Phase 2
Completed N=293
COVID-19 Study to Assess Immunogenicity, Safety, and Tolerability of Moderna mRNA-1273 Vaccine Administered With Casirivimab+Imdevimab in Healthy Adult Volunteers
Healthy · Chronic Stable Illness
Source: ClinicalTrials.gov NCT04852978 ↗
Enrolled (actual)
293
Serious AEs
1.7%
Results posted
Aug 2024
Primary outcomePrimary: 50% Inhibitory Dilution (ID50) Titers of Vaccine-induced Neutralizing Antibodies to the SARS-CoV-2 S Protein in Individuals Who Received High Dose REGN10933+REGN10987 (1200 mg) — 2594.9; 1818.6; 980.8; 2576.8 Titer
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
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 50% Inhibitory Dilution (ID50) Titers of Vaccine-induced Neutralizing Antibodies to the SARS-CoV-2 S Protein in Individuals Who Received High Dose REGN10933+REGN10987 (1200 mg) |
2594.9; 1818.6; 980.8; 2576.8 | — |
| PRIMARY 50% Inhibitory Dilution (ID50) Titers of Vaccine-induced Neutralizing Antibodies to the SARS-CoV-2 S Protein in Individual Who Received Submaximal Dose Levels of REGN10933+REGN10987 (Less Than 1200 mg) |
2594.9; 780.8; 716.1; 4922.8; 2422.2; 1549.5 | — |
| SECONDARY Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgA) |
18.7; 15.7; 20.7; 15.7; 20.1; 24.4 | — |
| SECONDARY Median Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgA) |
3.2; 0.8; 0.6; 1.6; 1.1; 1.9 | — |
| SECONDARY Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgA) |
-9.8; -2.3; -10.1; 5.0; 13.7; 13.3 | — |
| SECONDARY Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgA) |
11.7; 12.8; 8.5; 11.6; 14.2; 14.7 | — |
| SECONDARY Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgA) |
1.0; 1.0; 1.0; 1.0; 1.0; 1.0 | — |
| SECONDARY Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgA) |
0.8; -20.2; -8.8; 3.0; -3.2; 2.2 | — |
| SECONDARY Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgG) |
4.5; 8.1; 4.4; 3.2; 5.9; 59.8 | — |
| SECONDARY Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgG) |
0.4; 1.0; 1.0; 1.0; 1.0; 1.0 | — |
| SECONDARY Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgG) |
58.9; 3.0; -18.7; 18.3; 29.4; 5.4 | — |
| SECONDARY Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgG) |
6.6; 14.0; 6.8; 5.6; 9.0; 111.4 | — |
| SECONDARY Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgG) |
0.4; 0.7; 1.0; 0.5; 1.0; 1.0 | — |
| SECONDARY Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgG) |
58.3; 7.3; -13.0; 27.5; 25.8; 18.2 | — |
| SECONDARY Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgM) |
7.0; 7.1; 7.5; 6.4; 6.5; 6.9 | — |
| SECONDARY Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgM) |
5.9; 3.5; -1.5; -4.7; 6.0; 3.6 | — |
| SECONDARY Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgM) |
1.0; 1.0; 1.0; 1.0; 1.0; 1.0 | — |
| SECONDARY Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgM) |
5.1; 5.7; 7.1; 5.7; 3.9; 4.8 | — |
| SECONDARY Relative Difference Expressed as a Percent in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgM) |
8.9; 14.7; 6.3; -12.1; 3.9; -7.3 | — |
| SECONDARY Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgM) |
1.0; 1.0; 1.0; 1.0; 1.0; 1.0 | — |
| 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 |
40.0; 40.0; 40.0; 40.0; 40.0; 40.0 | — |
| SECONDARY Number of Participants With Treatment-emergent Adverse Events (TEAEs) Throughout the Study |
22; 13; 16; 17; 15; 16 | — |
| SECONDARY Number of Participants With Treatment-emergent Serious Adverse Events (SAEs) Throughout the Study |
2; 0; 0; 0; 0; 0 | — |
| SECONDARY Number of Participants With Infusion-related Reactions (Grade ≥2) to REGN10933+REGN10987 |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Number of Participants With Injection Site Reactions (Grade ≥3) to REGN10933+REGN10987 |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Number of Participants With Injection Site Reactions (Grade ≥3) to Moderna mRNA-1273 Vaccine |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Number of Participants With Hypersensitivity Reactions (Grade ≥2) to REGN10933+REGN10987 or Each Dose of Moderna mRNA-1273 Vaccine |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Concentrations of REGN10933 in Serum Over Time |
0.0219; 0; 0; 0; 0; 5.12 | — |
| SECONDARY Concentrations of REGN10987 in Serum Over Time |
0.0223; 0; 0; 0; 0; 6.00 | — |
| SECONDARY Immunogenicity, as Measured by Anti-drug Antibodies (ADA) to REGN10987 |
48.1; 55.6; 44.4; 46.7; 56.7; 56.5 | — |
| SECONDARY Immunogenicity, as Measured by Anti-drug Antibodies (ADA) to REGN10933 |
66.7; 59.3; 44.4; 30.0; 36.7; 91.3 | — |
| SECONDARY Immunogenicity, as Measured by Neutralizing Antibodies (NAb) to REGN10987 |
16; 12; 16; 17; 20; 15 | — |
| SECONDARY Immunogenicity, as Measured by Neutralizing Antibodies (NAb) to REGN10933 |
27; 25; 26; 22; 23; 21 | — |
Eligibility Criteria
Key Inclusion Criteria
- 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
- 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
- Positive RT-PCR test result for SARS-CoV-2 infection at screening or baseline
- Positive serology test result for anti-SARS-CoV-2 antibodies at screening or baseline
- COVID-19 diagnosis, positive SARS-CoV-2 infection, or positive SARS-CoV-2 serology at any time prior to screening
- Previously received an investigational, authorized, or approved coronavirus vaccine (eg, SARS-CoV-2 vaccine, MERS-CoV vaccine)
- Currently enrolled in, or has plans to enroll in, any interventional study to prevent or treat COVID-19
- Received investigational or approved passive antibodies for SARS-CoV-2 infection prophylaxis ad defined in the protocol
- Received intravenous immunoglobulin (IVIG) or blood products in the last 3 months
- 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
- 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
- Medically attended acute illness or hospitalization (ie, >24 hours) for any reason within 30 days prior to screening
- Clinical history of myocarditis and/or pericarditis
Note: Other protocol-defined Inclusion/ Exclusion Criteria apply
Data sourced from ClinicalTrials.gov (NCT04852978). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.