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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
54
Three intra muscular administrations at Day 0, Month 1 and Month 3
Three intra muscular administrations at Day 0, Month 1 and Month 3
Three intra muscular administrations at Day 0, Month 1 and Month 3
Center for Vaccinology Ghent
Ghent, East Flanders, Belgium
Safety primary outcome (local solicited symptoms)
Local solicited symptoms will be assessed by diary card and scripted questions for 7 days after each administration: administration site pain, induration, erythema, pruritus and swelling
Time frame: Day 0 to Day 7 after each administration
Safety primary outcome (general solicited symptoms)
General solicited symptoms will be assessed by diary card and scripted questions for 7 days after each administration: malaise, fatigue, body temperature (measured axillary), generalized myalgia.
Time frame: Day 0 to Day 7 after each administration
Safety primary outcome (Unsolicited AE´s)
Unsolicited AEs will be recorded through open-ended general inquiries
Time frame: From Day 0 to Month 4
Safety primary outcome (SAEs and pregnancies)
SAEs and pregnancies will be recorded during the whole study
Time frame: From Day 0 to Month 12
Safety primary outcome (Vital signs)
Vital signs (blood pressure, heart rate and body temperature)
Time frame: From Day 0 to Month 12
Safety primary outcome (physical examination)
general evaluation based on the Investigator judgment and local evaluation of the administration site
Time frame: From Day 0 to Month 12
Safety primary outcome (Clinical evaluation - part I)
Complete blood count
Time frame: From Day 0 to Month 12
Safety primary outcome (Clinical evaluation - part II)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Three intra muscular administrations at Day 0, Month 1 and Month 3. The diluent is used as placebo.
Comprehensive Metabolic Panel
Time frame: From Day 0 to Month 12
Humoral Immunogenicity
* Human cytomegalovirus (HCMV) gB immunoglobulin G (IgG) by enzyme-linked immunosorbent assay (ELISA) * HCMV neutralization on MRC-5 cells * HCMV neutralization on ARPE-19 cells (depending on neutralization assay results in MRC-5 cells) * Lymphocytic choriomeningitis virus (LCMV) neutralization on ARPE-19 cells
Time frame: From Day 0 to Month 12
Cellular Immunogenicity
* LCMV NP-specific interferon γ (IFN-γ) Enzyme-Linked Immunospot Assay (ELISPOT) * LCMV NP-specific intracellular cytokine staining (ICS) of CD4+ and CD8+ T cells for IFN-γ, IL-2, TNF-α, CD107a and CD40L * HCMV pp65-specific IFN-γ ELISPOT * HCMV gB-specific IFN-γ ELISPOT * HCMV pp65-specific ICS of CD4+ and CD8+ T cells for IFN-γ, IL-2, TNF-α, CD107a and CD40L * HCMV gB-specific ICS of CD4+ and CD8+ T cells for IFN-γ, IL-2, TNF-α, CD107a and CD40L
Time frame: From Day 0 to Month 12