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

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ClinicalTrials.gov Identifier: NCT02637583
Recruitment Status : Recruiting
First Posted : December 22, 2015
Last Update Posted : April 9, 2018
Sponsor:
Information provided by (Responsible Party):
Mathias Pletz, Jena University Hospital

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.


Condition or disease Intervention/treatment Phase
Pneumococcal Infections Drug: PCV13 Drug: PPV23 Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 132 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Sequential Versus Simultaneous Vaccination With Pneumococcal Conjugate Vaccine (Prevenar 13) and Pneumococcal Polysaccharide Vaccine (Pneumovax 23) in Elderly: Immunological Memory and Antibody Levels
Actual Study Start Date : October 18, 2017
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : September 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: 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
Drug: PCV13
Intramuscular injection of 13-valent pneumococcal conjugate vaccine once
Other Name: Prevenar 13

Drug: PPV23
Intramuscular injection of 23-valent pneumococcal polysaccharide vaccine once
Other Name: Pneumovax 23

Experimental: Simultaneous vaccination PCV13 and PPV23
PCV13 0.5ml intramuscular injection once on day 0 followed by PPV23 0.5ml intramuscular injection on day 0
Drug: PCV13
Intramuscular injection of 13-valent pneumococcal conjugate vaccine once
Other Name: Prevenar 13

Drug: PPV23
Intramuscular injection of 23-valent pneumococcal polysaccharide vaccine once
Other Name: Pneumovax 23

Active Comparator: Single vaccinationPPV23
PPV23 0.5ml intramuscular injection on day 0
Drug: PPV23
Intramuscular injection of 23-valent pneumococcal polysaccharide vaccine once
Other Name: Pneumovax 23




Primary Outcome Measures :
  1. Immune response of B-memory cells [ Time Frame: 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 Outcome Measures :
  1. Immune response of B-memory cells [ Time Frame: 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.

  2. Humoral immune response [ Time Frame: 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

  3. Safety (Adverse events and serious adverse events) [ Time Frame: 28 days after each vaccination ]
    Adverse events and serious adverse events



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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02637583


Contacts
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Contact: Christina Forstner, MD +4936419324769 christina.forstner@med-uni.jena.de
Contact: Mathias Pletz, MD, PhD +4936419324650 mathias.pletz@med.uni-jena.de

Locations
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Germany
Center of Infectious Diseases and Infection Control, Jena University Hospital Recruiting
Jena, Germany
Contact: Mathias Pletz, MD         
Sponsors and Collaborators
Jena University Hospital
Investigators
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Principal Investigator: Mathias Pletz, MD, PhD University Hospital of Jena, Center of Infectious Diseases and Infection Control

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Responsible Party: Mathias Pletz, Prof. Dr. Mathias Pletz, Jena University Hospital
ClinicalTrials.gov Identifier: NCT02637583     History of Changes
Other Study ID Numbers: EudraCT 2014-004013-85
First Posted: December 22, 2015    Key Record Dates
Last Update Posted: April 9, 2018
Last Verified: April 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Mathias Pletz, Jena University Hospital:
conjugate vaccine
polysaccharide vaccine

Additional relevant MeSH terms:
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Pneumococcal Infections
Streptococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Vaccines
Antibodies
Heptavalent Pneumococcal Conjugate Vaccine
Immunologic Factors
Physiological Effects of Drugs