NCT04852978

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 295 (actual)
• Sponsor: Regeneron Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Accepted

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

Conditions

• Healthy
• Chronic Stable Illness

Interventions

Type	Name	Description
DRUG	casirivimab+imdevimab	Wave 1 Intravenous (IV) administration Wave 2 Subcutaneous administration
BIOLOGICAL	Moderna mRNA-1273 vaccine	Single intramuscular (IM) injection

Timeline

• Start date: 2021-04-29
• Primary completion: 2022-11-21
• Completion: 2022-11-21
• First posted: 2021-04-21
• Last updated: 2025-10-20
• Results posted: 2024-08-20

Locations

6 sites across 1 country: United States

Regulatory

• FDA-regulated drug study