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

NCT02637583 | Completed Phase 4

• 1 other identifier: EudraCT 2014-004013-85
• Study Type: interventional
• Target: 123
• Locations: 1 country
• Sites: 1

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.

Conditions

Pneumococcal Infections

Keywords

conjugate vaccine; polysaccharide vaccine

Outcome Measures

Primary Outcomes (1)

• 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.

  27-28 weeks after first vaccination

Secondary Outcomes (3)

• Immune response of B-memory cells

  1-2 weeks, 26 weeks, 52 weeks, 104 weeks

• Humoral immune response

  4 weeks, 26 weeks, 30 weeks, 52 weeks, 104 weeks

• Safety (Adverse events and serious adverse events)

  28 days after each vaccination

Study Arms (3)

Sequential vaccination PCV13 and PPV23

ACTIVE COMPARATOR

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

Drug: PCV13; Drug: PPV23

Simultaneous vaccination PCV13 and PPV23

EXPERIMENTAL

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

Drug: PCV13; Drug: PPV23

Single vaccinationPPV23

ACTIVE COMPARATOR

PPV23 0.5ml intramuscular injection on day 0

Drug: PPV23

Interventions

PCV13 DRUG

Intramuscular injection of 13-valent pneumococcal conjugate vaccine once

Also known as: Prevenar 13

Sequential vaccination PCV13 and PPV23; Simultaneous vaccination PCV13 and PPV23

PPV23 DRUG

Intramuscular injection of 23-valent pneumococcal polysaccharide vaccine once

Also known as: Pneumovax (MSD)

Sequential vaccination PCV13 and PPV23; Simultaneous vaccination PCV13 and PPV23; Single vaccinationPPV23

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Unvaccinated adults \>= 60 years
• Written informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Jena University Hospital: lead

Study Sites (1)

Center of Infectious Diseases and Infection Control, Jena University Hospital

Jena, Germany

Location

MeSH Terms

Conditions

Pneumococcal Infections

Interventions

13-valent pneumococcal vaccine; Pneumococcal Vaccines

Condition Hierarchy (Ancestors)

Streptococcal Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Streptococcal Vaccines; Bacterial Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Officials

• Mathias Pletz, MD, PhD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. Mathias Pletz

Study Record Dates

• First Submitted: October 21, 2015
• First Posted: December 22, 2015
• Study Start: October 18, 2017
• Primary Completion: November 7, 2022
• Study Completion: November 6, 2023
• Last Updated: December 1, 2023

Record last verified: 2023-11

Locations

DE (1)