Chronic Stable Illness, Healthy
Conditions
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
Interventions
Wave 1 Intravenous (IV) administration Wave 2 Subcutaneous administration
BIOLOGICALModerna mRNA-1273 vaccine
Single intramuscular (IM) injection
Sponsors
Regeneron Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
Yes
Inclusion 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/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) | 56 days after first dose of vaccine | High dose - (1200 mg arms) |
| 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) | 56 days after first dose of vaccine | Submaximal dose - (150 mg, 300 mg, 600 mg, 48 mg, and 12 mg) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgA) | Up to 365 Days from 1st dose of Vaccination | Anti-S1-RBD protein. Relative difference is calculated as: \[(LS Geometric Mean Active Arm - LS Geometric Mean Vaccine Alone Arm) / LS Geometric Mean Vaccine Alone Arm\] x 100% |
| Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgA) | Up to 365 Days from 1st dose of Vaccination | \- Anti-S protein (Spike protein) |
| Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgA) | Up to 365 Days from 1st dose of vaccination | Anti-S protein Fold Change based on medians = (median value in vaccine only arm / median value in the active arm) |
| Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgA) | Up to 365 Days from 1st dose of Vaccination | Anti-S protein Relative difference is calculated as: \[(LS Geometric Mean Active Arm - LS Geometric Mean Vaccine Alone Arm) / LS Geometric Mean Vaccine Alone Arm\] x 100% |
| Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgG) | Up to 365 Days from 1st dose of vaccination | Anti-S protein |
| Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgG) | Up to 365 Days from 1st dose of vaccination | Anti-S protein Fold Change based on medians = (median value in vaccine only arm / median value in the active arm) |
| Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgG) | Up to 365 Days from 1st dose of vaccination | Anti-S protein (Spike) Relative difference is calculated as: \[(LS Geometric Mean Active Arm - LS Geometric Mean Vaccine Alone Arm) / LS Geometric Mean Vaccine Alone Arm\] x 100% |
| Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgG) | Up to 365 Days from 1st dose of vaccination | Anti-S1-RBD |
| Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgG) | Up to 365 Days from 1st dose of vaccination | Anti-S1-RBD protein Fold Change based on medians = (median value in vaccine only arm / median value in the active arm) |
| Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgG) | Up to 365 Days from 1st dose of vaccination | Anti-S1-RBD protein Relative difference is calculated as: \[(LS Geometric Mean Active Arm - LS Geometric Mean Vaccine Alone Arm) / LS Geometric Mean Vaccine Alone Arm\] x 100% |
| Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgM) | Up to 365 Days from 1st dose of vaccination | Anti-S1-RBD |
| Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgM) | Up to 365 Days from 1st dose of vaccination | Anti-S1-RBD protein Relative difference is calculated as: \[(LS Geometric Mean Active Arm - LS Geometric Mean Vaccine Alone Arm) / LS Geometric Mean Vaccine Alone Arm\] x 100% |
| Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgM) | Up to 365 Days from 1st dose of vaccination | Anti-S1-RBD protein Fold Change based on medians = (median value in vaccine only arm / median value in the active arm) |
| Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgM) | Up to 365 Days from 1st dose of vaccination | Anti-S protein (Spike protein) |
| Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgA) | Up to 365 Days from 1st dose of Vaccination | Anti-S1-RBD protein |
| Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgM) | Up to 365 Days from 1st dose of vaccination | Anti-S protein (Spike protein) Fold Change based on medians = (median value in vaccine only arm / median value in the active arm) |
| 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 365 Days from 1st dose of vaccination | — |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) Throughout the Study | Up to 401 Days | — |
| Number of Participants With Treatment-emergent Serious Adverse Events (SAEs) Throughout the Study | Up to 401 Days | — |
| Number of Participants With Infusion-related Reactions (Grade ≥2) to REGN10933+REGN10987 | Through Day 4 post-infusion | — |
| Number of Participants With Injection Site Reactions (Grade ≥3) to REGN10933+REGN10987 | Through Day 4 post-infusion | — |
| Number of Participants With Injection Site Reactions (Grade ≥3) to Moderna mRNA-1273 Vaccine | Through Day 4 post-infusion | — |
| Number 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 | Grade 2 - characterized by an adverse local or general response from exposure and oral intervention indicated Grade 3 - hospitalization indicated and intravenous response required Grade 4 - Life Threatening consequence and urgent intervention indicated Grade 5 - Death |
| Concentrations of REGN10933 in Serum Over Time | Up to 182 Days | — |
| Concentrations of REGN10987 in Serum Over Time | Up to 182 Days | — |
| Immunogenicity, as Measured by Anti-drug Antibodies (ADA) to REGN10987 | Up to Day 183 | — |
| Immunogenicity, as Measured by Anti-drug Antibodies (ADA) to REGN10933 | Up to Day 183 | — |
| Immunogenicity, as Measured by Neutralizing Antibodies (NAb) to REGN10987 | Up to Day 183 | — |
| Immunogenicity, as Measured by Neutralizing Antibodies (NAb) to REGN10933 | Up to Day 183 | — |
| Relative Difference Expressed as a Percent in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgM) | Up to 365 Days from 1st dose of vaccination | Anti-S protein (Spike protein) Relative difference is calculated as: \[(LS Geometric Mean Active Arm - LS Geometric Mean Vaccine Alone Arm) / LS Geometric Mean Vaccine Alone Arm\] x 100% |
| Median Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgA) | Up to 365 Days from 1st dose of Vaccination | Anti-S1-RBD protein. Fold Change based on medians = (median value in vaccine only arm / median value in the active arm) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Vaccine Only Vaccine only, no study drug | 48 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 IV REGN10933+REGN10987 + Vaccine 1200 mg Day 1 IV | 28 |
| REGN10933+REGN10987 + Vaccine 300 mg Day 1 IV REGN10933+REGN10987 + Vaccine 300 mg Day 1 IV | 29 |
| REGN10933+REGN10987 + Vaccine 150 mg Day 1 IV REGN10933+REGN10987 + Vaccine 150 mg Day 1 IV | 28 |
| REGN10933+REGN10987 + Vaccine 48 mg Day 1 IV REGN10933+REGN10987 + Vaccine 48 mg Day 1 IV | 33 |
| REGN10933+REGN10987 + Vaccine 12 mg Day 1 IV REGN10933+REGN10987 + Vaccine 12 mg Day 1 IV | 31 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | 26 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | 35 |
| REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC | 35 |
| Total | 293 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 | FG008 |
|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study | Death | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 |
| Overall Study | Lost to Follow-up | 3 | 2 | 2 | 0 | 2 | 4 | 1 | 2 | 2 |
| Overall Study | Physician Decision | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 2 | 0 |
| Overall Study | Sponsor request | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 4 | 2 | 2 | 1 | 5 | 3 | 2 | 2 | 1 |
Baseline characteristics
| Characteristic | Vaccine Only | REGN10933+REGN10987 + Vaccine 1200 mg Day 1 IV | REGN10933+REGN10987 + Vaccine 300 mg Day 1 IV | REGN10933+REGN10987 + Vaccine 150 mg Day 1 IV | REGN10933+REGN10987 + Vaccine 48 mg Day 1 IV | REGN10933+REGN10987 + Vaccine 12 mg Day 1 IV | REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC | Total |
|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | 40.2 years STANDARD_DEVIATION 12.17 | 41.8 years STANDARD_DEVIATION 13.98 | 39.3 years STANDARD_DEVIATION 12.76 | 39.7 years STANDARD_DEVIATION 13.5 | 41.6 years STANDARD_DEVIATION 12.73 | 41.1 years STANDARD_DEVIATION 11.23 | 39.8 years STANDARD_DEVIATION 13.76 | 43.8 years STANDARD_DEVIATION 12.99 | 46.3 years STANDARD_DEVIATION 11.53 | 41.6 years STANDARD_DEVIATION 12.7 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 16 Participants | 9 Participants | 12 Participants | 9 Participants | 16 Participants | 19 Participants | 17 Participants | 11 Participants | 12 Participants | 121 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 31 Participants | 19 Participants | 17 Participants | 19 Participants | 17 Participants | 12 Participants | 9 Participants | 24 Participants | 23 Participants | 171 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 16 Participants | 10 Participants | 7 Participants | 9 Participants | 9 Participants | 7 Participants | 7 Participants | 10 Participants | 7 Participants | 82 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 32 Participants | 18 Participants | 22 Participants | 18 Participants | 23 Participants | 21 Participants | 19 Participants | 24 Participants | 27 Participants | 204 Participants |
| Sex: Female, Male Female | 28 Participants | 13 Participants | 9 Participants | 13 Participants | 17 Participants | 16 Participants | 14 Participants | 14 Participants | 19 Participants | 143 Participants |
| Sex: Female, Male Male | 20 Participants | 15 Participants | 20 Participants | 15 Participants | 16 Participants | 15 Participants | 12 Participants | 21 Participants | 16 Participants | 150 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 48 | 0 / 28 | 0 / 29 | 0 / 28 | 0 / 35 | 0 / 35 | 0 / 33 | 0 / 31 | 1 / 26 |
| other Total, other adverse events | 11 / 48 | 13 / 28 | 9 / 29 | 14 / 28 | 15 / 35 | 23 / 35 | 12 / 33 | 14 / 31 | 9 / 26 |
| serious Total, serious adverse events | 2 / 48 | 0 / 28 | 0 / 29 | 0 / 28 | 1 / 35 | 0 / 35 | 0 / 33 | 0 / 31 | 2 / 26 |
Outcome results
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)
High dose - (1200 mg arms)
Time frame: 56 days after first dose of vaccine
Population: Per protocol set (PPS) includes all randomized participants who have received both doses of vaccine and who do not meet the exclusion criteria. The PPS is the primary analysis set for assessing vaccine response related endpoints.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Vaccine Only | 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 Titer | Standard Deviation 1981.5 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 IV | 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) | 1818.6 Titer | Standard Deviation 2365.8 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | 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) | 980.8 Titer | Standard Deviation 1015.1 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | 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) | 2576.8 Titer | Standard Deviation 2736.1 |
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)
Submaximal dose - (150 mg, 300 mg, 600 mg, 48 mg, and 12 mg)
Time frame: 56 days after first dose of vaccine
Population: Per protocol set (PPS) includes all randomized participants who have received both doses of vaccine and who do not meet the exclusion criteria. The PPS is the primary analysis set for assessing vaccine response related endpoints.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Vaccine Only | 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 Titer | Standard Deviation 1981.5 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 IV | 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) | 780.8 Titer | Standard Deviation 771.1 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | 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) | 716.1 Titer | Standard Deviation 664.9 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | 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) | 4922.8 Titer | Standard Deviation 11157.3 |
| REGN10933+REGN10987 + Vaccine 12 mg Day 1 IV | 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) | 2422.2 Titer | Standard Deviation 2882.7 |
| REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC | 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) | 1549.5 Titer | Standard Deviation 4334.1 |
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
Time frame: Up to 365 Days from 1st dose of vaccination
Population: Per protocol set (PPS) includes all randomized participants who have received both doses of vaccine and who do not meet the exclusion criteria. The PPS is the primary analysis set for assessing vaccine response related endpoints. As was pre-specified in the study protocol, only participants in the Vaccine Only and REGN10933+REGN10987 + Vaccine 1200 mg Day 7 Arm/Group were assessed for measure 6 days after the first vaccine.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Vaccine Only | 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 | Baseline | 40.0 Titer | Standard Deviation 0 |
| Vaccine Only | 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 | 56 Days | 2594.9 Titer | Standard Deviation 1981.5 |
| Vaccine Only | 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 | 168 Days | 2889.5 Titer | Standard Deviation 3890.9 |
| Vaccine Only | 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 | 42 Days | 4391.0 Titer | Standard Deviation 4567.2 |
| Vaccine Only | 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 | 252 Days | 10110.8 Titer | Standard Deviation 11107.8 |
| Vaccine Only | 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 | 28 Days | 640.5 Titer | Standard Deviation 2173.9 |
| Vaccine Only | 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 | 14 Days | 928.4 Titer | Standard Deviation 4600 |
| Vaccine Only | 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 | 365 Days | 7250.9 Titer | Standard Deviation 6902 |
| Vaccine Only | 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 | 6 Days | 40.0 Titer | Standard Deviation 0 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 IV | 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 | Baseline | 40.0 Titer | Standard Deviation 0 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 IV | 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 | 56 Days | 1818.6 Titer | Standard Deviation 2365.8 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 IV | 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 | 28 Days | 499.8 Titer | Standard Deviation 1420.1 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 IV | 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 | 365 Days | 7184.3 Titer | Standard Deviation 6172.6 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 IV | 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 | 14 Days | 518.7 Titer | Standard Deviation 1446 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 IV | 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 | 252 Days | 3815.0 Titer | Standard Deviation 4058.1 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 IV | 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 | 42 Days | 2623.7 Titer | Standard Deviation 2216.8 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 IV | 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 | 168 Days | 1756.4 Titer | Standard Deviation 2759 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | 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 | 56 Days | 780.8 Titer | Standard Deviation 771.1 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | 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 | 42 Days | 1322.6 Titer | Standard Deviation 1198.8 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | 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 | Baseline | 40.0 Titer | Standard Deviation 0 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | 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 | 252 Days | 2712.6 Titer | Standard Deviation 2898.7 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | 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 | 365 Days | 3934.6 Titer | Standard Deviation 3800 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | 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 | 168 Days | 649.4 Titer | Standard Deviation 791.1 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | 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 | 28 Days | 136.2 Titer | Standard Deviation 169.8 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | 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 | 14 Days | 81.0 Titer | Standard Deviation 59.9 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | 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 | 14 Days | 84.2 Titer | Standard Deviation 78.1 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | 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 | 252 Days | 4891.0 Titer | Standard Deviation 5258.5 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | 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 | 28 Days | 177.7 Titer | Standard Deviation 581.6 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | 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 | Baseline | 40.0 Titer | Standard Deviation 0 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | 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 | 168 Days | 1670.2 Titer | Standard Deviation 2774.3 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | 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 | 42 Days | 1284.8 Titer | Standard Deviation 1434.1 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | 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 | 365 Days | 4408.0 Titer | Standard Deviation 3941 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | 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 | 56 Days | 716.1 Titer | Standard Deviation 664.9 |
