First-in-Human Study of Cytomegalovirus

On Wednesday, 20th of July 2016, HOOKIPA BIOTECH announced the start of the first-in-human study to evaluate the safety and immunogenicity of HB-101.

HB-101 is a vaccine candidate against human cytomegalovirus(HCMV) consisting of two recombinant, replication-deficient lymphocytic choriomeningitis virus (rLCMV) vectors, one expressing pp65 protein and one ¬†expressing a truncated gB protein of cytomegalovirus. It is based on the company’s viral vector platform which can be applied repeatedly to boost immune system and stimulate potent B-cell and CD8+ T-cell immune response.


Phase 1 study will recruit 54 healthy, male and female subjects, negative for HCMV, at Center for Vaccinology, Ghent University Hospital. Subjects are enrolled at cohort of 18, with each cohort receiving either a low dose, middle dose or high dose of vaccine(n=14) or placebo(n=4). Vaccine will be administered at day 0, month 1 and month 3 with the trial running for 15 months.

Will HB-101 be the first CMV vaccine to be approved? Hopefully it will be.

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