A Phase 2a, Open Label Extension Study to Assess the Safety and Long-Term Immunogenicity of ARCT-021
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 65
- 试验地点
- 1
- 主要终点
- Number of Participants With Solicited Local and Systemic Adverse Events
研究概览
简要总结
This is an open-label study enrolling healthy adults that participated in Study ARCT-021-01 (the Parent Study). Participants will receive either a single injection of ARCT-021 or no injection and be followed for up to 365 days.
详细描述
This is a phase 2a, open-label study enrolling up to 106 healthy adults that participated in Study ARCT-021-01 (the Parent Study). Participants will enter this study approximately 3 months after their final study visit in the Parent Study. Participants that received placebo in the Parent Study or who are seronegative for SARS-CoV-2 neutralizing antibodies at screening will receive a single dose of ARCT-021 and will be followed for 365 days. Participants that received two injections of ARCT-021 in the Parent Study will not receive any further injections of ARCT-021 and will be followed for 281 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Individuals who:
- •are able to give consent
- •must have completed Study ARCT-021-01
- •agree to comply with all study visits and procedures
- •Only for subjects that will receive ARCT-021 in this study:
- •are healthy and medically stable
- •are not planning to donate blood or plasma until 28 days after the last dose of ARCT-
- •are willing to refrain from strenuous exercise/activity and alcohol for at least 72 hours prior to study visits and until 28 days after the last dose of ARCT-
- •are willing to adhere to contraception requirements if sexually active and/or are of child-bearing potential
排除标准
- •Individuals who:
- •are unable to comply with the study visits or procedures in Study ARCT-021-01
- •received placebo in the Parent Study and who are not willing to receive ARCT-021 in this study.
- •Only for subjects that will receive ARCT-021 in this study:
- •have or will receive any of the SARS CoV-2 or another experimental coronavirus during this study.
- •have a diagnosis of new clinically significant abnormalities including but not limited to
- •Respiratory disease requiring daily medications or oxygen currently or any treatment of respiratory disease exacerbations
- •Significant heart conditions
- •Significant neurological conditions
- •Significant blood disorders
- •Newly diagnosed autoimmune disease
- •Major surgery
- •have abnormal screening laboratory results
- •have uncontrolled diabetes
- •use of any prescription or over-the-counter medications within 7 days prior to vaccination
- •have received immunoglobulins and/or any blood or blood products
- •have a bleeding disorder
- •have uncontrolled blood pressure
- •have been treated with another investigational drug, biological agent, or device since completion of the Parent Study
- •have received or plan to receive:
- •A licensed, live vaccine within 4 weeks before or after study vaccination, or
- •A licensed, inactivated vaccine within 2 weeks before or after study vaccination
- •have traveled outside of Singapore within 30 days before the vaccination or plans to travel outside of Singapore within 60 days after vaccination.
- •other restrictions may apply
研究组 & 干预措施
ARCT-021
Participants will receive a single dose of ARCT-021 on Day 1
干预措施: ARCT-021 (Biological)
结局指标
主要结局
Number of Participants With Solicited Local and Systemic Adverse Events
时间窗: Up to Day 7 (7 days after vaccine administration)
Solicited local adverse events were defined as pain, tenderness, erythema, or swelling at the injection site. Solicited systemic adverse events were defined as fever, fatigue, headache, chills, nausea, vomiting, diarrhoea, myalgia, and arthralgia. A summary of serious and all other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
Number of Participants With Unsolicited Adverse Events
时间窗: Up to Day 29 (28 days after vaccine administration)
Unsolicited adverse events were defined as any spontaneously occurring adverse event (serious and non-serious). A summary of serious and all other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
Number of Participants With Serious Adverse Events (SAEs), Unsolicited Adverse Events Associated With New Onset of Chronic Disease (NOCD) or Medically Attended Adverse Events (MAAEs)
时间窗: Up to a maximum of approximately 12 months
SAEs were defined as any event that resulted in death, was life threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, a congenital anomaly or birth defect, or was an important medical event. A NOCD was defined as a MAAE that led to the new diagnosis of a chronic medical condition that was not present or suspected prior to enrollment. A MAAE was an adverse event that led to an unscheduled visit (including a telemedicine visit) to a healthcare practitioner. A summary of serious and all other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
次要结局
- Geometric Mean Titer (GMT) of Serum Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Neutralizing Antibodies(Cohorts 1a and 1b: Days 1, 29, 57, Cohort 2: Day 29)
- Geometric Mean Fold Rise (GMFR) in SARS-CoV-2 Neutralizing Antibody Titers(Cohort 1a: Days 29, 57, Cohort 1b: Days 1, 29, 57, and Cohort 2: Day 29)
- Number of ARCT-021-naïve Participants (Cohort 1a) With Seroconversion (Neutralizing Antibodies)(Days 29, and 57)
- Geometric Mean Concentration (GMC) of Serum SARS-CoV-2 Binding Antibodies(Cohorts 1a and 1b: Days 1, 29, 57, Cohort 2: Day 29)
- GMFR in SARS-CoV-2 Binding Antibody Titers(Cohort 1a: Days 29, 57, Cohort 1b: Days 1, 29, 57, and Cohort 2: Day 29)
- Number of ARCT-021-naïve Participants (Cohort 1a) With Seroconversion (Binding Antibodies)(Days 29, and 57)