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Low dose HB-101

Phase 1

Cytomegalovirus Infection | Monoclonal antibody | Other |HOOKIPA Pharma Inc.|Last Updated: Apr 3, 2018

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment54
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02798692Trial to Evaluate Safety and Immunogenicity of a Vaccine Against HCMVPHASE1 COMPLETED 54 — — Jun 1, 2016Mar 1, 2018Apr 3, 20181 Belgium
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Study Endpoints
Primary Endpoints
Safety primary outcome (local solicited symptoms)
Day 0 to Day 7 after each administration

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

Safety primary outcome (general solicited symptoms)
Day 0 to Day 7 after each administration

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.

Safety primary outcome (Unsolicited AE´s)
From Day 0 to Month 4

Unsolicited AEs will be recorded through open-ended general inquiries

Safety primary outcome (SAEs and pregnancies)
From Day 0 to Month 12

SAEs and pregnancies will be recorded during the whole study

Safety primary outcome (Vital signs)
From Day 0 to Month 12

Vital signs (blood pressure, heart rate and body temperature)

Safety primary outcome (physical examination)
From Day 0 to Month 12

general evaluation based on the Investigator judgment and local evaluation of the administration site

Safety primary outcome (Clinical evaluation - part I)
From Day 0 to Month 12

Complete blood count

Safety primary outcome (Clinical evaluation - part II)
From Day 0 to Month 12

Comprehensive Metabolic Panel

Secondary Endpoints
Humoral Immunogenicity
From Day 0 to Month 12
Cellular Immunogenicity
From Day 0 to Month 12
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposePREVENTION
Treatment Arms
ArmTypeDescription
Low dose HB-101 groupACTIVE_COMPARATORIntervention:Three administrations of a low dose of HB-101
Medium dose HB-101 groupACTIVE_COMPARATORIntervention:Three administrations of a middle dose of HB-101.
High dose HB101 groupACTIVE_COMPARATORIntervention:Three administrations of a high dose of HB-101.
Placebo groupPLACEBO_COMPARATORIntervention:Three administrations of placebo (diluent)
Interventions
NameTypeDescription
Low dose HB-101BIOLOGICALThree intra muscular administrations at Day 0, Month 1 and Month 3
Medium dose HB-101BIOLOGICALThree intra muscular administrations at Day 0, Month 1 and Month 3
High dose HB-101BIOLOGICALThree intra muscular administrations at Day 0, Month 1 and Month 3
PlaceboBIOLOGICALThree intra muscular administrations at Day 0, Month 1 and Month 3. The diluent is used as placebo.
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Eligibility Criteria
Age Range18 Years — 45 Years
SexALL
Healthy VolunteersYes
Study Sites1

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 stud...

Countries:Belgium
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