Sequential Versus Simultaneous Pneumococcal Vaccination in Elderly: Immunological Memory and Antibody Levels

Jena University Hospital123 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

123

Conditions

Pneumococcal Infections

Eligibility

Sex: ALLMin age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: 27-28 weeks after first vaccination

Secondary Outcomes

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.

Time frame: 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

Time frame: 4 weeks, 26 weeks, 30 weeks, 52 weeks, 104 weeks

Safety (Adverse events and serious adverse events)

Adverse events and serious adverse events

Time frame: 28 days after each vaccination