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COVID-19 Study to Assess Immunogenicity, Safety, and Tolerability of Moderna mRNA-1273 Vaccine Administered With Casirivimab+Imdevimab in Healthy Adult Volunteers

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ClinicalTrials.gov Identifier: NCT04852978
Recruitment Status : Recruiting
First Posted : April 21, 2021
Last Update Posted : July 16, 2021
Sponsor:
Information provided by (Responsible Party):
Regeneron Pharmaceuticals

Brief Summary:

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

Condition or disease Intervention/treatment Phase
Healthy Chronic Stable Illness Drug: REGN10933+REGN10987 Biological: Moderna mRNA-1273 vaccine Phase 2

Expanded Access : An investigational treatment associated with this study is available outside the clinical trial.   More info ...

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : April 29, 2021
Estimated Primary Completion Date : October 6, 2021
Estimated Study Completion Date : August 30, 2022

Arm Intervention/treatment
Experimental: Wave 1 Dose 1 Drug: REGN10933+REGN10987
Wave 1 Intravenous (IV) administration Wave 2 Subcutaneous administration
Other Names:
  • REGN-COV2
  • Casirivimab
  • Imdevimab
  • REGEN-COV™

Biological: Moderna mRNA-1273 vaccine
Single intramuscular (IM) injection

Experimental: Wave 1 Dose 2 Drug: REGN10933+REGN10987
Wave 1 Intravenous (IV) administration Wave 2 Subcutaneous administration
Other Names:
  • REGN-COV2
  • Casirivimab
  • Imdevimab
  • REGEN-COV™

Biological: Moderna mRNA-1273 vaccine
Single intramuscular (IM) injection

Experimental: Wave 1 Dose 3 Drug: REGN10933+REGN10987
Wave 1 Intravenous (IV) administration Wave 2 Subcutaneous administration
Other Names:
  • REGN-COV2
  • Casirivimab
  • Imdevimab
  • REGEN-COV™

Biological: Moderna mRNA-1273 vaccine
Single intramuscular (IM) injection

Experimental: Wave 1 Vaccine only Biological: Moderna mRNA-1273 vaccine
Single intramuscular (IM) injection

Experimental: Wave 2 Dose 1 Drug: REGN10933+REGN10987
Wave 1 Intravenous (IV) administration Wave 2 Subcutaneous administration
Other Names:
  • REGN-COV2
  • Casirivimab
  • Imdevimab
  • REGEN-COV™

Biological: Moderna mRNA-1273 vaccine
Single intramuscular (IM) injection

Experimental: Wave 2 Dose 2 Drug: REGN10933+REGN10987
Wave 1 Intravenous (IV) administration Wave 2 Subcutaneous administration
Other Names:
  • REGN-COV2
  • Casirivimab
  • Imdevimab
  • REGEN-COV™

Biological: Moderna mRNA-1273 vaccine
Single intramuscular (IM) injection

Experimental: Wave 2 Vaccine only Biological: Moderna mRNA-1273 vaccine
Single intramuscular (IM) injection




Primary Outcome Measures :
  1. 50% inhibitory dilution (ID50) titers of vaccine-induced neutralizing antibodies to the SARS-CoV-2 S protein [ Time Frame: 56 days after first dose of vaccine ]
    Study Arms 1, 4 (High dose)

  2. 50% inhibitory dilution (ID50) titers of vaccine-induced neutralizing antibodies to the SARS-CoV-2 S protein [ Time Frame: 56 days after first dose of vaccine ]
    Study Arms 2, 3, 5 (Submaximal dose)


Secondary Outcome Measures :
  1. Absolute values in concentrations of vaccine-induced antibodies to SARS-CoV-2 antigens over time [ Time Frame: Up to 401 Days ]
    • Anti-S protein
    • Anti-RBD
    • Other S protein subdomains (including S1, S2, and NTD)

  2. Change from baseline in concentrations of vaccine-induced antibodies to SARS-CoV-2 antigens over time [ Time Frame: Up to 401 Days ]
    • Anti-S protein
    • Anti-RBD
    • Other S protein subdomains (including S1, S2, and NTD)

  3. Percentage change from baseline in concentrations of vaccine-induced antibodies to SARS-CoV-2 antigens over time [ Time Frame: Up to 401 Days ]
    • Anti-S protein
    • Anti-RBD
    • Other S protein subdomains (including S1, S2, and NTD)

  4. 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 401 Days ]
  5. Proportion of participants with treatment-emergent adverse events (TEAEs) throughout the study [ Time Frame: Up to 401 Days ]
  6. Proportion of participants with treatment-emergent serious adverse events (SAEs) throughout the study [ Time Frame: Up to 401 Days ]
  7. Proportion of participants with infusion-related reactions (grade ≥2) to REGN10933+REGN10987 [ Time Frame: Through Day 4 ]
  8. Proportion of participants with injection site reactions (grade ≥3) to REGN10933+REGN10987 or each dose of Moderna mRNA-1273 vaccine [ Time Frame: Through Day 4 post-injection ]
  9. Proportion 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 ]
  10. Concentrations of REGN10933 in serum over time [ Time Frame: Up to Day 183 ]
  11. Concentrations of REGN10987 in serum over time [ Time Frame: Up to Day 183 ]
  12. Immunogenicity, as measured by anti-drug antibodies (ADA) to REGN10933 [ Time Frame: Up to Day 183 ]
  13. Immunogenicity, as measured by ADA to REGN10987 [ Time Frame: Up to Day 183 ]
  14. Immunogenicity, as measured by neutralizing antibodies (NAb) to REGN10933 [ Time Frame: Up to Day 183 ]
  15. Immunogenicity, as measured by NAb to REGN10987 [ Time Frame: Up to Day 183 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Key Inclusion Criteria:

  1. 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
  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

Key Exclusion Criteria:

  1. Positive RT-PCR test result for SARS-CoV-2 infection at screening or baseline
  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

Note: Other protocol-defined Inclusion/ Exclusion Criteria apply


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04852978


Contacts
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Contact: Clinical Trials Administrator 844-734-6643 clinicaltrials@regeneron.com

Locations
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United States, Arkansas
Regeneron Research Site Recruiting
Little Rock, Arkansas, United States, 72211
Regeneron Research Site Recruiting
Rogers, Arkansas, United States, 72758
United States, Florida
Regeneron Research Site Recruiting
Miami, Florida, United States, 33186
Regeneron Research Site Recruiting
Orlando, Florida, United States, 32789
United States, Ohio
Regeneron Research Site Recruiting
Dayton, Ohio, United States, 45417
Sponsors and Collaborators
Regeneron Pharmaceuticals
Investigators
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Study Director: Clinical Trial Management Regeneron Pharmaceuticals
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Responsible Party: Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier: NCT04852978    
Other Study ID Numbers: R10933-10987-COV-2118
First Posted: April 21, 2021    Key Record Dates
Last Update Posted: July 16, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: When Regeneron has received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc.) for the product and indication, has made the study results publicly available (e.g., scientific publication, scientific conference, clinical trial registry), has the legal authority to share the data, and has ensured the ability to protect participant privacy.
Access Criteria: Qualified researchers can submit a proposal for access to individual patient or aggregate level data from a Regeneron-sponsored clinical trial through Vivli. Regeneron's Independent Research Request Evaluation Criteria can be found at: https://www.regeneron.com/sites/default/files/Regeneron-External-Data-Sharing-Policy-and-Independent-Research-Request-Evaluation-Criteria.pdf
URL: https://vivli.org/

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No