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Tests treatment safety and results for Herpes Zoster
Official title Study to Evaluate the Safety and Immunogenicity of a Lyophilized Herpes Zoster Virus mRNA Vaccine
ClinicalTrials.gov ID: NCT07400003
What this study is testing
What is Low-dose experimental vaccine?
Low-dose experimental vaccine is an investigational medicine, being studied as a potential treatment for herpes zoster.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 and older. Healthy volunteers may be eligible.
You may be able to join if
- 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...
- Agree to comply with the visit schedule, sample collection, vaccination, and other trial procedures throughout the study period, and remain...
You likely can't join if
- 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...
- 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...
- Poorly controlled chronic diseases or significant medical history, including but not limited to cardiovascular diseases (e.g., poorly controlled...
- History of myocarditis, pericarditis, or idiopathic cardiomyopathy, or any condition that increases the risk of myocarditis or pericarditis;
See the full eligibility 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...
- 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.
- 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)...
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Xinjiang, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 40 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Xinjiang, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.