Herpes ZosterPhase 1/2NCT07400003
Study to Evaluate the Safety and Immunogenicity of a Lyophilized Herpes Zoster Virus mRNA Vaccine
A Phase 1/2 study testing Low-dose experimental vaccine and High-dose experimental vaccine in people with Herpes Zoster and mRNA Vaccine, run by Sinovac Biotech Co., Ltd at 1 site in China.
Trial summary
This clinical trial included two parts, Part A and Part B. The goal of Part A is to evaluate the safety and preliminary immunogenicity of the lyophilized herpes zoster virus mRNA vaccine (HZ mRNA vaccine) in healthy populations aged 40 years and older. Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Herpes Zoster, mRNA Vaccine
- What is being tested?
- Low-dose experimental vaccine and High-dose experimental vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 519 participants
- Where
- 1 siteChina
- Study dates
- 6 Jan 2026to 30 Apr 2027
- Phase
- Phase 1/2
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 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Phase I: Age ≥ 40 years; Phase II: Age ≥ 50 years;
- Participants are able to understand and voluntarily sign the informed consent form;
- Able to provide legal identification;
- Participants of childbearing potential and their sexual partners agree to voluntarily adopt effective contraceptive measures from the signing of the informed consent form until 6 months after the last dose of the investigational vaccine, with no plans for sperm or egg donation;
- Agree to comply with the visit schedule, sample collection, vaccination, and other trial procedures throughout the study period, and remain accessible at all times during the trial.
Who cannot join
- History of chickenpox or herpes zoster in adulthood;
- History of chickenpox or herpes zoster vaccination (including administration of registered products or participation in clinical trials of chickenpox or herpes zoster vaccines);
- Close contact with patients infected with chickenpox or herpes zoster within the past 30 days;
- Clinically significant abnormalities in protocol-specified clinical laboratory tests prior to vaccination (applicable to Phase I clinical trials only):
- Hematological parameters: White blood cell count (WBC), hemoglobin (Hb), platelet count (Plt); B. Blood biochemical parameters: Alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin (TBIL), fasting blood glucose (Glu), creatinine (CR); C. Urinalysis parameter: Urine protein (PRO); D. Coagulation parameters: Prothrombin time (PT), activated partial thromboplastin time (APTT), fibrinogen (Fib), international normalized ratio (INR); E. 12-lead electrocardiogram (ECG).
- Poorly controlled chronic diseases or significant medical history, including but not limited to cardiovascular diseases (e.g., poorly controlled hypertension defined as systolic blood pressure ≥140 mmHg and/or diastolic blood pressure ≥90 mmHg for participants aged 40-59 years prior to enrollment, or systolic blood pressure ≥150 mmHg and/or diastolic blood pressure ≥100 mmHg for participants aged ≥60 years), metabolic disorders (e.g., poorly controlled diabetes), hematological diseases, hepatic or renal diseases, digestive system diseases, respiratory system diseases, history of major organ transplantation, or malignancy within the past five years;
Show all 21Show fewer
- History of myocarditis, pericarditis, or idiopathic cardiomyopathy, or any condition that increases the risk of myocarditis or pericarditis;
- Autoimmune diseases, immunodeficiency diseases, or family history thereof (including but not limited to psoriasis, systemic lupus erythematosus, ankylosing spondylitis, autoimmune thyroid diseases, acute disseminated encephalomyelitis, facial paralysis, hypersensitivity reactions, polymyalgia rheumatica, rheumatoid arthritis, Guillain-Barré syndrome, asplenia, functional asplenia, HIV infection);
- Coagulation disorders (e.g., coagulation factor deficiencies, platelet abnormalities, or other coagulopathies);
- Current or previous severe neurological disorders (epilepsy, convulsions, or seizures) or psychiatric illnesses, or family history of psychiatric disorders;
- Acute illnesses or acute exacerbations of chronic diseases within the past 7 days, or known or suspected active infections;
- Immunosuppressive therapy or other immunomodulatory treatments (prednisone ≥20 mg/day or equivalent for >14 days), cytotoxic therapy within the past 6 months, or planned use during the trial;
