Herpes ZosterPhase 1NCT06375512
A Study to Describe the Safety, Reactogenicity, and Immunogenicity of Herpes Zoster IN001 mRNA Vaccine (IN001) in Healthy Participants
A Phase 1 study testing HZ Vaccine (IN001) and Shingrix in people with Herpes Zoster, run by Shenzhen Shenxin Biotechnology Co., Ltd at 3 sites in 2 countries.
Trial 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 Read more about this study
- Who is it for?
- Ages 50 to 69 yearsHealthy volunteers can take part
- Conditions the study is for
- Herpes Zoster
- What is being tested?
- HZ Vaccine (IN001) and Shingrix
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 5 Jul 2024to 20 Feb 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 69 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
- 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.
- 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.
Who cannot join
- 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™.
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- 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.
- 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.
- Participants with a known history of vaccination against varicella or HZ.
- 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.
- 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.
- Participants requiring systemic corticosteroids 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.
- 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.
- Participants receiving treatment with another investigational 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).
- 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.
- 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.
- Positive alcohol breath test result or positive urine drug screen at screening and Study Day 0.
- 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.
- Participants with a demonstrated inability to comply with the study procedures.
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Australia2 sites
Emeritus Research Pty Ltd
Melbourne, Victoria, 3124
Emeritus Research Pty Ltd
Sydney, New South Wales, 2019
About this study
Official title: A Phase 1, Randomized, Multicenter, Double-blind, Dose-ranging Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of Herpes Zoster IN001 mRNA Vaccine (IN001) in Healthy Participants 50 to 69 Years Old
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
- Being tested
- HZ Vaccine (IN001), Placebo, Shingrix
- 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
- Medical subject headings
- Herpes Zoster, Chickenpox, Virus Diseases, Skin Diseases, Infectious, Herpesviridae Infections, DNA Virus Infections, Infections, Varicella Zoster Virus Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HZ Vaccine (IN001)Biological
Formulation for injection
PlaceboBiological
0.9% sodium chloride (normal saline) for injection
ShingrixBiological
Sterile suspension for injection
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Biological: HZ Vaccine (IN001); Biological: Placebo |
| Arm 2: Dose B | Experimental | Participants will receive IN001 by IM injection on Day 0 and Day 56. Receives: Biological: HZ Vaccine (IN001) |
| Arm 3: Dose C | Experimental | Participants will receive IN001 by IM injection on Day 0 and Day 56. Receives: Biological: HZ Vaccine (IN001) |
| Arm 4: Dose D | Experimental | Participants will receive IN001 by IM injection on Day 0 and Day 56. Receives: Biological: HZ Vaccine (IN001) |
| Arm 5: Shingrix | Active comparator | Participants will receive Shingrix by IM injection on Day 0 and Day 56. Receives: Biological: Shingrix |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Reporting Solicited Local Reactions
Measured: For 14 days after each vaccination
Percentage of Participants Reporting Solicited Systemic Reactions
Measured: For 14 days after each vaccination
Percentage of Participants With Unsolicited Adverse Events (AEs)
Measured: For 28 days after each vaccination
Percentage of Participants With Any Medically Attended AEs (MAAEs)
Measured: 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
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
Measured: 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)
Measured: Baseline (before first vaccination); 56 days post-first vaccination; 14 and 28 days post-second vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2024
- Study start5 Jul 2024
- Primary completion20 Feb 2026
- Study completion20 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Herpes ZosterStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shenzhen Shenxin Biotechnology Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06375512
- Sponsor's protocol ID
- IN001001
- Status last verified
- Mar 2026
- First submitted
- 17 Apr 2024
- Last updated
- 31 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Multicenter, Double-blind, Dose-ranging Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of Herpes Zoster IN001 mRNA Vaccine (IN001) in Healthy Participants 50 to 69 Years Old
- ClinicalTrials.gov ID
- NCT06375512
- Acronym / sponsor ID
- IN001001
- Conditions
- Herpes Zoster
- Keywords
- IN001, mRNA Vaccine, Vaccine, Varicella-zoster Virus, VZV, Viral Diseases, Shingles, Messenger RNA
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Shenzhen Shenxin Biotechnology Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 5 Jul 2024 (actual)
- Primary completion
- 20 Feb 2026 (actual)
- Study completion
- 20 Feb 2026 (actual)
- First posted
- 19 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Dose A | Experimental | Biological: HZ Vaccine (IN001), Biological: PlaceboParticipants will receive placebo by intramuscular (IM) injection on Day 0 followed with IN001 by IM injection on Day 56. |
| Arm 2: Dose B | Experimental | Biological: HZ Vaccine (IN001)Participants will receive IN001 by IM injection on Day 0 and Day 56. |
| Arm 3: Dose C | Experimental | Biological: HZ Vaccine (IN001)Participants will receive IN001 by IM injection on Day 0 and Day 56. |
| Arm 4: Dose D | Experimental | Biological: HZ Vaccine (IN001)Participants will receive IN001 by IM injection on Day 0 and Day 56. |
| Arm 5: Shingrix | Active comparator | Biological: ShingrixParticipants will receive Shingrix by IM injection on Day 0 and Day 56. |
Who may qualify
- Ages
- 50 to 69 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
- 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.
- 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.
Key exclusion criteria (27 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HZ Vaccine (IN001)Formulation for injection | Biological | Arm 1: Dose A, Arm 2: Dose B, Arm 3: Dose C, Arm 4: Dose D |
| Placebo0.9% sodium chloride (normal saline) for injection | Biological | Arm 1: Dose A |
| ShingrixSterile suspension for injection | Biological | Arm 5: Shingrix |
Primary outcome
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
8 secondary outcomes
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HZ Vaccine (IN001) and Shingrix in people with Herpes Zoster, run by Shenzhen Shenxin Biotechnology Co., Ltd at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Australia, United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants Reporting Solicited Local Reactions (time frame: For 14 days after each vaccination). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2026.