ClinicalTrials.gg
CompletedNCT06375512Updated Mar 31, 2026

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

A Phase 1 interventional study of HZ Vaccine (IN001) and Placebo in Herpes Zoster, sponsored by Shenzhen Shenxin Biotechnology Co., Ltd. Completed at 3 sites in 2 countries. Open to participants aged 50 Years to 69 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-03-31.

Sponsored by Shenzhen Shenxin Biotechnology Co., Ltd · Phase 1, Interventional, and Prevention

Phase
Phase 1
Study type
Interventional
Enrollment
150
Allocation
Randomized
Ages
50 Years to 69 Years
Sex
All
01

Study 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

02

Conditions studied

  • 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
03

In context

Herpes Zoster

299 studies on the registry are indexed under Herpes Zoster; 55 are open to participants now.

This study's enrollment of 150 is close to the median of 160 across 247 interventional studies indexed under Herpes Zoster.

Browse Herpes Zoster studies →

Lead sponsor

Shenzhen Shenxin Biotechnology Co., Ltd is the lead sponsor of 5 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years to 69 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility criteria

Key Inclusion Criteria:

  1. Healthy male or female participants aged between 50 to 69 years of age, inclusive.
  2. Body weight ≥ 50 kg for males and ≥ 45 kg for females and (BMI) in the range of 18.5 to 35 kg/m\^2.
  3. Participants with asymptomatic medical conditions (eg, hypertension, dyslipidemia) that are not associated with end-organ damage may be included provided they are being appropriately treated as per standard of care, are clinically stable, and are not receiving treatments that would be exclusionary in the opinion of the Investigator.
  4. For all women of (WOCBP) females must be non-pregnant and non-lactating and must use a highly effective method from at least 30 days prior to enrollment through to 6 months after second vaccination.
  5. Willing to provide documented and comply with the requirements of the clinical study protocol.

Key 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 heart disease (eg, 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. Participants with suspected or confirmed COVID-19 should be excluded and referred for medical care.
  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 reactions including anaphylaxis and urticaria, or other significant adverse reactions to IN001 or its ; or participants with a known history of severe allergic reaction (eg, anaphylaxis) to any component of SHINGRIX™ or after a previous dose of SHINGRIX™.
  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 ≥ 140 mmHg or supine average diastolic blood pressure ≥ 90 mmHg at screening).
  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.
  11. Participants with a history of congenital or acquired immunodeficiency.
  12. Participants with an or immunodeficient state, asplenia, or recurrent severe infections.
  13. Participants with a known history of chronic infection including, but not limited to, (HIV), virus (HBV), virus (HCV), and active tuberculosis.
  14. Positive HBV and HCV panel and/or positive HIV test.
  15. Participants with positive syphilis test.
  16. Participants with chronic illness that, in the opinion of the Investigator, is at a stage where it might interfere with trial participation or interpretation of study results.
  17. Participants with a known history of vaccination against varicella or HZ.
  18. Participants who have received immunoglobulins and/or any blood or blood products within 4 months before the first study vaccination or who plan to receive such products at any time during the study.
  19. Participants who have received immunomodulatory, immunostimulatory, or immunosuppressant drugs including interferon and cytotoxic drugs within 3 months of screening (or 5 half-lives, whichever is longer) or who plan to receive them across the duration of the study.
  20. Participants requiring systemic exceeding 10 mg/day of prednisone equivalent for ≥ 10 days within 30 days of screening. The use of topical, ophthalmic, inhaled, and intranasal steroid preparations will be permitted.
  21. Participants who have received or plan to receive any licensed vaccine ≤ 28 days prior to the first vaccination (Day 0) or who plan to receive a licensed vaccine ≤ 28 days after the first study vaccination or ≤ 28 days before or after the second study vaccination. The only exception is licensed inactivated influenza vaccine or non-replicating influenza vaccine, which may be given ≥ 14 days before or ≥ 28 days after receipt the first or second study vaccination.
  22. Participants receiving treatment with another drug, biological agent, or device ≤ 28 days of screening, or 5 half-lives of the investigational drug, whichever is longer; or currently enrolled in or plans to participate in another clinical trial with an investigational agent during the study period (including the follow-up period of the study).
  23. Participants with history of drug abuse within 1 year prior to screening or recreational use of soft drugs (such as marijuana) within 1 month or hard drugs (such as cocaine, phencyclidine, opioid derivatives including heroin, and amphetamine derivatives) within 3 months prior to screening.
  24. History of alcohol abuse within 1 year prior to screening or regular use of alcohol within 6 months prior to screening that exceeds 10 units for women or 15 units for men of alcohol per week.
  25. Positive alcohol breath test result or positive urine drug screen at screening and Study Day 0.
  26. Participants who are Investigator site staff members, employees of the Sponsor or the clinical research organization directly involved in the conduct of the study, or site staff members otherwise supervised by the Investigator or immediate family members of any of the previously mentioned individuals.
  27. Participants with a demonstrated inability to comply with the study procedures.
Terms in these criteria, in plain language(12)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Excipients

The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

05

Study design

Phase
Phase 1
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
150 participants (actual)

Study arms

  • Experimental
    Arm 1: Dose A

    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

  • Experimental
    Arm 2: Dose B

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

    Biological: HZ Vaccine (IN001)

  • Experimental
    Arm 3: Dose C

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

    Biological: HZ Vaccine (IN001)

  • Experimental
    Arm 4: Dose D

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

    Biological: HZ Vaccine (IN001)

  • Active comparator
    Arm 5: Shingrix

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

    Biological: Shingrix

Interventions

  • BiologicalHZ Vaccine (IN001)

    Formulation for injection

  • BiologicalPlacebo

    0.9% sodium chloride (normal saline) for injection

  • BiologicalShingrix

    Sterile suspension for injection

06

What researchers measure

Primary outcomes

  1. Percentage of Participants Reporting Solicited Local Reactions

    Time frame: For 14 days after each vaccination

  2. Percentage of Participants Reporting Solicited Systemic Reactions

    Time frame: For 14 days after each vaccination

  3. Percentage of Participants With Unsolicited Adverse Events (AEs)

    Time frame: For 28 days after each vaccination

  4. Percentage of Participants With Any Medically Attended AEs (MAAEs)

    Time frame: From initial vaccination to 6 months after the second vaccination

  5. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

07

Study locations

3 sites
  • CenExel
    Hollywood, Florida 33024, United States
  • Emeritus Research Pty Ltd
    Sydney, New South Wales 2019, Australia
  • Emeritus Research Pty Ltd
    Melbourne, Victoria 3124, Australia
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 31, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06375512
Lead sponsor
Shenzhen Shenxin Biotechnology Co., Ltd
Responsible party
Sponsor
First posted
Apr 19, 2024
Start date
Jul 5, 2024
Primary completion
Feb 20, 2026
Completion
Feb 20, 2026
Last update
Mar 31, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.

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