Clinical trial NCT02637583: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pneumococcal Infections
Keywords: conjugate vaccine
polysaccharide vaccine
Lead sponsor: Jena University Hospital
Sponsor class: OTHER
First posted: 2015-12-22
Enrollment: 123
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Immune response of B-memory cells
timeFrame: 27-28 weeks after first vaccination
Secondary outcomes:
measure: Immune response of B-memory cells
timeFrame: 1-2 weeks, 26 weeks, 52 weeks, 104 weeks
measure: Humoral immune response
timeFrame: 4 weeks, 26 weeks, 30 weeks, 52 weeks, 104 weeks
measure: Safety (Adverse events and serious adverse events)
timeFrame: 28 days after each vaccination
Other outcomes:
Locations:
city: Jena
country: Germany
facility: Center of Infectious Diseases and Infection Control, Jena University Hospital
Study officials:
affiliation: University Hospital of Jena, Center of Infectious Diseases and Infection Control
name: Mathias Pletz, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: