COVID-19 Study to Assess Immunogenicity, Safety, and Tolerability of Moderna mRNA-1273 Vaccine Administered With Casirivimab+Imdevimab in Healthy Adult Volunteers
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
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
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Study Type
Study Type
Enrollment (Actual)
Enrollment
Phase
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Arkansas
-
Little Rock, Arkansas, United States, 72211
- Regeneron Research Site
-
Rogers, Arkansas, United States, 72758
- Regeneron Research Site
-
-
Florida
-
Hialeah, Florida, United States, 33012
- Regeneron Research Site
-
Miami, Florida, United States, 33186
- Regeneron Research Site
-
Orlando, Florida, United States, 32789
- Regeneron Research Site
-
-
Ohio
-
Dayton, Ohio, United States, 45417
- Regeneron Research Site
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Key Inclusion Criteria:
- 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
Key Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Experimental: Wave 1 Dose 1
|
Wave 1 Intravenous (IV) administration Wave 2 Subcutaneous administration
Other Names:
Single intramuscular (IM) injection
|
|
Experimental: Wave 1 Dose 2
|
Wave 1 Intravenous (IV) administration Wave 2 Subcutaneous administration
Other Names:
Single intramuscular (IM) injection
|
|
Experimental: Wave 1 Dose 3
|
Wave 1 Intravenous (IV) administration Wave 2 Subcutaneous administration
Other Names:
Single intramuscular (IM) injection
|
|
Experimental: Wave 1 Vaccine only
|
Single intramuscular (IM) injection
|
|
Experimental: Wave 2 Dose 1
|
Wave 1 Intravenous (IV) administration Wave 2 Subcutaneous administration
Other Names:
Single intramuscular (IM) injection
|
|
Experimental: Wave 2 Dose 2
|
Wave 1 Intravenous (IV) administration Wave 2 Subcutaneous administration
Other Names:
Single intramuscular (IM) injection
|
|
Experimental: Wave 2 Vaccine only
|
Single intramuscular (IM) injection
|
|
Experimental: Wave 3 Dose 1
|
Wave 1 Intravenous (IV) administration Wave 2 Subcutaneous administration
Other Names:
Single intramuscular (IM) injection
|
|
Experimental: Wave 3 Dose 2
|
Wave 1 Intravenous (IV) administration Wave 2 Subcutaneous administration
Other Names:
Single intramuscular (IM) injection
|
|
Experimental: Wave 3 Vaccine only
|
Single intramuscular (IM) injection
|
|
Experimental: Wave 4 Dose 1
|
Wave 1 Intravenous (IV) administration Wave 2 Subcutaneous administration
Other Names:
Single intramuscular (IM) injection
|
|
Experimental: Wave 4 Vaccine only
|
Single intramuscular (IM) injection
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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)
Time Frame: 56 days after first dose of vaccine
|
High dose - (1200 mg arms)
|
56 days after first dose of vaccine
|
|
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)
Time Frame: 56 days after first dose of vaccine
|
Submaximal dose - (150 mg, 300 mg, 600 mg, 48 mg, and 12 mg)
|
56 days after first dose of vaccine
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgA)
Time Frame: Up to 365 Days from 1st dose of Vaccination
|
Anti-S1-RBD protein
|
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)
Time Frame: Up to 365 Days from 1st dose of Vaccination
|
Anti-S1-RBD protein.
Fold Change based on medians = (median value in vaccine only arm / median value in the active arm)
|
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)
Time Frame: Up to 365 Days from 1st dose of Vaccination
|
Anti-S1-RBD protein.
