Study to Evaluate the Safety and Immunogenicity of a Lyophilized Herpes Zoster Virus mRNA Vaccine
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age40+
SponsorSinovac Biotech Co., Ltd
About this trial
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
Qualifiers
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;
Disqualifiers
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;
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;
Trial design
Treatments tested in this trial
- Low-dose experimental vaccine
- High-dose experimental vaccine
- Active-controlled vaccine A
- Active-controlled vaccine B
- Placebo group
Treatment groups
519 Participants
are divided into 5 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov