NCT02798692

Trial to Evaluate Safety and Immunogenicity of a Vaccine Against HCMV

Randomized, Placebo-controlled, Double-blind Phase I Dose-escalating Trial to Evaluate the Safety and Immunogenicity of a Vaccine Against Human Cytomegalovirus

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 54 (actual)
• Sponsor: Hookipa Biotech GmbH · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Cytomegalovirus Infection

Interventions

Type	Name	Description
BIOLOGICAL	Low dose HB-101	Three intra muscular administrations at Day 0, Month 1 and Month 3
BIOLOGICAL	Medium dose HB-101	Three intra muscular administrations at Day 0, Month 1 and Month 3
BIOLOGICAL	High dose HB-101	Three intra muscular administrations at Day 0, Month 1 and Month 3
BIOLOGICAL	Placebo	Three intra muscular administrations at Day 0, Month 1 and Month 3. The diluent is used as placebo.

Timeline

• Start date: 2016-06-01
• Primary completion: 2017-05-01
• Completion: 2018-03-01
• First posted: 2016-06-14
• Last updated: 2018-04-03

Locations

1 site across 1 country: Belgium