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

NCT ID: NCT02637583

Last Updated: 2023-12-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

123 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-18

Study Completion Date

2023-11-06

Brief Summary

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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.

Detailed Description

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Conditions

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Pneumococcal Infections

Keywords

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conjugate vaccine polysaccharide vaccine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Sequential vaccination PCV13 and PPV23

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

Group Type ACTIVE_COMPARATOR

PCV13

Intervention Type DRUG

Intramuscular injection of 13-valent pneumococcal conjugate vaccine once

PPV23

Intervention Type DRUG

Intramuscular injection of 23-valent pneumococcal polysaccharide vaccine once

Simultaneous vaccination PCV13 and PPV23

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

Group Type EXPERIMENTAL

PCV13

Intervention Type DRUG

Intramuscular injection of 13-valent pneumococcal conjugate vaccine once

PPV23

Intervention Type DRUG

Intramuscular injection of 23-valent pneumococcal polysaccharide vaccine once

Single vaccinationPPV23

PPV23 0.5ml intramuscular injection on day 0

Group Type ACTIVE_COMPARATOR

PPV23

Intervention Type DRUG

Intramuscular injection of 23-valent pneumococcal polysaccharide vaccine once

Interventions

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PCV13

Intramuscular injection of 13-valent pneumococcal conjugate vaccine once

Intervention Type DRUG

PPV23

Intramuscular injection of 23-valent pneumococcal polysaccharide vaccine once

Intervention Type DRUG

Other Intervention Names

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Prevenar 13 Pneumovax (MSD)

Eligibility Criteria

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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
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Jena University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Mathias Pletz

Prof. Dr. Mathias Pletz

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mathias Pletz, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital of Jena, Center of Infectious Diseases and Infection Control

Locations

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Center of Infectious Diseases and Infection Control, Jena University Hospital

Jena, , Germany

Site Status

Countries

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Germany

Other Identifiers

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EudraCT 2014-004013-85

Identifier Type: -

Identifier Source: org_study_id