NCT07289503进行中（未招募）1 期
A Randomized, Blinded and Placebo-Control Phase I Clinical Trial to Evaluate the Safety and Immunogenicity of Lyophilized Respiratory Syncytial Virus mRNA Vaccine in Adults Aged 18 Years or Above
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- Incidence of solicited AEs and ARs after a single dose
研究概览
简要总结
The primary objective of this study is to evaluate the tolerability, reactogenicity and safety of a single injection of three dose levels of ABO1105 in adults aged 18 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
- 18 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 ≥18 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 3 months following vaccination.
排除标准
- •Presence of one or more respiratory symptoms within 7 days prior to vaccination, lasting for at least 24 hours.
- •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.
- •Laboratory-confirmed history of RSV infection within the past 12 months, or previous vaccination with a respiratory syncytial virus vaccine.
- •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 18-59, 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 products or its excipients, or severe allergic reactions to other vaccines, foods, or medications.
- •Use or planned use of any vaccine other than the investigational products through 30 days prior to and 30 days after vaccination in this trial.
- •Current participation in another clinical trial within 30 days 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 within 6 months prior to 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 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 2: Dose level B in adults aged 18 years or above
Other
Single injection of Dose level B of ABO1105
干预措施: ABO1105 (Biological)
Cohort 2: Dose level B in adults aged 18 years or above
Other
Single injection of Dose level B of ABO1105
干预措施: Placebo (Drug)
Cohort 1: Dose level A in adults aged 18 years or above
Other
Single injection of Dose level A of ABO1105
干预措施: ABO1105 (Biological)
Cohort 1: Dose level A in adults aged 18 years or above
Other
Single injection of Dose level A of ABO1105
干预措施: Placebo (Drug)
Cohort 3: Dose level C in adults aged 18 years or above
Other
Single injection of Dose level C of ABO1105
干预措施: ABO1105 (Biological)
Cohort 3: Dose level C in adults aged 18 years or above
Other
Single injection of Dose level C of ABO1105
干预措施: Placebo (Drug)
结局指标
主要结局
Incidence of solicited AEs and ARs after a single dose
时间窗: up to Day 14
Incidence of unsolicited AEs and ARs after a single dose
时间窗: up to Day 30
次要结局
未报告次要终点
研究者
研究点 (1)
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