Immunogenicity and Safety of an Inactivated SARS-CoV-2 Vaccine (Sinopharm BBIBP-CorV) Coadministered With Rabies Vaccine in China: a Multicentre, Randomised, Controlled, Phase 4 Trial
试验速览
- 阶段
- 4 期
- 入组人数
- 360
- 试验地点
- 2
- 主要终点
- Seroconversion rate against rabies virus
研究概览
简要总结
Evaluation of immunogenicity and safety of inactivated COVID-19 vaccine (BBIBP-Cov) coadministered with rabies vaccine.
详细描述
The participants aged ≥18 who had received two doses of inactivated COVID-19 vaccine were recruited and randomly assigned to one of three study groups: Co-Ad group, COVID-19 vaccine group and Rabies vaccine group.
The participants in Co-Ad group and COVID-19 vaccine group received a booster dose of inactivated COVID-19 vaccine.The participants in Co-Ad group and Rabies vaccine group received three doses of rabies vaccine for pre-exposure immunization. The participants in Co-Ad group received the first dose of rabies vaccine (Day 0) and the inactivated COVID-19 vaccine simultaneously.
Any local or systemic adverse events after vaccination will be recorded.
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
- •Participants aged ≥
- •Have the ability to understand the study procedures, voluntarily sign informed consent.
- •Be able and willing to complete the entire study plan during the study follow-up period.
- •Participants have not received any rabies vaccine.
- •Participants have received 2 doses of inactivated COVID-19 vaccine for 6-12 months.
- •The time interval between the last vaccination is ≥14 days.
- •Body temperature < 37.3 °C confirmed by clinical examination before enrollment .
排除标准
- •for the first dose:
- •Participants who have received the third dose of COVID-19 vaccine.
- •Participants who have previously been infected with COVID-19 or who have tested positive for SARS-CoV-
- •Having a history or family history of convulsions, epilepsy, encephalopathy and psychosis.
- •Being allergic to any component of vaccines and a history of severe allergic reactions to any vaccine.
- •Participants are suffering from immunodeficiency, receiving immunosuppressant therapy (oral steroid hormones) during treatment for malignancy, or having low immunity due to HIV within 14 days before enrollment, or having congenital immune disorders in close family members.
- •Injection of non-specific immunoglobulin within 1 month before enrollment.
- •Participants are suffering from acute febrile diseases and infectious diseases, or have used anti-inflammatory/antiviral/antipyretic/antiallergic drugs within 3 days before enrollment.
- •A history of clearly diagnosed thrombocytopenia or other clotting disorders that may contraindicate subcutaneous injection.
- •Participants with severe chronic diseases or acute episodes of chronic diseases, hypertension or diabetes that cannot be controlled by drugs.
- •Participants with infectious, suppurative and allergic skin diseases.
- •Pregnant and lactating women.
- •Other Participants whose physical conditions, as determined by the investigator, are not suitable for inclusion in clinical studies.
- •Exclusion criteria for the second or third dose:
- •Participants who had vaccine-related serious adverse reactions after vaccination.
- •Systemic adverse reactions/anaphylaxis with severity ≥3 after vaccination as determined by the investigator.
- •Participants experienced new conditions that met the "exclusion criteria for the first dose ".
- •Other reasons for exclusion considered by the investigator.
研究组 & 干预措施
Co-Ad group
A total of 120 participants received one dose of inactivated COVID-19 vaccine and three doses of rabies vaccine.
Participants received one dose of inactivated COVID-19 vaccine and rabies vaccine on Day 0, and one dose of rabies vaccine on Day 7 and Day 28.
Blood sampling was performed on Day 0, Day 28 and Day 42.
干预措施: coadministration (Biological)
Rabies vaccine group
A total of 120 participants received three doses of rabies vaccine on Day 0, Day 7 and Day 28.
Blood sampling was performed on Day 0 and Day 42.
干预措施: rabies vaccine (Biological)
COVID-19 vaccine group
A total of 120 participants received one dose of inactivated COVID-19 vaccine on Day 0.
Blood sampling was performed on Day 0 and Day 28.
干预措施: COVID-19 vaccine (Biological)
结局指标
主要结局
Seroconversion rate against rabies virus
时间窗: 14 days after the 3th dose (Day 42)
The rate of seroconversion against rabies virus
Seroconversion rate against SARS-CoV-2
时间窗: 28 days after vaccination (Day 28)
The rate of seroconversion against SARS-CoV-2
Neutralizing antibody GMT against SARS-CoV-2
时间窗: 28 days after vaccination (Day 28)
Neutralizing antibody GMT against SARS-CoV-2 after vaccination
Neutralizing antibody GMC against rabies virus
时间窗: 14 days after the 3th dose (Day 42)
Neutralizing antibody GMC against rabies virus after 3th dose
Neutralizing antibody GMI against SARS-CoV-2
时间窗: 28 days after vaccination (Day 28)
Neutralizing antibody GMI against SARS-CoV-2 after vaccination
Neutralizing antibody GMI against rabies virus
时间窗: 14 days after the 3th dose (Day 42)
Neutralizing antibody GMI against rabies virus after 3th dose
次要结局
- Adverse events rate(0-7 days or 0-28 days following vaccinations)
- Serious adverse event rate(0-6 months)