Trial to Evaluate Safety and Immunogenicity of a Vaccine Against HCMV

NCT02798692 | Completed Phase 1 DMC

• 1 other identifier: H-100-001
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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.

Conditions

Cytomegalovirus Infection

Keywords

Prevention

Outcome Measures

Primary Outcomes (8)

• 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

  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.

  Day 0 to Day 7 after each administration

• Safety primary outcome (Unsolicited AE´s)

  Unsolicited AEs will be recorded through open-ended general inquiries

  From Day 0 to Month 4

• Safety primary outcome (SAEs and pregnancies)

  SAEs and pregnancies will be recorded during the whole study

  From Day 0 to Month 12

• Safety primary outcome (Vital signs)

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

  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

  From Day 0 to Month 12

• Safety primary outcome (Clinical evaluation - part I)

  Complete blood count

  From Day 0 to Month 12

• Safety primary outcome (Clinical evaluation - part II)

  Comprehensive Metabolic Panel

  From Day 0 to Month 12

Secondary Outcomes (2)

• Humoral Immunogenicity

  From Day 0 to Month 12

• Cellular Immunogenicity

  From Day 0 to Month 12

Study Arms (4)

Low dose HB-101 group

ACTIVE COMPARATOR

Intervention:Three administrations of a low dose of HB-101

Biological: Low dose HB-101

Medium dose HB-101 group

ACTIVE COMPARATOR

Intervention:Three administrations of a middle dose of HB-101.

Biological: Medium dose HB-101

High dose HB101 group

ACTIVE COMPARATOR

Intervention:Three administrations of a high dose of HB-101.

Biological: High dose HB-101

Placebo group

PLACEBO COMPARATOR

Intervention:Three administrations of placebo (diluent)

Biological: Placebo

Interventions

Low dose HB-101 BIOLOGICAL

Three intra muscular administrations at Day 0, Month 1 and Month 3

Low dose HB-101 group

Medium dose HB-101 BIOLOGICAL

Three intra muscular administrations at Day 0, Month 1 and Month 3

Medium dose HB-101 group

High dose HB-101 BIOLOGICAL

Three intra muscular administrations at Day 0, Month 1 and Month 3

High dose HB101 group

Placebo BIOLOGICAL

Three intra muscular administrations at Day 0, Month 1 and Month 3. The diluent is used as placebo.

Placebo group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hookipa Biotech GmbH: lead
• Centre for Vaccinology Ghent - CEVAC: collaborator

Study Sites (1)

Center for Vaccinology Ghent

Ghent, East Flanders, 9000, Belgium

Location

MeSH Terms

Conditions

Cytomegalovirus Infections

Condition Hierarchy (Ancestors)

Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections

Study Officials

• Geert Leroux-Roels, MD PhD Prof

  UZ Gent

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2016
• First Posted: June 14, 2016
• Study Start: June 1, 2016
• Primary Completion: May 1, 2017
• Study Completion: March 1, 2018
• Last Updated: April 3, 2018

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)