A Single-center, Randomized, Double-Blinded, Placebo-Controlled, Phase Ⅱ Clinical Trial of Recombinant COVID-19 Vaccine (Sf9 Cells), in the Subjects From Healthy Aged 18 Years and Above
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 960
- 试验地点
- 1
- 主要终点
- Geometric mean (GMT) of specific antibody
研究概览
简要总结
This is a phase Ⅱ, single-center, randomized, double-blind, placebo-controlled study, to evaluate the immunogenicity and safety of the recombinant COVID-19 vaccine (Sf9 cells) in the subjects from healthy adults and elderly adults aged 18 years and above (aged 18-60 and 60-85 years) with different immunization procedures (0, 21 days and 0, 14, 28 days) and doses (20μg/40μg).
详细描述
This is a phase Ⅱ, single-center, randomized, double-blind, placebo-controlled study, to evaluate the immunogenicity and safety of the recombinant COVID-19 vaccine (Sf9 cells) in the subjects from healthy adults and elderly adults aged 18 years and above (aged 18-60 and 60-85 years) . The phase Ⅱ clinical trials designed 8 research group, including two immunization procedures (0, 21 days and 0, 14, 28 days), two doses (20μg/0.5ml, 40μg/1.0ml) and two ages group (adults and elder): Each group including 120 participants. Vaccination or placebo group will be randomly assigned to receive in a 5:1 ratio, 960 in total.
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, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged 18 years and above.
- •Able to understand the content of informed consent and willing to sign the informed consent.
- •Able and willing to complete all the secluded study process during the whole study follow-up period (about 7 months).
- •Axillary temperature ≤37.0℃.
- •General good health as established by medical history and physical examination.
排除标准
- •First dose exclusion criteria:
- •Positive serum immunoglobulin M (IgM) and IgG to the SARS-CoV-
- •A Known History of HIV infection
- •Family history of seizure, epilepsy, brain or mental disease.
- •Participant that has an allergic history to any ingredient of vaccines.
- •Woman who is pregnant, breast-feeding or positive in pregnancy test on day of enrollment, or is planning to be pregnant during the next 6 months.
- •Any acute fever disease or infections.
- •Have a medical history of SARS.
- •Have serious cardiovascular diseases, such as arrhythmia, conduction block, myocardial infarction, severe hypertension and not well-controlled.
- •Major chronic illness, such as asthma, diabetes, or thyroid disease, and not well-controlled.
- •Hereditary angioneurotic edema or acquired angioneurotic edema.
- •Urticaria in last one year.
- •Asplenia or functional asplenia.
- •Platelet disorder or other bleeding disorder may cause injection contraindication.
- •Faint at the sight of blood or needles.
- •Prior administration of immunodepressant or corticosteroids, antianaphylactics treatment, cytotoxic treatment in last 6 months.
- •Prior administration of blood products in last 4 months.
- •Prior administration of other research medicines in last 1 month.
- •Prior administration of attenuated vaccine in last 1 month.
- •Prior administration of subunit vaccine or inactivated vaccine in last 14 days.
- •Being treated for tuberculosis.
- •Any condition that in the opinion of the investigators may interfere with the evaluation of study objectives.
- •Exclusion criteria for subsequent doses:
- •Patients with severe allergic reactions after the previous dose of vaccination;
- •Patients with serious adverse events causally related to the previous dose of vaccination.
结局指标
主要结局
Geometric mean (GMT) of specific antibody
时间窗: 1 months after immunization in each study group
Geometric mean (GMT) of specific antibody against Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Spike protein Receptor-binding domain(S-RBD) protein (ELISA)
The incidence of adverse reaction (AR)
时间窗: 0 to 7 days after vaccination in each study group
The incidence of adverse reaction (AR)
次要结局
- The incidence of adverse events (AE)(0 to 28 days after vaccination in each study group)
- The incidence of severe adverse events (SAE)(0 to 28 days after vaccination in each study group)
- The incidence of serious adverse events(6 months after vaccination in each study group)
- Geometric mean (GMT) of anti-SARS-CoV-2-specific neutralizing antibodies(14 days after immunization in each study group)
- The positive conversion rate of S-RBD protein-specific antibody(14 days, 30 days after immunization in each study group)
- Geometric mean fold increase (GMI) of S-RBD protein-specific antibody(14 days, 30 days after immunization in each study group)
- The positive conversion rate of anti-SARS-CoV-2 specific neutralizing antibody(14 days, 30 days after immunization in each study group)
- Geometric mean fold increase (GMI) of anti-SARS-CoV-2 specific neutralizing antibodies(14 days, 30 days after immunization in each study group)