Safety and Immunogenicity of a Heterologous Immunization of Recombinant COVID-19 Vaccine (Ad5 Vector) and RBD-based Protein Subunit Vaccine Against COVID-19 in Chinese Healthy Population
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- GMT of neutralizing antibodies against live SARS-CoV-2 virus at Day 14 after the booster vaccination.
研究概览
简要总结
This is a randomized, observer-blind, placebo-controlled study, for evaluation of safety and immunogenicity of heterologous prime-boost immunization of recombinant COVID-19 vaccine (adenovirus type-5 vector) and RBD-based protein subunit vaccine (ZF2001) against COVID-19 in Chinese healthy population. 120 healthy subjects aged over 18 years of age who have been vaccinated with recombinant adenovirus type-5 vectored vaccine will be recruited in this study. Of them, 60 subjects will be enrolled in the "0-28 days" regimen and other 60 will be enrolled in "0-56 days" regimen. Subjects, 30 of them are 18-59 years old and 30 are 60 years old and above in each regimen will be randomly vaccinated with the second dose of subunit vaccine(ZF2001) against COVID-19 or a commercial influenza vaccine in a ratio of 2:1. They will then be vaccinated with the third dose of ZF2001 on month 4 after the second dose. The occurrence of adverse events within 28 days and serious adverse events within 6 months after the last vaccination will be observed. In addition, blood samples will be collected on day 0 before the second vaccination, day 14, 28 after the second vaccination and day 14, month 6 after third vaccination to test serum antibody levels and to profile the immune cells' subgroups and germlines. Each subject will remain in this study for approximately 12 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
- Triple (Participant, 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
- 否
入选标准
- •The subjects ≥ 18 years old who has completed one dose of recombinant Ad5 vectored COVID-19 vaccine.
- •The subjects 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 can complete the 6-month follow-up of the study.
- •Axillary temperature ≤ 37.0 ℃
- •Individuals who are in good health condition at the time of entry into the trial as determined by medical history, physical examination and clinical judgment of the investigator and meet the requirements of these products immunization.
排除标准
- •have a 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, pregnant or breast-feeding, or have a pregnancy plan within six months.
- •have acute febrile diseases and infectious diseases.
- •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 trial vaccine.
- •have asplenia or functional asplenia.
- •have thrombocytopenia or other coagulation disorders (which may cause contraindications for intramuscular injection).
- •have the history of immunosuppressive therapy, anti allergy therapy, cytotoxic therapy or inhaled corticosteroids (excluding corticosteroid spray therapy for allergic rhinitis, and acute corticosteroid therapy without dermatitis) over the past 6 months.
- •have received blood products within 4 months before injection of trial vaccines.
- •have received another investigational product within one month before injection of trial vaccine.
- •have received attenuated vaccine within 1 month before injection of trial vaccine except the recombinant Ad5 vectored COVID-19 vaccine.
- •have received subunit or inactivated vaccine within 14 days before the vaccination with trial vaccine.
- •under anti tuberculosis treatment.
- •not be able to follow the protocol, or not be able to understand the informed consent according to the researcher's judgment, due to various medical, psychological, social or other conditions.
结局指标
主要结局
GMT of neutralizing antibodies against live SARS-CoV-2 virus at Day 14 after the booster vaccination.
时间窗: At Day 14 after the booster vaccination
GMT of neutralizing antibodies against live SARS-CoV-2 virus at Day 14 after the booster vaccination.
Incidence of solicited adverse events within 7 days after vaccination.
时间窗: Within 7 days after vaccination
Incidence of solicited adverse events within 7 days after vaccination.
次要结局
- Incidence of adverse reactions within 28 days after vaccination.(Within 28 days after vaccination)
- Incidence of adverse events within 28 days after vaccination.(Within 28 days after vaccination.)
- Proportion of the participants with at least a four-fold increase of the binding antibodies against SARS-CoV-2 S and RBD protein at day 14, day 28 after the second vaccination, and day 14, month 6 after the third vaccination.(at day 14, day 28 after the second vaccination, and day 14, month 6 after the third vaccination.)
- Incidence of unsolicited AE within 28 days after vaccination.(Within 28 days after vaccination.)
- Proportion of the participants with at least a four-fold increase of neutralizing antibodies against live SARS-CoV-2 virus at day 14, day 28 after the second vaccination, and day 14, month 6 after the third vaccination.(at day 14, day 28 after the second vaccination, and day 14, month 6 after the third vaccination.)
- Incidence of serious adverse events(SAE) from the first dose to the 6 months after completing the last dose of vaccination.(From the first dose to the 6 months after completing the last dose of vaccination.)
- GMT of binding antibodies against SARS-CoV-2 S and RBD protein measured by ELISA at day 14, day 28 after the second vaccination, and day 14, month 6 after the third vaccination.(at day 14, day 28 after the second vaccination, and day 14, month 6 after the third vaccination.)
- Fold increase of binding antibodies against SARS-CoV-2 S and RBD protein at day 14, day 28 after the second vaccination, and day 14, month 6 after the third vaccination.(at day 14, day 28 after the second vaccination, and day 14, month 6 after the third vaccination.)
- GMT of neutralizing antibodies against live SARS-CoV-2 virus at day 28 after the second vaccination, and day 14, month 6 after the third vaccination(at day 28 after the second vaccination, and day 14, month 6 after the third vaccination)
- Fold increase of neutralizing antibodies against live SARS-CoV-2 virus at day 14, day 28 after the second vaccination and day 14, month 6 after the third vaccination.(at day 14, day 28 after the second vaccination and day 14, month 6 after the third vaccination.)