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Trial to Evaluate Safety and Immunogenicity of a Vaccine Against HCMV

NCT02798692 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2018-04-03

No results posted yet for this study

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.

Conditions

  • Cytomegalovirus Infection

Interventions

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.

Sponsors & Collaborators

  • Centre for Vaccinology Ghent - CEVAC

    collaborator UNKNOWN

  • Hookipa Biotech GmbH

    lead INDUSTRY

Principal Investigators

  • Geert Leroux-Roels, MD PhD Prof · UZ Gent

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-06-30
Primary Completion
2017-05-31
Completion
2018-03-31

Countries

  • Belgium

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02798692 on ClinicalTrials.gov