Sequential Versus Simultaneous Pneumococcal Vaccination in Elderly: Immunological Memory and Antibody Levels
Status:
Recruiting
Trial end date:
2024-10-01
Target enrollment:
Participant gender:
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.