Observer-Blind, Randomized, Controlled Study of Immunogenicity and Safety of SARS-Cov-2 Protein Subunit Recombinant Vaccine (Bio Farma) as a Booster Dose Against COVID-19 in Adults 18 Years of Age and Older
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- PT Bio Farma
- 入组人数
- 696
- 试验地点
- 2
- 主要终点
- Immunogenicity of the candidate vaccine
研究概览
简要总结
Observer-blind, randomized, active-controlled prospective intervention study of Immunogenicity & Safety of SARS-Cov-2 Protein Subunit Recombinant Vaccine (Bio Farma) as a Booster Dose Against COVID-19 in Adults 18 Years of Age and Older.
详细描述
This trial is observer-blind, randomized, prospective intervention study. In this study 900 subjects who had received complete primary doses of authorized/approved inactivated (Sinovac®), mRNA (Pfizer®), or viral vector (AstraZeneca®) COVID-19 vaccine and willing to participate in the booster study by signing the consent form, will be involved in this trial.
Subject will be divided into six groups, each 150 subjects per arm who had received a complete primary dose of inactivated (Sinovac®) vaccine, mRNA (Pfizer®) vaccine, or viral vector (AstraZeneca®) vaccine will receive one booster dose of SARS-CoV-2 subunit protein recombinant vaccine or active control.
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
- Double (Participant, Investigator)
盲法说明
Vaccine candidate and active comparator are masking.
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
- •Clinically healthy adults 18 years of age and older.
- •Subjects who have previously received complete primary series of authorized/approved inactivated (Sinovac®), mRNA (Pfizer®), or viral vector COVID-19 vaccine (AstraZeneca®) with the last dose administered a minimum of 6 months prior to inclusion but not longer than 12 months prior to inclusion.
- •Subjects have been informed properly regarding the study and signed the informed consent form.
- •Subjects will commit to comply with the instructions of the investigator and the schedule of the trial.
排除标准
- •Subject concomitantly enrolled or scheduled to be enrolled in another trial.
- •Subject who has received booster dose of COVID-19 vaccine.
- •Subject who has history of COVID-19 in the last 3 months (based on anamnesis or other examinations).
- •Evolving mild, moderate or severe illness, especially infectious disease or fever (body temperature ≥37.5℃, measured with infrared thermometer/thermal gun).
- •Women who are pregnant or planning to become pregnant during the study period (judged by self-report of subjects and urine pregnancy test results).
- •History of asthma, history of allergy to vaccines or vaccine ingredients, and severe adverse reactions to vaccines, such as urticaria, dyspnea, and angioneurotic edema.
- •History of uncontrolled coagulopathy or blood disorders contraindicating intramuscular injection.
- •Patients with serious chronic diseases (serious cardiovascular diseases, uncontrolled hypertension and diabetes, liver and kidney diseases, malignant tumors, etc) which according to the investigator might interfere with the assessment of the trial objectives.
- •Subjects who have any history of confirmed or suspected immunosuppressive or immunodeficient state, or received in the previous 4 weeks a treatment likely to alter the immune response (intravenous immunoglobulins, blood-derived products or long-term corticosteroid therapy (> 2 weeks)).
- •Subjects who have history of uncontrolled epilepsy or other progressive neurological disorders, such as Guillain-Barre Syndrome.
- •Subjects receive any vaccination (other than COVID-19 vaccine) within 1 month before and after IP immunization.
- •Subjects plan to move from the study area before the end of study period.
研究组 & 干预措施
Primary dose of inactivated (Sinovac®) vaccine (1)
Subject who had received a complete primary dose of inactivated (Sinovac®) vaccine
干预措施: SARS-CoV-2 subunit protein recombinant vaccine (Biological)
Primary dose of mRNA (Pfizer®) vaccine (1)
Subject who had received a complete primary dose of mRNA (Pfizer®) vaccine
干预措施: SARS-CoV-2 subunit protein recombinant vaccine (Biological)
Primary dose of Viral Vector (AstraZeneca®) vaccine (1)
Subject who had received a complete primary dose of viral vector (AstraZeneca®) vaccine
干预措施: SARS-CoV-2 subunit protein recombinant vaccine (Biological)
Primary dose of inactivated (Sinovac®) vaccine (2)
Subject who had received a complete primary dose of inactivated (Sinovac®) vaccine
干预措施: Active Comparator (Biological)
Primary dose of mRNA (Pfizer®) vaccine (2)
Subject who had received a complete primary dose of mRNA (Pfizer®) vaccine
干预措施: Active Comparator (Biological)
Primary dose of Viral Vector (AstraZeneca®) vaccine (2)
Subject who had received a complete primary dose of viral vector (AstraZeneca®) vaccine
干预措施: Active Comparator (Biological)
结局指标
主要结局
Immunogenicity of the candidate vaccine
时间窗: 14 days after booster vaccination
Geometric Mean Titer (GMT) and GMT ratio of neutralizing antibody to the SARS-CoV-2
次要结局
- Seropositive rate of the candidate vaccine(Baseline, 14 days and 6 months after booster vaccination)
- Comparison of immunogenicity between candidate vaccine and control group(Baseline, 14 days, and 6 months after booster vaccination)
- Safety of the candidate vaccine(28 days after booster vaccination)
- Serious Adverse Event (SAE) of the vaccine(6 months after booster vaccination)
- Seroconversion rate of the candidate vaccine(baseline and 14 days after booster vaccination)
- Seropositive rate and GMT of candidate vaccine(Baseline, 14 days, and 6 months after booster vaccination)