- Administration of immunoglobulins or other blood products within the past 3 months (use of hepatitis B immunoglobulin within the past 1 month), or planned use during the trial;
- Participation in other clinical studies within the past 30 days or planned participation during this trial;
- Vaccination with live-attenuated vaccines or nucleic acid vaccines within the past 28 days, or vaccination with subunit, inactivated, or other types of vaccines within the past 14 days;
- Known allergy to vaccines or vaccine components, such as urticaria, dyspnea, or angioedema following vaccination;
- Pregnancy, lactation, or positive urine pregnancy test in female participants;
- Fever (axillary temperature ≥37.3°C) within 3 days prior to vaccination or use of antipyretics, analgesics, or antihistamines (e.g., acetaminophen, ibuprofen, loratadine, cetirizine, etc.) as reported during inquiry;
- Physical examination deemed unsatisfactory on the day of planned vaccination;
- Skin lesions, inflammation, ulcers, rashes, scars, or other conditions at the target injection site that may interfere with administration or local reaction assessment;
- Any other factors deemed by the investigator to render the participant unsuitable for participation in the clinical trial.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Xinjiang Uygur Autonomous Region Center for Disease Control and Prevention
Xinjiang, 831100
Jiao Xue, 86+13899089997, 64282811@qq.com
About this study
Official title: A Randomized, Double-Blind, Controlled Phase I/II Clinical Trial to Evaluate the Safety and Immunogenicity of Different Doses of a Lyophilized Herpes Zoster Virus mRNA Vaccine in Adults Aged 40 Years and Older
This clinical trial included two parts, Part A and Part B. The goal of Part A is to evaluate the safety and preliminary immunogenicity of the lyophilized herpes zoster virus mRNA vaccine (HZ mRNA vaccine) in healthy populations aged 40 years and older. The goal of Part B is to select the optimal dosage and schedule in healthy populations aged 50 years and older to support next further study.
Read the detailed description
This is a randomized, double-blind, controlled study. Part A employed sequential enrollment by age and dosage. All participants received two doses of the study vaccine. Safety observation conducted throughout the study. Humoral and celluar immunity were evaluated.
In Part B, participants randomly received either different dosage study vaccine or active controlled vaccine, with different immunization schedule. Safety observation conducted throughout the study. Humoral and celluar immunity were evaluated. Immune persistence was also evaluated at multiple timepoints after vaccination.
- Conditions
- Herpes Zoster, mRNA Vaccine
- Being tested
- Low-dose experimental vaccine, High-dose experimental vaccine, Active-controlled vaccine A, Active-controlled vaccine B, Placebo group
- Medical subject headings
- Herpes Zoster
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-dose experimental vaccineBiological
Lyophilized herpes zoster virus mRNA vaccine
High-dose experimental vaccineBiological
Lyophilized herpes zoster virus mRNA vaccine
Active-controlled vaccine ABiological
herpes zoster attenuated live vaccine, lyophilized
Active-controlled vaccine BBiological
Shingrix®
Placebo groupOther
Saline
| Study group | Role | What they receive |
|---|---|---|
| Low-dose group | Experimental | Participants will receive two doses of lyophilized herpes zoster virus mRNA vaccine (low dosage), with 30 days or 60 days apart Receives: Biological: Low-dose experimental vaccine |
| High-dose group | Experimental | Participants will receive two doses of lyophilized herpes zoster virus mRNA vaccine (high dosage), with 30 days or 60 days apart Receives: Biological: High-dose experimental vaccine |
| Comparator A | Active comparator | Participants will receive a single dose of saline on day 0 and a single dose of herpes zoster vaccine, live on day 60 Receives: Biological: Active-controlled vaccine A |
| Comparator B | Active comparator | Participants will receive two doses of recombinant zoster vaccine (CHO cell), with 60 days apart Receives: Biological: Active-controlled vaccine B |
| Comparator C | Placebo comparator | Participants will receive two doses of saline, with 60 days apart Receives: Other: Placebo group |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of adverse reactions within 30 days
The incidence of adverse reactions within 0~30 days after each dose vaccination.
