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

Primary Purpose

Pneumococcal Infections

Status
Active
Phase
Phase 4
Locations
Germany
Study Type
Interventional
Intervention
PCV13
PPV23
Sponsored by
Jena University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pneumococcal Infections focused on measuring conjugate vaccine, polysaccharide vaccine

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Active Comparator

Arm Label

Sequential vaccination PCV13 and PPV23

Simultaneous vaccination PCV13 and PPV23

Single vaccinationPPV23

Arm Description

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

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

PPV23 0.5ml intramuscular injection on day 0

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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
Safety (Adverse events and serious adverse events)
Adverse events and serious adverse events

Full Information

First Posted
October 21, 2015
Last Updated
November 9, 2022
Sponsor
Jena University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02637583
Brief Title
Sequential Versus Simultaneous Pneumococcal Vaccination in Elderly: Immunological Memory and Antibody Levels
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 18, 2017 (Actual)
Primary Completion Date
November 7, 2022 (Actual)
Study Completion Date
November 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Jena University Hospital

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pneumococcal Infections
Keywords
conjugate vaccine, polysaccharide vaccine

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
132 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Sequential vaccination PCV13 and PPV23
Arm Type
Active Comparator
Arm Description
PCV13 0.5 ml intramuscular injection once on day 0 PPV23 0.5 ml intramuscular injection once 6 months later
Arm Title
Simultaneous vaccination PCV13 and PPV23
Arm Type
Experimental
Arm Description
PCV13 0.5ml intramuscular injection once on day 0 followed by PPV23 0.5ml intramuscular injection on day 0
Arm Title
Single vaccinationPPV23
Arm Type
Active Comparator
Arm Description
PPV23 0.5ml intramuscular injection on day 0
Intervention Type
Drug
Intervention Name(s)
PCV13
Other Intervention Name(s)
Prevenar 13
Intervention Description
Intramuscular injection of 13-valent pneumococcal conjugate vaccine once
Intervention Type
Drug
Intervention Name(s)
PPV23
Other Intervention Name(s)
Pneumovax (MSD)
Intervention Description
Intramuscular injection of 23-valent pneumococcal polysaccharide vaccine once
Primary Outcome Measure Information:
Title
Immune response of B-memory cells
Description
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 Outcome Measure Information:
Title
Immune response of B-memory cells
Description
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
Title
Humoral immune response
Description
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
Title
Safety (Adverse events and serious adverse events)
Description
Adverse events and serious adverse events
Time Frame
28 days after each vaccination

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mathias Pletz, MD, PhD
Organizational Affiliation
University Hospital of Jena, Center of Infectious Diseases and Infection Control
Official's Role
Principal Investigator
Facility Information:
Facility Name
Center of Infectious Diseases and Infection Control, Jena University Hospital
City
Jena
Country
Germany

12. IPD Sharing Statement

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

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