Study to Assess the Safety, Tolerability and Explore the Immunogenicity of EG-HZ in Healthy Adult Volunteers

NCT04210752 | Completed Phase 1 DMC

• 1 other identifier: EG-HZ-101
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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).

Conditions

Prevention of Herpes Zoster (HZ)

Outcome Measures

Primary Outcomes (1)

• 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

  Through study completion, estimated 9 months

Secondary Outcomes (1)

• To explore the immunogenicity of EG-HZ at various excipient combinations

  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

Study Arms (5)

Treatment 1 (EG-HZ-001)

EXPERIMENTAL

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

Drug: Treatment 1 (EG-HZ-001)

Treatment 2 (EG-HZ-002)

EXPERIMENTAL

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

Drug: Treatment 2 (EG-HZ-002)

Treatment 3 (EG-HZ-003)

EXPERIMENTAL

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

Drug: Treatment 3 (EG-HZ-003)

Treatment 4 (EG-HZ-004)

EXPERIMENTAL

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

Drug: Treatment 4 (EG-HZ-004)

Treatment 5 (Shingrix)

EXPERIMENTAL

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

Drug: Treatment 5

Interventions

Treatment 1 (EG-HZ-001) DRUG

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

Also known as: EG-HZ

Treatment 1 (EG-HZ-001)

Treatment 2 (EG-HZ-002) DRUG

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

Also known as: EG-HZ

Treatment 2 (EG-HZ-002)

Treatment 3 (EG-HZ-003) DRUG

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

Also known as: EG-HZ

Treatment 3 (EG-HZ-003)

Treatment 4 (EG-HZ-004) DRUG

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

Also known as: EG-HZ

Treatment 4 (EG-HZ-004)

Treatment 5 DRUG

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

Also known as: Comparator

Treatment 5 (Shingrix)

Eligibility Criteria

• Age: 50 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• Healthy male and female volunteers aged 50 to 70 years at time of Screening;
• Subjects must have a BMI between ≥18.0 and ≤35.0 kg/m2 at Screening;
• Availability to volunteer for the entire study duration and willing to adhere to all protocol requirements;
• Must have a negative urine pregnancy test on the day of dosing prior to each vaccination;
• Subjects must have clinical laboratory values within normal ranges as specified by the testing laboratory, unless deemed NCS by the PI;
• Normal physical findings, vital signs, 12-lead ECG, and no significant medical condition at the time of Screening, as judged by the PI;
• Must agree to abstain from alcohol intake from 48 hours before each vaccination;
• 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;
• 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;
• 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:
• Birth control pills (The Pill)
• Depot or injectable birth control
• IUD

You may not qualify if:

• Pregnant or lactating at Screening or planning to become pregnant (self or partner) at any time during the study, including the follow-up period;
• History of severe allergic reaction (e.g., anaphylaxis) to any component of the vaccine;
• History of herpes zoster (Shingles);
• Previous vaccination against HZ (either a registered product or an investigational product through participation in a HZ vaccine study);
• Previous vaccination against VZV;
• 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);
• 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);
• Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the Investigator, contraindicate intramuscular injection;
• 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);
• Receipt of any immunoglobulins or blood/plasma products within 60 days prior to vaccination on Day 1 and until the EOS/ET visit;
• Positive test for HCV, HBsAg, or HIV antibody at Screening;
• History or presence of any clinically unstable medical, surgical or psychiatric condition, at the discretion of the Investigator;
• 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;
• History of significant hypersensitivity or anaphylaxis involving any drug, food or other precipitating agent (e.g., bee sting);
• 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;

Sponsors & Collaborators

• EyeGene Inc.: lead
• Novotech (Australia) Pty Limited: collaborator

Study Sites (1)

Q-Pharm Pty Ltd (Nucleus Network)

Herston, Queensland, 4006,, Australia

Location

Related Publications (1)

• de Oliveira Gomes J, Gagliardi AM, Andriolo BN, Torloni MR, Andriolo RB, Puga MEDS, Canteiro Cruz E. Vaccines for preventing herpes zoster in older adults. Cochrane Database Syst Rev. 2023 Oct 2;10(10):CD008858. doi: 10.1002/14651858.CD008858.pub5.

  PMID: 37781954 DERIVED

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2019
• First Posted: December 26, 2019
• Study Start: February 24, 2020
• Primary Completion: December 3, 2020
• Study Completion: December 3, 2020
• Last Updated: February 8, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)