In this study, the tetravalent bioconjugate candidate vaccine Kleb4V will be tested to obtain
first-time-in-human (FTIH) data on its safety and immunogenicity in healthy adults.
Kleb4V is a tetravalent bioconjugate vaccine including O antigen-polysaccharides of the most
predominant Klebsiella pneumoniae serotypes, which will be formulated with or without
Adjuvant System, AS03. Study participants will be randomized towards Kleb4V Low dose with or
without AS03, Kleb4V Target dose with or without AS03, or placebo.
The study will be conducted in two steps. In Step1 (safety cohort): safety and tolerability
of Kleb4V without and with Adjuvant AS03 will be evaluated first in adults of 18-40 y, and
subsequently in the target population of older adults 55-70 y. Enrolment will be staggered in
groups of small numbers to the different doses and formulations.
In Step 2 (target cohort): Older adults (55-70y) will be concomitantly randomized to receive
1 of the 4 different vaccine formulations or placebo.
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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