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The purpose of the present study is to compare the immunological response of pneumococcal serotype specific B-cells, the humoral immune response and safety after sequential vaccination versus simultaneous vaccination with 13-valent pneumococcal conjugate vaccine (PCV13) and 23-valent polysaccharide vaccine (PPV23) versus single vaccination with PPV23 in a prospective, randomized controlled monocentric head-to head clinical study in elderly. The hypothesis of this study is that simultaneous vaccination with PCV13 and PPV23 might achieve an improved immune-response compared to sequential vaccination or single vaccination.
Adults >=60 years without previous pneumococcal vaccination will be randomized in three groups and receive either PCV13 on day 0 plus PPV23 6 months later (sequential vaccination) or they receive PCV13 plus PPV23 simultaneous on day 0 (simultaneous vaccination) or they receive PPV23 on day 0 (single vaccination). Blood will be taken for pneumococcal serotype-specific B-memory cells against four vaccine-serotypes (ST), included in PCV13 and PPV23, vaccine-serotype 3 (ST3), vaccine-serotype 14 (ST14), vaccine-serotype 19A (ST19A) and vaccine-serotype 23F (ST23F) at visit 1, 2,4,5,7 and 8 and for antibody levels against the 12 vaccine-serotypes included in PCV13 and PPV23 at visit 1, 3, 4, 6, 7 and 8 in all three groups. Adverse events will be recorded for 28 days after each vaccination.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequential vaccination PCV13 and PPV23 | Active Comparator | PCV13 0.5 ml intramuscular injection once on day 0 PPV23 0.5 ml intramuscular injection once 6 months later |
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| Simultaneous vaccination PCV13 and PPV23 | Experimental | PCV13 0.5ml intramuscular injection once on day 0 followed by PPV23 0.5ml intramuscular injection on day 0 |
|
| Single vaccinationPPV23 | Active Comparator | PPV23 0.5ml intramuscular injection on day 0 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PCV13 | Drug | Intramuscular injection of 13-valent pneumococcal conjugate vaccine once |
|
| Measure | Description | Time Frame |
|---|---|---|
| Immune response of B-memory cells | Change of immune response of B memory cells against 4 pneumococcal serotypes ST3,ST14,ST19A und ST23F compared to day 0 will be determined by multiparameter flow cytometry. Pneumococcal specific B-cells will be identified by labeling with fluorochrome-coupled polysaccharide antigen, B-memory cells will be identified by expression of characteristic membrane proteins and quantified. | 27-28 weeks after first vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Immune response of B-memory cells | Change immune response of B memory cells against 4 pneumococcal serotypes ST3,ST14,ST19A und ST23F compared to day 0 will be determined by multiparameter flow cytometry. Pneumococcal specific B-cells will be identified by labeling with fluorochrome-coupled polysaccharide antigen, B-memory cells will be identified by expression of characteristic membrane proteins and quantified. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mathias Pletz, MD, PhD | University Hospital of Jena, Center of Infectious Diseases and Infection Control | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center of Infectious Diseases and Infection Control, Jena University Hospital | Jena | Germany |
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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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| ID | Term |
|---|---|
| C538862 | 13-valent pneumococcal vaccine |
| D022242 | Pneumococcal Vaccines |
| ID | Term |
|---|---|
| D022541 | Streptococcal Vaccines |
| D001428 | Bacterial Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
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|
| PPV23 | Drug | Intramuscular injection of 23-valent pneumococcal polysaccharide vaccine once |
|
|
| 1-2 weeks, 26 weeks, 52 weeks, 104 weeks |
| Humoral immune response | Change of serotype-specific immunoglobulin G concentrations against 12 pneumococcal vaccine-serotypes included in both vaccines PCV13 and PPV23 compared to day 0 | 4 weeks, 26 weeks, 30 weeks, 52 weeks, 104 weeks |
| Safety (Adverse events and serious adverse events) | Adverse events and serious adverse events | 28 days after each vaccination |
| D007239 | Infections |
| D045424 |
| Complex Mixtures |