A Randomized, Blinded and Positive-Control Phase I Clinical Trial to Evaluate the Immunogenicity and Safety of Lyophilized Herpes Zoster mRNA Vaccine in Adults Aged 40 Years or Above
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 180
- 试验地点
- 2
- 主要终点
- Incidence of unsolicited AEs and ARs after each dose
研究概览
简要总结
The primary objective of this study is to evaluate the tolerability, reactogenicity and safety of 2 injections (approximately 2 months apart) of three different dose levels of ABO1108 in adults aged 40 years or above.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Voluntarily sign the Informed Consent Form (ICF) approved by the Ethics Committee and agree to participate in the trial before undergoing any trial procedures.
- •Healthy adults ≥40 years of age, participants with underlying diseases that are stably controlled may be accepted.
- •Willing to and physically able to communicate with the investigators, understand and comply with protocol required follow-up, simple self-observation and recording using the Diary Card.
- •Male participants (and their female partners) and female participants of childbearing potential agree to continue effective contraception through 12 months following vaccination.
排除标准
- •Acute illness or fever on the day of vaccination or within 3 days prior to vaccination, or use of anti-inflammatory, anti-allergy, antibiotic, or antiviral medications due to physical discomfort.
- •Clinically significant abnormal vital signs, including but not limited to:
- •Resting pulse rate <50 beats per minute or >100 beats per minute
- •Systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg for participants aged 40-59, or systolic blood pressure ≥150 mmHg or diastolic blood pressure ≥90 mmHg for participants aged ≥60
- •Body mass index (BMI) ≤18 kg/m² or ≥30 kg/m²
- •Clinically significant abnormalities of laboratory indicators or 12-lead ECG during the screening period.
- •Female participants known to be pregnant or breastfeeding, or positive pregnancy test for women of childbearing potential.
- •History of allergy to the investigational product or its excipients, or severe allergic reactions to other vaccines, foods, or medications.
- •History of herpes zoster at any previous time, history of varicella or close contact with varicella/herpes zoster patients within the past year.
- •Previous vaccination with herpes zoster or varicella vaccine (including marketed or investigational vaccines) or planned vaccination during the trial period.
- •Use or planned use of any vaccine other than the investigational products through 30 days prior to and 30 days after vaccinations in this trial.
- •Current participation in another clinical trial within 6 months prior to vaccination or planned participation before the end of this trial.
- •Clinician-diagnosed coagulation abnormalities.
- •Known medical history or diagnosis confirming the subject has a condition affecting immune system function.
- •History of myocarditis, pericarditis, or idiopathic cardiomyopathy, or presence of any condition that may increase the risk of myocarditis or pericarditis.
- •Severe or uncontrolled respiratory, cardiovascular, neurological, hematological, lymphatic, hepatic, renal, metabolic, or skeletal diseases; known severe congenital malformations; developmental disorders; or clinically diagnosed severe chronic conditions that may affect trial outcomes.
- •Current infectious period of any communicable disease, acute infection, or acute phase of chronic infection, or ongoing anti-tuberculosis treatment; or prior positive test for hepatitis B surface antigen, hepatitis C virus antibody, or Treponema pallidum antibody.
- •Past or current diagnosis of neurological or psychiatric disorders, or family history of neurological/psychiatric disorders; or other neurological conditions deemed unsuitable for trial participation by the investigator.
- •Long-term use of immunosuppressants or immunomodulators through 6 months prior to and one month after the last vaccination, excluding topical medications. Topical medications should not exceed recommended doses or induce systemic exposure.
- •Treatment with immunoglobulins and/or blood products or blood donation through 3 months prior to and 3 months after the last vaccination in this trial.
- •Suspected or known alcohol dependence or drug abuse, which may affect safety assessment or trial compliance.
- •Planned long-term or permanent relocation away from the trial site area before trial completion.
- •Investigators, sponsors, and contract research organization (CRO) staff directly involved in the trial.
- •Other circumstances deemed unsuitable for trial participation by the investigator.
研究组 & 干预措施
Cohort 3: Dose level C in adults aged 40 years or above
Two injections of Dose level C of ABO1108 or placebo or active competitor given approximately 60 days apart
干预措施: SHINGRIX (Biological)
Cohort 1: Dose level A in adults aged 40 years or above
Two injections of Dose level A of ABO1108 or placebo or active competitor given approximately 60 days apart
干预措施: ABO1108 (Biological)
Cohort 2: Dose level B in adults aged 40 years or above
Two injections of Dose level B of ABO1108 or placebo or active competitor given approximately 60 days apart
干预措施: Placebo (Drug)
Cohort 1: Dose level A in adults aged 40 years or above
Two injections of Dose level A of ABO1108 or placebo or active competitor given approximately 60 days apart
干预措施: Placebo (Drug)
Cohort 2: Dose level B in adults aged 40 years or above
Two injections of Dose level B of ABO1108 or placebo or active competitor given approximately 60 days apart
干预措施: ABO1108 (Biological)
Cohort 3: Dose level C in adults aged 40 years or above
Two injections of Dose level C of ABO1108 or placebo or active competitor given approximately 60 days apart
干预措施: ABO1108 (Biological)
Cohort 3: Dose level C in adults aged 40 years or above
Two injections of Dose level C of ABO1108 or placebo or active competitor given approximately 60 days apart
干预措施: Placebo (Drug)
Cohort 1: Dose level A in adults aged 40 years or above
Two injections of Dose level A of ABO1108 or placebo or active competitor given approximately 60 days apart
干预措施: SHINGRIX (Biological)
Cohort 2: Dose level B in adults aged 40 years or above
Two injections of Dose level B of ABO1108 or placebo or active competitor given approximately 60 days apart
干预措施: SHINGRIX (Biological)
结局指标
主要结局
Incidence of unsolicited AEs and ARs after each dose
时间窗: up to day 90 (30 days after each dose)
Incidence of solicited AEs and ARs after each dose
时间窗: up to day 74 (14 days after each dose)
次要结局
未报告次要终点