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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT04210752
Ethics application status
Date submitted
17/12/2019
Date registered
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)

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
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
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
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
Sex
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
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
24/02/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
3/12/2020
Sample size
Target
Accrual to date
Final
40
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
Trial website
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
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04210752