Cytomegalovirus Infection Clinical Trial
Official title:
Randomized, Placebo-controlled, Double-blind Phase I Dose-escalating Trial to Evaluate the Safety and Immunogenicity of a Vaccine Against Human Cytomegalovirus
The objectives of this first-in-human is to evaluate the safety and the immunogenicity of three administrations of a bivalent vaccine candidate against human cytomegalovirus, at three different dose levels.
Hookipa Biotech AG is developing a replication-deficient lymphocytic choriomeningitis virus
(rLCMV) vector platform. HB-101 is a bivalent vaccine containing two recombinant,
replication-deficient lymphocytic choriomeningitis virus (rLCMV) vectors, one expressing the
pp65 protein of the human cytomegalovirus (HCMV) and one expressing the gB protein of human
cytomegalovirus (HCMV).
This Phase 1 will enroll three successive cohorts of 18 healthy volunteers. Each cohort will
receive either a low dose, a middle dose or a high dose of the vaccine (n=14 volunteers), or
placebo (n=4). A DSMB will review the safety data for the low dose cohort, before progressing
to the middle, and so before high dose. Eight DSMB meetings have been planned for the whole
study.
The subjects will be followed up to 12 months post first administration.
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