| REGN10933+REGN10987 + Vaccine 12 mg Day 1 IV | 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 | 56 Days | 4922.8 Titer | Standard Deviation 11157.3 |
| REGN10933+REGN10987 + Vaccine 12 mg Day 1 IV | 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 | 365 Days | 7070.1 Titer | Standard Deviation 9060.8 |
| REGN10933+REGN10987 + Vaccine 12 mg Day 1 IV | 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 | 252 Days | 4844.8 Titer | Standard Deviation 6960.8 |
| REGN10933+REGN10987 + Vaccine 12 mg Day 1 IV | 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 | 14 Days | 2686.8 Titer | Standard Deviation 9365.3 |
| REGN10933+REGN10987 + Vaccine 12 mg Day 1 IV | 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 | 28 Days | 3887.0 Titer | Standard Deviation 16628.4 |
| REGN10933+REGN10987 + Vaccine 12 mg Day 1 IV | 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 | 42 Days | 6926.8 Titer | Standard Deviation 14487 |
| REGN10933+REGN10987 + Vaccine 12 mg Day 1 IV | 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 | 168 Days | 3316.2 Titer | Standard Deviation 4137.5 |
| REGN10933+REGN10987 + Vaccine 12 mg Day 1 IV | 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 | Baseline | 40.0 Titer | Standard Deviation 0 |
| REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC | 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 | 56 Days | 2422.2 Titer | Standard Deviation 2882.7 |
| REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC | 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 | 14 Days | 780.4 Titer | Standard Deviation 2955.9 |
| REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC | 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 | 252 Days | 6491.6 Titer | Standard Deviation 12406.5 |
| REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC | 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 | Baseline | 40.0 Titer | Standard Deviation 0 |
| REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC | 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 | 28 Days | 631.3 Titer | Standard Deviation 1955.2 |
| REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC | 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 | 42 Days | 3744.3 Titer | Standard Deviation 4066.7 |
| REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC | 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 | 168 Days | 1007.5 Titer | Standard Deviation 871.8 |
| REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC | 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 | 365 Days | 13175.9 Titer | Standard Deviation 26414.2 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | 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 | 14 Days | 1847.5 Titer | Standard Deviation 6787.1 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | 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 | 28 Days | 785.6 Titer | Standard Deviation 2134.7 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | 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 | Baseline | 40.0 Titer | Standard Deviation 0 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | 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 | 56 Days | 2576.8 Titer | Standard Deviation 2736.1 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | 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 | 252 Days | 7311.4 Titer | Standard Deviation 8802.4 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | 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 | 42 Days | 4351.9 Titer | Standard Deviation 4553.9 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | 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 | 6 Days | 827.8 Titer | Standard Deviation 3859.4 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | 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 | 168 Days | 2968.4 Titer | Standard Deviation 3399.8 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | 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 | 365 Days | 4949.7 Titer | Standard Deviation 4445.6 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | 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 | 56 Days | 980.8 Titer | Standard Deviation 1015.1 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | 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 | 42 Days | 1418.2 Titer | Standard Deviation 1414.8 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | 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 | 28 Days | 113.7 Titer | Standard Deviation 102 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | 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 | 365 Days | 6287.3 Titer | Standard Deviation 6023.3 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | 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 | 168 Days | 1261.4 Titer | Standard Deviation 2139.7 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | 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 | 14 Days | 93.3 Titer | Standard Deviation 78.8 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | 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 | 252 Days | 7034.7 Titer | Standard Deviation 9548.7 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | 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 | Baseline | 40.0 Titer | Standard Deviation 0 |
| REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC | 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 | Baseline | 40.0 Titer | Standard Deviation 0 |
| REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC | 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 | 56 Days | 1549.5 Titer | Standard Deviation 4334.1 |
| REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC | 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 | 14 Days | 1325.2 Titer | Standard Deviation 6386.1 |
| REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC | 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 | 168 Days | 974.6 Titer | Standard Deviation 1124.6 |
| REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC | 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 | 365 Days | 7174.4 Titer | Standard Deviation 7753.8 |
| REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC | 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 | 28 Days | 1108.3 Titer | Standard Deviation 5103.2 |
| REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC | 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 | 42 Days | 2167.2 Titer | Standard Deviation 5160.7 |
| REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC | 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 | 252 Days | 5041.1 Titer | Standard Deviation 6443 |
Secondary
Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgA)
Anti-S1-RBD protein
Time frame: Up to 365 Days from 1st dose of Vaccination
Population: Per protocol set (PPS) includes all randomized participants who have received both doses of vaccine and who do not meet the exclusion criteria. The PPS is the primary analysis set for assessing vaccine response related endpoints. As was pre-specified in the study protocol, only participants in the Vaccine Only and REGN10933+REGN10987 + Vaccine 1200 mg Day 7 Arm/Group were assessed for measure 6 days after the first vaccine.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Vaccine Only | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgA) | 14 Days after 1st Vaccine | 1176.5 Binding Antibody Unit (BAU)/mL | Standard Deviation 1758.5 |
| Vaccine Only | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgA) | 42 Days after 1st Vaccine | 2610.7 Binding Antibody Unit (BAU)/mL | Standard Deviation 2032.3 |
| Vaccine Only | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgA) | 168 Days after 1st Vaccine | 1825.0 Binding Antibody Unit (BAU)/mL | Standard Deviation 2690.3 |
| Vaccine Only | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgA) | 6 Days after 1st Vaccine | 47.5 Binding Antibody Unit (BAU)/mL | Standard Deviation 31.8 |
| Vaccine Only | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgA) | Baseline | 18.7 Binding Antibody Unit (BAU)/mL | Standard Deviation 9.2 |
| Vaccine Only | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgA) | 252 Days after 1st Vaccine | 3665.4 Binding Antibody Unit (BAU)/mL | Standard Deviation 3141 |
| Vaccine Only | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgA) | 56 Days after 1st Vaccine | 1327.7 Binding Antibody Unit (BAU)/mL | Standard Deviation 1497.7 |
| Vaccine Only | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgA) | 28 Days after 1st Vaccine | 373.0 Binding Antibody Unit (BAU)/mL | Standard Deviation 416.1 |
| Vaccine Only | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgA) | 365 Days after 1st Vaccine | 2722.7 Binding Antibody Unit (BAU)/mL | Standard Deviation 2680 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 IV | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgA) | 42 Days after 1st Vaccine | 2318.5 Binding Antibody Unit (BAU)/mL | Standard Deviation 2387.2 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 IV | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgA) | 28 Days after 1st Vaccine | 276.3 Binding Antibody Unit (BAU)/mL | Standard Deviation 461.4 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 IV | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgA) | 252 Days after 1st Vaccine | 3488.8 Binding Antibody Unit (BAU)/mL | Standard Deviation 3126.5 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 IV | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgA) | 168 Days after 1st Vaccine | 986.3 Binding Antibody Unit (BAU)/mL | Standard Deviation 1718.1 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 IV | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgA) | Baseline | 15.7 Binding Antibody Unit (BAU)/mL | Standard Deviation 0 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 IV | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgA) | 365 Days after 1st Vaccine | 3904.4 Binding Antibody Unit (BAU)/mL | Standard Deviation 3036.1 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 IV | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgA) | 56 Days after 1st Vaccine | 1146.2 Binding Antibody Unit (BAU)/mL | Standard Deviation 1738.7 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 IV | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgA) | 14 Days after 1st Vaccine | 884.0 Binding Antibody Unit (BAU)/mL | Standard Deviation 860 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgA) | 42 Days after 1st Vaccine | 2190.4 Binding Antibody Unit (BAU)/mL | Standard Deviation 2163.5 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgA) | 365 Days after 1st Vaccine | 2804.1 Binding Antibody Unit (BAU)/mL | Standard Deviation 2533.8 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgA) | 28 Days after 1st Vaccine | 297.8 Binding Antibody Unit (BAU)/mL | Standard Deviation 514.2 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgA) | 14 Days after 1st Vaccine | 1510.6 Binding Antibody Unit (BAU)/mL | Standard Deviation 2141.5 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgA) | 252 Days after 1st Vaccine | 3180.0 Binding Antibody Unit (BAU)/mL | Standard Deviation 3171.6 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgA) | 168 Days after 1st Vaccine | 358.8 Binding Antibody Unit (BAU)/mL | Standard Deviation 610.3 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgA) | Baseline | 20.7 Binding Antibody Unit (BAU)/mL | Standard Deviation 25.2 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgA) | 56 Days after 1st Vaccine | 769.1 Binding Antibody Unit (BAU)/mL | Standard Deviation 836.1 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgA) | 56 Days after 1st Vaccine | 845.9 Binding Antibody Unit (BAU)/mL | Standard Deviation 1056.3 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgA) | 252 Days after 1st Vaccine | 3174.7 Binding Antibody Unit (BAU)/mL | Standard Deviation 2840.8 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgA) | Baseline | 15.7 Binding Antibody Unit (BAU)/mL | Standard Deviation 0 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgA) | 14 Days after 1st Vaccine | 730.4 Binding Antibody Unit (BAU)/mL | Standard Deviation 963.2 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgA) | 28 Days after 1st Vaccine | 171.9 Binding Antibody Unit (BAU)/mL | Standard Deviation 193.1 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgA) | 42 Days after 1st Vaccine | 2022.8 Binding Antibody Unit (BAU)/mL | Standard Deviation 2170.3 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgA) | 168 Days after 1st Vaccine | 1211.0 Binding Antibody Unit (BAU)/mL | Standard Deviation 2194.5 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgA) | 365 Days after 1st Vaccine | 3008.7 Binding Antibody Unit (BAU)/mL | Standard Deviation 2609 |
| REGN10933+REGN10987 + Vaccine 12 mg Day 1 IV | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgA) | 56 Days after 1st Vaccine | 787.9 Binding Antibody Unit (BAU)/mL | Standard Deviation 630.1 |
| REGN10933+REGN10987 + Vaccine 12 mg Day 1 IV | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgA) | Baseline | 20.1 Binding Antibody Unit (BAU)/mL | Standard Deviation 11.6 |
| REGN10933+REGN10987 + Vaccine 12 mg Day 1 IV | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgA) | 14 Days after 1st Vaccine | 638.6 Binding Antibody Unit (BAU)/mL | Standard Deviation 662.1 |
| REGN10933+REGN10987 + Vaccine 12 mg Day 1 IV | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgA) | 28 Days after 1st Vaccine | 209.0 Binding Antibody Unit (BAU)/mL | Standard Deviation 207 |
| REGN10933+REGN10987 + Vaccine 12 mg Day 1 IV | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgA) | 168 Days after 1st Vaccine | 1772.6 Binding Antibody Unit (BAU)/mL | Standard Deviation 2353.2 |
| REGN10933+REGN10987 + Vaccine 12 mg Day 1 IV | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgA) | 42 Days after 1st Vaccine | 1989.5 Binding Antibody Unit (BAU)/mL | Standard Deviation 1797 |
| REGN10933+REGN10987 + Vaccine 12 mg Day 1 IV | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgA) | 365 Days after 1st Vaccine | 2180.7 Binding Antibody Unit (BAU)/mL | Standard Deviation 1934.9 |
| REGN10933+REGN10987 + Vaccine 12 mg Day 1 IV | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgA) | 252 Days after 1st Vaccine | 1508.8 Binding Antibody Unit (BAU)/mL | Standard Deviation 1831 |
| REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgA) | 56 Days after 1st Vaccine | 669.4 Binding Antibody Unit (BAU)/mL | Standard Deviation 813.7 |
| REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgA) | 14 Days after 1st Vaccine | 673.7 Binding Antibody Unit (BAU)/mL | Standard Deviation 871 |
| REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgA) | 42 Days after 1st Vaccine | 1246.5 Binding Antibody Unit (BAU)/mL | Standard Deviation 1017.9 |
| REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgA) | Baseline | 24.4 Binding Antibody Unit (BAU)/mL | Standard Deviation 22.5 |
| REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgA) | 252 Days after 1st Vaccine | 1539.2 Binding Antibody Unit (BAU)/mL | Standard Deviation 1681.9 |
| REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgA) | 168 Days after 1st Vaccine | 871.1 Binding Antibody Unit (BAU)/mL | Standard Deviation 1584.9 |
| REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgA) | 28 Days after 1st Vaccine | 246.0 Binding Antibody Unit (BAU)/mL | Standard Deviation 451.3 |
| REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgA) | 365 Days after 1st Vaccine | 2155.8 Binding Antibody Unit (BAU)/mL | Standard Deviation 2369.2 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgA) | 168 Days after 1st Vaccine | 3053.1 Binding Antibody Unit (BAU)/mL | Standard Deviation 3077.9 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgA) | 42 Days after 1st Vaccine | 1460.5 Binding Antibody Unit (BAU)/mL | Standard Deviation 1724.8 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgA) | Baseline | 22.6 Binding Antibody Unit (BAU)/mL | Standard Deviation 14.4 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgA) | 56 Days after 1st Vaccine | 841.7 Binding Antibody Unit (BAU)/mL | Standard Deviation 1587 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgA) | 252 Days after 1st Vaccine | 2898.1 Binding Antibody Unit (BAU)/mL | Standard Deviation 2674.8 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgA) | 28 Days after 1st Vaccine | 592.3 Binding Antibody Unit (BAU)/mL | Standard Deviation 1587.1 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgA) | 14 Days after 1st Vaccine | 1046.0 Binding Antibody Unit (BAU)/mL | Standard Deviation 1726.3 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgA) | 365 Days after 1st Vaccine | 2727.5 Binding Antibody Unit (BAU)/mL | Standard Deviation 2632.9 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgA) | 6 Days after 1st Vaccine | 352.9 Binding Antibody Unit (BAU)/mL | Standard Deviation 1590.7 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgA) | 14 Days after 1st Vaccine | 1184.6 Binding Antibody Unit (BAU)/mL | Standard Deviation 1716.7 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgA) | 56 Days after 1st Vaccine | 889.6 Binding Antibody Unit (BAU)/mL | Standard Deviation 1475.2 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgA) | 365 Days after 1st Vaccine | 3193.5 Binding Antibody Unit (BAU)/mL | Standard Deviation 2890.2 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgA) | 28 Days after 1st Vaccine | 351.0 Binding Antibody Unit (BAU)/mL | Standard Deviation 566.1 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgA) | 168 Days after 1st Vaccine | 715.2 Binding Antibody Unit (BAU)/mL | Standard Deviation 1658.4 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgA) | 252 Days after 1st Vaccine | 4269.9 Binding Antibody Unit (BAU)/mL | Standard Deviation 3316.2 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgA) | Baseline | 20.2 Binding Antibody Unit (BAU)/mL | Standard Deviation 11.2 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgA) | 42 Days after 1st Vaccine | 1714.4 Binding Antibody Unit (BAU)/mL | Standard Deviation 1779.3 |
| REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgA) | 28 Days after 1st Vaccine | 259.4 Binding Antibody Unit (BAU)/mL | Standard Deviation 520.4 |
| REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgA) | 168 Days after 1st Vaccine | 346.2 Binding Antibody Unit (BAU)/mL | Standard Deviation 888.1 |
| REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgA) | 365 Days after 1st Vaccine | 3136.9 Binding Antibody Unit (BAU)/mL | Standard Deviation 2864.3 |
| REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgA) | 14 Days after 1st Vaccine | 902.0 Binding Antibody Unit (BAU)/mL | Standard Deviation 1485.9 |
| REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgA) | 56 Days after 1st Vaccine | 732.0 Binding Antibody Unit (BAU)/mL | Standard Deviation 785.6 |
| REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgA) | 42 Days after 1st Vaccine | 1763.1 Binding Antibody Unit (BAU)/mL | Standard Deviation 1444 |
| REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgA) | 252 Days after 1st Vaccine | 3556.1 Binding Antibody Unit (BAU)/mL | Standard Deviation 3122.6 |
| REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgA) | Baseline | 17.6 Binding Antibody Unit (BAU)/mL | Standard Deviation 10.5 |
Secondary
Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgG)
Anti-S1-RBD
Time frame: Up to 365 Days from 1st dose of vaccination
Population: Per protocol set (PPS) includes all randomized participants who have received both doses of vaccine and who do not meet the exclusion criteria. The PPS is the primary analysis set for assessing vaccine response related endpoints. As was pre-specified in the study protocol, only participants in the Vaccine Only and REGN10933+REGN10987 + Vaccine 1200 mg Day 7 Arm/Group were assessed for measure 6 days after the first vaccine.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Vaccine Only | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgG) | 252 Days after 1st Vaccine | 13505.1 Binding Antibody Unit (BAU)/mL | Standard Deviation 15811 |
| Vaccine Only | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgG) | 42 Days after 1st Vaccine | 7638.6 Binding Antibody Unit (BAU)/mL | Standard Deviation 7214.2 |
| Vaccine Only | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgG) | 56 Days after 1st Vaccine | 5595.6 Binding Antibody Unit (BAU)/mL | Standard Deviation 6439.6 |
| Vaccine Only | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgG) | 6 Days after 1st Vaccine | 7.2 Binding Antibody Unit (BAU)/mL | Standard Deviation 2.8 |
| Vaccine Only | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgG) | Baseline | 6.6 Binding Antibody Unit (BAU)/mL | Standard Deviation 4 |
| Vaccine Only | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgG) | 14 Days after 1st Vaccine | 403.4 Binding Antibody Unit (BAU)/mL | Standard Deviation 650.2 |
| Vaccine Only | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgG) | 168 Days after 1st Vaccine | 4007.7 Binding Antibody Unit (BAU)/mL | Standard Deviation 6218.6 |
| Vaccine Only | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgG) | 365 Days after 1st Vaccine | 11268.3 Binding Antibody Unit (BAU)/mL | Standard Deviation 11087.5 |
| Vaccine Only | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgG) | 28 Days after 1st Vaccine | 809.4 Binding Antibody Unit (BAU)/mL | Standard Deviation 1100.8 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 IV | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgG) | 365 Days after 1st Vaccine | 21517.0 Binding Antibody Unit (BAU)/mL | Standard Deviation 23659.3 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 IV | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgG) | Baseline | 14.0 Binding Antibody Unit (BAU)/mL | Standard Deviation 21.4 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 IV | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgG) | 42 Days after 1st Vaccine | 7336.3 Binding Antibody Unit (BAU)/mL | Standard Deviation 6920.7 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 IV | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgG) | 56 Days after 1st Vaccine | 6945.4 Binding Antibody Unit (BAU)/mL | Standard Deviation 10762.4 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 IV | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgG) | 14 Days after 1st Vaccine | 521.4 Binding Antibody Unit (BAU)/mL | Standard Deviation 1411.9 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 IV | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgG) | 252 Days after 1st Vaccine | 13428.1 Binding Antibody Unit (BAU)/mL | Standard Deviation 15027.8 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 IV | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgG) | 28 Days after 1st Vaccine | 448.4 Binding Antibody Unit (BAU)/mL | Standard Deviation 841.7 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 IV | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgG) | 168 Days after 1st Vaccine | 4208.6 Binding Antibody Unit (BAU)/mL | Standard Deviation 9593.8 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgG) | 168 Days after 1st Vaccine | 1578.5 Binding Antibody Unit (BAU)/mL | Standard Deviation 3810.3 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgG) | 252 Days after 1st Vaccine | 9549.2 Binding Antibody Unit (BAU)/mL | Standard Deviation 14673.8 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgG) | 14 Days after 1st Vaccine | 185.9 Binding Antibody Unit (BAU)/mL | Standard Deviation 262 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgG) | 28 Days after 1st Vaccine | 206.0 Binding Antibody Unit (BAU)/mL | Standard Deviation 177.2 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgG) | 365 Days after 1st Vaccine | 16569.7 Binding Antibody Unit (BAU)/mL | Standard Deviation 15884 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgG) | Baseline | 6.8 Binding Antibody Unit (BAU)/mL | Standard Deviation 2.8 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgG) | 56 Days after 1st Vaccine | 3123.9 Binding Antibody Unit (BAU)/mL | Standard Deviation 1915.7 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgG) | 42 Days after 1st Vaccine | 4969.6 Binding Antibody Unit (BAU)/mL | Standard Deviation 4706.1 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgG) | 252 Days after 1st Vaccine | 1487.0 Binding Antibody Unit (BAU)/mL | Standard Deviation 18618.2 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgG) | 56 Days after 1st Vaccine | 3148.8 Binding Antibody Unit (BAU)/mL | Standard Deviation 3404.7 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgG) | 42 Days after 1st Vaccine | 4776.7 Binding Antibody Unit (BAU)/mL | Standard Deviation 5241.9 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgG) | 14 Days after 1st Vaccine | 153.1 Binding Antibody Unit (BAU)/mL | Standard Deviation 218.2 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgG) | 365 Days after 1st Vaccine | 16959.2 Binding Antibody Unit (BAU)/mL | Standard Deviation 20989.3 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgG) | 168 Days after 1st Vaccine | 3438.9 Binding Antibody Unit (BAU)/mL | Standard Deviation 7459.7 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgG) | 28 Days after 1st Vaccine | 182.3 Binding Antibody Unit (BAU)/mL | Standard Deviation 214.1 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgG) | Baseline | 5.6 Binding Antibody Unit (BAU)/mL | Standard Deviation 3 |
| REGN10933+REGN10987 + Vaccine 12 mg Day 1 IV | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgG) | 42 Days after 1st Vaccine | 10764.3 Binding Antibody Unit (BAU)/mL | Standard Deviation 17718.4 |
| REGN10933+REGN10987 + Vaccine 12 mg Day 1 IV | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgG) | 365 Days after 1st Vaccine | 10225.9 Binding Antibody Unit (BAU)/mL | Standard Deviation 13257.7 |
| REGN10933+REGN10987 + Vaccine 12 mg Day 1 IV | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgG) | 14 Days after 1st Vaccine | 2830.5 Binding Antibody Unit (BAU)/mL | Standard Deviation 9711.1 |
| REGN10933+REGN10987 + Vaccine 12 mg Day 1 IV | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgG) | 28 Days after 1st Vaccine | 2050.2 Binding Antibody Unit (BAU)/mL | Standard Deviation 6594.9 |
| REGN10933+REGN10987 + Vaccine 12 mg Day 1 IV | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgG) | 56 Days after 1st Vaccine | 7023.8 Binding Antibody Unit (BAU)/mL | Standard Deviation 14395.7 |
| REGN10933+REGN10987 + Vaccine 12 mg Day 1 IV | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgG) | 168 Days after 1st Vaccine | 5873.1 Binding Antibody Unit (BAU)/mL | Standard Deviation 9336.1 |
| REGN10933+REGN10987 + Vaccine 12 mg Day 1 IV | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgG) | 252 Days after 1st Vaccine | 9124.4 Binding Antibody Unit (BAU)/mL | Standard Deviation 11583.7 |
| REGN10933+REGN10987 + Vaccine 12 mg Day 1 IV | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgG) | Baseline | 9.0 Binding Antibody Unit (BAU)/mL | Standard Deviation 6 |
| REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgG) | 14 Days after 1st Vaccine | 493.7 Binding Antibody Unit (BAU)/mL | Standard Deviation 1936.3 |
| REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgG) | 42 Days after 1st Vaccine | 3229.9 Binding Antibody Unit (BAU)/mL | Standard Deviation 1467.4 |
| REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgG) | 365 Days after 1st Vaccine | 11261.7 Binding Antibody Unit (BAU)/mL | Standard Deviation 15375.7 |
| REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgG) | 168 Days after 1st Vaccine | 2243.6 Binding Antibody Unit (BAU)/mL | Standard Deviation 3035.3 |
| REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgG) | 28 Days after 1st Vaccine | 418.5 Binding Antibody Unit (BAU)/mL | Standard Deviation 1282 |
| REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgG) | Baseline | 111.4 Binding Antibody Unit (BAU)/mL | Standard Deviation 512.7 |
| REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgG) | 252 Days after 1st Vaccine | 11189.1 Binding Antibody Unit (BAU)/mL | Standard Deviation 16641.6 |
| REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgG) | 56 Days after 1st Vaccine | 4077.9 Binding Antibody Unit (BAU)/mL | Standard Deviation 4581.2 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgG) | 28 Days after 1st Vaccine | 1417.6 Binding Antibody Unit (BAU)/mL | Standard Deviation 5411.7 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgG) | 252 Days after 1st Vaccine | 12902.6 Binding Antibody Unit (BAU)/mL | Standard Deviation 10578.8 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgG) | 56 Days after 1st Vaccine | 4864.7 Binding Antibody Unit (BAU)/mL | Standard Deviation 6282.4 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgG) | 14 Days after 1st Vaccine | 1340.3 Binding Antibody Unit (BAU)/mL | Standard Deviation 5510 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgG) | 6 Days after 1st Vaccine | 940.8 Binding Antibody Unit (BAU)/mL | Standard Deviation 4569.2 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgG) | 168 Days after 1st Vaccine | 10359.9 Binding Antibody Unit (BAU)/mL | Standard Deviation 14463.6 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgG) | Baseline | 9.2 Binding Antibody Unit (BAU)/mL | Standard Deviation 8.7 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgG) | 365 Days after 1st Vaccine | 6301.3 Binding Antibody Unit (BAU)/mL | Standard Deviation 5284.8 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgG) | 42 Days after 1st Vaccine | 5665.7 Binding Antibody Unit (BAU)/mL | Standard Deviation 5297.2 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgG) | 365 Days after 1st Vaccine | 19774.5 Binding Antibody Unit (BAU)/mL | Standard Deviation 16462.8 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgG) | 56 Days after 1st Vaccine | 3080.5 Binding Antibody Unit (BAU)/mL | Standard Deviation 2507.4 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgG) | 252 Days after 1st Vaccine | 14503.6 Binding Antibody Unit (BAU)/mL | Standard Deviation 19241.8 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgG) | 14 Days after 1st Vaccine | 159.7 Binding Antibody Unit (BAU)/mL | Standard Deviation 165.2 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgG) | 42 Days after 1st Vaccine | 4342.8 Binding Antibody Unit (BAU)/mL | Standard Deviation 3047.2 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgG) | Baseline | 5.4 Binding Antibody Unit (BAU)/mL | Standard Deviation 2.4 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgG) | 28 Days after 1st Vaccine | 353.5 Binding Antibody Unit (BAU)/mL | Standard Deviation 434.6 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgG) | 168 Days after 1st Vaccine | 1372.4 Binding Antibody Unit (BAU)/mL | Standard Deviation 2310.7 |
| REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgG) | 365 Days after 1st Vaccine | 23135.5 Binding Antibody Unit (BAU)/mL | Standard Deviation 19481.4 |
| REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgG) | Baseline | 7.5 Binding Antibody Unit (BAU)/mL | Standard Deviation 10.3 |
| REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgG) | 14 Days after 1st Vaccine | 290.9 Binding Antibody Unit (BAU)/mL | Standard Deviation 729.9 |
| REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgG) | 28 Days after 1st Vaccine | 597.0 Binding Antibody Unit (BAU)/mL | Standard Deviation 2153.3 |
| REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgG) | 42 Days after 1st Vaccine | 4537.6 Binding Antibody Unit (BAU)/mL | Standard Deviation 4153.6 |
| REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgG) | 56 Days after 1st Vaccine | 3775.4 Binding Antibody Unit (BAU)/mL | Standard Deviation 3840.3 |
| REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgG) | 168 Days after 1st Vaccine | 1262.8 Binding Antibody Unit (BAU)/mL | Standard Deviation 1957.9 |
| REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgG) | 252 Days after 1st Vaccine | 17456.8 Binding Antibody Unit (BAU)/mL | Standard Deviation 23681.5 |
Secondary
Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgM)
Anti-S1-RBD
Time frame: Up to 365 Days from 1st dose of vaccination
Population: Per protocol set (PPS) includes all randomized participants who have received both doses of vaccine and who do not meet the exclusion criteria. The PPS is the primary analysis set for assessing vaccine response related endpoints. As was pre-specified in the study protocol, only participants in the Vaccine Only and REGN10933+REGN10987 + Vaccine 1200 mg Day 7 Arm/Group were assessed for measure 6 days after the first vaccine.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Vaccine Only | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgM) | 6 Days after 1st Vaccine | 8.9 Binding Antibody Unit (BAU)/mL | Standard Deviation 6.8 |
| Vaccine Only | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgM) | 14 Days after 1st Vaccine | 53.8 Binding Antibody Unit (BAU)/mL | Standard Deviation 70.8 |
| Vaccine Only | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgM) | 252 Days after 1st Vaccine | 13.6 Binding Antibody Unit (BAU)/mL | Standard Deviation 13.3 |
| Vaccine Only | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgM) | 168 Days after 1st Vaccine | 11.7 Binding Antibody Unit (BAU)/mL | Standard Deviation 9.5 |
| Vaccine Only | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgM) | 56 Days after 1st Vaccine | 34.1 Binding Antibody Unit (BAU)/mL | Standard Deviation 34.9 |
| Vaccine Only | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgM) | 42 Days after 1st Vaccine | 55.5 Binding Antibody Unit (BAU)/mL | Standard Deviation 57.2 |
| Vaccine Only | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgM) | 28 Days after 1st Vaccine | 34.5 Binding Antibody Unit (BAU)/mL | Standard Deviation 32.4 |
| Vaccine Only | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgM) | Baseline | 7.0 Binding Antibody Unit (BAU)/mL | Standard Deviation 7.3 |
