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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PhtD Group 1 | Experimental | Subjects will receive PhtD vaccine formulation 1 without any adjuvant. |
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| PhtD Group 2 | Experimental | Subjects will receive adjuvanted PhtD vaccine formulation 2. |
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| PhtD Group 3 | Experimental | Subjects will receive adjuvanted PhtD vaccine formulation 3. |
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| PhtD Group 4 | Experimental | Subjects will receive adjuvanted PhtD vaccine formulation 4. |
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| PhtD Group 5 | Experimental | Subjects will receive adjuvanted PhtD vaccine formulation 5. |
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| 23 PPV Group | Active Comparator |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PhtD vaccine with/without adjuvant | Biological | Two doses of different formulations of PhtD vaccine administered intramuscularly in the deltoid region of the right arm at month 0 and month 2. |
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence, intensity and relationship of any solicited local and general signs and symptoms | 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 | During a 30-day follow up period (i.e. Days 0-29) after each vaccine dose | |
| Occurrence of all serious adverse events (SAEs) | During the 12 months of the study | |
| Anti-PhtD antibody concentration in all vaccine groups (measured by ELISA) | One month after the first injection | |
| Anti-PhtD antibody concentration in all vaccine groups (measured by ELISA) | One month after two injections |
| Measure | Description | Time Frame |
|---|---|---|
| Number and percentage of subjects with normal or abnormal values, for biochemical assessments and for hematological analysis | At month 0, 1, 3 and 12 | |
| Anti-PhtD antibody concentration in all groups (measured by ELISA) | At 12 months after the first vaccination |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Brussels | 1200 | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24176494 | Derived | Leroux-Roels I, Devaster JM, Leroux-Roels G, Verlant V, Henckaerts I, Moris P, Hermand P, Van Belle P, Poolman JT, Vandepapeliere P, Horsmans Y. Adjuvant system AS02V enhances humoral and cellular immune responses to pneumococcal protein PhtD vaccine in healthy young and older adults: randomised, controlled trials. Vaccine. 2015 Jan 15;33(4):577-84. doi: 10.1016/j.vaccine.2013.10.052. Epub 2013 Oct 29. |
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| ID | Term |
|---|---|
| D011008 | Pneumococcal Infections |
| ID | Term |
|---|---|
| D013290 | Streptococcal Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
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Subjects will receive the Pneumovax 23TM vaccine and NaCl.
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| Pneumovax 23TM | Biological | One dose of Pneumovax 23TM vaccine administered intramuscularly in the deltoid region of the right arm at month 0. |
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| NaCl | Biological | One dose administered intramuscularly in the deltoid region of the right arm at month 2. |
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| Anti-PhtD antibody avidity (measured by ELISA) | 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) | At month 0, 1, 3 and 12 |
| Frequency of PhtD-specific plasma cells generated by in vitro cultivated memory B-cells in a subset of subjects (measured by B-cell ELISPOT) | 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) | 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) | 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) | 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) | 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) | At Day 0, 1, 60 and 61 |
| D007239 | Infections |