A Study to Describe the Safety, Reactogenicity, and Immunogenicity of Herpes Zoster IN001 mRNA Vaccine (IN001) in Healthy Participants

NCT06375512 | Completed Phase 1 FDA Drug

• 1 other identifier: IN001001
• Study Type: interventional
• Target: 150
• Locations: 2 countries
• Sites: 3

Brief Summary

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

Conditions

Herpes Zoster

Keywords

IN001; mRNA Vaccine; Vaccine; Varicella-zoster Virus; VZV; Viral Diseases; Shingles; Messenger RNA; Herpes Zoster (HZ); Skin Diseases, Infectious; Safety; Reactogenicity; Immunogenicity; Innorna; Shenxin; Herpesviridae Infections; DNA Virus Infections; Infections; Varicella Zoster Virus Infection; Skin Diseases, Viral; Skin Diseases

Outcome Measures

Primary Outcomes (5)

• 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

Secondary Outcomes (8)

• 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

  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

Study Arms (5)

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.

Biological: HZ Vaccine (IN001); Biological: Placebo

Arm 2: Dose B

EXPERIMENTAL

Participants will receive IN001 by IM injection on Day 0 and Day 56.

Biological: HZ Vaccine (IN001)

Arm 3: Dose C

EXPERIMENTAL

Participants will receive IN001 by IM injection on Day 0 and Day 56.

Biological: HZ Vaccine (IN001)

Arm 4: Dose D

EXPERIMENTAL

Participants will receive IN001 by IM injection on Day 0 and Day 56.

Biological: HZ Vaccine (IN001)

Arm 5: Shingrix

ACTIVE COMPARATOR

Participants will receive Shingrix by IM injection on Day 0 and Day 56.

Biological: Shingrix

Interventions

HZ Vaccine (IN001) BIOLOGICAL

Formulation for injection

Arm 1: Dose A; Arm 2: Dose B; Arm 3: Dose C; Arm 4: Dose D

Placebo BIOLOGICAL

0.9% sodium chloride (normal saline) for injection

Arm 1: Dose A

Shingrix BIOLOGICAL

Sterile suspension for injection

Arm 5: Shingrix

Eligibility Criteria

• Age: 50 Years - 69 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy male or female participants aged between 50 to 69 years of age, inclusive.
• Body weight ≥ 50 kg for males and ≥ 45 kg for females and body mass index (BMI) in the range of 18.5 to 35 kg/m\^2.
• For all women of childbearing potential (WOCBP) females must be non-pregnant and non-lactating and must use a highly effective contraceptive method from at least 30 days prior to enrollment through to 6 months after second vaccination.
• Willing to provide documented informed consent and comply with the requirements of the clinical study protocol.

You may not qualify if:

• Participants with a known history of HZ.
• Participants with a known history of GBS, encephalomyelitis, or transverse myelitis.
• Participants with a known history of heart disease (eg, heart failure, recent coronary artery disease, myocarditis, pericarditis, or cardiomyopathy).
• Participants with acute medical illness or febrile illness, including oral temperature ≥ 38.0°C (≥ 100.4°F) within 1 day prior to screening. Participants with suspected or confirmed COVID-19 should be excluded and referred for medical care.
• Participants with any medical, neurological, or psychiatric condition that, in the opinion of the Investigator, could place the participant at an unacceptable risk of injury or render the participant unable to comply with all study procedures and achieve successful completion of the trial.
• Participants with a known history of hypersensitivity reactions including anaphylaxis and urticaria, or other significant adverse reactions to IN001 or its excipients; or participants with a known history of severe allergic reaction (eg, anaphylaxis) to any component of SHINGRIX™ or after a previous dose of SHINGRIX™.
• Participants who have a positive pregnancy test at the screening visit or who intend to become pregnant during or breastfeed through Study Day 236 (6 months after second vaccination).
• Participants with uncontrolled hypertension (supine systolic blood pressure ≥ 140 mmHg or supine average diastolic blood pressure ≥ 90 mmHg at screening).
• Participants with a history of significant hematologic abnormalities or history of thrombosis with thrombocytopenia syndrome.
• Participants with hematology and/or clinical chemistry laboratory result(s) that meet the definition of a Grade ≥ 2 abnormality as delineated in the FDA guidance.
• Participants with a history of congenital or acquired immunodeficiency.
• Participants with an immunosuppressive or immunodeficient state, asplenia, or recurrent severe infections.
• Participants with a known history of chronic infection including, but not limited to, human immunodeficiency virus (HIV), hepatitis B virus (HBV), hepatitis C virus (HCV), and active tuberculosis.
• Positive HBV and HCV panel and/or positive HIV test.
• Participants with positive syphilis test.

Sponsors & Collaborators

• Shenzhen Shenxin Biotechnology Co., Ltd: lead

Study Sites (3)

CenExel

Hollywood, Florida, 33024, United States

Location

Emeritus Research Pty Ltd

Sydney, New South Wales, 2019, Australia

Location

Emeritus Research Pty Ltd

Melbourne, Victoria, 3124, Australia

Location

MeSH Terms

Conditions

Herpes Zoster; Chickenpox; Virus Diseases; Skin Diseases, Infectious; Herpesviridae Infections; DNA Virus Infections; Infections; Varicella Zoster Virus Infection; Skin Diseases, Viral; Skin Diseases

Condition Hierarchy (Ancestors)

Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 17, 2024
• First Posted: April 19, 2024
• Study Start: July 5, 2024
• Primary Completion: February 20, 2026
• Study Completion: February 20, 2026
• Last Updated: March 31, 2026

Record last verified: 2026-03

Locations

AU (2); US (1)