| Vaccine Only | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgM) | 365 Days after 1st Vaccine | 9.2 Binding Antibody Unit (BAU)/mL | Standard Deviation 6.5 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 IV | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgM) | 365 Days after 1st Vaccine | 8.6 Binding Antibody Unit (BAU)/mL | Standard Deviation 5.6 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 IV | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgM) | Baseline | 7.1 Binding Antibody Unit (BAU)/mL | Standard Deviation 5.2 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 IV | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgM) | 14 Days after 1st Vaccine | 29.2 Binding Antibody Unit (BAU)/mL | Standard Deviation 38.7 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 IV | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgM) | 28 Days after 1st Vaccine | 17.3 Binding Antibody Unit (BAU)/mL | Standard Deviation 22.3 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 IV | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgM) | 42 Days after 1st Vaccine | 38.5 Binding Antibody Unit (BAU)/mL | Standard Deviation 55.9 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 IV | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgM) | 56 Days after 1st Vaccine | 20.6 Binding Antibody Unit (BAU)/mL | Standard Deviation 29.4 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 IV | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgM) | 168 Days after 1st Vaccine | 8.9 Binding Antibody Unit (BAU)/mL | Standard Deviation 6.1 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 IV | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgM) | 252 Days after 1st Vaccine | 10.2 Binding Antibody Unit (BAU)/mL | Standard Deviation 6.9 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgM) | Baseline | 7.5 Binding Antibody Unit (BAU)/mL | Standard Deviation 7.7 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgM) | 14 Days after 1st Vaccine | 25.5 Binding Antibody Unit (BAU)/mL | Standard Deviation 26.2 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgM) | 252 Days after 1st Vaccine | 11.1 Binding Antibody Unit (BAU)/mL | Standard Deviation 12.7 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgM) | 56 Days after 1st Vaccine | 11.8 Binding Antibody Unit (BAU)/mL | Standard Deviation 9.7 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgM) | 168 Days after 1st Vaccine | 8.7 Binding Antibody Unit (BAU)/mL | Standard Deviation 10.6 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgM) | 28 Days after 1st Vaccine | 14.8 Binding Antibody Unit (BAU)/mL | Standard Deviation 16 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgM) | 365 Days after 1st Vaccine | 8.1 Binding Antibody Unit (BAU)/mL | Standard Deviation 6.4 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgM) | 42 Days after 1st Vaccine | 20.3 Binding Antibody Unit (BAU)/mL | Standard Deviation 16.8 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgM) | 252 Days after 1st Vaccine | 10.5 Binding Antibody Unit (BAU)/mL | Standard Deviation 9.1 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgM) | 168 Days after 1st Vaccine | 10.8 Binding Antibody Unit (BAU)/mL | Standard Deviation 14.4 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgM) | 28 Days after 1st Vaccine | 17.5 Binding Antibody Unit (BAU)/mL | Standard Deviation 25.1 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgM) | Baseline | 6.4 Binding Antibody Unit (BAU)/mL | Standard Deviation 4.1 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgM) | 56 Days after 1st Vaccine | 12.2 Binding Antibody Unit (BAU)/mL | Standard Deviation 9.3 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgM) | 42 Days after 1st Vaccine | 21.7 Binding Antibody Unit (BAU)/mL | Standard Deviation 18.3 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgM) | 14 Days after 1st Vaccine | 35.1 Binding Antibody Unit (BAU)/mL | Standard Deviation 64.5 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgM) | 365 Days after 1st Vaccine | 9.6 Binding Antibody Unit (BAU)/mL | Standard Deviation 9.7 |
| REGN10933+REGN10987 + Vaccine 12 mg Day 1 IV | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgM) | 42 Days after 1st Vaccine | 869.2 Binding Antibody Unit (BAU)/mL | Standard Deviation 4396.1 |
| REGN10933+REGN10987 + Vaccine 12 mg Day 1 IV | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgM) | 168 Days after 1st Vaccine | 15.8 Binding Antibody Unit (BAU)/mL | Standard Deviation 22.1 |
| REGN10933+REGN10987 + Vaccine 12 mg Day 1 IV | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgM) | 365 Days after 1st Vaccine | 13.7 Binding Antibody Unit (BAU)/mL | Standard Deviation 18.3 |
| REGN10933+REGN10987 + Vaccine 12 mg Day 1 IV | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgM) | 56 Days after 1st Vaccine | 37.0 Binding Antibody Unit (BAU)/mL | Standard Deviation 79.2 |
| REGN10933+REGN10987 + Vaccine 12 mg Day 1 IV | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgM) | Baseline | 6.5 Binding Antibody Unit (BAU)/mL | Standard Deviation 6.8 |
| REGN10933+REGN10987 + Vaccine 12 mg Day 1 IV | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgM) | 252 Days after 1st Vaccine | 17.9 Binding Antibody Unit (BAU)/mL | Standard Deviation 36.1 |
| REGN10933+REGN10987 + Vaccine 12 mg Day 1 IV | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgM) | 28 Days after 1st Vaccine | 848.9 Binding Antibody Unit (BAU)/mL | Standard Deviation 4400 |
| REGN10933+REGN10987 + Vaccine 12 mg Day 1 IV | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgM) | 14 Days after 1st Vaccine | 852.6 Binding Antibody Unit (BAU)/mL | Standard Deviation 4399.3 |
| REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgM) | 14 Days after 1st Vaccine | 14.3 Binding Antibody Unit (BAU)/mL | Standard Deviation 13.9 |
| REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgM) | 252 Days after 1st Vaccine | 10.2 Binding Antibody Unit (BAU)/mL | Standard Deviation 12.6 |
| REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgM) | 28 Days after 1st Vaccine | 14.2 Binding Antibody Unit (BAU)/mL | Standard Deviation 16.1 |
| REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgM) | 42 Days after 1st Vaccine | 37.9 Binding Antibody Unit (BAU)/mL | Standard Deviation 33.7 |
| REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgM) | 365 Days after 1st Vaccine | 7.2 Binding Antibody Unit (BAU)/mL | Standard Deviation 5.7 |
| REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgM) | 56 Days after 1st Vaccine | 19.8 Binding Antibody Unit (BAU)/mL | Standard Deviation 16.7 |
| REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgM) | Baseline | 6.9 Binding Antibody Unit (BAU)/mL | Standard Deviation 4.2 |
| REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgM) | 168 Days after 1st Vaccine | 9.4 Binding Antibody Unit (BAU)/mL | Standard Deviation 10.9 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgM) | 252 Days after 1st Vaccine | 12.8 Binding Antibody Unit (BAU)/mL | Standard Deviation 18.5 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgM) | 365 Days after 1st Vaccine | 14.6 Binding Antibody Unit (BAU)/mL | Standard Deviation 22.8 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgM) | 6 Days after 1st Vaccine | 13.1 Binding Antibody Unit (BAU)/mL | Standard Deviation 20.9 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgM) | 168 Days after 1st Vaccine | 12.1 Binding Antibody Unit (BAU)/mL | Standard Deviation 9.2 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgM) | 28 Days after 1st Vaccine | 27.3 Binding Antibody Unit (BAU)/mL | Standard Deviation 28.1 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgM) | 56 Days after 1st Vaccine | 27.1 Binding Antibody Unit (BAU)/mL | Standard Deviation 23.3 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgM) | Baseline | 7.0 Binding Antibody Unit (BAU)/mL | Standard Deviation 4.9 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgM) | 14 Days after 1st Vaccine | 42.3 Binding Antibody Unit (BAU)/mL | Standard Deviation 47.9 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgM) | 42 Days after 1st Vaccine | 40.5 Binding Antibody Unit (BAU)/mL | Standard Deviation 38.4 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgM) | Baseline | 6.1 Binding Antibody Unit (BAU)/mL | Standard Deviation 3.2 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgM) | 252 Days after 1st Vaccine | 875.0 Binding Antibody Unit (BAU)/mL | Standard Deviation 4481.7 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgM) | 168 Days after 1st Vaccine | 9.1 Binding Antibody Unit (BAU)/mL | Standard Deviation 11.4 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgM) | 42 Days after 1st Vaccine | 762.2 Binding Antibody Unit (BAU)/mL | Standard Deviation 4113 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgM) | 28 Days after 1st Vaccine | 750.8 Binding Antibody Unit (BAU)/mL | Standard Deviation 4114.9 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgM) | 365 Days after 1st Vaccine | 10.6 Binding Antibody Unit (BAU)/mL | Standard Deviation 15.7 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgM) | 14 Days after 1st Vaccine | 774.5 Binding Antibody Unit (BAU)/mL | Standard Deviation 4180.7 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgM) | 56 Days after 1st Vaccine | 30.9 Binding Antibody Unit (BAU)/mL | Standard Deviation 63 |
| REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgM) | 365 Days after 1st Vaccine | 11.8 Binding Antibody Unit (BAU)/mL | Standard Deviation 13.5 |
| REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgM) | Baseline | 5.7 Binding Antibody Unit (BAU)/mL | Standard Deviation 2.6 |
| REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgM) | 14 Days after 1st Vaccine | 34.4 Binding Antibody Unit (BAU)/mL | Standard Deviation 81.2 |
| REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgM) | 28 Days after 1st Vaccine | 17.9 Binding Antibody Unit (BAU)/mL | Standard Deviation 39.7 |
| REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgM) | 42 Days after 1st Vaccine | 29.0 Binding Antibody Unit (BAU)/mL | Standard Deviation 35.5 |
| REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgM) | 56 Days after 1st Vaccine | 17.6 Binding Antibody Unit (BAU)/mL | Standard Deviation 19.9 |
| REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgM) | 168 Days after 1st Vaccine | 6.5 Binding Antibody Unit (BAU)/mL | Standard Deviation 4.4 |
| REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgM) | 252 Days after 1st Vaccine | 16.9 Binding Antibody Unit (BAU)/mL | Standard Deviation 22.8 |
Secondary
Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgA)
\- Anti-S protein (Spike protein)
Time frame: Up to 365 Days from 1st dose of Vaccination
Population: Per protocol set (PPS) includes all randomized participants who have received both doses of vaccine and who do not meet the exclusion criteria. The PPS is the primary analysis set for assessing vaccine response related endpoints. As was pre-specified in the study protocol, only participants in the Vaccine Only and REGN10933+REGN10987 + Vaccine 1200 mg Day 7 Arm/Group were assessed for measure 6 days after the first vaccine.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Vaccine Only | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgA) | 252 Days after 1st Vaccine | 4666.6 Binding Antibody Unit (BAU)/mL | Standard Deviation 5091.4 |
| Vaccine Only | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgA) | 28 Days after 1st Vaccine | 522.1 Binding Antibody Unit (BAU)/mL | Standard Deviation 466.7 |
| Vaccine Only | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgA) | Baseline | 11.7 Binding Antibody Unit (BAU)/mL | Standard Deviation 10.8 |
| Vaccine Only | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgA) | 42 Days after 1st Vaccine | 3147.1 Binding Antibody Unit (BAU)/mL | Standard Deviation 2905.2 |
| Vaccine Only | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgA) | 56 Days after 1st Vaccine | 1393.0 Binding Antibody Unit (BAU)/mL | Standard Deviation 1232.5 |
| Vaccine Only | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgA) | 6 Days after 1st Vaccine | 27.1 Binding Antibody Unit (BAU)/mL | Standard Deviation 29.2 |
| Vaccine Only | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgA) | 365 Days after 1st Vaccine | 2808.8 Binding Antibody Unit (BAU)/mL | Standard Deviation 2971.8 |
| Vaccine Only | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgA) | 14 Days after 1st Vaccine | 1597.4 Binding Antibody Unit (BAU)/mL | Standard Deviation 2367.2 |
| Vaccine Only | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgA) | 168 Days after 1st Vaccine | 2060.3 Binding Antibody Unit (BAU)/mL | Standard Deviation 3446.9 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 IV | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgA) | 28 Days after 1st Vaccine | 400.1 Binding Antibody Unit (BAU)/mL | Standard Deviation 534.2 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 IV | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgA) | 365 Days after 1st Vaccine | 3549.5 Binding Antibody Unit (BAU)/mL | Standard Deviation 2982.6 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 IV | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgA) | 252 Days after 1st Vaccine | 3753.9 Binding Antibody Unit (BAU)/mL | Standard Deviation 3919 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 IV | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgA) | 168 Days after 1st Vaccine | 931.9 Binding Antibody Unit (BAU)/mL | Standard Deviation 1466 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 IV | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgA) | 56 Days after 1st Vaccine | 1218.0 Binding Antibody Unit (BAU)/mL | Standard Deviation 1192.6 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 IV | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgA) | 42 Days after 1st Vaccine | 2868.6 Binding Antibody Unit (BAU)/mL | Standard Deviation 2645 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 IV | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgA) | 14 Days after 1st Vaccine | 1319.8 Binding Antibody Unit (BAU)/mL | Standard Deviation 1020.4 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 IV | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgA) | Baseline | 12.8 Binding Antibody Unit (BAU)/mL | Standard Deviation 15.7 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgA) | 365 Days after 1st Vaccine | 2703.2 Binding Antibody Unit (BAU)/mL | Standard Deviation 2444.5 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgA) | 56 Days after 1st Vaccine | 941.5 Binding Antibody Unit (BAU)/mL | Standard Deviation 817.6 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgA) | Baseline | 8.5 Binding Antibody Unit (BAU)/mL | Standard Deviation 7.3 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgA) | 14 Days after 1st Vaccine | 1984.7 Binding Antibody Unit (BAU)/mL | Standard Deviation 2708.3 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgA) | 252 Days after 1st Vaccine | 3940.5 Binding Antibody Unit (BAU)/mL | Standard Deviation 5162.1 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgA) | 28 Days after 1st Vaccine | 337.5 Binding Antibody Unit (BAU)/mL | Standard Deviation 386.9 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgA) | 42 Days after 1st Vaccine | 2472.4 Binding Antibody Unit (BAU)/mL | Standard Deviation 2243.8 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgA) | 168 Days after 1st Vaccine | 405.6 Binding Antibody Unit (BAU)/mL | Standard Deviation 568.3 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgA) | 14 Days after 1st Vaccine | 1003.7 Binding Antibody Unit (BAU)/mL | Standard Deviation 1102 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgA) | 28 Days after 1st Vaccine | 246.6 Binding Antibody Unit (BAU)/mL | Standard Deviation 207.4 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgA) | 42 Days after 1st Vaccine | 2765.6 Binding Antibody Unit (BAU)/mL | Standard Deviation 3830.7 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgA) | 168 Days after 1st Vaccine | 1378.0 Binding Antibody Unit (BAU)/mL | Standard Deviation 3168.9 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgA) | 365 Days after 1st Vaccine | 2903.6 Binding Antibody Unit (BAU)/mL | Standard Deviation 3225.5 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgA) | 252 Days after 1st Vaccine | 3497.8 Binding Antibody Unit (BAU)/mL | Standard Deviation 3891.3 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgA) | Baseline | 11.6 Binding Antibody Unit (BAU)/mL | Standard Deviation 14.7 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgA) | 56 Days after 1st Vaccine | 858.8 Binding Antibody Unit (BAU)/mL | Standard Deviation 849.3 |
| REGN10933+REGN10987 + Vaccine 12 mg Day 1 IV | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgA) | 14 Days after 1st Vaccine | 1020.7 Binding Antibody Unit (BAU)/mL | Standard Deviation 879.1 |
| REGN10933+REGN10987 + Vaccine 12 mg Day 1 IV | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgA) | 28 Days after 1st Vaccine | 321.4 Binding Antibody Unit (BAU)/mL | Standard Deviation 309.2 |
| REGN10933+REGN10987 + Vaccine 12 mg Day 1 IV | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgA) | 252 Days after 1st Vaccine | 1341.3 Binding Antibody Unit (BAU)/mL | Standard Deviation 1963.8 |
