Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06569823 | Safety and Immunogenicity of an Investigational Herpes Zoster Vaccine (Z-1018) Compared to Shingrix® in Healthy Adults 50 Years of Age and Over | PHASE1 | ACTIVE NOT_RECRUITING | 764 | — | — | Jun 17, 2024 | Nov 1, 2031 | May 29, 2026 | 16 | Australia, New Zealand |
| NCT05245838 | Trial to Evaluate the Safety, Tolerability, and Immunogenicity of an Investigational Herpes Zoster Vaccine (Z-1018) Compared to Shingrix® in Healthy Adult Volunteers | PHASE1 | COMPLETED | 150 | — | — | Jan 10, 2022 | Oct 20, 2022 | Nov 7, 2022 | 4 | Australia |
Solicited local and systemic post-injection reactions (PIRs)
Adverse events (AEs)
Serious adverse events (SAEs) Medically-attended adverse events (MAEs) Immune-mediated adverse events of special interest (imAESIs)
Composite vaccine response rate in glycoprotein E (gE) -specific CD4+ T cells and anti-gE IgG antibodies in the Per Protocol (PP) population
Geometric mean concentration (GMC) and geometric mean ratio of IgG antibodies to varicella-zoster virus (VZV) antigen-gE in the Per Protocol (PP) population
| Arm | Type | Description |
|---|---|---|
| Z-1018 A1 (Part 1) | EXPERIMENTAL | Participants will receive a dose of Z-1018 by intramuscular (IM) injection on Day 1 and Day 85. |
| Z-1018 A2 (Part 1) | EXPERIMENTAL | Participants will receive a dose of Z-1018 by intramuscular (IM) injection on Day 1 and Day 85. |
| Z-1018 B1(a) (Part 1) | EXPERIMENTAL | Participants will receive a dose of Z-1018 by intramuscular (IM) injection on Day 1 and Day 57. |
| Z-1018 B2(a) (Part 1 and Part 2) | EXPERIMENTAL | Participants will receive a dose of Z-1018 by intramuscular (IM) injection on Day 1 and Day 57. |
| Z-1018 B1(b) (Part 1) | EXPERIMENTAL | Participants will receive a dose of Z-1018 by intramuscular (IM) injection on Day 1 and Day 85 |
| Z-1018 B2(b) (Part 1) | EXPERIMENTAL | Participants will receive a dose of Z-1018 by intramuscular (IM) injection on Day 1 and Day 85 |
| Z-1018 Formulation C1(a) (Part 1) | EXPERIMENTAL | Participants will receive a dose of Z-1018 by intramuscular (IM) injection on Day 1 and Day 57. |
| Z-1018 Formulation C2(a) (Part 1) | EXPERIMENTAL | Participants will receive a dose of Z-1018 by intramuscular (IM) injection on Day 1 and Day 57. |
| Z-1018 Formulation C1(b) (Part 1) | EXPERIMENTAL | Participants will receive a dose of Z-1018 by intramuscular (IM) injection on Day 1 and Day 85. |
| Z-1018 Formulation C2(b) (Part 1) | EXPERIMENTAL | Participants will receive a dose of Z-1018 by intramuscular (IM) injection on Day 1 and Day 85. |
| Shingrix (Part 1 and Part 2) | EXPERIMENTAL | Participants will receive a dose of Shingrix by intramuscular (IM) injection on Day 1 and Day 57, or Day 1 and Day 85. |
| Z-1018 Dose Level 1 | EXPERIMENTAL | 100 mcg gE + 3000 mcg CpG 1018 |
| Z-1018 Dose Level 1a | EXPERIMENTAL | 100 mcg gE + 3000 mcg CpG 1018 + alum |
| Z-1018 Dose Level 2 | EXPERIMENTAL | 100 mcg gE + 6000 mcg CpG 1018 |
| Z-1018 Dose Level 2a | EXPERIMENTAL | 100 mcg gE + 6000 mcg CpG 1018 + alum |
| Shingrix | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Z-1018 | BIOLOGICAL | Formulation for injection |
| Shingrix | BIOLOGICAL | Formulation for injection |
Inclusion Criteria: 1. Willing to participate; informed consent provided for the study 2. Male or female ≥ 50 years of age (Part 1: 50 through 69 years of age, inclusive; Part 2: ≥ 70 years of age 3. In good health in the opinion of the investigator, based upon medical history, physical examination...