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The study will evaluate the safety, tolerability, and immunogenicity (your immune system's reaction) of the study vaccine called Herpes Zoster IN001 mRNA Vaccine (IN001) in healthy participants who are between 50 and 69 years of age
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1: Dose A | Experimental | Participants will receive placebo by intramuscular (IM) injection on Day 0 followed with IN001 by IM injection on Day 56. |
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| Arm 2: Dose B | Experimental | Participants will receive IN001 by IM injection on Day 0 and Day 56. |
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| Arm 3: Dose C | Experimental | Participants will receive IN001 by IM injection on Day 0 and Day 56. |
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| Arm 4: Dose D | Experimental | Participants will receive IN001 by IM injection on Day 0 and Day 56. |
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| Arm 5: Shingrix | Active Comparator | Participants will receive Shingrix by IM injection on Day 0 and Day 56. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HZ Vaccine (IN001) | Biological | Formulation for injection |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Reporting Solicited Local Reactions | For 14 days after each vaccination | |
| Percentage of Participants Reporting Solicited Systemic Reactions | For 14 days after each vaccination | |
| Percentage of Participants With Unsolicited Adverse Events (AEs) | For 28 days after each vaccination | |
| Percentage of Participants With Any Medically Attended AEs (MAAEs) | From initial vaccination to 6 months after the second vaccination | |
| Percentage of Participants With Any Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs), AEs Leading to Vaccine Discontinuation, and AEs Leading to Study Withdrawal | From initial vaccination to 12 months after the second vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Geometric Mean Concentration (GMC) of Anti-glycoprotein E (gE) Antibodies as Measured by Enzyme-Linked Immunosorbent Assay (ELISA) | Baseline (before first vaccination); 28 and 56 days post-first vaccination; 14 and 28 days and 3, 6 and 12 months post-second vaccination | |
| Change from Baseline in Geometric Mean Fold Rise (GMFR) of Anti-gE Antibodies as Measured by ELISA |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CenExel | Hollywood | Florida | 33024 | United States | ||
| Emeritus Research Pty Ltd |
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| Placebo | Biological | 0.9% sodium chloride (normal saline) for injection |
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| Shingrix | Biological | Sterile suspension for injection |
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| 28 and 56 days post-first vaccination; 14 and 28 days and 3, 6 and 12 months post-second vaccination |
| Proportion of Participants with Vaccine Response in Anti-gE Antibodies as Measured by ELISA | 28 and 56 days post-first vaccination; 14 and 28 days and 3, 6 and 12 months post-second vaccination |
| Geometric Mean Titer (GMT) of Anti-VZV Neutralizing Antibodies as Measured by Neutralization Assay | baseline (before first vaccination); 56 days post-first vaccination; 28 days and 6 and 12 months post-second vaccination |
| Change from Baseline in GMFR of Anti-VZV Neutralizing Antibodies as Measured by Neutralization Assay | 56 days post-first vaccination; 28 days and 6 and 12 months post-second vaccination |
| Proportion of Participants with Vaccine Response in Anti-VZV Neutralizing Antibodies as Measured by Neutralization Assay | 56 days post-first vaccination; 28 days and 6 and 12 months post-second vaccination |
| gE-specific T Cell Response (IFN-γ and IL-4 Secreting T Cells) as Measured by Enzyme-Linked Immunospot (ELISpot) | Baseline (before first vaccination); 28 and 56 days post-first vaccination; 28 days and 3, 6 and 12 months post-second vaccination |
| Frequencies of gE-specific CD4+ and CD8+ T Cells Expressing Activation Markers (i.e., IFN-γ, IL-2, TNFα, CD40L) as Measured by Intracellular Cytokine Staining (ICS) | Baseline (before first vaccination); 56 days post-first vaccination; 14 and 28 days post-second vaccination |
| Sydney |
| New South Wales |
| 2019 |
| Australia |
| Emeritus Research Pty Ltd | Melbourne | Victoria | 3124 | Australia |
| ID | Term |
|---|---|
| D006562 | Herpes Zoster |
| D002644 | Chickenpox |
| D014777 | Virus Diseases |
| D012874 | Skin Diseases, Infectious |
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D007239 | Infections |
| D000073618 | Varicella Zoster Virus Infection |
| D017193 | Skin Diseases, Viral |
| D012871 | Skin Diseases |
| ID | Term |
|---|---|
| D017437 | Skin and Connective Tissue Diseases |
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