A Multicenter, Randomized, and Observer-blind Clinical Trial to Evaluate the Safety and Immunogenicity of Ad5-based COVID-19 Vaccine Against Coronavirus Variants in Adults (≥ 18 Years) Who Have Been Immunized With 2 Doses of mRNA Vaccines Plus One Dose of Booster AZD1222 Vaccine
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 主要终点
- Immunogenicity of Ad5-nCoV/O or Ad5-nCoV/O-IH versus BNT162b2 as the 2nd booster dose.
研究概览
简要总结
Subjects who have completed the primary mRNA vaccine immunizations and the 1st booster AZD1222 immunization for more than 6 months will be randomized to receive a 2nd booster dose of Ad5-nCoV/O, Ad5-nCoV/O-IH or mRNA-based COVID-19 vaccine in a ratio of 2:2:1.
详细描述
This is a multicenter, randomized, observer-blind, and parallel-controlled clinical study to evaluate the immune responses and safety profiles in adults (≥ 18 years) receiving investigational products (intramuscular injection or nebulized inhalation) ≥ 180 days after the immunization of 2 doses of BNT162b2 vaccines plus one dose of booster AZD1222 vaccine. This study will enroll about 30% participants aged 60 years and above.
Subjects who have completed the primary mRNA vaccine immunizations and the 1st booster AZD1222 immunization for more than 6 months will be randomized to receive a 2nd booster dose of Ad5-nCoV/O, Ad5-nCoV/O-IH or mRNA-based COVID-19 vaccine in a ratio of 2:2:1.
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
- Single (Investigator)
盲法说明
observer-blind clinical trial
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 aged 18 years and above at the time of screening.
- •Received the 1st booster vaccination at least 180 days earlier.
- •Agree to attend all visits and sign the written informed consent form.
排除标准
- •Have a history of seizures, epilepsy, encephalopathy, psychosis.
- •History of severe anaphylaxis or allergy to any vaccine component.
- •Positive urine pregnancy test result, pregnant, lactating women.
- •Medical history of Guillain-Barré syndrome.
- •Have had asthma attacks within 2 years.
- •Have severe nasal or oral diseases, such as rhinitis (sinusitis), allergic rhinitis, oral ulcer, throat swelling, etc.
- •Bleeding disorder (e.g. protein S or factor deficiency, coagulopathy or platelet disorder).
- •Have chronic systematic infection or chronic obstructive pulmonary disease (COPD), etc.
- •Administration of immunoglobulins and/or any blood products within three months prior to the planned administration of the vaccine candidate.
- •Current diagnosis or receiving treatment for tuberculosis or cancer.
- •History of SARS-CoV-2 infection for less than 3 months.
- •Received or plan to receive any vaccines (licensed or investigational), within 14 days before and after study vaccination.
- •Have an axillary temperature of > 37.0℃.
- •Any other significant diseases, disorders or findings which may significantly increase the risk to the volunteer because of participation in the study, and affect the ability of the volunteer to participate in the study or impair interpretation of the study data.
结局指标
主要结局
Immunogenicity of Ad5-nCoV/O or Ad5-nCoV/O-IH versus BNT162b2 as the 2nd booster dose.
时间窗: Day 28 post vaccination
The geometric mean titers (GMT) of anti-Omicron pseudovirus neutralizing antibody on Day 28 post vaccination in all participants
次要结局
- Incidence of Adverse Reactions (ARs)(within 14 days post vaccination)
- Virological confirmed severe COVID-19 cases.(from Day 14 post-vaccination)
- Immunogenicity of anti-Nucleocapsid antibody(before vaccination)
- Incidence of SAE(within 12 months post vaccination)
- Immunogenicity of S-RBD serum IgA antibody(on Month 3, Month 6, and Month 12 post-vaccination)
- Virological confirmed COVID-19 cases(from Day 14 post-vaccination)
- Immunogenicity of S-RBD IgG antibody(on Month 3, Month 6, and Month 12 post-vaccination)
- Immunogenicity of saliva secretory IgA (SIgA)(on Day 14 and Day 28 post-vaccination)
- The level and positive rate of interferon γ (IFN-γ)(on Day 14 and Day 28 after the 2nd booster dose)
- The incidence of AR and AE(within 28 days post vaccination)
- Immunogenicity of pseudovirus neutralizing antibody(on Month 3, Month 6, and Month 12 post-vaccination)
- Virological confirmed asymptomatic COVID-19 cases(from Day 14 post-vaccination)
- The neutralizing antibody against other VOCs or emerging variant(s).(on Day 28)