Trial to Evaluate Safety and Immunogenicity of a Vaccine Against HCMV
NCT ID: NCT02798692
Last Updated: 2018-04-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
54 participants
INTERVENTIONAL
2016-06-30
2018-03-31
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Low dose HB-101 group
Intervention:Three administrations of a low dose of HB-101
Low dose HB-101
Three intra muscular administrations at Day 0, Month 1 and Month 3
Medium dose HB-101 group
Intervention:Three administrations of a middle dose of HB-101.
Medium dose HB-101
Three intra muscular administrations at Day 0, Month 1 and Month 3
High dose HB101 group
Intervention:Three administrations of a high dose of HB-101.
High dose HB-101
Three intra muscular administrations at Day 0, Month 1 and Month 3
Placebo group
Intervention:Three administrations of placebo (diluent)
Placebo
Three intra muscular administrations at Day 0, Month 1 and Month 3. The diluent is used as placebo.
Interventions
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Low dose HB-101
Three intra muscular administrations at Day 0, Month 1 and Month 3
Medium dose HB-101
Three intra muscular administrations at Day 0, Month 1 and Month 3
High dose HB-101
Three intra muscular administrations at Day 0, Month 1 and Month 3
Placebo
Three intra muscular administrations at Day 0, Month 1 and Month 3. The diluent is used as placebo.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
45 Years
ALL
Yes
Sponsors
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Centre for Vaccinology Ghent - CEVAC
UNKNOWN
Hookipa Biotech GmbH
INDUSTRY
Responsible Party
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Principal Investigators
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Geert Leroux-Roels, MD PhD Prof
Role: PRINCIPAL_INVESTIGATOR
UZ Gent
Locations
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Center for Vaccinology Ghent
Ghent, East Flanders, Belgium
Countries
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Other Identifiers
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H-100-001
Identifier Type: -
Identifier Source: org_study_id
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