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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT04210752
Registration number
NCT04210752
Ethics application status
Date submitted
17/12/2019
Date registered
26/12/2019
Date last updated
8/02/2021
Titles & IDs
Public title
Study to Assess the Safety, Tolerability and Explore the Immunogenicity of EG-HZ in Healthy Adult Volunteers
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Scientific title
A Phase 1, Randomised, Activator-Controlled, Double-Blind, Parallel Study to Assess the Safety, Tolerability and Explore the Immunogenicity of EG-HZ in Healthy Adult Volunteers
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Secondary ID [1]
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EG-HZ-101
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Prevention of Herpes Zoster (HZ)
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Condition category
Condition code
Infection
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Other infectious diseases
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Treatment 1 (EG-HZ-001)
Treatment: Drugs - Treatment 2 (EG-HZ-002)
Treatment: Drugs - Treatment 3 (EG-HZ-003)
Treatment: Drugs - Treatment 4 (EG-HZ-004)
Treatment: Drugs - Treatment 5
Experimental: Treatment 1 (EG-HZ-001) - Subjects will receive two single IM vaccinations, 2 months apart, the first on Day 1 and the second on Day 60 (±5 days). Subjects will be randomised to treatment at a ratio of 1:1:1:1:1 (n=8 per treatment)
Route of administration: Intramuscular injection
Experimental: Treatment 2 (EG-HZ-002) - Subjects will receive two single IM vaccinations, 2 months apart, the first on Day 1 and the second on Day 60 (±5 days). Subjects will be randomised to treatment at a ratio of 1:1:1:1:1 (n=8 per treatment)
Route of administration: Intramuscular injection
Experimental: Treatment 3 (EG-HZ-003) - Subjects will receive two single IM vaccinations, 2 months apart, the first on Day 1 and the second on Day 60 (±5 days). Subjects will be randomised to treatment at a ratio of 1:1:1:1:1 (n=8 per treatment)
Route of administration: Intramuscular injection
Experimental: Treatment 4 (EG-HZ-004) - Subjects will receive two single IM vaccinations, 2 months apart, the first on Day 1 and the second on Day 60 (±5 days). Subjects will be randomised to treatment at a ratio of 1:1:1:1:1 (n=8 per treatment)
Route of administration: Intramuscular injection
Experimental: Treatment 5 (Shingrix) - Shingrix
Suspension for injection supplied as a single dose vial of lyophilised VZVgE antigen component to be reconstituted with the accompanying vial of AS01B adjuvant suspension component. After reconstitution, a single dose of ShingrixTM is 0.5 mL.
Route of Administration: Intramuscular injection
Treatment: Drugs: Treatment 1 (EG-HZ-001)
Subjects will receive two single IM vaccinations, 2 months apart, the first on Day 1 and the second on Day 60 (±5 days). Subjects will be randomised to treatment at a ratio of 1:1:1:1:1 (n=8 per treatment)
Route of Administration: IM injection
Treatment: Drugs: Treatment 2 (EG-HZ-002)
Subjects will receive two single IM vaccinations, 2 months apart, the first on Day 1 and the second on Day 60 (±5 days). Subjects will be randomised to treatment at a ratio of 1:1:1:1:1 (n=8 per treatment)
Route of Administration: IM injection
Treatment: Drugs: Treatment 3 (EG-HZ-003)
Subjects will receive two single IM vaccinations, 2 months apart, the first on Day 1 and the second on Day 60 (±5 days). Subjects will be randomised to treatment at a ratio of 1:1:1:1:1 (n=8 per treatment)
Route of Administration: IM injection
Treatment: Drugs: Treatment 4 (EG-HZ-004)
Subjects will receive two single IM vaccinations, 2 months apart, the first on Day 1 and the second on Day 60 (±5 days). Subjects will be randomised to treatment at a ratio of 1:1:1:1:1 (n=8 per treatment)
Route of Administration: IM injection
Treatment: Drugs: Treatment 5
Shingrix
Suspension for injection supplied as a single dose vial of lyophilised VZVgE antigen component to be reconstituted with the accompanying vial of AS01B adjuvant suspension component. After reconstitution, a single dose of ShingrixTM is 0.5 mL.
