A Phase 2 Study to Describe the Safety, Reactogenicity, and Immunogenicity of Herpes Zoster IN001 mRNA Vaccine (IN001) in Healthy Participants

NCT07205796 | Not Yet Recruiting Phase 2 FDA Drug

• 1 other identifier: IN001005
• Study Type: interventional
• Target: 480
• Locations: 0 countries
• Sites: N/A

Brief Summary

The study will evaluate the safety, tolerability, and immunogenicity (your immune system's reaction) of 3 dose levels of the study vaccine called Herpes Zoster IN001 mRNA Vaccine (IN001) in healthy participants who are between 50 and 79 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 (11)

• Geometric Mean Concentration (GMC) of Anti-glycoprotein E (gE) Antibodies as Measured by Enzyme-Linked Immunosorbent Assay (ELISA)

  Baseline (before first vaccination); 28 days post-second vaccination

• Change from Baseline in Geometric Mean Fold Rise (GMFR) of Anti-gE Antibodies as Measured by ELISA

  28 days post-second vaccination

• Geometric Mean Titer (GMT) of Anti-VZV Neutralizing Antibodies as Measured by Neutralization Assay

  Baseline (before first vaccination); 28 days post-second vaccination

• Change from Baseline in GMFR of Anti-VZV Neutralizing Antibodies as Measured by Neutralization Assay

  28 days post-second vaccination

• Proportion of Participants with Vaccine Response in Anti-gE Antibodies as Measured by ELISA

  28 days post-second vaccination

• Proportion of Participants with Vaccine Response in Anti-VZV Neutralizing Antibodies as Measured by Neutralization Assay

  28 days post-second vaccination

• Percentage of Participants Reporting Solicited Local Reactions

  For 14 days after each vaccination

• Percentage of Participants Reporting Solicited Systemic Events

  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 the first 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 the first vaccination to 12 months after the second vaccination

Secondary Outcomes (8)

• GMC of Anti-gE Antibodies as Measured by ELISA

  Baseline (before first vaccination); 28 and 56 days post-first vaccination; 14 days and 3, 6 and 12 months post-second vaccination

• Change from Baseline in GMFR of Anti-gE Antibodies as Measured by ELISA

  28 and 56 days post-first vaccination; 14 days and 3, 6 and 12 months post-second vaccination

• GMT of Anti-VZV Neutralizing Antibodies as Measured by Neutralization Assay

  Baseline (before first vaccination); 56 days post-first vaccination; 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; 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 days and 3, 6 and 12 months post-second vaccination

Study Arms (4)

IN001 Dose A (Arm 1)

EXPERIMENTAL

Participants will receive IN001 at dose level A by IM injection on Day 0 and Day 56.

Biological: HZ Vaccine (IN001)

IN001 Dose B (Arm 2)

EXPERIMENTAL

Participants will receive IN001 at dose level B by IM injection on Day 0 and Day 56.

Biological: HZ Vaccine (IN001)

IN001 Dose C (Arm 3)

EXPERIMENTAL

Participants will receive IN001 at dose level C by IM injection on Day 0 and Day 56.

Biological: HZ Vaccine (IN001)

Shingrix (Arm 4)

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

IN001 Dose A (Arm 1); IN001 Dose B (Arm 2); IN001 Dose C (Arm 3)

Shingrix BIOLOGICAL

Sterile suspension for injection

Shingrix (Arm 4)

Eligibility Criteria

• Age: 50 Years - 79 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female adults, of any race or ethnicity, between 50 and 79 years of age, inclusive, at Screening.
• Male and female participants must have a body mass index between 18.5 and 34.9 kg/m\^2, inclusive, at Screening, and body weight ≥ 50 kg for males and ≥ 45 kg for females.
• Participants must be able to freely provide documented informed consent prior to study procedures being performed.
• Participants must be in good general health as determined by comprehensive evaluation by Investigators at the time of enrollment.
• Participants must be able and agree to comply with all study visits and procedures (including blood tests, diary completion, receipt of telephone calls from the site, willingness to be available for unscheduled clinic visits).
• Females of reproductive age will not be pregnant or lactating.
• Females of childbearing potential, who are sexually active and at risk for pregnancy with their partner(s), must have used appropriate method of contraception at least 30 days prior to enrollment and agree to use a highly effective method of contraception consistently and correctly from enrollment to Study Day 236 (6 months after second vaccination). The Investigator or designee, in consultation with the participant, will confirm that the participant has selected an appropriate method of contraception for the individual participant and his or her partner from the list of appropriate contraception methods and will confirm that the participant has been instructed in its consistent and correct use.
• Participants must be willing to refrain from blood donation throughout study participation.

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 severe heart disease (i.e., 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. These individuals may be offered the opportunity to enter the study after the fever and/or acute illness has been resolved.
• 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 (e.g., anaphylaxis) to any mRNA vaccine (e.g., COVID-19 mRNA vaccine, RSV mRNA vaccine), any component of SHINGRIX\^TM, or after a previous dose of SHINGRIX\^TM.
• 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 \[BP\] \> 140 mmHg or supine average diastolic BP \> 90 mmHg at Screening). Eligibility may be reassessed with a single repeat measurement at the Investigator's discretion, and the repeat value will be used for determination.
• 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. However, if the institutional normal reference ranges differ from those defined by the region or site, exceptions may be considered on a case-by-case basis with the agreement of the Investigator and the Sponsor.
• 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 of human immunodeficiency virus (HIV), hepatitis B virus (HBV), hepatitis C virus (HCV), or active tuberculosis.
• Positive HBV and HCV panel and/or positive HIV test. Participants whose results are compatible with prior immunization (indicating evidence of protection) may be included at the discretion of the Investigator that take into account factors such as the timing and effectiveness of the previous immunization.
• Participants with positive syphilis test.

Sponsors & Collaborators

• Shenzhen Shenxin Biotechnology Co., Ltd: lead

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

Central Study Contacts

Clinical Development Innorna

CONTACT

+86-755-86532375; cd@innorna.com

Study Design

• Study Type: interventional
• Phase: phase 2
• 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: September 26, 2025
• First Posted: October 3, 2025
• Study Start: May 1, 2026
• Primary Completion (Estimated): December 30, 2027
• Study Completion (Estimated): December 30, 2027
• Last Updated: October 7, 2025

Record last verified: 2025-10