Measured: 0~30 days after each dose vaccination
Seroconversion rate of gE antibody
The seroconversion rate of gE antibody on Day 30 after two doses vaccination.
Measured: Day 30 after two doses
Geometric mean concentration (GMC) of gE antibody
The GMC of gE antibody on Day 30 after two doses vaccination.
Measured: Day 30 after two doses
Secondary outcomes (10)
Adverse reactions within 0~14 days
The incidence of adverse reactions within 0~14 days after each dose vaccination.
Measured: 0~14 days after each dose vaccination
Incidence of serious adverse events (SAEs)
The incidence of SAEs from the first dose to 12 months after the second dose.
Measured: From the first dose to 12 months after the second dose
Incidence of adverse events of special interest（AESI)
The incidence of AESI from the first dose to 12 months after the second dose.
Measured: From the first dose to 12 months after the second dose
GMC of gE antibody
The GMC of gE antibody on Day 30 or Day 60 after the first dose, and on Day 14、Day 180 and Day 360 after the second dose
Measured: On Day 30 or Day 60 after the first dose, and on Day 14、Day 180 and Day 360 after the second dose
Geometric mean fold rise (GMFR) of gE antibody
The GMFR of gE antibody on Day 30 or Day 60 after the first dose, and on Day 14 and Day 30 after the second dose
Measured: On Day 30 or Day 60 after the first dose, and on Day 14 and Day 30 after the second dose
Seroconversion rate of varicella-zoster virus (VZV) antibody
The seroconversion rate of VZV antibody on Day 30 or Day 60 after the first dose, and on Day 14、Day 30、Day 180 and Day 360 after the second dose.
Measured: On Day 30 or Day 60 after the first dose, and on Day 14、Day 30、Day 180 and Day 360 after the second dose
GMT of VZV antibody
The GMT of VZV antibody on Day 30 or Day 60 after the first dose, and on Day 14、Day 30、Day 180 and Day 360 after the second dose
Measured: On Day 30 or Day 60 after the first dose, and on Day 14、Day 30、Day 180 and Day 360 after the second dose
GMFR of VZV antibody
The GMFR of VZV antibody on Day 30 or Day 60 after the first dose, and on Day 14 and Day 30 after the second dose
Measured: On Day 30 or Day 60 after the first dose, and on Day 14 and Day 30 after the second dose
Frequency of CD4/CD8+ T cells secreting gE-specific cytokines
The frequency of CD4/CD8+ T cells secreting gE-specific cytokines (IFN-γ, IL-2, TNF-α, CD40L) on Day 30 or Day 60 after the first dose, and on Day 14、Day 30、Day 180 and Day 360 after the second dose.
Measured: On Day 30 or Day 60 after the first dose, and on Day 14、Day 30、Day 180 and Day 360 after the second dose
Cellular immune response rate
The cellular immune response rate on Day 30 or Day 60 after the first dose, and on Day 14 and Day 30 after the second dose.
Measured: On Day 30 or Day 60 after the first dose, and on Day 14 and Day 30 after the second dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2026
- Study start6 Jan 2026
- Primary completion31 May 2026 (estimated)
- Study completion30 Apr 2027 (estimated)
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 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 519 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sinovac Biotech Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Na Xie, Principal investigator, Xinjiang Uygur Autonomous Region Center for Disease Control and Prevention
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07400003
- Sponsor's protocol ID
- PRO-mHZ-1001
- Status last verified
- Feb 2026
- First submitted
- 26 Jan 2026
- Last updated
- 10 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No