Back to results

Trial to Evaluate Safety and Immunogenicity of a Vaccine Against HCMV

Primary Purpose

Cytomegalovirus Infection

Status

Completed

Phase

Phase 1

Locations

Belgium

Study Type

Interventional

Intervention

Low dose HB-101

Medium dose HB-101

High dose HB-101

Placebo

About this trial

This is an interventional prevention trial for Cytomegalovirus Infection focused on measuring Prevention

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

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 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:

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.

Sites / Locations

Center for Vaccinology Ghent

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Low dose HB-101 group

Medium dose HB-101 group

High dose HB101 group

Placebo group

Arm Description

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

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

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

Intervention:Three administrations of placebo (diluent)

Outcomes

Primary Outcome Measures

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

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.

Safety primary outcome (Unsolicited AE´s)

Unsolicited AEs will be recorded through open-ended general inquiries

Safety primary outcome (SAEs and pregnancies)

SAEs and pregnancies will be recorded during the whole study

Safety primary outcome (Vital signs)

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

Safety primary outcome (physical examination)

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

Safety primary outcome (Clinical evaluation - part I)

Complete blood count

Safety primary outcome (Clinical evaluation - part II)

Comprehensive Metabolic Panel

Secondary Outcome Measures

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

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

Full Information

NCT ID

NCT02798692

First Posted

June 9, 2016

Last Updated

April 1, 2018

Sponsor

Hookipa Biotech GmbH

Collaborators

Centre for Vaccinology Ghent - CEVAC

1. Study Identification

Unique Protocol Identification Number

NCT02798692

Brief Title

Trial to Evaluate Safety and Immunogenicity of a Vaccine Against HCMV

Official Title

Randomized, Placebo-controlled, Double-blind Phase I Dose-escalating Trial to Evaluate the Safety and Immunogenicity of a Vaccine Against Human Cytomegalovirus

Study Type

Interventional

2. Study Status

Record Verification Date

March 2018

Overall Recruitment Status

Completed

Study Start Date

June 2016 (Actual)

Primary Completion Date

May 2017 (Actual)

Study Completion Date

March 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Hookipa Biotech GmbH

Collaborators

Centre for Vaccinology Ghent - CEVAC

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

Detailed Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cytomegalovirus Infection

Keywords

Prevention

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

54 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Low dose HB-101 group

Arm Type

Active Comparator

Arm Description

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

Arm Title

Medium dose HB-101 group

Arm Type

Active Comparator

Arm Description

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

Arm Title

High dose HB101 group

Arm Type

Active Comparator

Arm Description

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

Arm Title

Placebo group

Arm Type

Placebo Comparator

Arm Description

Intervention:Three administrations of placebo (diluent)

Intervention Type

Biological

Intervention Name(s)

Low dose HB-101

Intervention Description

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

Intervention Type

Biological

Intervention Name(s)

Medium dose HB-101

Intervention Description

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

Intervention Type

Biological

Intervention Name(s)

High dose HB-101

Intervention Description

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

Intervention Type

Biological

Intervention Name(s)

Placebo

Intervention Description

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

Primary Outcome Measure Information:

Title

Safety primary outcome (local solicited symptoms)

Description

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

Title

Safety primary outcome (general solicited symptoms)

Description

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

Title

Safety primary outcome (Unsolicited AE´s)

Description

Unsolicited AEs will be recorded through open-ended general inquiries

Time Frame

From Day 0 to Month 4

Title

Safety primary outcome (SAEs and pregnancies)

Description

SAEs and pregnancies will be recorded during the whole study

Time Frame

From Day 0 to Month 12

Title

Safety primary outcome (Vital signs)

Description

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

Time Frame

From Day 0 to Month 12

Title

Safety primary outcome (physical examination)

Description

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

Time Frame

From Day 0 to Month 12

Title

Safety primary outcome (Clinical evaluation - part I)

Description

Complete blood count

Time Frame

From Day 0 to Month 12

Title

Safety primary outcome (Clinical evaluation - part II)

Description

Comprehensive Metabolic Panel

Time Frame

From Day 0 to Month 12

Secondary Outcome Measure Information:

Title

Humoral Immunogenicity

Description

Time Frame

From Day 0 to Month 12

Title

Cellular Immunogenicity

Description

Time Frame

From Day 0 to Month 12

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility Criteria

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 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: 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Geert Leroux-Roels, MD PhD Prof

Organizational Affiliation

UZ Gent

Official's Role

Principal Investigator

Facility Information:

Facility Name

Center for Vaccinology Ghent

City

Ghent

State/Province

East Flanders

ZIP/Postal Code

9000

Country

Belgium

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Trial to Evaluate Safety and Immunogenicity of a Vaccine Against HCMV

We'll reach out to this number within 24 hrs