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
This trial accepts healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Low-dose experimental vaccine
Biological/VaccineLyophilized herpes zoster virus mRNA vaccine
High-dose experimental vaccine
Biological/VaccineLyophilized herpes zoster virus mRNA vaccine
Active-controlled vaccine A
Biological/Vaccineherpes zoster attenuated live vaccine, lyophilized
Active-controlled vaccine B
Biological/VaccineShingrix®
Placebo group
Other interventionSaline
Treatment groups
519 Participants
are divided into 5 treatment groupsGroup A: Low-dose groupExperimental treatment 1 intervention
Group B: High-dose groupExperimental treatment 1 intervention
Group C: Comparator AActive comparator 1 intervention
Group D: Comparator BActive comparator 1 intervention
Group E: Comparator CPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
The incidence of adverse reactions within 30 days
The incidence of adverse reactions within 0\~30 days after each dose vaccination.
Time frame
0~30 days after each dose vaccination2
Seroconversion rate of gE antibody
The seroconversion rate of gE antibody on Day 30 after two doses vaccination.
Time frame
Day 30 after two doses3
Geometric mean concentration (GMC) of gE antibody
The GMC of gE antibody on Day 30 after two doses vaccination.
Time frame
Day 30 after two dosesSecondary outcomes
1
Adverse reactions within 0~14 days
The incidence of adverse reactions within 0\~14 days after each dose vaccination.
Time frame
0~14 days after each dose vaccination2
Incidence of serious adverse events (SAEs)
The incidence of SAEs from the first dose to 12 months after the second dose.
Time frame
From the first dose to 12 months after the second dose3
Incidence of adverse events of special interest（AESI)
The incidence of AESI from the first dose to 12 months after the second dose.
Time frame
From the first dose to 12 months after the second dose4
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
Time frame
On Day 30 or Day 60 after the first dose, and on Day 14、Day 180 and Day 360 after the second doseSponsors and contacts
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Source ClinicalTrials.gov