COVID-19 Study to Assess Immunogenicity, Safety, and Tolerability of Moderna mRNA-1273 Vaccine Administered With Casirivimab+Imdevimab in Healthy Adult Volunteers
NCT ID: NCT04852978
Last Updated: 2025-10-17
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
295 participants
INTERVENTIONAL
2021-04-29
2022-11-21
Brief Summary
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* 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
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Wave 1 Dose 1
casirivimab+imdevimab
Wave 1 Intravenous (IV) administration Wave 2 Subcutaneous administration
Moderna mRNA-1273 vaccine
Single intramuscular (IM) injection
Wave 1 Dose 2
casirivimab+imdevimab
Wave 1 Intravenous (IV) administration Wave 2 Subcutaneous administration
Moderna mRNA-1273 vaccine
Single intramuscular (IM) injection
Wave 1 Dose 3
casirivimab+imdevimab
Wave 1 Intravenous (IV) administration Wave 2 Subcutaneous administration
Moderna mRNA-1273 vaccine
Single intramuscular (IM) injection
Wave 1 Vaccine only
Moderna mRNA-1273 vaccine
Single intramuscular (IM) injection
Wave 2 Dose 1
casirivimab+imdevimab
Wave 1 Intravenous (IV) administration Wave 2 Subcutaneous administration
Moderna mRNA-1273 vaccine
Single intramuscular (IM) injection
Wave 2 Dose 2
casirivimab+imdevimab
Wave 1 Intravenous (IV) administration Wave 2 Subcutaneous administration
Moderna mRNA-1273 vaccine
Single intramuscular (IM) injection
Wave 2 Vaccine only
Moderna mRNA-1273 vaccine
Single intramuscular (IM) injection
Wave 3 Dose 1
casirivimab+imdevimab
Wave 1 Intravenous (IV) administration Wave 2 Subcutaneous administration
Moderna mRNA-1273 vaccine
Single intramuscular (IM) injection
Wave 3 Dose 2
casirivimab+imdevimab
Wave 1 Intravenous (IV) administration Wave 2 Subcutaneous administration
Moderna mRNA-1273 vaccine
Single intramuscular (IM) injection
Wave 3 Vaccine only
Moderna mRNA-1273 vaccine
Single intramuscular (IM) injection
Wave 4 Dose 1
casirivimab+imdevimab
Wave 1 Intravenous (IV) administration Wave 2 Subcutaneous administration
Moderna mRNA-1273 vaccine
Single intramuscular (IM) injection
Wave 4 Vaccine only
Moderna mRNA-1273 vaccine
Single intramuscular (IM) injection
Interventions
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casirivimab+imdevimab
Wave 1 Intravenous (IV) administration Wave 2 Subcutaneous administration
Moderna mRNA-1273 vaccine
Single intramuscular (IM) injection
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. 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
Exclusion Criteria
2. Positive serology test result for anti-SARS-CoV-2 antibodies at screening or baseline
3. COVID-19 diagnosis, positive SARS-CoV-2 infection, or positive SARS-CoV-2 serology at any time prior to screening
4. Previously received an investigational, authorized, or approved coronavirus vaccine (eg, SARS-CoV-2 vaccine, MERS-CoV vaccine)
5. Currently enrolled in, or has plans to enroll in, any interventional study to prevent or treat COVID-19
6. Received investigational or approved passive antibodies for SARS-CoV-2 infection prophylaxis ad defined in the protocol
7. Received intravenous immunoglobulin (IVIG) or blood products in the last 3 months
8. 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
9. 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
10. Medically attended acute illness or hospitalization (ie, \>24 hours) for any reason within 30 days prior to screening
11. Clinical history of myocarditis and/or pericarditis
18 Years
90 Years
ALL
Yes
Sponsors
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Regeneron Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trial Management
Role: STUDY_DIRECTOR
Regeneron Pharmaceuticals
Locations
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Regeneron Research Site
Little Rock, Arkansas, United States
Regeneron Research Site
Rogers, Arkansas, United States
Regeneron Research Site
Hialeah, Florida, United States
Regeneron Research Site
Miami, Florida, United States
Regeneron Research Site
Orlando, Florida, United States
Regeneron Research Site
Dayton, Ohio, United States
Countries
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References
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Isa F, Gonzalez Ortiz AM, Meyer J, Hamilton JD, Olenchock BA, Brackin T, Ganguly S, Forleo-Neto E, Faria L, Heirman I, Marovich M, Hutter J, Polakowski L, Irvin SC, Thakur M, Hooper AT, Baum A, Petro CD, Fakih FA, McElrath MJ, De Rosa SC, Cohen KW, Williams LD, Hellman CA, Odeh AJ, Patel AH, Tomaras GD, Geba GP, Kyratsous CA, Musser B, Yancopoulos GD, Herman GA; Trial Working Group. Effect of timing of casirivimab and imdevimab administration relative to mRNA-1273 COVID-19 vaccination on vaccine-induced SARS-CoV-2 neutralising antibody responses: a prospective, open-label, phase 2, randomised controlled trial. Lancet Infect Dis. 2025 Jan;25(1):52-67. doi: 10.1016/S1473-3099(24)00421-3. Epub 2024 Sep 2.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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R10933-10987-COV-2118
Identifier Type: -
Identifier Source: org_study_id
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