protocolSection identificationModule nctId: NCT06375512, orgStudyIdInfo id: IN001001, briefTitle: A Study to Describe the Safety, Reactogenicity, and Immunogenicity of Herpes Zoster IN001 mRNA Vaccine (IN001) in Healthy Participants, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-07, primaryCompletionDateStruct date: 2025-12, completionDateStruct date: 2026-06, studyFirstPostDateStruct date: 2024-04-19, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: Shenzhen Shenxin Biotechnology Co., Ltd, class: INDUSTRY, descriptionModule briefSummary: 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, conditionsModule conditions: Herpes Zoster, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 150, type: ESTIMATED, armsInterventionsModule interventions name: HZ Vaccine (IN001), interventions name: Placebo, interventions name: Shingrix, outcomesModule primaryOutcomes measure: Percentage of Participants Reporting Solicited Local Reactions, primaryOutcomes measure: Percentage of Participants Reporting Solicited Systemic Reactions, primaryOutcomes measure: Percentage of Participants With Unsolicited Adverse Events (AEs), primaryOutcomes measure: Percentage of Participants With Any Medically Attended AEs (MAAEs), primaryOutcomes measure: 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, secondaryOutcomes measure: Geometric Mean Concentration (GMC) of Anti-glycoprotein E (gE) Antibodies as Measured by Enzyme-Linked Immunosorbent Assay (ELISA), secondaryOutcomes measure: Change from Baseline in Geometric Mean Fold Rise (GMFR) of Anti-gE Antibodies as Measured by ELISA, secondaryOutcomes measure: Proportion of Participants with Vaccine Response in Anti-gE Antibodies as Measured by ELISA, secondaryOutcomes measure: Geometric Mean Titer (GMT) of Anti-VZV Neutralizing Antibodies as Measured by Neutralization Assay, secondaryOutcomes measure: Change from Baseline in GMFR of Anti-VZV Neutralizing Antibodies as Measured by Neutralization Assay, secondaryOutcomes measure: Proportion of Participants with Vaccine Response in Anti-VZV Neutralizing Antibodies as Measured by Neutralization Assay, secondaryOutcomes measure: gE-specific T Cell Response (IFN-γ and IL-4 Secreting T Cells) as Measured by Enzyme-Linked Immunospot (ELISpot), secondaryOutcomes measure: 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), eligibilityModule sex: ALL, minimumAge: 50 Years, maximumAge: 69 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False