Immunogenicity and Safety of the Heterologous Prime-boost Immunization with an Adenovirus Type-5 Vector-based COVID-19 Vaccine (Ad5-nCoV) After Three-dose Priming with an Inactivated COVID-19 Vaccine in Adults Aged 18 Years and Above: a Randomized, Open-label, Parallel-controlled Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 362
- 试验地点
- 1
- 主要终点
- GMT of neutralizing antibodies against live SARS-CoV-2 virus on day 28 after the booster dose.
研究概览
简要总结
This is an open-label, randomized, parallel-controlled clinical trial to evaluate the safety and immunogenicity of heterologous prime-boost immunization with an aerosolized (Ad5-nCoV-IH) or intramuscular (Ad5-nCoV-IM) Ad5-nCoV after three-dose priming with an inactivated COVID-19 vaccine (CoronaVac) in adults aged 18 years and above. A total of 360 subjects will be included. Approximately 210 subjects who have completed three doses of CoronaVac more than 6 months ago in the prior clinical trial and other 150 eligible subjects will be recruited and randomized respectively in a ratio of 1:1:1 to receive a booster dose of Ad5-nCoV-IH or Ad5-nCoV-IM or ICV. 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 on the day 0 before and 14, 28 days and 3, 6 months 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
- •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.
- •Participants who have received three-dose of inactivated SARS-CoV-2 vaccine more than 6 months ago.
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.
- •Vaccine-related SAE occurred after previous vaccination with COVID-19 vaccine.
- •Women with positive urine pregnancy test or in lactation.
- •Have acute febrile diseases or infectious diseases or have a history of SARS.
- •Axillary temperature>37.0℃
- •Have serious cardiovascular diseases, 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 is not stable, such as asthma, diabetes, thyroid disease
- •Congenital or acquired angioedema / neuroedema.
- •Have the history of urticaria 1 year before.
- •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
Approximately 70 subjects recruited from the prior clinical trial and newly enrolled 50 subjects will receive a booster dose of aerosolized Ad5-nCoV after three-dose priming with ICV
干预措施: Ad5-nCoV-IH (Biological)
Group B
Approximately 70 subjects recruited from the prior clinical trial and newly enrolled 50 subjects will receive a booster dose of intramuscular Ad5-nCoV after three-dose priming with CoronaVac
干预措施: Ad5-nCoV-IM (Biological)
Group C
Approximately 70 subjects recruited from the prior clinical trial and newly enrolled 50 subjects will receive homologous fourth dose of CoronaVac.
干预措施: CoronaVac (Biological)
结局指标
主要结局
GMT of neutralizing antibodies against live SARS-CoV-2 virus on day 28 after the booster dose.
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.
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.
次要结局
- Geometric Mean Fold Increase (GMI) 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)
- Incidence of serious adverse events (SAE) until 6 months after the booster dose.(Within 6 months after the booster dose)
- Geometric mean concentration (GMC), GMI and seroconversion of anti-SARS-CoV-2 NP-specific, RBD-specific and NTD-specific IgG measured by ELISA 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)
- Incidence of adverse reactions within 30 minutes after the booster dose.(Within 30 minutes after the booster dose)
- Incidence of adverse events within 28 days after the booster dose.(Within 28 days after the booster dose)
- GMT, GMI 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)
- Incidence of adverse reactions within 14 days after the booster dose.(Within 14 days after the booster dose)