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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
150
Formulation for injection
0.9% sodium chloride (normal saline) for injection
Sterile suspension for injection
CenExel
Hollywood, Florida, United States
Emeritus Research Pty Ltd
Sydney, New South Wales, Australia
Emeritus Research Pty Ltd
Melbourne, Victoria, Australia
Percentage of Participants Reporting Solicited Local Reactions
Time frame: For 14 days after each vaccination
Percentage of Participants Reporting Solicited Systemic Reactions
Time frame: For 14 days after each vaccination
Percentage of Participants With Unsolicited Adverse Events (AEs)
Time frame: For 28 days after each vaccination
Percentage of Participants With Any Medically Attended AEs (MAAEs)
Time frame: 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
Time frame: From initial vaccination to 12 months after the second vaccination
Geometric Mean Concentration (GMC) of Anti-glycoprotein E (gE) Antibodies as Measured by Enzyme-Linked Immunosorbent Assay (ELISA)
Time frame: 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
Time frame: 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
Time frame: 28 and 56 days post-first vaccination; 14 and 28 days and 3, 6 and 12 months post-second vaccination
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Geometric Mean Titer (GMT) of Anti-VZV Neutralizing Antibodies as Measured by Neutralization Assay
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: Baseline (before first vaccination); 56 days post-first vaccination; 14 and 28 days post-second vaccination