NCT04852978已完成2 期
A Phase 2 Randomized, Open-Label, Parallel Group Study to Assess the Immunogenicity, Safety, and Tolerability of Moderna mRNA-1273 Vaccine Administered With Casirivimab+Imdevimab in Healthy Adult Volunteers
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 295
- 试验地点
- 1
- 主要终点
- 50% Inhibitory Dilution (ID50) Titers of Vaccine-induced Neutralizing Antibodies to the SARS-CoV-2 S Protein in Individual Who Received Submaximal Dose Levels of REGN10933+REGN10987 (Less Than 1200 mg)
研究概览
简要总结
The primary objectives of the study are:
- To evaluate the extent of effect, if any, of REGN10933+REGN10987 administration on vaccine-induced neutralizing antibody responses to SARS-CoV-2 by Moderna mRNA-1273
- To evaluate the time interval required between REGN10933+REGN10987 administration and Moderna mRNA-1273 vaccination, to ensure no meaningful impact on vaccine-induced neutralizing antibody responses to SARS-CoV-2
The secondary objectives of the study are:
- To quantify the alteration of antigen specificity of vaccine-induced SARS-CoV-2 antibody responses when administered with different dose regimens of REGN10933+REGN10987
- To evaluate the safety and tolerability of REGN10933+REGN10987 and Moderna mRNA-1273 vaccine when administered in close succession
- To assess the concentrations of REGN10933 and REGN10987 in serum over time in participants who receive REGN10933+REGN10987 and Moderna mRNA-1273 vaccine
- To evaluate the immunogenicity of REGN10933 and REGN10987 over time
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
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy or has chronic medical condition(s) that are stable and well-controlled in the opinion of the investigator and that are not likely to require significant medical intervention through the end of study
- •Willing and able to comply with study visits and study-related procedures, including compliance with site precautionary requirements related to SARS-CoV-2 infection and transmission
排除标准
- •Positive RT-PCR test result for SARS-CoV-2 infection at screening or baseline
- •Positive serology test result for anti-SARS-CoV-2 antibodies at screening or baseline
- •COVID-19 diagnosis, positive SARS-CoV-2 infection, or positive SARS-CoV-2 serology at any time prior to screening
- •Previously received an investigational, authorized, or approved coronavirus vaccine (eg, SARS-CoV-2 vaccine, MERS-CoV vaccine)
- •Currently enrolled in, or has plans to enroll in, any interventional study to prevent or treat COVID-19
- •Received investigational or approved passive antibodies for SARS-CoV-2 infection prophylaxis ad defined in the protocol
- •Received intravenous immunoglobulin (IVIG) or blood products in the last 3 months
- •Any physical examination findings and/or history of any illness that, in the opinion of the study investigator, might confound the results of the study or pose an additional risk to the subject by study participation
- •History of clinically significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, psychiatric or neurological disease, as assessed by the investigator, that may confound the results of the study or pose an additional risk to the subject by study participation
- •Medically attended acute illness or hospitalization (ie, >24 hours) for any reason within 30 days prior to screening
- •Clinical history of myocarditis and/or pericarditis
- •Note: Other protocol-defined Inclusion/ Exclusion Criteria apply
研究组 & 干预措施
Wave 2 Dose 2
Experimental
干预措施: Moderna mRNA-1273 vaccine (Biological)
Wave 2 Vaccine only
Experimental
干预措施: Moderna mRNA-1273 vaccine (Biological)
Wave 4 Dose 1
Experimental
干预措施: Moderna mRNA-1273 vaccine (Biological)
Wave 1 Dose 1
Experimental
干预措施: casirivimab+imdevimab (Drug)
Wave 1 Dose 1
Experimental
干预措施: Moderna mRNA-1273 vaccine (Biological)
Wave 1 Dose 2
Experimental
干预措施: casirivimab+imdevimab (Drug)
Wave 1 Dose 2
Experimental
干预措施: Moderna mRNA-1273 vaccine (Biological)
Wave 1 Dose 3
Experimental
干预措施: casirivimab+imdevimab (Drug)
Wave 1 Dose 3
Experimental
干预措施: Moderna mRNA-1273 vaccine (Biological)
Wave 1 Vaccine only
Experimental
干预措施: Moderna mRNA-1273 vaccine (Biological)
Wave 2 Dose 1
Experimental
干预措施: casirivimab+imdevimab (Drug)
Wave 2 Dose 1
Experimental
干预措施: Moderna mRNA-1273 vaccine (Biological)
Wave 2 Dose 2
Experimental
干预措施: casirivimab+imdevimab (Drug)
Wave 3 Dose 1
Experimental
干预措施: casirivimab+imdevimab (Drug)
Wave 3 Dose 1
Experimental
干预措施: Moderna mRNA-1273 vaccine (Biological)
Wave 3 Dose 2
Experimental
干预措施: casirivimab+imdevimab (Drug)
Wave 3 Dose 2
Experimental
干预措施: Moderna mRNA-1273 vaccine (Biological)
Wave 3 Vaccine only
Experimental
干预措施: Moderna mRNA-1273 vaccine (Biological)
Wave 4 Dose 1
Experimental
干预措施: casirivimab+imdevimab (Drug)
Wave 4 Vaccine only
Experimental
干预措施: Moderna mRNA-1273 vaccine (Biological)
结局指标
主要结局
