Heterologous Prime-boost Immunization with an Aerosolised Adenovirus Type-5 Vector-based COVID-19 Vaccine (Ad5-nCoV) After Two-dose Priming with an Inactivated SARS-CoV-2 Vaccine in Adults Aged 18 Years and Above: a Multicenter, Open-label, Partially Parallel-controlled Clinical Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 10,285
- 试验地点
- 1
- 主要终点
- Incidence of adverse reactions within 28 days after the booster dose.
研究概览
简要总结
This is a multicenter, open-label, partially radomized, parallel-controlled clinical trial to evaluate the safety and immunogenicity of heterologous prime-boost immunization with an aerosolised adenovirus type-5 vector-based COVID-19 vaccine (Ad5-nCoV-IH) after two-dose priming with an inactivated SARS-CoV-2 vaccine (ICV) in adults aged 18 years and above. 10420 healthy subjects aged over or equal to 18 years whom have received two doses of ICV before 6 months or more, will be recruited from six provinces in China in this study.Of them, 10000 eligible participants in an open cohort will receive a booster dose of Ad5-nCoV-IH to evaluate the safety profile. Another 420 participants were involved in immunogenicity cohort and randomized in a ratio of 1:1 to receive a boost of Ad5-nCoV-IH or ICV. The ICV homologous to the priming series will be supplied as the booster. The occurrence of adverse reactions within 28 days and serious adverse events within 6 months after vaccination will be observed in all participants. In addition, blood and saliva samples will be collected from all participants in immunogenicity cohort on the day 0 before and 14, 28 and month 3 and 6 after the booster vaccination. Each subject will remain in this study for approximately 6 months.
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
- None
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
- •Health subjects aged ≥18 years.
- •Have received two-dose inactivated SARS-CoV-2 vaccine before 6 months or more.
- •The subject can provide with informed consent and sign informed consent form (ICF).
- •The subjects are able to and willing to comply with the requirements of the clinical trial program and could complete the 6-month follow-up of the study.
排除标准
- •Have the medical history or family history of convulsion, epilepsy, encephalopathy and psychosis.
- •Be allergic to any component of the research vaccines, or used to have a history of hypersensitivity or serious reactions to vaccination.
- •Women with positive urine pregnancy test.
- •Have acute febrile diseases and infectious diseases.
- •Axillary temperature>37.0℃.
- •Have serious cardiovascular disease, such as arrhythmia, conduction block, myocardial infarction, severe hypertension that cannot be controlled by medication (systolic blood pressure ≥180mmHg and/or diastolic blood pressure ≥110mmHg when measured in the field).
- •Have severe chronic diseases or condition in progress cannot be smoothly controlled, such as asthma, diabetes, thyroid disease.
- •Congenital or acquired angioedema / neuroedema.
- •Have the history of urticaria 1 year before receiving the investigational vaccine.
- •Have asplenia or functional asplenia.
- •Patients with chronic obstructive pulmonary disease, pulmonary fibrosis and other pulmonary abnormalities.
- •Have history of SARS-CoV-2 infection or COVID-
- •Have symptoms of upper respiratory tract infection.
- •Have traveled to medium or high risk areas or traveled abroad in the past 21 days, and epidemiologically contacted with SARS-CoV-
- •Any medical, psychological, social, or other conditions that, in the investigator's judgment, are inconsistent with the protocol or affect the subject's informed consent.
研究组 & 干预措施
Group A
Subjects in safety cohort will receive one heterologous booster dose of aerosolized Ad5-nCoV
干预措施: Aerosolized Ad5-nCoV (Biological)
Group B
Subjects in immunogenicity cohort will receive one heterologous booster dose of aerosolized Ad5-nCoV
干预措施: Aerosolized Ad5-nCoV (Biological)
Group C
Subjects in immunogenicity cohort will receive one homologous booster dose of ICV.
干预措施: Inactivated SARS-CoV-2 vaccine (Biological)
结局指标
主要结局
Incidence of adverse reactions within 28 days after the booster dose.
时间窗: Within 28 days the booster dose
Incidence of adverse reactions within 28 days after the booster dose.
GMT of neutralizing antibodies against live SARS-CoV-2 virus on day 28 after the booster dose in immunogenicity cohort.
时间窗: On day 28 after the booster dose
GMT of neutralizing antibodies against live SARS-CoV-2 virus on day 28 after the booster dose in immunogenicity cohort.
次要结局
- Incidence of adverse reactions within 30 minutes after the booster dose.(Within 30 minutes after the booster dose)
- Incidence of adverse reactions within 14 days after the booster dose.(Within 14 days after the booster dose)
- Incidence of adverse events within 28 days after the booster dose.(Within 28 days after the booster dose)
- Incidence of serious adverse events (SAE) till the 6 months after the booster dose.(Within 6 months after the booster dose)
- Fold increase and seroconversion of neutralizing antibodies against live SARS-CoV-2 virus on day 28 after the booster dose.(On day 28 after the boost vaccination)
- GMT, Fold increase and seroconversion of neutralizing antibodies against live SARS-CoV-2 virus on day 14, month 3 and 6 after the booster dose.(On day 14, month 3 and 6 after the booster dose)
- GMT, fold increase and seroconversion of neutralizing antibodies against live SARS-CoV-2 virus at month 3, 6, and 12 after the booster dose.(At month 3, 6, and 12 after the boost vaccination.)
- Geometric mean concentration (GMC), fold increase and seroconversion of binding IgG against S protein of SARS-CoV-2 on day 14, day 28 and month 3 and 6 after the booster dose.(On day 14, day 28 and month 3 and 6 after the booster dose)
- GMT of neutralizing antibodies against live SARS-CoV-2 virus in participants with pre-existing anti-Ad5 antibody titers>1:200 or ≤1:200 at baseline.(On day 28 after the booster dose)
- The levels of IFN-γ、TNF-α、IL-2、IL-4、IL-5、IL-13 secreted by specific T cells on day 14 after the booster vaccination.(On day 14 after the booster vaccination)
- GMT, fold increase and seroconversion of neutralizing antibodies against VOC/VOI of SARS-CoV-2 virus on day 28 after the booster dose.(On day 28 after the booster dose)