| REGN10933+REGN10987 + Vaccine 12 mg Day 1 IV | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgA) | 168 Days after 1st Vaccine | 1966.2 Binding Antibody Unit (BAU)/mL | Standard Deviation 3280.9 |
| REGN10933+REGN10987 + Vaccine 12 mg Day 1 IV | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgA) | 365 Days after 1st Vaccine | 2302.4 Binding Antibody Unit (BAU)/mL | Standard Deviation 3101 |
| REGN10933+REGN10987 + Vaccine 12 mg Day 1 IV | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgA) | 56 Days after 1st Vaccine | 1013.9 Binding Antibody Unit (BAU)/mL | Standard Deviation 818.1 |
| REGN10933+REGN10987 + Vaccine 12 mg Day 1 IV | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgA) | 42 Days after 1st Vaccine | 2396.0 Binding Antibody Unit (BAU)/mL | Standard Deviation 1923.4 |
| REGN10933+REGN10987 + Vaccine 12 mg Day 1 IV | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgA) | Baseline | 14.2 Binding Antibody Unit (BAU)/mL | Standard Deviation 21.7 |
| REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgA) | 56 Days after 1st Vaccine | 813.1 Binding Antibody Unit (BAU)/mL | Standard Deviation 753.4 |
| REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgA) | Baseline | 14.7 Binding Antibody Unit (BAU)/mL | Standard Deviation 26.1 |
| REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgA) | 252 Days after 1st Vaccine | 1911.1 Binding Antibody Unit (BAU)/mL | Standard Deviation 3022.5 |
| REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgA) | 14 Days after 1st Vaccine | 970.4 Binding Antibody Unit (BAU)/mL | Standard Deviation 1165 |
| REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgA) | 28 Days after 1st Vaccine | 343.1 Binding Antibody Unit (BAU)/mL | Standard Deviation 490 |
| REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgA) | 42 Days after 1st Vaccine | 1892.7 Binding Antibody Unit (BAU)/mL | Standard Deviation 1462.3 |
| REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgA) | 168 Days after 1st Vaccine | 1251.0 Binding Antibody Unit (BAU)/mL | Standard Deviation 3206.3 |
| REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgA) | 365 Days after 1st Vaccine | 3204.6 Binding Antibody Unit (BAU)/mL | Standard Deviation 4670.9 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgA) | 252 Days after 1st Vaccine | 2867.2 Binding Antibody Unit (BAU)/mL | Standard Deviation 3284.6 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgA) | 28 Days after 1st Vaccine | 581.7 Binding Antibody Unit (BAU)/mL | Standard Deviation 1292.8 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgA) | Baseline | 17.3 Binding Antibody Unit (BAU)/mL | Standard Deviation 39.7 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgA) | 56 Days after 1st Vaccine | 872.3 Binding Antibody Unit (BAU)/mL | Standard Deviation 1076.6 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgA) | 14 Days after 1st Vaccine | 1636.9 Binding Antibody Unit (BAU)/mL | Standard Deviation 3070.8 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgA) | 42 Days after 1st Vaccine | 2089.8 Binding Antibody Unit (BAU)/mL | Standard Deviation 2548.4 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgA) | 6 Days after 1st Vaccine | 662.5 Binding Antibody Unit (BAU)/mL | Standard Deviation 3155.1 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgA) | 168 Days after 1st Vaccine | 2982.3 Binding Antibody Unit (BAU)/mL | Standard Deviation 3720.5 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgA) | 365 Days after 1st Vaccine | 2944.1 Binding Antibody Unit (BAU)/mL | Standard Deviation 3850.8 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgA) | 56 Days after 1st Vaccine | 1009.6 Binding Antibody Unit (BAU)/mL | Standard Deviation 1182.4 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgA) | 42 Days after 1st Vaccine | 2080.7 Binding Antibody Unit (BAU)/mL | Standard Deviation 1477.7 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgA) | 28 Days after 1st Vaccine | 434.5 Binding Antibody Unit (BAU)/mL | Standard Deviation 425 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgA) | 365 Days after 1st Vaccine | 3717.2 Binding Antibody Unit (BAU)/mL | Standard Deviation 4290.7 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgA) | 168 Days after 1st Vaccine | 702.1 Binding Antibody Unit (BAU)/mL | Standard Deviation 1502.8 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgA) | 14 Days after 1st Vaccine | 1742.4 Binding Antibody Unit (BAU)/mL | Standard Deviation 2871 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgA) | 252 Days after 1st Vaccine | 5957.8 Binding Antibody Unit (BAU)/mL | Standard Deviation 5727.3 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgA) | Baseline | 7.7 Binding Antibody Unit (BAU)/mL | Standard Deviation 3.8 |
| REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgA) | Baseline | 12.9 Binding Antibody Unit (BAU)/mL | Standard Deviation 18.6 |
| REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgA) | 56 Days after 1st Vaccine | 911.9 Binding Antibody Unit (BAU)/mL | Standard Deviation 889.7 |
| REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgA) | 14 Days after 1st Vaccine | 1494.4 Binding Antibody Unit (BAU)/mL | Standard Deviation 2303 |
| REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgA) | 168 Days after 1st Vaccine | 354.8 Binding Antibody Unit (BAU)/mL | Standard Deviation 591.3 |
| REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgA) | 365 Days after 1st Vaccine | 3648.0 Binding Antibody Unit (BAU)/mL | Standard Deviation 4074.5 |
| REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgA) | 28 Days after 1st Vaccine | 349.0 Binding Antibody Unit (BAU)/mL | Standard Deviation 518.6 |
| REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgA) | 42 Days after 1st Vaccine | 2029.1 Binding Antibody Unit (BAU)/mL | Standard Deviation 1652.4 |
| REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgA) | 252 Days after 1st Vaccine | 5012.0 Binding Antibody Unit (BAU)/mL | Standard Deviation 5693.1 |
Secondary
Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgG)
Anti-S protein
Time frame: Up to 365 Days from 1st dose of vaccination
Population: Per protocol set (PPS) includes all randomized participants who have received both doses of vaccine and who do not meet the exclusion criteria. The PPS is the primary analysis set for assessing vaccine response related endpoints. As was pre-specified in the study protocol, only participants in the Vaccine Only and REGN10933+REGN10987 + Vaccine 1200 mg Day 7 Arm/Group were assessed for measure 6 days after the first vaccine.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Vaccine Only | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgG) | 28 Days after 1st Vaccine | 676.8 Binding Antibody Unit (BAU)/mL | Standard Deviation 878.5 |
| Vaccine Only | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgG) | 252 Days after 1st Vaccine | 6319.0 Binding Antibody Unit (BAU)/mL | Standard Deviation 6625.5 |
| Vaccine Only | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgG) | 365 Days after 1st Vaccine | 5724.1 Binding Antibody Unit (BAU)/mL | Standard Deviation 4944.5 |
| Vaccine Only | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgG) | 168 Days after 1st Vaccine | 2208.7 Binding Antibody Unit (BAU)/mL | Standard Deviation 3093.8 |
| Vaccine Only | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgG) | Baseline | 4.5 Binding Antibody Unit (BAU)/mL | Standard Deviation 3.9 |
| Vaccine Only | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgG) | 56 Days after 1st Vaccine | 3459.1 Binding Antibody Unit (BAU)/mL | Standard Deviation 3498.4 |
| Vaccine Only | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgG) | 6 Days after 1st Vaccine | 4.0 Binding Antibody Unit (BAU)/mL | Standard Deviation 1.8 |
| Vaccine Only | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgG) | 14 Days after 1st Vaccine | 409.7 Binding Antibody Unit (BAU)/mL | Standard Deviation 527.4 |
| Vaccine Only | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgG) | 42 Days after 1st Vaccine | 4900.0 Binding Antibody Unit (BAU)/mL | Standard Deviation 3970.8 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 IV | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgG) | Baseline | 8.1 Binding Antibody Unit (BAU)/mL | Standard Deviation 10.4 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 IV | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgG) | 14 Days after 1st Vaccine | 600.2 Binding Antibody Unit (BAU)/mL | Standard Deviation 1399.6 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 IV | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgG) | 252 Days after 1st Vaccine | 5682.5 Binding Antibody Unit (BAU)/mL | Standard Deviation 6074.3 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 IV | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgG) | 168 Days after 1st Vaccine | 2156.7 Binding Antibody Unit (BAU)/mL | Standard Deviation 4354.7 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 IV | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgG) | 42 Days after 1st Vaccine | 3814.3 Binding Antibody Unit (BAU)/mL | Standard Deviation 3083.2 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 IV | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgG) | 365 Days after 1st Vaccine | 8865.1 Binding Antibody Unit (BAU)/mL | Standard Deviation 7110.6 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 IV | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgG) | 56 Days after 1st Vaccine | 3737.3 Binding Antibody Unit (BAU)/mL | Standard Deviation 4638.6 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 IV | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgG) | 28 Days after 1st Vaccine | 468.6 Binding Antibody Unit (BAU)/mL | Standard Deviation 860.3 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgG) | 14 Days after 1st Vaccine | 205.9 Binding Antibody Unit (BAU)/mL | Standard Deviation 175.8 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgG) | 252 Days after 1st Vaccine | 4138.0 Binding Antibody Unit (BAU)/mL | Standard Deviation 5343 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgG) | 28 Days after 1st Vaccine | 173.3 Binding Antibody Unit (BAU)/mL | Standard Deviation 137.1 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgG) | Baseline | 4.4 Binding Antibody Unit (BAU)/mL | Standard Deviation 2.7 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgG) | 42 Days after 1st Vaccine | 2769.7 Binding Antibody Unit (BAU)/mL | Standard Deviation 2535.4 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgG) | 365 Days after 1st Vaccine | 7888.9 Binding Antibody Unit (BAU)/mL | Standard Deviation 7014.8 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgG) | 56 Days after 1st Vaccine | 1841.8 Binding Antibody Unit (BAU)/mL | Standard Deviation 1012.7 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgG) | 168 Days after 1st Vaccine | 900.0 Binding Antibody Unit (BAU)/mL | Standard Deviation 2018.7 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgG) | 42 Days after 1st Vaccine | 2816.7 Binding Antibody Unit (BAU)/mL | Standard Deviation 2858.9 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgG) | 28 Days after 1st Vaccine | 183.7 Binding Antibody Unit (BAU)/mL | Standard Deviation 168.5 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgG) | 168 Days after 1st Vaccine | 1862.8 Binding Antibody Unit (BAU)/mL | Standard Deviation 3723.4 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgG) | 252 Days after 1st Vaccine | 7004.3 Binding Antibody Unit (BAU)/mL | Standard Deviation 7077.5 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgG) | 365 Days after 1st Vaccine | 7596.9 Binding Antibody Unit (BAU)/mL | Standard Deviation 7438.6 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgG) | 14 Days after 1st Vaccine | 256.3 Binding Antibody Unit (BAU)/mL | Standard Deviation 298.9 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgG) | 56 Days after 1st Vaccine | 1849.9 Binding Antibody Unit (BAU)/mL | Standard Deviation 1693.2 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgG) | Baseline | 3.2 Binding Antibody Unit (BAU)/mL | Standard Deviation 1.2 |
| REGN10933+REGN10987 + Vaccine 12 mg Day 1 IV | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgG) | 252 Days after 1st Vaccine | 4784.2 Binding Antibody Unit (BAU)/mL | Standard Deviation 4832.5 |
| REGN10933+REGN10987 + Vaccine 12 mg Day 1 IV | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgG) | 42 Days after 1st Vaccine | 5074.9 Binding Antibody Unit (BAU)/mL | Standard Deviation 6044.3 |
| REGN10933+REGN10987 + Vaccine 12 mg Day 1 IV | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgG) | 28 Days after 1st Vaccine | 1450.6 Binding Antibody Unit (BAU)/mL | Standard Deviation 4361.4 |
| REGN10933+REGN10987 + Vaccine 12 mg Day 1 IV | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgG) | 56 Days after 1st Vaccine | 3432.9 Binding Antibody Unit (BAU)/mL | Standard Deviation 5246.8 |
| REGN10933+REGN10987 + Vaccine 12 mg Day 1 IV | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgG) | Baseline | 5.9 Binding Antibody Unit (BAU)/mL | Standard Deviation 6.7 |
| REGN10933+REGN10987 + Vaccine 12 mg Day 1 IV | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgG) | 365 Days after 1st Vaccine | 4954.4 Binding Antibody Unit (BAU)/mL | Standard Deviation 5226.5 |
| REGN10933+REGN10987 + Vaccine 12 mg Day 1 IV | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgG) | 14 Days after 1st Vaccine | 1742.9 Binding Antibody Unit (BAU)/mL | Standard Deviation 5319.5 |
| REGN10933+REGN10987 + Vaccine 12 mg Day 1 IV | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgG) | 168 Days after 1st Vaccine | 2973.3 Binding Antibody Unit (BAU)/mL | Standard Deviation 4045.5 |
| REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgG) | 168 Days after 1st Vaccine | 1346.4 Binding Antibody Unit (BAU)/mL | Standard Deviation 1762 |
| REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgG) | 28 Days after 1st Vaccine | 366.7 Binding Antibody Unit (BAU)/mL | Standard Deviation 1040.5 |
| REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgG) | 42 Days after 1st Vaccine | 2179.8 Binding Antibody Unit (BAU)/mL | Standard Deviation 928.5 |
| REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgG) | 14 Days after 1st Vaccine | 497.1 Binding Antibody Unit (BAU)/mL | Standard Deviation 1620 |
| REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgG) | Baseline | 59.8 Binding Antibody Unit (BAU)/mL | Standard Deviation 267.1 |
| REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgG) | 56 Days after 1st Vaccine | 2227.5 Binding Antibody Unit (BAU)/mL | Standard Deviation 2300 |
| REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgG) | 365 Days after 1st Vaccine | 5263.3 Binding Antibody Unit (BAU)/mL | Standard Deviation 6235.8 |
| REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgG) | 252 Days after 1st Vaccine | 4974.1 Binding Antibody Unit (BAU)/mL | Standard Deviation 6150 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgG) | 14 Days after 1st Vaccine | 1059.4 Binding Antibody Unit (BAU)/mL | Standard Deviation 3414.4 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgG) | Baseline | 5.1 Binding Antibody Unit (BAU)/mL | Standard Deviation 5.4 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgG) | 6 Days after 1st Vaccine | 624.8 Binding Antibody Unit (BAU)/mL | Standard Deviation 3025.9 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgG) | 56 Days after 1st Vaccine | 3358.0 Binding Antibody Unit (BAU)/mL | Standard Deviation 4515.3 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgG) | 252 Days after 1st Vaccine | 6830.1 Binding Antibody Unit (BAU)/mL | Standard Deviation 5394.9 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgG) | 28 Days after 1st Vaccine | 973.5 Binding Antibody Unit (BAU)/mL | Standard Deviation 3309.8 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgG) | 42 Days after 1st Vaccine | 3968.7 Binding Antibody Unit (BAU)/mL | Standard Deviation 3806.8 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgG) | 168 Days after 1st Vaccine | 4609.3 Binding Antibody Unit (BAU)/mL | Standard Deviation 5678.3 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgG) | 365 Days after 1st Vaccine | 3819.3 Binding Antibody Unit (BAU)/mL | Standard Deviation 3262.7 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgG) | 168 Days after 1st Vaccine | 940.1 Binding Antibody Unit (BAU)/mL | Standard Deviation 1486.8 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgG) | Baseline | 3.0 Binding Antibody Unit (BAU)/mL | Standard Deviation 1.4 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgG) | 14 Days after 1st Vaccine | 211.8 Binding Antibody Unit (BAU)/mL | Standard Deviation 226.6 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgG) | 28 Days after 1st Vaccine | 318.2 Binding Antibody Unit (BAU)/mL | Standard Deviation 390.6 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgG) | 42 Days after 1st Vaccine | 2797.7 Binding Antibody Unit (BAU)/mL | Standard Deviation 1787.2 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgG) | 56 Days after 1st Vaccine | 1980.6 Binding Antibody Unit (BAU)/mL | Standard Deviation 1470.2 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgG) | 252 Days after 1st Vaccine | 6806.3 Binding Antibody Unit (BAU)/mL | Standard Deviation 7138.7 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgG) | 365 Days after 1st Vaccine | 9836.6 Binding Antibody Unit (BAU)/mL | Standard Deviation 7299.8 |
| REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgG) | 168 Days after 1st Vaccine | 729.5 Binding Antibody Unit (BAU)/mL | Standard Deviation 889.1 |
| REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgG) | 56 Days after 1st Vaccine | 2361.7 Binding Antibody Unit (BAU)/mL | Standard Deviation 2513.4 |
| REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgG) | 42 Days after 1st Vaccine | 2852.9 Binding Antibody Unit (BAU)/mL | Standard Deviation 2450.6 |
| REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgG) | 28 Days after 1st Vaccine | 598.7 Binding Antibody Unit (BAU)/mL | Standard Deviation 2096.6 |
| REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgG) | 14 Days after 1st Vaccine | 345.1 Binding Antibody Unit (BAU)/mL | Standard Deviation 679 |
| REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgG) | Baseline | 4.0 Binding Antibody Unit (BAU)/mL | Standard Deviation 3.3 |
| REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgG) | 365 Days after 1st Vaccine | 10863.1 Binding Antibody Unit (BAU)/mL | Standard Deviation 7822.4 |
| REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgG) | 252 Days after 1st Vaccine | 6855.6 Binding Antibody Unit (BAU)/mL | Standard Deviation 7833.3 |
Secondary
Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgM)
Anti-S protein (Spike protein)
Time frame: Up to 365 Days from 1st dose of vaccination
Population: Per protocol set (PPS) includes all randomized participants who have received both doses of vaccine and who do not meet the exclusion criteria. The PPS is the primary analysis set for assessing vaccine response related endpoints. As was pre-specified in the study protocol, only participants in the Vaccine Only and REGN10933+REGN10987 + Vaccine 1200 mg Day 7 Arm/Group were assessed for measure 6 days after the first vaccine.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Vaccine Only | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgM) | Baseline | 5.1 Binding Antibody Unit (BAU)/mL | Standard Deviation 5.6 |
| Vaccine Only | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgM) | 42 Days after 1st Vaccine | 86.3 Binding Antibody Unit (BAU)/mL | Standard Deviation 90 |
| Vaccine Only | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgM) | 168 Days after 1st Vaccine | 10.4 Binding Antibody Unit (BAU)/mL | Standard Deviation 9.6 |
| Vaccine Only | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgM) | 6 Days after 1st Vaccine | 5.0 Binding Antibody Unit (BAU)/mL | Standard Deviation 2.6 |
| Vaccine Only | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgM) | 14 Days after 1st Vaccine | 82.1 Binding Antibody Unit (BAU)/mL | Standard Deviation 84.1 |
| Vaccine Only | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgM) | 252 Days after 1st Vaccine | 13.1 Binding Antibody Unit (BAU)/mL | Standard Deviation 13.9 |
| Vaccine Only | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgM) | 56 Days after 1st Vaccine | 50.3 Binding Antibody Unit (BAU)/mL | Standard Deviation 58.4 |
| Vaccine Only | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgM) | 28 Days after 1st Vaccine | 52.6 Binding Antibody Unit (BAU)/mL | Standard Deviation 48.3 |
| Vaccine Only | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgM) | 365 Days after 1st Vaccine | 8.8 Binding Antibody Unit (BAU)/mL | Standard Deviation 7.6 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 IV | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgM) | 365 Days after 1st Vaccine | 8.9 Binding Antibody Unit (BAU)/mL | Standard Deviation 6.4 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 IV | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgM) | 42 Days after 1st Vaccine | 57.2 Binding Antibody Unit (BAU)/mL | Standard Deviation 90.2 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 IV | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgM) | 28 Days after 1st Vaccine | 24.3 Binding Antibody Unit (BAU)/mL | Standard Deviation 37.2 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 IV | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgM) | 252 Days after 1st Vaccine | 9.6 Binding Antibody Unit (BAU)/mL | Standard Deviation 6.9 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 IV | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgM) | 56 Days after 1st Vaccine | 28.1 Binding Antibody Unit (BAU)/mL | Standard Deviation 44 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 IV | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgM) | Baseline | 5.7 Binding Antibody Unit (BAU)/mL | Standard Deviation 6.6 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 IV | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgM) | 14 Days after 1st Vaccine | 50.1 Binding Antibody Unit (BAU)/mL | Standard Deviation 61 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 IV | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgM) | 168 Days after 1st Vaccine | 7.0 Binding Antibody Unit (BAU)/mL | Standard Deviation 6.4 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgM) | 42 Days after 1st Vaccine | 31.1 Binding Antibody Unit (BAU)/mL | Standard Deviation 29.5 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgM) | 56 Days after 1st Vaccine | 17.8 Binding Antibody Unit (BAU)/mL | Standard Deviation 20.9 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgM) | 365 Days after 1st Vaccine | 9.5 Binding Antibody Unit (BAU)/mL | Standard Deviation 9.9 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgM) | 28 Days after 1st Vaccine | 18.7 Binding Antibody Unit (BAU)/mL | Standard Deviation 28.8 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgM) | 14 Days after 1st Vaccine | 32.2 Binding Antibody Unit (BAU)/mL | Standard Deviation 33.4 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgM) | 168 Days after 1st Vaccine | 8.8 Binding Antibody Unit (BAU)/mL | Standard Deviation 12.4 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgM) | Baseline | 7.1 Binding Antibody Unit (BAU)/mL | Standard Deviation 9.6 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgM) | 252 Days after 1st Vaccine | 10.2 Binding Antibody Unit (BAU)/mL | Standard Deviation 11 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgM) | 365 Days after 1st Vaccine | 8.3 Binding Antibody Unit (BAU)/mL | Standard Deviation 6.9 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgM) | 252 Days after 1st Vaccine | 9.3 Binding Antibody Unit (BAU)/mL | Standard Deviation 6.8 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgM) | Baseline | 5.7 Binding Antibody Unit (BAU)/mL | Standard Deviation 6.3 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgM) | 14 Days after 1st Vaccine | 53.8 Binding Antibody Unit (BAU)/mL | Standard Deviation 99.1 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgM) | 28 Days after 1st Vaccine | 23.0 Binding Antibody Unit (BAU)/mL | Standard Deviation 37.6 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgM) | 42 Days after 1st Vaccine | 30.4 Binding Antibody Unit (BAU)/mL | Standard Deviation 26.3 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgM) | 56 Days after 1st Vaccine | 14.2 Binding Antibody Unit (BAU)/mL | Standard Deviation 10.6 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgM) | 168 Days after 1st Vaccine | 9.7 Binding Antibody Unit (BAU)/mL | Standard Deviation 14 |
| REGN10933+REGN10987 + Vaccine 12 mg Day 1 IV | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgM) | Baseline | 3.9 Binding Antibody Unit (BAU)/mL | Standard Deviation 2.9 |
| REGN10933+REGN10987 + Vaccine 12 mg Day 1 IV | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgM) | 42 Days after 1st Vaccine | 604.2 Binding Antibody Unit (BAU)/mL | Standard Deviation 2914.7 |
| REGN10933+REGN10987 + Vaccine 12 mg Day 1 IV | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgM) | 56 Days after 1st Vaccine | 47.7 Binding Antibody Unit (BAU)/mL | Standard Deviation 96.6 |
| REGN10933+REGN10987 + Vaccine 12 mg Day 1 IV | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgM) | 14 Days after 1st Vaccine | 579.5 Binding Antibody Unit (BAU)/mL | Standard Deviation 2919.4 |
| REGN10933+REGN10987 + Vaccine 12 mg Day 1 IV | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgM) | 28 Days after 1st Vaccine | 56.0 Binding Antibody Unit (BAU)/mL | Standard Deviation 187.7 |
| REGN10933+REGN10987 + Vaccine 12 mg Day 1 IV | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgM) | 365 Days after 1st Vaccine | 13.0 Binding Antibody Unit (BAU)/mL | Standard Deviation 20.4 |
| REGN10933+REGN10987 + Vaccine 12 mg Day 1 IV | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgM) | 168 Days after 1st Vaccine | 16.6 Binding Antibody Unit (BAU)/mL | Standard Deviation 21.9 |
| REGN10933+REGN10987 + Vaccine 12 mg Day 1 IV | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgM) | 252 Days after 1st Vaccine | 19.9 Binding Antibody Unit (BAU)/mL | Standard Deviation 45.7 |
| REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgM) | 28 Days after 1st Vaccine | 41.4 Binding Antibody Unit (BAU)/mL | Standard Deviation 136.9 |
| REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgM) | 42 Days after 1st Vaccine | 66.2 Binding Antibody Unit (BAU)/mL | Standard Deviation 85.5 |
| REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgM) | 252 Days after 1st Vaccine | 11.7 Binding Antibody Unit (BAU)/mL | Standard Deviation 13.4 |
| REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgM) | 56 Days after 1st Vaccine | 32.3 Binding Antibody Unit (BAU)/mL | Standard Deviation 39.8 |
| REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgM) | 14 Days after 1st Vaccine | 21.4 Binding Antibody Unit (BAU)/mL | Standard Deviation 21.8 |
| REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgM) | Baseline | 4.8 Binding Antibody Unit (BAU)/mL | Standard Deviation 3.5 |
| REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgM) | 168 Days after 1st Vaccine | 11.5 Binding Antibody Unit (BAU)/mL | Standard Deviation 13.4 |
| REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgM) | 365 Days after 1st Vaccine | 8.0 Binding Antibody Unit (BAU)/mL | Standard Deviation 6.6 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgM) | 365 Days after 1st Vaccine | 13.1 Binding Antibody Unit (BAU)/mL | Standard Deviation 18.6 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgM) | 252 Days after 1st Vaccine | 14.1 Binding Antibody Unit (BAU)/mL | Standard Deviation 18.5 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgM) | 6 Days after 1st Vaccine | 10.0 Binding Antibody Unit (BAU)/mL | Standard Deviation 21.3 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgM) | 14 Days after 1st Vaccine | 57.9 Binding Antibody Unit (BAU)/mL | Standard Deviation 56.6 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgM) | 28 Days after 1st Vaccine | 34.3 Binding Antibody Unit (BAU)/mL | Standard Deviation 34.7 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgM) | 56 Days after 1st Vaccine | 42.2 Binding Antibody Unit (BAU)/mL | Standard Deviation 43.1 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgM) | 168 Days after 1st Vaccine | 12.1 Binding Antibody Unit (BAU)/mL | Standard Deviation 8.5 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgM) | Baseline | 4.3 Binding Antibody Unit (BAU)/mL | Standard Deviation 2.9 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgM) | 42 Days after 1st Vaccine | 61.4 Binding Antibody Unit (BAU)/mL | Standard Deviation 57.3 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgM) | 168 Days after 1st Vaccine | 7.0 Binding Antibody Unit (BAU)/mL | Standard Deviation 10.6 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgM) | Baseline | 3.7 Binding Antibody Unit (BAU)/mL | Standard Deviation 2 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgM) | 14 Days after 1st Vaccine | 535.1 Binding Antibody Unit (BAU)/mL | Standard Deviation 2773.1 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgM) | 28 Days after 1st Vaccine | 55.1 Binding Antibody Unit (BAU)/mL | Standard Deviation 151 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgM) | 42 Days after 1st Vaccine | 65.5 Binding Antibody Unit (BAU)/mL | Standard Deviation 111.5 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgM) | 56 Days after 1st Vaccine | 40.3 Binding Antibody Unit (BAU)/mL | Standard Deviation 74.5 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgM) | 252 Days after 1st Vaccine | 38.4 Binding Antibody Unit (BAU)/mL | Standard Deviation 147.4 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgM) | 365 Days after 1st Vaccine | 9.3 Binding Antibody Unit (BAU)/mL | Standard Deviation 10 |
| REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgM) | 168 Days after 1st Vaccine | 5.9 Binding Antibody Unit (BAU)/mL | Standard Deviation 4.8 |
| REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgM) | 56 Days after 1st Vaccine | 25.9 Binding Antibody Unit (BAU)/mL | Standard Deviation 29.1 |
| REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgM) | 42 Days after 1st Vaccine | 42.8 Binding Antibody Unit (BAU)/mL | Standard Deviation 47.5 |
| REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgM) | 28 Days after 1st Vaccine | 23.4 Binding Antibody Unit (BAU)/mL | Standard Deviation 52.6 |
| REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgM) | 14 Days after 1st Vaccine | 53.8 Binding Antibody Unit (BAU)/mL | Standard Deviation 133.3 |
| REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgM) | Baseline | 4.3 Binding Antibody Unit (BAU)/mL | Standard Deviation 3.7 |
| REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgM) | 365 Days after 1st Vaccine | 12.5 Binding Antibody Unit (BAU)/mL | Standard Deviation 13.1 |
| REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC | Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgM) | 252 Days after 1st Vaccine | 15.7 Binding Antibody Unit (BAU)/mL | Standard Deviation 19.1 |
Secondary
Concentrations of REGN10933 in Serum Over Time
Time frame: Up to 182 Days
Population: The pharmacokinetics (PK) analysis sets (PKAS) are defined for each study drug separately and includes all subjects who received any study drug and who had at least 1 non-missing result following the first dose of the respective study drug.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Vaccine Only | Concentrations of REGN10933 in Serum Over Time | 14 Days | 46.8 mg/L | Standard Deviation 11.3 |
| Vaccine Only | Concentrations of REGN10933 in Serum Over Time | 182 Days | 0.898 mg/L | Standard Deviation 1.06 |
| Vaccine Only | Concentrations of REGN10933 in Serum Over Time | 0 Days (End of Infusion) | 145 mg/L | Standard Deviation 40.8 |
| Vaccine Only | Concentrations of REGN10933 in Serum Over Time | 56 Days | 13.4 mg/L | Standard Deviation 5.87 |
| Vaccine Only | Concentrations of REGN10933 in Serum Over Time | 42 Days | 18.7 mg/L | Standard Deviation 7.98 |
| Vaccine Only | Concentrations of REGN10933 in Serum Over Time | 70 Days | 9.98 mg/L | Standard Deviation 6.06 |
| Vaccine Only | Concentrations of REGN10933 in Serum Over Time | 0 Days (Pre-dose) | 0.0219 mg/L | Standard Deviation 0.114 |
| Vaccine Only | Concentrations of REGN10933 in Serum Over Time | 28 Days | 29.5 mg/L | Standard Deviation 9.89 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 IV | Concentrations of REGN10933 in Serum Over Time | 182 Days | 0.180 mg/L | Standard Deviation 0.212 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 IV | Concentrations of REGN10933 in Serum Over Time | 70 Days | 2.34 mg/L | Standard Deviation 1.33 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 IV | Concentrations of REGN10933 in Serum Over Time | 0 Days (Pre-dose) | 0 mg/L | Standard Deviation 0 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 IV | Concentrations of REGN10933 in Serum Over Time | 56 Days | 3.51 mg/L | Standard Deviation 1.78 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 IV | Concentrations of REGN10933 in Serum Over Time | 0 Days (End of Infusion) | 40.5 mg/L | Standard Deviation 16.2 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 IV | Concentrations of REGN10933 in Serum Over Time | 42 Days | 5.38 mg/L | Standard Deviation 2.4 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 IV | Concentrations of REGN10933 in Serum Over Time | 14 Days | 12.7 mg/L | Standard Deviation 3.79 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 IV | Concentrations of REGN10933 in Serum Over Time | 28 Days | 8.24 mg/L | Standard Deviation 3.02 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Concentrations of REGN10933 in Serum Over Time | 182 Days | 0.137 mg/L | Standard Deviation 0.356 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Concentrations of REGN10933 in Serum Over Time | 14 Days | 8.30 mg/L | Standard Deviation 3.94 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Concentrations of REGN10933 in Serum Over Time | 70 Days | 1.42 mg/L | Standard Deviation 0.804 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Concentrations of REGN10933 in Serum Over Time | 28 Days | 5.12 mg/L | Standard Deviation 2.28 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Concentrations of REGN10933 in Serum Over Time | 42 Days | 3.35 mg/L | Standard Deviation 1.71 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Concentrations of REGN10933 in Serum Over Time | 0 Days (End of Infusion) | 26.8 mg/L | Standard Deviation 16.9 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Concentrations of REGN10933 in Serum Over Time | 56 Days | 2.10 mg/L | Standard Deviation 1.14 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Concentrations of REGN10933 in Serum Over Time | 0 Days (Pre-dose) | 0 mg/L | Standard Deviation 0 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Concentrations of REGN10933 in Serum Over Time | 70 Days | 0.522 mg/L | Standard Deviation 0.456 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Concentrations of REGN10933 in Serum Over Time | 0 Days (End of Infusion) | 7.84 mg/L | Standard Deviation 4.28 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Concentrations of REGN10933 in Serum Over Time | 0 Days (Pre-dose) | 0 mg/L | Standard Deviation 0 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Concentrations of REGN10933 in Serum Over Time | 56 Days | 0.754 mg/L | Standard Deviation 0.569 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Concentrations of REGN10933 in Serum Over Time | 14 Days | 2.62 mg/L | Standard Deviation 1.44 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Concentrations of REGN10933 in Serum Over Time | 42 Days | 1.19 mg/L | Standard Deviation 0.861 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Concentrations of REGN10933 in Serum Over Time | 28 Days | 1.76 mg/L | Standard Deviation 1.13 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Concentrations of REGN10933 in Serum Over Time | 182 Days | 0.00693 mg/L | Standard Deviation 0.036 |
