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

Jena University Hospital

Status and phase: Completed; Phase 4

Conditions: Pneumococcal Infections

Treatments: Drug: PPV23; Drug: PCV13

Study type: Interventional

Funder types: Other

Identifiers

NCT02637583

EudraCT 2014-004013-85

Details and patient eligibility

About

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.

Enrollment: 123 patients

Sex: All

Ages: 60+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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123 participants in 3 patient groups

Sequential vaccination PCV13 and PPV23

Active Comparator group

Description:

PCV13 0.5 ml intramuscular injection once on day 0 PPV23 0.5 ml intramuscular injection once 6 months later

Treatment:

Drug: PCV13

Drug: PPV23

Simultaneous vaccination PCV13 and PPV23

Experimental group

Description:

PCV13 0.5ml intramuscular injection once on day 0 followed by PPV23 0.5ml intramuscular injection on day 0

Treatment:

Drug: PCV13

Drug: PPV23

Single vaccinationPPV23

Active Comparator group

Description:

PPV23 0.5ml intramuscular injection on day 0

Treatment:

Drug: PPV23