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NCT Number: NCT02637583

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

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.

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Key information

Conditions

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

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Center of Infectious Diseases and Infection Control, Jena University Hospital

Jena, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PCV13

Drug

Intramuscular injection of 13-valent pneumococcal conjugate vaccine once

Other names: Prevenar 13

PPV23

Drug

Intramuscular injection of 23-valent pneumococcal polysaccharide vaccine once

Other names: Pneumovax (MSD)

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Jena University Hospital

Other

Registry information

Official study title

Sequential Versus Simultaneous Vaccination With Pneumococcal Conjugate Vaccine (Prevenar 13) and Pneumococcal Polysaccharide Vaccine (Pneumovax 23) in Elderly: Immunological Memory and Antibody Levels

Important dates

Study start
2017
Primary completion
2022
Study completion
2023
First posted
Dec 22, 2015
Registry last updated
Dec 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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