NCT07400003 Study to Evaluate the Safety and Immunogenicity of a Lyophilized Herpes Zoster Virus mRNA Vaccine
| NCT ID | NCT07400003 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Sinovac Biotech Co., Ltd |
| Condition | Herpes Zoster |
| Study Type | INTERVENTIONAL |
| Enrollment | 519 participants |
| Start Date | 2026-01-06 |
| Primary Completion | 2026-05-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 519 participants in total. It began in 2026-01-06 with a primary completion date of 2026-05-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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. 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.
Eligibility Criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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): A. 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; * 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.
Contact & Investigator
Na Xie
PRINCIPAL INVESTIGATOR
Xinjiang Uygur Autonomous Region Center for Disease Control and Prevention
Frequently Asked Questions
Who can join the NCT07400003 clinical trial?
This trial is open to participants of all sexes, aged 40 Years or older, studying Herpes Zoster. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07400003 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07400003 currently recruiting?
Yes, NCT07400003 is actively recruiting participants. Contact the research team at xn@xjcdc.com for enrollment information.
Where is the NCT07400003 trial being conducted?
This trial is being conducted at Xinjiang, China.
Who is sponsoring the NCT07400003 clinical trial?
NCT07400003 is sponsored by Sinovac Biotech Co., Ltd. The principal investigator is Na Xie at Xinjiang Uygur Autonomous Region Center for Disease Control and Prevention. The trial plans to enroll 519 participants.