Route of Administration: IM injection
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
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Assessment method [1]
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Safety and tolerability determined by abnormal clinical laboratory tests, vitals signs, physical exam, ECG parameters. It is an composite Outcome
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Timepoint [1]
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Through study completion, estimated 9 months
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Secondary outcome [1]
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To explore the immunogenicity of EG-HZ at various excipient combinations
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Assessment method [1]
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Immunogenicity is determined by Anti-Glycoprotein E total immunoglobulin G (IgG) antibody concentration at 1 month (Day 90) and 6 months (Day 240) post last vaccination.
Humoral immunity: anti-Varicella zoster virus total IgG antibody; anti-Glycoprotein E total IgG antibody.
Cell-mediated immunity: CD4+ T cell; CD8+ T cell
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Timepoint [1]
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Blood samples for analysis of immunogenicity will be collected pre-dose and at multiple time points post-dose following administration of each vaccination. Through study completion, estimated 9 months
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Eligibility
Key inclusion criteria
1. Able to understand and comply with the study procedures, understand the risks involved
in the study, and provide written informed consent before the first study-specific
procedure;
2. Healthy male and female volunteers aged 50 to 70 years at time of Screening;
3. Subjects must have a BMI between =18.0 and =35.0 kg/m2 at Screening;
4. Availability to volunteer for the entire study duration and willing to adhere to all
protocol requirements;
5. Must have a negative urine pregnancy test on the day of dosing prior to each
vaccination;
6. Subjects must have clinical laboratory values within normal ranges as specified by the
testing laboratory, unless deemed NCS by the PI;
7. Normal physical findings, vital signs, 12-lead ECG, and no significant medical
condition at the time of Screening, as judged by the PI;
8. Must agree to abstain from alcohol intake from 48 hours before each vaccination;
9. Must be non-smokers or, if light or occasional smokers (<10 cigarettes per day), must
agree to abstain from smoking from 48 hours before each vaccination;
10. Must have a negative urine drug screen/alcohol breath test on the day of dosing prior
to each vaccination. Repeat urine drug screens will be permitted for suspected false
positive results;
11. Must agree to use highly effective, medically accepted double-barrier contraception
(both male and female partners) from Screening until study completion as specified
below in this criterion. Highly effective double-barrier contraception is defined as
use of a condom
AND one of the following:
1. Birth control pills (The Pill)
2. Depot or injectable birth control
3. IUD
4. Birth Control Patch (e.g., Ortho Evra)
5. NuvaRing®
6. Implantable contraception (e.g., Implanon)
7. Documented evidence of surgical sterilisation at least 6 months prior to Screening,
i.e., tubal ligation or hysterectomy for women or vasectomy for men
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Minimum age
50
Years
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Maximum age
70
Years
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
1. Pregnant or lactating at Screening or planning to become pregnant (self or partner) at
any time during the study, including the follow-up period;
2. History of severe allergic reaction (e.g., anaphylaxis) to any component of the
vaccine;
3. History of herpes zoster (Shingles);
4. Previous vaccination against HZ (either a registered product or an investigational
product through participation in a HZ vaccine study);
5. Previous vaccination against VZV;
6. Chronic administration (defined as more than 14 consecutive days) of
immunosuppressants or other immune-modifying drugs within 3 months prior to the first
vaccine dose (intra-articular, intra-bursal, or topical [skin or eyes] corticosteroids
are permitted at the discretion of the PI);
7. History of autoimmune disease/s which required therapeutic intervention/s, or any
active autoimmune disease requiring therapeutic intervention/s including but not
limited to: systemic or cutaneous lupus erythematosus, autoimmune arthritis/rheumatoid
arthritis, Guillain-Barré syndrome, multiple sclerosis, Sjögren's syndrome, idiopathic
thrombocytopenic purpura, glomerulonephritis, autoimmune thyroiditis, giant cell
arteritis (temporal arteritis), psoriasis, and insulin-dependent diabetes mellitus
(i.e. type 1 diabetes);
8. Bleeding diathesis or condition associated with prolonged bleeding that would, in the
opinion of the Investigator, contraindicate intramuscular injection;
9. Vaccines administered or scheduled in the period from 4 weeks prior to Dose 1 through
to 28 days post-vaccination dose 2, excluding licensed non-replicating vaccines (i.e.,
inactivated and subunit vaccines, including inactivated and subunit influenza vaccines
for seasonal or pandemic flu, with or without adjuvant) administered up to 8 days
prior to each dose and/or at least 14 days after any dose of study vaccine (to be
determined at the discretion of the PI);
10. Receipt of any immunoglobulins or blood/plasma products within 60 days prior to
vaccination on Day 1 and until the EOS/ET visit;
11. Positive test for HCV, HBsAg, or HIV antibody at Screening;
12. History or presence of any clinically unstable medical, surgical or psychiatric
condition, at the discretion of the Investigator;
13. Active malignancy and/or history of malignancy in the past 5 years, except for
completely excised basal cell carcinoma or low grade cervical intraepithelial
neoplasia;
14. History of significant hypersensitivity or anaphylaxis involving any drug, food or
other precipitating agent (e.g., bee sting);
15. Abnormal laboratory values or investigations (including ECG) that, in the opinion of
the Investigator, are deemed clinically significant and would preclude participation
in the study;
16. Renal insufficiency defined by eGFR <90 mL/min (CKD-EPI);
17. Hepatic synthetic insufficiency as defined as a serum albumin of <35 g/L; or serum
bilirubin >20 µmol/L;
18. Acute disease or acute stage of chronic disease and/or fever at the time of enrolment.
Fever is defined as temperature = 37.5°C (99.5°F), regardless of the route. Subjects
with a minor illness (such as mild diarrhoea, mild upper respiratory infection)
without fever may, be enrolled at the discretion of the Investigator;
19. Regular use of any prescribed or non-prescribed medications, including herbal
remedies, which, in the opinion of the Investigator, might adversely affect the safety
of the subject or the interpretability of study results. Participants who are taking a
stable dose of medication for a controlled medications include, for example, stable
doses of antidepressants, cholesterol lowering agents, high blood pressure medication,
reflux medication, hormone replacement therapy, NSAIDs, paracetamol, occasional
Ventolin, etc.);
20. History of or present alcohol abuse, or excessive intake of alcohol, as judged by the
Investigator;
21. Blood donation or significant blood loss within 30 days prior to the first study drug
administration and until the EOS/ET visit;
22. Plasma donation within 7 days prior to the first study drug administration and until
the EOS/ET visit;
23. Administration of another IP (defined as a compound that has not been approved for
marketing) or has participated in any other clinical study that included IP treatment
within 3 months prior to administration of IP in this study;
24. Any person who is initially excluded from study participation based on one or more of
the time-limited exclusion criteria (e.g., acute illness) may be considered for
enrollment once the condition has resolved as long as the subject continues to meet
all other entry criteria;
25. Subject taking any non-topical antiviral therapy with activity against herpes viruses,
including but not limited to acyclovir, famciclovir, ganciclovir, and valacyclovir 3
days prior to vaccination or 14 days after;
26. Any other reason that, in the opinion of the Investigator, might interfere with the
evaluation required by the study;
27. The subject is, in the opinion of the Investigator, unlikely to comply with the
clinical study protocol or is unsuitable for any other reason.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 1
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
24/02/2020
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
3/12/2020
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Sample size
Target
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Accrual to date
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Final
40
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Recruitment in Australia
Recruitment state(s)
QLD
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Recruitment hospital [1]
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Q-Pharm Pty Ltd (Nucleus Network) - Herston
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Recruitment postcode(s) [1]
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4006, - Herston
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Funding & Sponsors
Primary sponsor type
Other
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Name
EyeGene Inc.
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Address
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Country
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Other collaborator category [1]
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Commercial sector/Industry
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Name [1]
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Novotech (Australia) Pty Limited
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Address [1]
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Country [1]
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Ethics approval
Ethics application status
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Summary
Brief summary
This is a Phase 1, first in human (FIH), randomised, active-controlled, double-blind study
designed to assess the safety and tolerability and explore preliminary efficacy of the EG-HZ
vaccine. Oversight will be provided by a Safety Review Committee (SRC).
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Trial website
https://clinicaltrials.gov/ct2/show/NCT04210752
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT04210752
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