NCT05067894已完成1 期
A Phase I, Observer-Blind, Randomized, Controlled Study of the Safety and Immunogenicity of SARS-CoV-2 Protein Subunit Recombinant Vaccine in Healthy Populations Aged 18 Years and Above in Indonesia
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- PT Bio Farma
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Safety of the SARS-CoV-2 protein subunit recombinant vaccine within 7 days after each dose
研究概览
简要总结
The study is an observer-blind, randomized, controlled prospective intervention study of Phase I. The primary objective is To evaluate the safety of the SARS-CoV-2 protein subunit recombinant vaccine within 7 days after each dose.
详细描述
This trial is observer blinded, comparative, randomized, phase I study. Approximately 60 subjects will be recruited (18 years and above).
The investigational product is 0.5 ml in three dose-regimen (for all subjects) with 28 days apart between doses, compare to an active control (inactivated SARS-CoV-2 vaccine)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
Observer blind: Investigational Product and Active Comparator are masking. Lot number is 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 subjects within the following age groups: adults (18-59 years) and elderly (60 years and above.
- •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
- •Subjects concomitantly enrolled or scheduled to be enrolled in another trial.
- •History of vaccination with any investigational product against Covid-19 during or 6 months prior to enrollment.
- •Subjects who have 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).
- •The result of rapid antigen test is positive.
- •Women who are lactating, pregnant or planning to become pregnant during the study period (judged by self-report of subjects and urine pregnancy test results).
- •Abnormality hematology and biochemical 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 Investigational Product (IP) immunization.
- •Subjects plan to move from the study area before the end of study period.
结局指标
主要结局
Safety of the SARS-CoV-2 protein subunit recombinant vaccine within 7 days after each dose
时间窗: 7 days after each dose
percentage of subjects with solicited and unsolicited Adverse Events (AE)
次要结局
- safety of the SARS-CoV-2 protein subunit recombinant vaccine within 28 days after each dose(28 days after each dose)
- Comparison of AE/ Serious Adverse Events (SAE) between intervention vaccine and active control(28 days after each dose)
- Deviation of laboratory evaluation(7 days after whole schedule dose)
- Immunogenicity profile of the SARS-CoV-2 protein subunit recombinant vaccine after second dose(28 days after each dose)
- Comparison of immunogenicity between 2 and 3 doses(28 days after second and third dose)
研究者
研究点 (1)
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