Pneumococcal Infections
Conditions
Keywords
conjugate vaccine, polysaccharide vaccine
Brief summary
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.
Interventions
DRUGPCV13
Intramuscular injection of 13-valent pneumococcal conjugate vaccine once
DRUGPPV23
Intramuscular injection of 23-valent pneumococcal polysaccharide vaccine once
Sponsors
Jena University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Unvaccinated adults \>= 60 years * Written informed consent
Exclusion criteria
* Hypersensitivity against substances included in both vaccines * Previous pneumococcal vaccination * Pneumonia within the last two months * Active infection * Autoimmune disease * Ongoing or planned immunosuppressive therapy (including corticosteroid treatment with prednisolon equivalent dose \>= 5 mg/d) * Active malignant disease * Drug abuse or alcoholic abuse * Expectation of life \< 2 years * Coagulation disorders * Burns or injury on the injection site * Plegia or paresis of extremity where injection is planned * Shock * parallel participation in other clinical trial with intervention * Infusion of blood products within the last half year
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Immune response of B-memory cells | 27-28 weeks after first vaccination | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Immune response of B-memory cells | 1-2 weeks, 26 weeks, 52 weeks, 104 weeks | 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. |
| Humoral immune response | 4 weeks, 26 weeks, 30 weeks, 52 weeks, 104 weeks | Change of serotype-specific immunoglobulin G concentrations against 12 pneumococcal vaccine-serotypes included in both vaccines PCV13 and PPV23 compared to day 0 |
| Safety (Adverse events and serious adverse events) | 28 days after each vaccination | Adverse events and serious adverse events |
Countries
Germany
Outcome results
None listed