| REGN10933+REGN10987 + Vaccine 12 mg Day 1 IV | Concentrations of REGN10933 in Serum Over Time | 42 Days | 0.237 mg/L | Standard Deviation 0.114 |
| REGN10933+REGN10987 + Vaccine 12 mg Day 1 IV | Concentrations of REGN10933 in Serum Over Time | 14 Days | 0.536 mg/L | Standard Deviation 0.229 |
| REGN10933+REGN10987 + Vaccine 12 mg Day 1 IV | Concentrations of REGN10933 in Serum Over Time | 0 Days (Pre-dose) | 0 mg/L | Standard Deviation 0 |
| REGN10933+REGN10987 + Vaccine 12 mg Day 1 IV | Concentrations of REGN10933 in Serum Over Time | 28 Days | 0.354 mg/L | Standard Deviation 0.15 |
| REGN10933+REGN10987 + Vaccine 12 mg Day 1 IV | Concentrations of REGN10933 in Serum Over Time | 0 Days (End of Infusion) | 1.84 mg/L | Standard Deviation 0.593 |
| REGN10933+REGN10987 + Vaccine 12 mg Day 1 IV | Concentrations of REGN10933 in Serum Over Time | 70 Days | 0.0105 mg/L | Standard Deviation 0.0408 |
| REGN10933+REGN10987 + Vaccine 12 mg Day 1 IV | Concentrations of REGN10933 in Serum Over Time | 56 Days | 0.131 mg/L | Standard Deviation 0.142 |
| REGN10933+REGN10987 + Vaccine 12 mg Day 1 IV | Concentrations of REGN10933 in Serum Over Time | 182 Days | 0 mg/L | Standard Deviation 0 |
| REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC | Concentrations of REGN10933 in Serum Over Time | 162 Days | 1.38 mg/L | Standard Deviation 1 |
| REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC | Concentrations of REGN10933 in Serum Over Time | 0 Days (Pre-dose) | 5.12 mg/L | Standard Deviation 26.1 |
| REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC | Concentrations of REGN10933 in Serum Over Time | 0 Days (End of Infusion) | 140 mg/L | Standard Deviation 54.4 |
| REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC | Concentrations of REGN10933 in Serum Over Time | 8 Days | 63.7 mg/L | Standard Deviation 11.7 |
| REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC | Concentrations of REGN10933 in Serum Over Time | 22 Days | 39.1 mg/L | Standard Deviation 10.9 |
| REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC | Concentrations of REGN10933 in Serum Over Time | 36 Days | 27.7 mg/L | Standard Deviation 7.8 |
| REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC | Concentrations of REGN10933 in Serum Over Time | 50 Days | 19.3 mg/L | Standard Deviation 5.45 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Concentrations of REGN10933 in Serum Over Time | 56 Days | 11.6 mg/L | Standard Deviation 5.04 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Concentrations of REGN10933 in Serum Over Time | 42 Days | 17.5 mg/L | Standard Deviation 6.3 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Concentrations of REGN10933 in Serum Over Time | 28 Days | 26.0 mg/L | Standard Deviation 8.04 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Concentrations of REGN10933 in Serum Over Time | 14 Days | 39.4 mg/L | Standard Deviation 11.5 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Concentrations of REGN10933 in Serum Over Time | 168 Days | 0.891 mg/L | Standard Deviation 0.712 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Concentrations of REGN10933 in Serum Over Time | 0 Days (End of Infusion) | 0.527 mg/L | Standard Deviation 0.966 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Concentrations of REGN10933 in Serum Over Time | 0 Days (Pre-dose) | 0 mg/L | Standard Deviation 0 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Concentrations of REGN10933 in Serum Over Time | 0 Days (Pre-dose) | 0 mg/L | Standard Deviation 0 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Concentrations of REGN10933 in Serum Over Time | 42 Days | 9.77 mg/L | Standard Deviation 5.01 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Concentrations of REGN10933 in Serum Over Time | 168 Days | 0.615 mg/L | Standard Deviation 0.797 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Concentrations of REGN10933 in Serum Over Time | 28 Days | 14.7 mg/L | Standard Deviation 6.25 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Concentrations of REGN10933 in Serum Over Time | 0 Days (End of Infusion) | 0.0765 mg/L | Standard Deviation 0.16 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Concentrations of REGN10933 in Serum Over Time | 14 Days | 20.4 mg/L | Standard Deviation 7.48 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Concentrations of REGN10933 in Serum Over Time | 56 Days | 6.70 mg/L | Standard Deviation 3.77 |
Secondary
Concentrations of REGN10987 in Serum Over Time
Time frame: Up to 182 Days
Population: The pharmacokinetics (PK) analysis sets (PKAS) are defined for each study drug separately and includes all subjects who received any study drug and who had at least 1 non-missing result following the first dose of the respective study drug.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Vaccine Only | Concentrations of REGN10987 in Serum Over Time | 42 Days | 13.7 mg/L | Standard Deviation 6.86 |
| Vaccine Only | Concentrations of REGN10987 in Serum Over Time | 28 Days | 23.8 mg/L | Standard Deviation 9.92 |
| Vaccine Only | Concentrations of REGN10987 in Serum Over Time | 0 Days (Pre-dose) | 0.0223 mg/L | Standard Deviation 0.116 |
| Vaccine Only | Concentrations of REGN10987 in Serum Over Time | 0 Days (End of Infusion) | 144 mg/L | Standard Deviation 42.5 |
| Vaccine Only | Concentrations of REGN10987 in Serum Over Time | 56 Days | 9.23 mg/L | Standard Deviation 4.97 |
| Vaccine Only | Concentrations of REGN10987 in Serum Over Time | 182 Days | 0.400 mg/L | Standard Deviation 0.617 |
| Vaccine Only | Concentrations of REGN10987 in Serum Over Time | 14 Days | 40.0 mg/L | Standard Deviation 11.2 |
| Vaccine Only | Concentrations of REGN10987 in Serum Over Time | 70 Days | 6.51 mg/L | Standard Deviation 4.53 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 IV | Concentrations of REGN10987 in Serum Over Time | 42 Days | 4.00 mg/L | Standard Deviation 2.02 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 IV | Concentrations of REGN10987 in Serum Over Time | 70 Days | 1.57 mg/L | Standard Deviation 1.04 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 IV | Concentrations of REGN10987 in Serum Over Time | 28 Days | 6.87 mg/L | Standard Deviation 2.84 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 IV | Concentrations of REGN10987 in Serum Over Time | 0 Days (End of Infusion) | 39.6 mg/L | Standard Deviation 15.5 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 IV | Concentrations of REGN10987 in Serum Over Time | 0 Days (Pre-dose) | 0 mg/L | Standard Deviation 0 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 IV | Concentrations of REGN10987 in Serum Over Time | 182 Days | 0.0401 mg/L | Standard Deviation 0.124 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 IV | Concentrations of REGN10987 in Serum Over Time | 14 Days | 11.2 mg/L | Standard Deviation 3.41 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 IV | Concentrations of REGN10987 in Serum Over Time | 56 Days | 2.51 mg/L | Standard Deviation 1.48 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Concentrations of REGN10987 in Serum Over Time | 42 Days | 2.54 mg/L | Standard Deviation 1.35 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Concentrations of REGN10987 in Serum Over Time | 0 Days (End of Infusion) | 28.9 mg/L | Standard Deviation 26.7 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Concentrations of REGN10987 in Serum Over Time | 182 Days | 0.0408 mg/L | Standard Deviation 0.179 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Concentrations of REGN10987 in Serum Over Time | 0 Days (Pre-dose) | 0 mg/L | Standard Deviation 0 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Concentrations of REGN10987 in Serum Over Time | 70 Days | 0.993 mg/L | Standard Deviation 0.63 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Concentrations of REGN10987 in Serum Over Time | 14 Days | 7.20 mg/L | Standard Deviation 3.09 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Concentrations of REGN10987 in Serum Over Time | 56 Days | 1.55 mg/L | Standard Deviation 0.903 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Concentrations of REGN10987 in Serum Over Time | 28 Days | 4.19 mg/L | Standard Deviation 1.95 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Concentrations of REGN10987 in Serum Over Time | 42 Days | 0.868 mg/L | Standard Deviation 0.641 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Concentrations of REGN10987 in Serum Over Time | 70 Days | 0.306 mg/L | Standard Deviation 0.344 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Concentrations of REGN10987 in Serum Over Time | 0 Days (End of Infusion) | 8.60 mg/L | Standard Deviation 5.1 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Concentrations of REGN10987 in Serum Over Time | 182 Days | 0 mg/L | Standard Deviation 0 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Concentrations of REGN10987 in Serum Over Time | 14 Days | 2.33 mg/L | Standard Deviation 1.37 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Concentrations of REGN10987 in Serum Over Time | 0 Days (Pre-dose) | 0 mg/L | Standard Deviation 0 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Concentrations of REGN10987 in Serum Over Time | 28 Days | 1.46 mg/L | Standard Deviation 0.968 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Concentrations of REGN10987 in Serum Over Time | 56 Days | 0.507 mg/L | Standard Deviation 0.453 |
| REGN10933+REGN10987 + Vaccine 12 mg Day 1 IV | Concentrations of REGN10987 in Serum Over Time | 42 Days | 0.138 mg/L | Standard Deviation 0.147 |
| REGN10933+REGN10987 + Vaccine 12 mg Day 1 IV | Concentrations of REGN10987 in Serum Over Time | 0 Days (End of Infusion) | 1.91 mg/L | Standard Deviation 0.687 |
| REGN10933+REGN10987 + Vaccine 12 mg Day 1 IV | Concentrations of REGN10987 in Serum Over Time | 182 Days | 0 mg/L | Standard Deviation 0 |
| REGN10933+REGN10987 + Vaccine 12 mg Day 1 IV | Concentrations of REGN10987 in Serum Over Time | 70 Days | 0.0115 mg/L | Standard Deviation 0.0444 |
| REGN10933+REGN10987 + Vaccine 12 mg Day 1 IV | Concentrations of REGN10987 in Serum Over Time | 0 Days (Pre-dose) | 0 mg/L | Standard Deviation 0 |
| REGN10933+REGN10987 + Vaccine 12 mg Day 1 IV | Concentrations of REGN10987 in Serum Over Time | 56 Days | 0.0776 mg/L | Standard Deviation 0.138 |
| REGN10933+REGN10987 + Vaccine 12 mg Day 1 IV | Concentrations of REGN10987 in Serum Over Time | 28 Days | 0.263 mg/L | Standard Deviation 0.189 |
| REGN10933+REGN10987 + Vaccine 12 mg Day 1 IV | Concentrations of REGN10987 in Serum Over Time | 14 Days | 0.438 mg/L | Standard Deviation 0.226 |
| REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC | Concentrations of REGN10987 in Serum Over Time | 0 Days (End of Infusion) | 150 mg/L | Standard Deviation 58 |
| REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC | Concentrations of REGN10987 in Serum Over Time | 22 Days | 35.0 mg/L | Standard Deviation 10.5 |
| REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC | Concentrations of REGN10987 in Serum Over Time | 8 Days | 61.6 mg/L | Standard Deviation 12 |
| REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC | Concentrations of REGN10987 in Serum Over Time | 162 Days | 0.566 mg/L | Standard Deviation 0.56 |
| REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC | Concentrations of REGN10987 in Serum Over Time | 36 Days | 22.2 mg/L | Standard Deviation 6.56 |
| REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC | Concentrations of REGN10987 in Serum Over Time | 50 Days | 14.5 mg/L | Standard Deviation 4.09 |
| REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC | Concentrations of REGN10987 in Serum Over Time | 0 Days (Pre-dose) | 6.00 mg/L | Standard Deviation 30.6 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Concentrations of REGN10987 in Serum Over Time | 28 Days | 21.0 mg/L | Standard Deviation 6.95 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Concentrations of REGN10987 in Serum Over Time | 0 Days (Pre-dose) | 0 mg/L | Standard Deviation 0 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Concentrations of REGN10987 in Serum Over Time | 0 Days (End of Infusion) | 0.580 mg/L | Standard Deviation 0.777 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Concentrations of REGN10987 in Serum Over Time | 14 Days | 33.8 mg/L | Standard Deviation 9.51 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Concentrations of REGN10987 in Serum Over Time | 42 Days | 13.3 mg/L | Standard Deviation 6.11 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Concentrations of REGN10987 in Serum Over Time | 56 Days | 8.02 mg/L | Standard Deviation 3.99 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Concentrations of REGN10987 in Serum Over Time | 168 Days | 0.347 mg/L | Standard Deviation 0.378 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Concentrations of REGN10987 in Serum Over Time | 0 Days (Pre-dose) | 0.00577 mg/L | Standard Deviation 0.0341 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Concentrations of REGN10987 in Serum Over Time | 168 Days | 0.251 mg/L | Standard Deviation 0.465 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Concentrations of REGN10987 in Serum Over Time | 42 Days | 7.71 mg/L | Standard Deviation 4.42 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Concentrations of REGN10987 in Serum Over Time | 28 Days | 12.1 mg/L | Standard Deviation 5.92 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Concentrations of REGN10987 in Serum Over Time | 14 Days | 18.0 mg/L | Standard Deviation 6.15 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Concentrations of REGN10987 in Serum Over Time | 0 Days (End of Infusion) | 0.232 mg/L | Standard Deviation 0.614 |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Concentrations of REGN10987 in Serum Over Time | 56 Days | 4.86 mg/L | Standard Deviation 3.07 |
Secondary
Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgG)
Anti-S1-RBD protein Fold Change based on medians = (median value in vaccine only arm / median value in the active arm)
Time frame: Up to 365 Days from 1st dose of vaccination
Population: Per protocol set (PPS) includes all randomized participants who have received both doses of vaccine and who do not meet the exclusion criteria. The PPS is the primary analysis set for assessing vaccine response related endpoints. As was pre-specified in the study protocol, only participants in the Vaccine Only and REGN10933+REGN10987 + Vaccine 1200 mg Day 7 Arm/Group were assessed for measure 6 days after the first vaccine.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Vaccine Only | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgG) | 42 Days after 1st Vaccine | 1.1 Fold Change |
| Vaccine Only | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgG) | 28 Days after 1st Vaccine | 2.8 Fold Change |
| Vaccine Only | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgG) | 252 Days after 1st Vaccine | 0.9 Fold Change |
| Vaccine Only | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgG) | Baseline | 0.4 Fold Change |
| Vaccine Only | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgG) | 168 Days after 1st Vaccine | 1.8 Fold Change |
| Vaccine Only | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgG) | 365 Days after 1st Vaccine | 0.7 Fold Change |
| Vaccine Only | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgG) | 56 Days after 1st Vaccine | 1.1 Fold Change |
