The purpose of this study is to examine the safety, reactogenicity and immunogenicity of the GlaxoSmithKline (GSK) Biologicals candidate pneumococcal vaccine containing PhtD in healthy elderly population aged 18-45 years of age.
The safety profile of the PhtD vaccine will be assessed in comparison to a comparator vaccine (Pneumovax 23TM). In order to further increase the immune response to vaccination, a novel adjuvant system will also be examined.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
150
Two doses of different formulations of PhtD vaccine administered intramuscularly in the deltoid region of the right arm at month 0 and month 2.
One dose of Pneumovax 23TM vaccine administered intramuscularly in the deltoid region of the right arm at month 0.
One dose administered intramuscularly in the deltoid region of the right arm at month 2.
GSK Investigational Site
Brussels, Belgium
Occurrence, intensity and relationship of any solicited local and general signs and symptoms
Time frame: During a 7-day follow up period (i.e. Days 0-6) after each vaccine dose
Occurrence, intensity and relationship to vaccination of unsolicited local and general signs and symptoms
Time frame: During a 30-day follow up period (i.e. Days 0-29) after each vaccine dose
Occurrence of all serious adverse events (SAEs)
Time frame: During the 12 months of the study
Anti-PhtD antibody concentration in all vaccine groups (measured by ELISA)
Time frame: One month after the first injection
Anti-PhtD antibody concentration in all vaccine groups (measured by ELISA)
Time frame: One month after two injections
Number and percentage of subjects with normal or abnormal values, for biochemical assessments and for hematological analysis
Time frame: At month 0, 1, 3 and 12
Anti-PhtD antibody concentration in all groups (measured by ELISA)
Time frame: At 12 months after the first vaccination
Anti-PhtD antibody avidity (measured by ELISA)
Time frame: At month 0, 1, 3 and 12
Evaluation of protection afforded by passive transfer of anti PhtD antibodies sera pooled from all individuals (passive transfer mice model assay)
Time frame: At month 0, 1, 3 and 12
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Frequency of PhtD-specific plasma cells generated by in vitro cultivated memory B-cells in a subset of subjects (measured by B-cell ELISPOT)
Time frame: At month 0, 3 and 12
Frequency of CD4 and/or CD8 T cells that produce cytokines IL-2, IL-4, IFNg, CD40L and/or GM-CSF, upon PhtD re-stimulation in vitro, to evaluate the T-cell response, in a subset of subjects (measured by intracellular cytokine cytometry)
Time frame: At month 0, 3 and 12
Anti-polysaccharide total gamma class immunoglobulin (IgG) concentration in the 23 valent Polysaccharide Pneumococcal Vaccine(23 PPV) group for 11 serotypes (1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19F, 23F) (ELISA)
Time frame: At month 0, 1 and 12
Opsonophagocytic activity titers in the 23 PPV group for 11 serotypes (1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19F, 23F (OPA assay)
Time frame: At month 0, 1 and 12
Frequency of polysaccharide(PS)-specific plasma cells generated by in vitro cultivated memory B-cells in the 23 PPV group in a subset of subjects (measured by B-cell ELISPOT)
Time frame: At month 0, 1 and 12
Circulating serum cytokines Interferon-gamma (INFγ) and Tumor necrosis factor-alpha (TNFα) content in all groups (measured by ELISA)
Time frame: At Day 0, 1, 60 and 61