to vaccination of unsolicited AEs.
timeFrame: During a 31 days follow-up period after each vaccination
measure: Occurrence and relationship to vaccination of any SAEs.
timeFrame: Throughout the study period
measure: Haematological and biochemical parameters.
timeFrame: At months 0, 1, 2, 6, 7 12 and 24
Secondary outcomes:
measure: Anti-gB antibody avidity in all groups;
timeFrame: At months 0, 1, 2, 6, 7 12 and 24
measure: Neutralizing anti-cytomegalovirus (CMV) antibody response in all groups
timeFrame: At months 0, 1, 2, 6, 7, 12 and 24;
measure: Anti-CMV tegument proteins antibody response in all groups;
timeFrame: At months 0, 1, 2, 6, 7, 12 and 24;
measure: 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;
timeFrame: At months 0, 1, 2, 6, 7, 12 and 24
measure: Anti-Herpes simplex virus (HSV) gD antibody response in all groups.
timeFrame: At months 0, 1, 2, 6, 7, 12 and 24
measure: Anti-glycoprotein B (gB) antibody concentrations in all groups;
timeFrame: At months 0, 1, 2, 6, 7, 12 and 24;
measure: Anti-CMV Western Blot in all groups.
timeFrame: At months 0, 1, 2, 6, 7, 12 and 24
Other outcomes:
Locations:
city: La Louvière
country: Belgium
facility: GSK Investigational Site
city: Wilrijk
country: Belgium
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: