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

Regeneron Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Healthy; Chronic Stable Illness

Treatments: Biological: Moderna mRNA-1273 vaccine; Drug: casirivimab+imdevimab

Study type: Interventional

Funder types: Industry

Identifiers

NCT04852978

R10933-10987-COV-2118

Details and patient eligibility

About

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

Enrollment: 295 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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
11. Clinical history of myocarditis and/or pericarditis

Note: Other protocol-defined Inclusion/ Exclusion Criteria apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

295 participants in 12 patient groups

Wave 1 Dose 1

Experimental group

Treatment:

Drug: casirivimab+imdevimab

Biological: Moderna mRNA-1273 vaccine

Wave 1 Dose 2

Experimental group

Treatment:

Drug: casirivimab+imdevimab

Biological: Moderna mRNA-1273 vaccine

Wave 1 Dose 3

Experimental group

Treatment:

Drug: casirivimab+imdevimab

Biological: Moderna mRNA-1273 vaccine

Wave 1 Vaccine only

Experimental group

Treatment:

Biological: Moderna mRNA-1273 vaccine

Wave 2 Dose 1

Experimental group

Treatment:

Drug: casirivimab+imdevimab

Biological: Moderna mRNA-1273 vaccine

Wave 2 Dose 2

Experimental group

Treatment:

Drug: casirivimab+imdevimab

Biological: Moderna mRNA-1273 vaccine

Wave 2 Vaccine only

Experimental group

Treatment:

Biological: Moderna mRNA-1273 vaccine

Wave 3 Dose 1

Experimental group

Treatment:

Drug: casirivimab+imdevimab

Biological: Moderna mRNA-1273 vaccine

Wave 3 Dose 2

Experimental group

Treatment:

Drug: casirivimab+imdevimab

Biological: Moderna mRNA-1273 vaccine

Wave 3 Vaccine only

Experimental group

Treatment:

Biological: Moderna mRNA-1273 vaccine

Wave 4 Dose 1

Experimental group

Treatment:

Drug: casirivimab+imdevimab

Biological: Moderna mRNA-1273 vaccine

Wave 4 Vaccine only

Experimental group

Treatment:

Biological: Moderna mRNA-1273 vaccine