Clinical trial NCT02798692: Trial to Evaluate Safety and Immunogenicity of a Vaccine Against HCMV
Official title: Randomized, Placebo-controlled, Double-blind Phase I Dose-escalating Trial to Evaluate the Safety and Immunogenicity of a Vaccine Against Human Cytomegalovirus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Cytomegalovirus Infection
Keywords: Prevention
Lead sponsor: Hookipa Biotech GmbH
Sponsor class: INDUSTRY
Collaborators: name: Centre for Vaccinology Ghent - CEVAC
First posted: 2016-06-14
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Signed informed consent
* Male or female, aged 18-45 years, in good health.
* Negative for HCMV
* Body mass index between 19 and 32 kg/m²
* Willing to forego receipt of other routine vaccinations (with the exception of seasonal influenza vaccination) for five months after study entry.
* For female volunteers: use of effective birth control for at least 2 months prior to study entry and willing to use effective birth control measures up to the Month 12 visit
* Comply with the requirements of this protocol (e.g. return for follow-up visits), as judged by the Investigator.

Exclusion Criteria:

* Works as a childcare provider.
* Pregnant or breastfeeding woman.
* Any screening safety laboratory value that is 2 times above the upper limit of normal value.
* Any confirmed or suspected immunodeficiency or autoimmune disorder.
* Treatment with any chronic immunosuppressive medication or other immuno-modifying drugs within 6 months prior to study entry. However, inhaled and topical steroids are allowed.
* Any vaccination other than for seasonal influenza within 3 months prior to study entry.
* Previous vaccination with an investigational HCMV vaccine.
* Receipt of blood, blood products and/or immunoglobulins within 3 months prior to study entry.
* History of severe allergic reactions and /or anaphylaxis
* Allergy to any component of the vaccine preparation.
* Expected to be unavailable to complete study follow up.
* Tested positive for HIV, HBsAg and/or anti-HCV.
* Participating in another clinical trial.
* Subject with a rash, dermatological condition or tattoos in the area of the injection site, as these may interfere with administration site reaction rating.

Primary outcomes:
measure: Safety primary outcome (local solicited symptoms)
timeFrame: Day 0 to Day 7 after each administration
measure: Safety primary outcome (general solicited symptoms)
timeFrame: Day 0 to Day 7 after each administration
measure: Safety primary outcome (Unsolicited AE´s)
timeFrame: From Day 0 to Month 4
measure: Safety primary outcome (SAEs and pregnancies)
timeFrame: From Day 0 to Month 12
measure: Safety primary outcome (Vital signs)
timeFrame: From Day 0 to Month 12
measure: Safety primary outcome (physical examination)
timeFrame: From Day 0 to Month 12
measure: Safety primary outcome (Clinical evaluation - part I)
timeFrame: From Day 0 to Month 12
measure: Safety primary outcome (Clinical evaluation - part II)
timeFrame: From Day 0 to Month 12
Secondary outcomes:
measure: Humoral Immunogenicity
timeFrame: From Day 0 to Month 12
measure: Cellular Immunogenicity
timeFrame: From Day 0 to Month 12
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: Center for Vaccinology Ghent
state: East Flanders
Study officials:
affiliation: UZ Gent
name: Geert Leroux-Roels, MD PhD Prof
role: PRINCIPAL_INVESTIGATOR
References: