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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT04210752




Registration number
NCT04210752
Ethics application status
Date submitted
17/12/2019
Date registered
26/12/2019
Date last updated
26/12/2019

Titles & IDs
Public title
Study to Assess the Safety, Tolerability and Explore the Immunogenicity of EG-HZ in Healthy Adult Volunteers
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
Secondary ID [1] 0 0
EG-HZ-101
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prevention of Herpes Zoster (HZ) 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
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)
Component Description (per dose):
Antigen (recombinant VZVgE protein): 50µg Excipients: CIA09A1 dLOS: 10 µg; QS21: 50 µg; DOTAP: 500 µg; DMPC: 500 µg
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)
Component Description (per dose):
Antigen (recombinant VZVgE protein): 50µg Excipients: CIA09A2 dLOS: 20 µg; QS21: 50 µg; DOTAP: 500 µg; DMPC: 500 µg
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)
Component Description (per dose):
Antigen (recombinant VZVgE protein): 50µg Excipients: CIA09A3 dLOS: 30 µg; QS21: 20 µg; DOTAP: 500 µg; DMPC: 500 µg 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)
Component Description (per dose):
Antigen (recombinant VZVgE protein): 50µg Excipients: CIA09A0 dLOS: 30 µg; QS21: 0 µg;
DOTAP: 500 µg; DMPC:
500 µg
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)
Component Description (per dose):
Antigen (recombinant VZVgE protein): 50µg Excipients: CIA09A1 dLOS: 10 µg; QS21: 50 µg; DOTAP: 500 µg; DMPC: 500 µg
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)
Component Description (per dose):
Antigen (recombinant VZVgE protein): 50µg Excipients: CIA09A2 dLOS: 20 µg; QS21: 50 µg; DOTAP: 500 µg; DMPC: 500 µg
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)
Component Description (per dose):
Antigen (recombinant VZVgE protein): 50µg Excipients: CIA09A3 dLOS: 30 µg; QS21: 20 µg; DOTAP: 500 µg; DMPC: 500 µg
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)
Component Description (per dose):
Antigen (recombinant VZVgE protein): 50µg Excipients: CIA09A0 dLOS: 30 µg; QS21: 0 µg;
DOTAP: 500 µg; DMPC:
500 µg
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

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 - Safety and tolerability determined by abnormal clinical laboratory tests, vitals signs, physical exam, ECG parameters. It is an composite Outcome
Timepoint [1] 0 0
Through study completion, estimated 9 months
Secondary outcome [1] 0 0
To explore the immunogenicity of EG-HZ at various excipient combinations - 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
Timepoint [1] 0 0
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

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
Minimum age
50 Years
Maximum age
70 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
Q-Pharm Pty Ltd (Nucleus Network) - Herston
Recruitment postcode(s) [1] 0 0
4006, - Herston

Funding & Sponsors
Primary sponsor type
Other
Name
EyeGene Inc.
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Novotech (Australia) Pty Limited
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

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).
Trial website
https://clinicaltrials.gov/show/NCT04210752
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Michelle Smith
Address 0 0
Country 0 0
Phone 0 0
21646706
Fax 0 0
Email 0 0
michelle.smith@novotech-cro.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT04210752