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.
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
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
40
Intramuscular injection, 3 doses
GSK Investigational Site
La Louvière, Belgium
GSK Investigational Site
Wilrijk, Belgium
Occurrence, intensity and relationship to vaccination of solicited local and general AEs.
Time frame: 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
Occurrence and relationship to vaccination of any SAEs.
Time frame: Throughout the study period
Haematological and biochemical parameters.
Time frame: At months 0, 1, 2, 6, 7 12 and 24
Anti-gB antibody avidity in all groups;
Time frame: At months 0, 1, 2, 6, 7 12 and 24
Neutralizing anti-cytomegalovirus (CMV) antibody response in all groups
Time frame: At months 0, 1, 2, 6, 7, 12 and 24;
Anti-CMV tegument proteins antibody response in all groups;
Time frame: At months 0, 1, 2, 6, 7, 12 and 24;
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
Anti-Herpes simplex virus (HSV) gD antibody response in all groups.
Time frame: At months 0, 1, 2, 6, 7, 12 and 24
Anti-glycoprotein B (gB) antibody concentrations in all groups;
Time frame: At months 0, 1, 2, 6, 7, 12 and 24;
Anti-CMV Western Blot in all groups.
Time frame: At months 0, 1, 2, 6, 7, 12 and 24
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