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

NOT_YET_RECRUITINGPHASE2

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

A Phase 2, Randomized, Multicenter, Active-controlled, Double-blind Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of a 2-dose Regimen of Herpes Zoster IN001 mRNA Vaccine (IN001) in Healthy Participants 50 to 79 Years Old

NCT07205796•Shenzhen Shenxin Biotechnology Co., Ltd

View on ClinicalTrials.gov

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.

Eligibility

Age

50 - 79 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•1. Male or female adults, of any race or ethnicity, between 50 and 79 years of age, inclusive, at Screening.
•2. 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.
•3. Participants must be able to freely provide documented informed consent prior to study procedures being performed.
•4. Participants must be in good general health as determined by comprehensive evaluation by Investigators at the time of enrollment.
•5. Participants with asymptomatic medical conditions that are not associated with end-organ damage may be include provided that they are being appropriately treated as per standard of care, are clinically stable, and are not receiving treatments what would be exclusionary in the opinion of the Investigator.
•6. 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).
•7. Females of reproductive age will not be pregnant or lactating.
•8. 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.
•9. Participants must be willing to refrain from blood donation throughout study participation.

Exclusion Criteria

•1. Participants with a known history of HZ.
•2. Participants with a known history of GBS, encephalomyelitis, or transverse myelitis.
•3. Participants with a known history of severe heart disease (i.e., heart failure, recent coronary artery disease, myocarditis, pericarditis, or cardiomyopathy).
•4. 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.
•5. 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.
•6. 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.
•7. 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).
•8. 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.
•9. Participants with a history of significant hematologic abnormalities or history of thrombosis with thrombocytopenia syndrome.
•10. 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.
+18 more criteria

Key Dates

Start Date

May 1, 2026

Primary Completion Date

December 30, 2027

Completion Date

December 30, 2027

Last Updated

October 7, 2025

Enrollment

480

ESTIMATED participants

Conditions

Herpes Zoster

Interventions

HZ Vaccine (IN001)

BIOLOGICAL

Shingrix

BIOLOGICAL

Contacts

Clinical Development Innorna

CONTACT

+86-755-86532375 cd@innorna.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 7, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

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