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| Name | Class |
|---|---|
| Novotech (Australia) Pty Limited | INDUSTRY |
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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).
Subjects will undergo a Screening period beginning up to 28 days prior to randomisation, the first of two vaccinations administered 2 months apart, pre- and post-dose assessment, follow-up visits, and an end of study (EOS) or early termination (ET) visit (as applicable).
Subjects will be randomised prior to vaccination on Day 1, to one (1) of five (5) treatment groups.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| 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 |
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| 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 |
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| 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
AND one of the following:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Q-Pharm Pty Ltd (Nucleus Network) | Herston | Queensland | 4006, | Australia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37781954 | Derived | 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. |
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| 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 |
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| 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 |
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| 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 |
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| 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 |
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| 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 |
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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 |