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

Pneumococcal Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02637583
• Other study ID #: EudraCT 2014-004013-85
• Status: Completed
• Phase: Phase 4
• Start date: October 18, 2017
• Est. completion date: November 6, 2023

Study information

• Verified date: November 2023
• Source: Jena University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 123
• Est. completion date: November 6, 2023
• Est. primary completion date: November 7, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pneumococcal Infections

Intervention

Drug:
• PCV13
Intramuscular injection of 13-valent pneumococcal conjugate vaccine once
• PPV23
Intramuscular injection of 23-valent pneumococcal polysaccharide vaccine once

Locations

Country	Name	City	State
Germany	Center of Infectious Diseases and Infection Control, Jena University Hospital	Jena

Sponsors (1)

Lead Sponsor	Collaborator
Jena University Hospital

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	1-2 weeks, 26 weeks, 52 weeks, 104 weeks
Secondary	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	4 weeks, 26 weeks, 30 weeks, 52 weeks, 104 weeks
Secondary	Safety (Adverse events and serious adverse events)	Adverse events and serious adverse events	28 days after each vaccination