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

Healthy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04852978
• Other study ID #: R10933-10987-COV-2118
• Status: Completed
• Phase: Phase 2
• Start date: April 29, 2021
• Est. completion date: November 21, 2022

Study information

• Verified date: December 2022
• Source: Regeneron Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 295
• Est. completion date: November 21, 2022
• Est. primary completion date: November 21, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

11. Clinical history of myocarditis and/or pericarditis Note: Other protocol-defined Inclusion/ Exclusion Criteria apply

Related Conditions & MeSH terms

• Chronic Stable Illness
• Healthy

Intervention

Drug:
• casirivimab+imdevimab
Wave 1 Intravenous (IV) administration Wave 2 Subcutaneous administration

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

Locations

Country	Name	City	State
United States	Regeneron Research Site	Dayton	Ohio
United States	Regeneron Research Site	Hialeah	Florida
United States	Regeneron Research Site	Little Rock	Arkansas
United States	Regeneron Research Site	Miami	Florida
United States	Regeneron Research Site	Orlando	Florida
United States	Regeneron Research Site	Rogers	Arkansas

Sponsors (1)

Lead Sponsor	Collaborator
Regeneron Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	50% inhibitory dilution (ID50) titers of vaccine-induced neutralizing antibodies to the SARS-CoV-2 S protein	High dose	56 days after first dose of vaccine
Primary	50% inhibitory dilution (ID50) titers of vaccine-induced neutralizing antibodies to the SARS-CoV-2 S protein	Submaximal dose	56 days after first dose of vaccine
Secondary	Absolute values in concentrations of vaccine-induced antibodies to SARS-CoV-2 antigens over time	Anti-S protein; Anti-RBD; Other S protein subdomains (including S1, S2, and NTD)	Up to 401 Days
Secondary	Change from baseline in concentrations of vaccine-induced antibodies to SARS-CoV-2 antigens over time	Anti-S protein; Anti-RBD; Other S protein subdomains (including S1, S2, and NTD)	Up to 401 Days
Secondary	Percentage change from baseline in concentrations of vaccine-induced antibodies to SARS-CoV-2 antigens over time	Anti-S protein; Anti-RBD; Other S protein subdomains (including S1, S2, and NTD)	Up to 401 Days
Secondary	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 401 Days
Secondary	Proportion of participants with treatment-emergent adverse events (TEAEs) throughout the study		Up to 401 Days
Secondary	Proportion of participants with treatment-emergent serious adverse events (SAEs) throughout the study		Up to 401 Days
Secondary	Proportion of participants with infusion-related reactions (grade =2) to REGN10933+REGN10987		Through Day 4 post-infusion
Secondary	Proportion of participants with injection site reactions (grade =3) to REGN10933+REGN10987 or each dose of Moderna mRNA-1273 vaccine		Through Day 4 post-injection
Secondary	Proportion 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
Secondary	Concentrations of REGN10933 in serum over time		Up to Day 183
Secondary	Concentrations of REGN10987 in serum over time		Up to Day 183
Secondary	Immunogenicity, as measured by anti-drug antibodies (ADA) to REGN10933		Up to Day 183
Secondary	Immunogenicity, as measured by ADA to REGN10987		Up to Day 183
Secondary	Immunogenicity, as measured by neutralizing antibodies (NAb) to REGN10933		Up to Day 183
Secondary	Immunogenicity, as measured by NAb to REGN10987		Up to Day 183