NCT05585567进行中（未招募）早期 1 期
A Single Center, Randomized, Open-labeled, Exploratory Clinical Study to Evaluate the Safety and Immunogenicity of Bivalent Vaccine V-01-B5 as a Booster Dose in Participants Aged 18-59 Years Vaccinated 3-dose Inactivated COVID-19 Vaccine
适应症
试验速览
- 阶段
- 早期 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Serious adverse event (SAE) and adverse event of special interest (AESI)
研究概览
简要总结
It is a single center, randomized, open-labeled, exploratory clinical study to evaluate the safety and immunogenicity of Recombinant SARS-CoV-2 Fusion Protein bivalent Vaccine V-01-B5 as a second booster in adults aged 18-59 years after vaccinated with 3-dose of inactivated vaccines.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 59 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults aged 18 -59 years old at time of consent, male or female;
- •Normal body temperature;
- •Participants who have completed 3-dose regimen of inactive vaccination (CoronaVac) against SARS-CoV-2 wild type in the past 5-9 months;
- •Female participants who are not pregnant at the time of enrollment (urine pregnancy test is negative), nor during lactating; and has no birth plan and agree to take effective contraception in 7 months after enrollment; and took effective and acceptable contraceptive methods in the previous 2 weeks before the enrollment;
- •Be able and willing to complete the study during the entire study and follow-up period;
- •Participants who have the ability to understand the study process, sign the informed consent form voluntarily , and be able to comply with the requirements of the clinical study protocol.
排除标准
- •Serious chronic diseases or uncontrolled diseases;
- •Uncontrolled neurological disorders, epilepsy;
- •Received any inactivated vaccine within 1 week or received any attenuated vaccines within 4 weeks;
- •Patients with congenital or acquired immunodeficiency;
- •History of severe allergy or be allergic to any components of the test vaccines;
- •History of hereditary hemorrhagic tendency or coagulation dysfunction;
- •Patients with malignant tumors and other patients have a life expectancy less than 1 year;
- •Refuse to sign the informed consent form or inability to complete follow-ups as required by the protocol;
- •History of previous COVID-19 infection;
- •Pregnant or breastfeeding women, or females of childbearing potential who not agree to or able to take effective and acceptable contraceptive methods during the study;
- •Participants who have participated in other clinical trials within 3 months or are participating in other clinical trials;
- •Those considered by the investigator as inappropriate to participate in the study.
结局指标
主要结局
Serious adverse event (SAE) and adverse event of special interest (AESI)
时间窗: Within 12 months after vaccination
Observe the SAE and AESI after vaccination
Adverse Event (AE)
时间窗: 30 minutes after vaccination
Observe the AEs occurs at different time point after vaccination
AEs
时间窗: 0-28 days after vaccination
Observe the AEs occurs at different time point after vaccination
Neutralizing antibody geometric mean titer (GMT) of Omicron BA.5
时间窗: 28 days after vaccination
Neutralizing antibody GMT of the most prevalent SARS-CoV-2 variant (Omicron BA.5)
次要结局
- Neutralizing antibody GMT of other SARS-CoV-2 variants(Until 12 months after vaccination)
- Neutralizing antibody titer of other SARS-CoV-2 variants (SVNT)(Until 12 months after vaccination)
- Anti-SARS-CoV-2 receptor-binding domain (RBD) antibody level(Until 12 months after vaccination)
- Neutralizing antibody titer of other SARS-CoV-2 variants (MRNT)(Until 12 months after vaccination)
研究者
研究点 (1)
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