50% Inhibitory Dilution (ID50) Titers of Vaccine-induced Neutralizing Antibodies to the SARS-CoV-2 S Protein in Individual Who Received Submaximal Dose Levels of REGN10933+REGN10987 (Less Than 1200 mg)
时间窗: 56 days after first dose of vaccine
Submaximal dose - (150 mg, 300 mg, 600 mg, 48 mg, and 12 mg)
50% Inhibitory Dilution (ID50) Titers of Vaccine-induced Neutralizing Antibodies to the SARS-CoV-2 S Protein in Individuals Who Received High Dose REGN10933+REGN10987 (1200 mg)
时间窗: 56 days after first dose of vaccine
High dose - (1200 mg arms)
次要结局
- Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgA)(Up to 365 Days from 1st dose of Vaccination)
- Median Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgA)(Up to 365 Days from 1st dose of Vaccination)
- Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgA)(Up to 365 Days from 1st dose of Vaccination)
- Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgA)(Up to 365 Days from 1st dose of Vaccination)
- Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgA)(Up to 365 Days from 1st dose of vaccination)
- Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgA)(Up to 365 Days from 1st dose of Vaccination)
- Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgG)(Up to 365 Days from 1st dose of vaccination)
- Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgG)(Up to 365 Days from 1st dose of vaccination)
- Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgG)(Up to 365 Days from 1st dose of vaccination)
- Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgG)(Up to 365 Days from 1st dose of vaccination)
- Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgG)(Up to 365 Days from 1st dose of vaccination)
- Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgM)(Up to 365 Days from 1st dose of vaccination)
- Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgM)(Up to 365 Days from 1st dose of vaccination)
- Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgG)(Up to 365 Days from 1st dose of vaccination)
- Number of Participants With Infusion-related Reactions (Grade ≥2) to REGN10933+REGN10987(Through Day 4 post-infusion)
- Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgM)(Up to 365 Days from 1st dose of vaccination)
- Relative Difference Expressed as a Percent in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgM)(Up to 365 Days from 1st dose of vaccination)
- Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgM)(Up to 365 Days from 1st dose of vaccination)
- Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgM)(Up to 365 Days from 1st dose of vaccination)
- Number of Participants With Treatment-emergent Serious Adverse Events (SAEs) Throughout the Study(Up to 401 Days)
- 50% Inhibitory Dilution (ID50) Titers of Vaccine-induced Neutralizing Antibodies to SARS-CoV-2 S Protein Assessed Over Time After the First Dose of Moderna mRNA-1273 Vaccine(Up to 365 Days from 1st dose of vaccination)
- Number of Participants With Treatment-emergent Adverse Events (TEAEs) Throughout the Study(Up to 401 Days)
- Number of Participants With Injection Site Reactions (Grade ≥3) to Moderna mRNA-1273 Vaccine(Through Day 4 post-infusion)
- Number of Participants With Injection Site Reactions (Grade ≥3) to REGN10933+REGN10987(Through Day 4 post-infusion)
- Number of Participants With Hypersensitivity Reactions (Grade ≥2) to REGN10933+REGN10987 or Each Dose of Moderna mRNA-1273 Vaccine(Through Day 29 post-infusion or post-injection)
- Concentrations of REGN10933 in Serum Over Time(Up to 182 Days)
- Concentrations of REGN10987 in Serum Over Time(Up to 182 Days)
- Immunogenicity, as Measured by Anti-drug Antibodies (ADA) to REGN10987(Up to Day 183)
- Immunogenicity, as Measured by Anti-drug Antibodies (ADA) to REGN10933(Up to Day 183)
- Immunogenicity, as Measured by Neutralizing Antibodies (NAb) to REGN10987(Up to Day 183)
- Immunogenicity, as Measured by Neutralizing Antibodies (NAb) to REGN10933(Up to Day 183)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
2 期
COVID-19 Study Assessing the Virologic Efficacy of REGN10933+REGN10987 Across Different Dose Regimens in Adult Outpatients With SARS-CoV-2 InfectionCOVID-19NCT04666441Regeneron Pharmaceuticals1,149
撤回
2 期
Safety and Efficacy of REGN2477+REGN1033 in Patients With Sporadic Inclusion Body MyositisSporadic Inclusion Body MyositisNCT03710941Regeneron Pharmaceuticals
终止
3 期
A Study to Examine the Efficacy and Safety of Anti-Fel d 1 Antibodies Injections in Cat-allergic Adolescent and Adult Patients With Allergic Rhinitis Who Live With a CatAllergic Rhinitis Due to Cat AllergyNCT04981717Regeneron Pharmaceuticals446
终止
3 期
REGN2810 (Anti-PD-1 Antibody), Platinum-based Doublet Chemotherapy, and Ipilimumab (Anti-CTLA-4 Antibody) Versus Pembrolizumab Monotherapy in Patients With Lung CancerNon-small Cell Lung CancerNCT03515629Regeneron Pharmaceuticals5
已完成
1 期
Study of the Blood Concentrations of Two Formulations of REGN1033 in Healthy SubjectsHealthyNCT02741739Regeneron Pharmaceuticals28