NCT07418229尚未招募1 期
A Randomized, Double-Blind, Placebo-Controlled Phase I Clinical Trial to Evaluate the Safety of Different Doses of a Lyophilized RSV mRNA Vaccine in Adults Aged 18 Years and Older
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Incidence of adverse events
研究概览
简要总结
To evaluate the safety of Sinovac RSV mRNA among participants aged ≥18 years
详细描述
This is a randomized, double-blind, placebo-controlled clinical trial, enrolling a total of 60 participants aged ≥18 years. Eligible participants will be enrolled sequentially by age (18~49 → ≥50 years old) and dosage (low → High), and then be randomized to the study group and the control group in a ratio of 2:1. Sentinel participant will be set. All participants were required to complete immediate reaction observation within 30 minutes after each vaccine dose, and adverse events until 30 days after vaccination, as well as serious adverse events and adverse event of special interest throughout the whole study period.
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
- Quadruple (Participant, Care Provider, 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
- •Participants can understand and voluntarily sign the informed consent form;
- •Able to provide legal identity documents;
- •Healthy individuals aged 18 years and above;
- •Participants of childbearing potential and their sexual partners voluntarily adopt effective contraceptive measures (such as correct use of condoms, or female participants using combined oral contraceptives, intrauterine devices) from the time the participant signs the informed consent form until 6 months after the administration of the investigational vaccine, and have no plans to donate sperm or ovums; Female participants of childbearing potential must also have adopted effective contraceptive measures within 2 weeks before enrollment.
排除标准
- •Participants who meet any of the following criteria will be excluded from this trial:
- •Those with fever on the day of vaccination with the trial vaccine, with an axillary temperature > 37.0℃ before vaccination;
- •Those with a history of previous RSV vaccination, or a history of RSV infection within 6 months before enrollment.
- •Known to be allergic to vaccines or vaccine components;
- •Before vaccination, the electrocardiogram examination and clinical laboratory test indicators specified in the protocol are abnormal and clinically significant;
- •Female participants who are breastfeeding or pregnant;
- •Having autoimmune diseases or immunodeficiency diseases (including but not limited to systemic lupus erythematosus, ankylosing spondylitis, autoimmune thyroid diseases, asplenia, functional asplenia, splenectomy, HIV infection);
- •History of poorly controlled chronic diseases or severe diseases, including but not limited to cardiovascular diseases (such as hypertension uncontrolled by drugs, i.e., systolic blood pressure ≥ 140 mmHg and/or diastolic blood pressure ≥ 90 mmHg for participants aged 18-59 years old, systolic blood pressure ≥ 150 mmHg and/or diastolic blood pressure ≥ 100 mmHg for participants aged 60 years old and above, as well as congenital heart disease, atrial fibrillation, myocarditis, pericarditis), hematological system diseases, liver and kidney diseases, respiratory system diseases, malignant tumors, history of transplantation of major functional organs, or any other diseases or physiological conditions that the researcher believes can interfere with the trial results;
- •Current encephalopathy (such as damage to cerebral nerve tissue caused by congenital hypoplasia of the brain, brain trauma, brain tumors, cerebral hemorrhage, brain infection, chemical drug poisoning, etc.);
- •Severe neurological diseases, such as a history of demyelinating diseases including but not limited to Guillain-Barré syndrome, multiple sclerosis, neuromyelitis optica, acute disseminated encephalomyelitis, etc., or a history of convulsions, epilepsy, or a family history of mental illness;
- •Having a doctor-diagnosed coagulation dysfunction (such as coagulation factor deficiency, coagulative diseases, abnormal platelets);
- •Having received systemic immunosuppressive agents or other immunomodulatory treatments (prednisone [≥ 20 mg/day] or its equivalent) for ≥ 14 days within the past 3 months, cytotoxic therapy, or planning to receive such treatments during the study period;
- •Having received immunoglobulin or other blood products within 3 months before receiving the trial vaccine, or planning to receive such treatments during the study period;
- •Currently participating in other clinical trials, or planning to receive such drugs or vaccines during the study period;
- •Having received live attenuated vaccines within the past 14 days or other vaccines with processes such as subunit or inactivated vaccines within 7 days;
- •Having various acute diseases or acute exacerbation of chronic diseases within the past 7 days, or known or suspected active infection;
- •Axillary temperature > 37.0℃ within the past 3 days, or use of anti-allergic drugs, non-steroidal antipyretic analgesics, etc.;
- •Those with skin damage, inflammation, ulceration, rash, scarring, or other conditions at the target vaccination site that may interfere with vaccination or observation of local reactions;
- •According to the researcher's judgment, participants have any other factors that make them unsuitable for participating in the clinical trial.
研究组 & 干预措施
Sinovac RSV mRNA vaccine low-dose group
Experimental
Participants will receive one dose of low-dose lyophilized RSV mRNA vaccine.
干预措施: Low-dose RSV mRNA vaccine (Biological)
Sinovac RSV mRNA vaccine high-dose group
Experimental
Participants will receive one dose of high-dose lyophilized RSV mRNA vaccine.
干预措施: High-dose RSV mRNA vaccine (Biological)
Placebo control group
Placebo Comparator
Participants will receive one dose of normal saline.
干预措施: Placebo (Other)
结局指标
主要结局
Incidence of adverse events
时间窗: Up to 30 days after vaccination
次要结局
- Incidence of serious adverse events and adverse events of special interest(Up to 12 months after vaccination)
- Incidence of adverse events(Up to 14 days after vaccination)
研究者
研究点 (1)
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