Cytomegalovirus InfectionPhase 1NCT02798692
Trial to Evaluate Safety and Immunogenicity of a Vaccine Against HCMV
A Phase 1 study testing Low dose HB-101, Medium dose HB-101 and High dose HB-101 in people with Cytomegalovirus Infection, run by Hookipa Biotech GmbH at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Cytomegalovirus Infection
- What is being tested?
- Low dose HB-101, Medium dose HB-101 and High dose HB-101
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 1 siteBelgium
- Study dates
- Jun 2016to Mar 2018
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized, Placebo-controlled, Double-blind Phase I Dose-escalating Trial to Evaluate the Safety and Immunogenicity of a Vaccine Against Human Cytomegalovirus
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.
Read the 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.
- Conditions
- Cytomegalovirus Infection
- Being tested
- Low dose HB-101, Medium dose HB-101, High dose HB-101, Placebo
- Keywords
- Prevention
- Medical subject headings
- Cytomegalovirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low dose HB-101Biological
Three intra muscular administrations at Day 0, Month 1 and Month 3
Medium dose HB-101Biological
Three intra muscular administrations at Day 0, Month 1 and Month 3
High dose HB-101Biological
Three intra muscular administrations at Day 0, Month 1 and Month 3
PlaceboBiological
Three intra muscular administrations at Day 0, Month 1 and Month 3. The diluent is used as placebo.
| Study group | Role | What they receive |
|---|---|---|
| Low dose HB-101 group | Active comparator | Intervention:Three administrations of a low dose of HB-101 Receives: Biological: Low dose HB-101 |
| Medium dose HB-101 group | Active comparator | Intervention:Three administrations of a middle dose of HB-101. Receives: Biological: Medium dose HB-101 |
| High dose HB101 group | Active comparator | Intervention:Three administrations of a high dose of HB-101. Receives: Biological: High dose HB-101 |
| Placebo group | Placebo comparator | Intervention:Three administrations of placebo (diluent) Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: Day 0 to Day 7 after each administration
Safety primary outcome (Unsolicited AE´s)
Unsolicited AEs will be recorded through open-ended general inquiries
Measured: From Day 0 to Month 4
Safety primary outcome (SAEs and pregnancies)
SAEs and pregnancies will be recorded during the whole study
Measured: From Day 0 to Month 12
Safety primary outcome (Vital signs)
Vital signs (blood pressure, heart rate and body temperature)
Measured: 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
Measured: From Day 0 to Month 12
Safety primary outcome (Clinical evaluation - part I)
Complete blood count
Measured: From Day 0 to Month 12
Safety primary outcome (Clinical evaluation - part II)
Comprehensive Metabolic Panel
Measured: From Day 0 to Month 12
Secondary outcomes (2)
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
Measured: 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
Measured: From Day 0 to Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2016 (estimated)
- Study startJun 2016
- Primary completionMay 2017
- Study completionMar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cytomegalovirus InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hookipa Biotech GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Centre for Vaccinology Ghent - CEVAC
- Responsible party
- Sponsor
- Investigators
- Geert Leroux-Roels, MD PhD Prof, Principal investigator, UZ Gent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02798692
- Sponsor's protocol ID
- H-100-001
- Status last verified
- Mar 2018
- First submitted
- 9 Jun 2016
- Last updated
- 3 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Placebo-controlled, Double-blind Phase I Dose-escalating Trial to Evaluate the Safety and Immunogenicity of a Vaccine Against Human Cytomegalovirus
- ClinicalTrials.gov ID
- NCT02798692
- Acronym / sponsor ID
- H-100-001
- Conditions
- Cytomegalovirus Infection
- Keywords
- Prevention
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Hookipa Biotech GmbHIndustry (pharma, biotech, devices)
- Collaborators
- Centre for Vaccinology Ghent - CEVAC
- Study start
- Jun 2016 (actual)
- Primary completion
- May 2017 (actual)
- Study completion
- Mar 2018 (actual)
- First posted
- 14 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Low dose HB-101 group | Active comparator | Biological: Low dose HB-101Intervention:Three administrations of a low dose of HB-101 |
| Medium dose HB-101 group | Active comparator | Biological: Medium dose HB-101Intervention:Three administrations of a middle dose of HB-101. |
| High dose HB101 group | Active comparator | Biological: High dose HB-101Intervention:Three administrations of a high dose of HB-101. |
| Placebo group | Placebo comparator | Biological: PlaceboIntervention:Three administrations of placebo (diluent) |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low dose HB-101Three intra muscular administrations at Day 0, Month 1 and Month 3 | Biological | Low dose HB-101 group |
| Medium dose HB-101Three intra muscular administrations at Day 0, Month 1 and Month 3 | Biological | Medium dose HB-101 group |
| High dose HB-101Three intra muscular administrations at Day 0, Month 1 and Month 3 | Biological | High dose HB101 group |
| PlaceboThree intra muscular administrations at Day 0, Month 1 and Month 3. The diluent is used as placebo. | Biological | Placebo group |
Primary outcome
Safety primary outcome (local solicited symptoms)
Time frame: 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)
Time frame: 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)
Time frame: From Day 0 to Month 4
Unsolicited AEs will be recorded through open-ended general inquiries
Safety primary outcome (SAEs and pregnancies)
Time frame: From Day 0 to Month 12
SAEs and pregnancies will be recorded during the whole study
Safety primary outcome (Vital signs)
Time frame: From Day 0 to Month 12
Vital signs (blood pressure, heart rate and body temperature)
Safety primary outcome (physical examination)
Time frame: 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)
Time frame: From Day 0 to Month 12
Complete blood count
Safety primary outcome (Clinical evaluation - part II)
Time frame: From Day 0 to Month 12
Comprehensive Metabolic Panel
2 secondary outcomes
Humoral Immunogenicity
Time frame: From Day 0 to Month 12
Cellular Immunogenicity
Time frame: From Day 0 to Month 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Geert Leroux-Roels, MD PhD Prof principal investigator
UZ Gent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Low dose HB-101, Medium dose HB-101 and High dose HB-101 in people with Cytomegalovirus Infection, run by Hookipa Biotech GmbH at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety primary outcome (local solicited symptoms) (time frame: Day 0 to Day 7 after each administration). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2018.