Relative difference is calculated as: [(LS Geometric Mean Active Arm - LS Geometric Mean Vaccine Alone Arm) / LS Geometric Mean Vaccine Alone Arm] x 100%
|
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)
Time Frame: Up to 365 Days from 1st dose of Vaccination
|
- Anti-S protein (Spike protein)
|
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)
Time Frame: Up to 365 Days from 1st dose of vaccination
|
Anti-S protein Fold Change based on medians = (median value in vaccine only arm / median value in the active arm)
|
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)
Time Frame: Up to 365 Days from 1st dose of Vaccination
|
Anti-S protein Relative difference is calculated as: [(LS Geometric Mean Active Arm - LS Geometric Mean Vaccine Alone Arm) / LS Geometric Mean Vaccine Alone Arm] x 100%
|
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)
Time Frame: Up to 365 Days from 1st dose of vaccination
|
Anti-S protein
|
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)
Time Frame: Up to 365 Days from 1st dose of vaccination
|
Anti-S protein Fold Change based on medians = (median value in vaccine only arm / median value in the active arm)
|
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)
Time Frame: Up to 365 Days from 1st dose of vaccination
|
Anti-S protein (Spike) Relative difference is calculated as: [(LS Geometric Mean Active Arm - LS Geometric Mean Vaccine Alone Arm) / LS Geometric Mean Vaccine Alone Arm] x 100%
|
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)
Time Frame: Up to 365 Days from 1st dose of vaccination
|
Anti-S1-RBD
|
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)
Time Frame: Up to 365 Days from 1st dose of vaccination
|
Anti-S1-RBD protein Fold Change based on medians = (median value in vaccine only arm / median value in the active arm)
|
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)
Time Frame: Up to 365 Days from 1st dose of vaccination
|
Anti-S1-RBD protein Relative difference is calculated as: [(LS Geometric Mean Active Arm - LS Geometric Mean Vaccine Alone Arm) / LS Geometric Mean Vaccine Alone Arm] x 100%
|
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 IgM)
Time Frame: Up to 365 Days from 1st dose of vaccination
|
Anti-S1-RBD
|
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)
Time Frame: Up to 365 Days from 1st dose of vaccination
|
Anti-S1-RBD protein Relative difference is calculated as: [(LS Geometric Mean Active Arm - LS Geometric Mean Vaccine Alone Arm) / LS Geometric Mean Vaccine Alone Arm] x 100%
|
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)
Time Frame: Up to 365 Days from 1st dose of vaccination
|
Anti-S1-RBD protein Fold Change based on medians = (median value in vaccine only arm / median value in the active arm)
|
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)
Time Frame: Up to 365 Days from 1st dose of vaccination
|
Anti-S protein (Spike protein)
|
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)
Time Frame: Up to 365 Days from 1st dose of vaccination
|
Anti-S protein (Spike protein) Relative difference is calculated as: [(LS Geometric Mean Active Arm - LS Geometric Mean Vaccine Alone Arm) / LS Geometric Mean Vaccine Alone Arm] x 100%
|
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)
Time Frame: Up to 365 Days from 1st dose of vaccination
|
Anti-S protein (Spike protein) Fold Change based on medians = (median value in vaccine only arm / median value in the active arm)
|
Up to 365 Days from 1st dose of vaccination
|
|
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
Time Frame: Up to 365 Days from 1st dose of vaccination
|
Up to 365 Days from 1st dose of vaccination
|
|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs) Throughout the Study
Time Frame: Up to 401 Days
|
Up to 401 Days
|
|
|
Number of Participants With Treatment-emergent Serious Adverse Events (SAEs) Throughout the Study
Time Frame: Up to 401 Days
|
Up to 401 Days
|
|
|
Number of Participants With Infusion-related Reactions (Grade ≥2) to REGN10933+REGN10987
Time Frame: Through Day 4 post-infusion
|
Through Day 4 post-infusion
|
|
|
Number of Participants With Injection Site Reactions (Grade ≥3) to REGN10933+REGN10987
Time Frame: Through Day 4 post-infusion
|
Through Day 4 post-infusion
|
|
|
Number of Participants With Injection Site Reactions (Grade ≥3) to Moderna mRNA-1273 Vaccine
Time Frame: Through Day 4 post-infusion
|
Through Day 4 post-infusion
|
|
|
Number of Participants With Hypersensitivity Reactions (Grade ≥2) to REGN10933+REGN10987 or Each Dose of Moderna mRNA-1273 Vaccine
Time Frame: Through Day 29 post-infusion or post-injection
|
Grade 2 - characterized by an adverse local or general response from exposure and oral intervention indicated Grade 3 - hospitalization indicated and intravenous response required Grade 4 - Life Threatening consequence and urgent intervention indicated Grade 5 - Death
|
Through Day 29 post-infusion or post-injection
|
|
Concentrations of REGN10933 in Serum Over Time
Time Frame: Up to 182 Days
|
Up to 182 Days
|
|
|
Concentrations of REGN10987 in Serum Over Time
Time Frame: Up to 182 Days
|
Up to 182 Days
|
|
|
Immunogenicity, as Measured by Anti-drug Antibodies (ADA) to REGN10987
Time Frame: Up to Day 183
|
Up to Day 183
|
|
|
Immunogenicity, as Measured by Anti-drug Antibodies (ADA) to REGN10933
Time Frame: Up to Day 183
|
Up to Day 183
|
|
|
Immunogenicity, as Measured by Neutralizing Antibodies (NAb) to REGN10987
Time Frame: Up to Day 183
|
Up to Day 183
|
|
|
Immunogenicity, as Measured by Neutralizing Antibodies (NAb) to REGN10933
Time Frame: Up to Day 183
|
Up to Day 183
|
Collaborators and Investigators
Sponsor
Sponsor
Investigators
Investigators
- Study Director: Clinical Trial Management, Regeneron Pharmaceuticals
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Actual)
Primary Completion
Study Completion (Actual)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Amino Acids, Peptides, and Proteins
- Proteins
- Biological Factors
- Biological Products
- Complex Mixtures
- Vaccines
- Viral Vaccines
- mRNA Vaccines
- Nucleic Acid-Based Vaccines
- Vaccines, Synthetic
- Recombinant Proteins
- COVID-19 Vaccines
- Antigens
- 2019-nCoV Vaccine mRNA-1273
- casirivimab and imdevimab drug combination
- casirivimab
- imdevimab
Other Study ID Numbers
Other Study ID Numbers
- R10933-10987-COV-2118
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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