Safety and Immunogenicity of a Recombinant SARS-CoV-2 S-Trimer Vaccine (CHO Cell) as Booster Shots in Healthy Adults Aged 18-59 Years Who Have Completed Two Doses of Inactivated SARS-CoV-2 Vaccine
试验速览
- 阶段
- 早期 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Incidence of Treatment-Emergent Adverse Events
研究概览
简要总结
Increased immune escape of emerging SARS-CoV-2 variants and waning neutralizing antibody levels over time indicate the importance of COVID-19 vaccine booster dose. Preclinical findings have shown that the recombinant SARS-CoV-2 S-Trimer vaccine exhibited favorable safety and immunogenicity. Herein, we conducted a randomized, open-label, positive control trial to assess the safety and immunogenicity of the booster shot in healthy subjects aged 18-59 years who have completed two-dose primary series of inactivated vaccine for 6-15 months. A total of 63 eligible participants were enrolled to receive the recombinant SARS-CoV-2 S-Trimer vaccine or inactivated vaccine, and only one participant in 30 μg recombinant SARS-CoV-2 S-Trimer vaccine cohort withdrew owing to personal work reasons on September 26, 2022. Subjects in each dose group (5 μg, 10 μg, 30 μg recombinant SARS-CoV-2 S-Trimer vaccine) was randomly assigned to receive the experimental vaccine or inactivated vaccine in a 2:1 ratio.
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 59 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Eligible participants were those who completed the two-dose primary series of ICV for 6-15 months
- •Voluntarily consented to participate in this trial
- •Agreed to take effective contraceptive measures (women of childbearing potential) from signing the informed consent form to 12 months after booster vaccination.
排除标准
- •History of allergy to any vaccine or its excipients;
- •Presence of severe, uncontrollable or hospitalized diseases;
- •History of major surgery within 3 months prior to enrollment;
- •History of Severe Acute Respiratory Syndrome (SARS), Middle East Respiratory Syndrome (MERS) or COVID-19;
- •Congenital or acquired immunodeficiency or autoimmune disease;
- •Any acute diseases or acute attacks of chronic diseases within 7 days prior to enrollment;
- •Receipt of any COVID-19 prophylactic medication other than primary series of ICV;
- •Long-term receipt (>14 consecutive days) of glucocorticoids or other immunosuppressive agents within the past 6 months;
- •Receipt of biological agents, immunopotentiators or immunosuppressants within the past 6 months;
- •Receipt of blood or blood-related products within 3 months prior to vaccination;
- •Administration of antipyretics, painkillers or antiallergics within 24 hours prior to vaccination;
- •Participating or planning to participate in other clinical trials during the study period;
- •Pregnant or lactating females, women of childbearing age of pregnancy test positive;
- •Presence of any underlying disease or condition which, in the opinion of the investigator, may place the subject at unacceptable risk, is unable to meet the requirements of the protocol, or interfere with the assessment of vaccine response.
研究组 & 干预措施
the 5 μg recombinant SARS-CoV-2 S-Trimer vaccine booster group
干预措施: the recombinant SARS-CoV-2 S-Trimer vaccine/inactivated SARS-CoV-2 vaccine (Biological)
the 10 μg recombinant SARS-CoV-2 S-Trimer vaccine booster group
干预措施: the recombinant SARS-CoV-2 S-Trimer vaccine/inactivated SARS-CoV-2 vaccine (Biological)
the 30 μg recombinant SARS-CoV-2 S-Trimer vaccine booster group
干预措施: the recombinant SARS-CoV-2 S-Trimer vaccine/inactivated SARS-CoV-2 vaccine (Biological)
ICV booster group
干预措施: the recombinant SARS-CoV-2 S-Trimer vaccine/inactivated SARS-CoV-2 vaccine (Biological)
结局指标
主要结局
Incidence of Treatment-Emergent Adverse Events
时间窗: within 28 days of booster immunization
Unsolicited local/systemic AEs within 28 days of booster immunization
humoral immunogenicity
时间窗: On Day 14 and Day 28 after booster immunization
The seroconversion rate of neutralizing antibody against Delta, Omicron BA.2.2 and Omicron BA.5.2 after the booster immunization
次要结局
- The safety outcomes were the counts and percentages of AEs, including SAEs and AESIs within 12 months, changes in laboratory safety parameters on the 3rd day following booster vaccination in comparison to baseline.(12 months)
- humoral immunogenicity(On 3rd month, 6th month after booster immunization)