Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Z-1018 · 2 trials · 3 indications
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...
Z-1018 is an investigational herpes zoster vaccine being developed for the prevention of shingles, also known as herpes zoster. It is being studied in healthy adults aged 50 years and older. The vaccine is currently in Phase 1 clinical development and has not been approved by regulatory authorities.
Z-1018 is being developed by Dynavax Technologies Corporation, a biopharmaceutical company traded on NASDAQ under the ticker symbol DVAX. The company is conducting clinical trials to evaluate the safety and immunogenicity of this investigational herpes zoster vaccine.
Z-1018 is in Phase 1 clinical development. It is an investigational vaccine and has not been approved by the FDA or any other regulatory agency. Two Phase 1 trials have been conducted, one completed and one active but not recruiting, to assess its safety and immune response.
Z-1018 has been studied in two Phase 1 clinical trials. NCT05245838, a completed trial with 150 participants, evaluated safety and immunogenicity compared to Shingrix in healthy adults. NCT06569823, an active trial with 764 participants, is comparing Z-1018 to Shingrix in healthy adults aged 50 and over.
No, Z-1018 is not the same as Shingrix. Z-1018 is an investigational herpes zoster vaccine being developed by Dynavax Technologies, while Shingrix is a licensed vaccine manufactured by GSK. Clinical trials are comparing Z-1018 directly against Shingrix to evaluate its safety and immunogenicity.
Z-1018 is a vaccine designed to prevent shingles, which is caused by the varicella-zoster virus. As a vaccine, it works by stimulating the immune system to produce a protective response against the virus. The specific antigen or molecular target has not been disclosed in the available information.