| Vaccine Only | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgG) | 14 Days after 1st Vaccine | 2.1 Fold Change |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 IV | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgG) | 252 Days after 1st Vaccine | 1.9 Fold Change |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 IV | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgG) | 28 Days after 1st Vaccine | 3.5 Fold Change |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 IV | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgG) | 56 Days after 1st Vaccine | 1.3 Fold Change |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 IV | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgG) | 365 Days after 1st Vaccine | 0.6 Fold Change |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 IV | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgG) | 14 Days after 1st Vaccine | 2.3 Fold Change |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 IV | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgG) | 168 Days after 1st Vaccine | 1.6 Fold Change |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 IV | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgG) | 42 Days after 1st Vaccine | 1.3 Fold Change |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 IV | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgG) | Baseline | 0.7 Fold Change |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgG) | 14 Days after 1st Vaccine | 3.4 Fold Change |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgG) | 252 Days after 1st Vaccine | 0.9 Fold Change |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgG) | Baseline | 1.0 Fold Change |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgG) | 28 Days after 1st Vaccine | 4.2 Fold Change |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgG) | 42 Days after 1st Vaccine | 1.5 Fold Change |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgG) | 365 Days after 1st Vaccine | 0.8 Fold Change |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgG) | 56 Days after 1st Vaccine | 1.8 Fold Change |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgG) | 168 Days after 1st Vaccine | 1.5 Fold Change |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgG) | 42 Days after 1st Vaccine | 1.0 Fold Change |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgG) | Baseline | 0.5 Fold Change |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgG) | 252 Days after 1st Vaccine | 1.5 Fold Change |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgG) | 28 Days after 1st Vaccine | 2.6 Fold Change |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgG) | 365 Days after 1st Vaccine | 1.4 Fold Change |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgG) | 14 Days after 1st Vaccine | 3.5 Fold Change |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgG) | 168 Days after 1st Vaccine | 0.4 Fold Change |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgG) | 56 Days after 1st Vaccine | 1.2 Fold Change |
| REGN10933+REGN10987 + Vaccine 12 mg Day 1 IV | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgG) | 56 Days after 1st Vaccine | 1.3 Fold Change |
| REGN10933+REGN10987 + Vaccine 12 mg Day 1 IV | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgG) | Baseline | 1.0 Fold Change |
| REGN10933+REGN10987 + Vaccine 12 mg Day 1 IV | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgG) | 168 Days after 1st Vaccine | 0.9 Fold Change |
| REGN10933+REGN10987 + Vaccine 12 mg Day 1 IV | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgG) | 252 Days after 1st Vaccine | 1.8 Fold Change |
| REGN10933+REGN10987 + Vaccine 12 mg Day 1 IV | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgG) | 14 Days after 1st Vaccine | 3.0 Fold Change |
| REGN10933+REGN10987 + Vaccine 12 mg Day 1 IV | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgG) | 365 Days after 1st Vaccine | 1.6 Fold Change |
| REGN10933+REGN10987 + Vaccine 12 mg Day 1 IV | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgG) | 42 Days after 1st Vaccine | 1.4 Fold Change |
| REGN10933+REGN10987 + Vaccine 12 mg Day 1 IV | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgG) | 28 Days after 1st Vaccine | 4.0 Fold Change |
| REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgG) | 28 Days after 1st Vaccine | 2.2 Fold Change |
| REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgG) | 6 Days after 1st Vaccine | 1.0 Fold Change |
| REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgG) | 42 Days after 1st Vaccine | 1.3 Fold Change |
| REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgG) | 365 Days after 1st Vaccine | 1.4 Fold Change |
| REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgG) | 168 Days after 1st Vaccine | 0.3 Fold Change |
| REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgG) | 56 Days after 1st Vaccine | 1.5 Fold Change |
| REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgG) | Baseline | 1.0 Fold Change |
| REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgG) | 14 Days after 1st Vaccine | 1.3 Fold Change |
| REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgG) | 252 Days after 1st Vaccine | 0.7 Fold Change |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgG) | 168 Days after 1st Vaccine | 1.3 Fold Change |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgG) | 14 Days after 1st Vaccine | 2.3 Fold Change |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgG) | Baseline | 1.0 Fold Change |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgG) | 28 Days after 1st Vaccine | 2.2 Fold Change |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgG) | 42 Days after 1st Vaccine | 1.3 Fold Change |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgG) | 56 Days after 1st Vaccine | 1.5 Fold Change |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgG) | 252 Days after 1st Vaccine | 1.1 Fold Change |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgG) | 365 Days after 1st Vaccine | 0.5 Fold Change |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgG) | 252 Days after 1st Vaccine | 1.5 Fold Change |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgG) | 56 Days after 1st Vaccine | 1.6 Fold Change |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgG) | 42 Days after 1st Vaccine | 1.2 Fold Change |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgG) | 28 Days after 1st Vaccine | 2.7 Fold Change |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgG) | Baseline | 1.0 Fold Change |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgG) | 14 Days after 1st Vaccine | 2.6 Fold Change |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgG) | 168 Days after 1st Vaccine | 1.5 Fold Change |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgG) | 365 Days after 1st Vaccine | 0.4 Fold Change |
Secondary
Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgM)
Anti-S1-RBD protein Fold Change based on medians = (median value in vaccine only arm / median value in the active arm)
Time frame: Up to 365 Days from 1st dose of vaccination
Population: Per protocol set (PPS) includes all randomized participants who have received both doses of vaccine and who do not meet the exclusion criteria. The PPS is the primary analysis set for assessing vaccine response related endpoints.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Vaccine Only | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgM) | 168 Days after 1st Vaccine | 2.1 Fold Change |
| Vaccine Only | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgM) | 14 Days after 1st Vaccine | 1.9 Fold Change |
| Vaccine Only | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgM) | 28 Days after 1st Vaccine | 2.3 Fold Change |
| Vaccine Only | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgM) | 365 Days after 1st Vaccine | 1.0 Fold Change |
| Vaccine Only | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgM) | 42 Days after 1st Vaccine | 2.0 Fold Change |
| Vaccine Only | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgM) | Baseline | 1.0 Fold Change |
| Vaccine Only | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgM) | 56 Days after 1st Vaccine | 1.5 Fold Change |
| Vaccine Only | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgM) | 252 Days after 1st Vaccine | 2.1 Fold Change |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 IV | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgM) | 252 Days after 1st Vaccine | 2.1 Fold Change |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 IV | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgM) | 168 Days after 1st Vaccine | 2.1 Fold Change |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 IV | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgM) | 365 Days after 1st Vaccine | 1.0 Fold Change |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 IV | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgM) | 28 Days after 1st Vaccine | 3.1 Fold Change |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 IV | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgM) | 56 Days after 1st Vaccine | 2.8 Fold Change |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 IV | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgM) | 14 Days after 1st Vaccine | 1.8 Fold Change |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 IV | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgM) | 42 Days after 1st Vaccine | 2.4 Fold Change |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 IV | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgM) | Baseline | 1.0 Fold Change |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgM) | 28 Days after 1st Vaccine | 5.0 Fold Change |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgM) | 365 Days after 1st Vaccine | 1.0 Fold Change |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgM) | 42 Days after 1st Vaccine | 2.8 Fold Change |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgM) | 56 Days after 1st Vaccine | 2.8 Fold Change |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgM) | 252 Days after 1st Vaccine | 2.1 Fold Change |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgM) | 14 Days after 1st Vaccine | 2.6 Fold Change |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgM) | 168 Days after 1st Vaccine | 2.1 Fold Change |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgM) | Baseline | 1.0 Fold Change |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgM) | 28 Days after 1st Vaccine | 2.1 Fold Change |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgM) | 252 Days after 1st Vaccine | 2.1 Fold Change |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgM) | Baseline | 1.0 Fold Change |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgM) | 168 Days after 1st Vaccine | 2.1 Fold Change |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgM) | 42 Days after 1st Vaccine | 1.6 Fold Change |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgM) | 14 Days after 1st Vaccine | 2.4 Fold Change |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgM) | 56 Days after 1st Vaccine | 1.1 Fold Change |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgM) | 365 Days after 1st Vaccine | 1.0 Fold Change |
| REGN10933+REGN10987 + Vaccine 12 mg Day 1 IV | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgM) | Baseline | 1.0 Fold Change |
| REGN10933+REGN10987 + Vaccine 12 mg Day 1 IV | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgM) | 365 Days after 1st Vaccine | 1.0 Fold Change |
| REGN10933+REGN10987 + Vaccine 12 mg Day 1 IV | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgM) | 14 Days after 1st Vaccine | 3.3 Fold Change |
| REGN10933+REGN10987 + Vaccine 12 mg Day 1 IV | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgM) | 28 Days after 1st Vaccine | 5.0 Fold Change |
| REGN10933+REGN10987 + Vaccine 12 mg Day 1 IV | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgM) | 252 Days after 1st Vaccine | 2.1 Fold Change |
| REGN10933+REGN10987 + Vaccine 12 mg Day 1 IV | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgM) | 56 Days after 1st Vaccine | 1.4 Fold Change |
| REGN10933+REGN10987 + Vaccine 12 mg Day 1 IV | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgM) | 42 Days after 1st Vaccine | 1.9 Fold Change |
| REGN10933+REGN10987 + Vaccine 12 mg Day 1 IV | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgM) | 168 Days after 1st Vaccine | 2.1 Fold Change |
| REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgM) | 14 Days after 1st Vaccine | 1.0 Fold Change |
| REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgM) | Baseline | 1.0 Fold Change |
| REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgM) | 28 Days after 1st Vaccine | 1.4 Fold Change |
| REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgM) | 42 Days after 1st Vaccine | 1.5 Fold Change |
| REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgM) | 56 Days after 1st Vaccine | 0.9 Fold Change |
| REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgM) | 168 Days after 1st Vaccine | 0.9 Fold Change |
| REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgM) | 252 Days after 1st Vaccine | 2.1 Fold Change |
| REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgM) | 365 Days after 1st Vaccine | 1.0 Fold Change |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgM) | 28 Days after 1st Vaccine | 2.3 Fold Change |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgM) | 56 Days after 1st Vaccine | 1.7 Fold Change |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgM) | 14 Days after 1st Vaccine | 2.1 Fold Change |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgM) | 365 Days after 1st Vaccine | 1.0 Fold Change |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgM) | Baseline | 1.0 Fold Change |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgM) | 252 Days after 1st Vaccine | 2.1 Fold Change |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgM) | 168 Days after 1st Vaccine | 2.1 Fold Change |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgM) | 42 Days after 1st Vaccine | 3.1 Fold Change |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgM) | 168 Days after 1st Vaccine | 2.1 Fold Change |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgM) | 42 Days after 1st Vaccine | 2.3 Fold Change |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgM) | 28 Days after 1st Vaccine | 5.0 Fold Change |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgM) | 252 Days after 1st Vaccine | 1.0 Fold Change |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgM) | 14 Days after 1st Vaccine | 2.3 Fold Change |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgM) | Baseline | 1.0 Fold Change |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgM) | 365 Days after 1st Vaccine | 1.0 Fold Change |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgM) | 56 Days after 1st Vaccine | 1.6 Fold Change |
Secondary
Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgA)
Anti-S protein Fold Change based on medians = (median value in vaccine only arm / median value in the active arm)
Time frame: Up to 365 Days from 1st dose of vaccination
Population: Per protocol set (PPS) includes all randomized participants who have received both doses of vaccine and who do not meet the exclusion criteria. The PPS is the primary analysis set for assessing vaccine response related endpoints. As was pre-specified in the study protocol, only participants in the Vaccine Only and REGN10933+REGN10987 + Vaccine 1200 mg Day 7 Arm/Group were assessed for measure 6 days after the first vaccine.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Vaccine Only | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgA) | 42 Days after 1st Vaccine | 1.4 Fold Change |
| Vaccine Only | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgA) | 28 Days after 1st Vaccine | 1.9 Fold Change |
| Vaccine Only | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgA) | 252 Days after 1st Vaccine | 0.9 Fold Change |
| Vaccine Only | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgA) | 168 Days after 1st Vaccine | 1.5 Fold Change |
| Vaccine Only | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgA) | Baseline | 1.0 Fold Change |
| Vaccine Only | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgA) | 365 Days after 1st Vaccine | 0.6 Fold Change |
| Vaccine Only | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgA) | 56 Days after 1st Vaccine | 1.5 Fold Change |
| Vaccine Only | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgA) | 14 Days after 1st Vaccine | 0.8 Fold Change |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 IV | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgA) | 42 Days after 1st Vaccine | 1.6 Fold Change |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 IV | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgA) | 28 Days after 1st Vaccine | 1.9 Fold Change |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 IV | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgA) | 14 Days after 1st Vaccine | 0.7 Fold Change |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 IV | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgA) | 252 Days after 1st Vaccine | 1.1 Fold Change |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 IV | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgA) | 56 Days after 1st Vaccine | 1.9 Fold Change |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 IV | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgA) | Baseline | 1.0 Fold Change |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 IV | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgA) | 168 Days after 1st Vaccine | 2.2 Fold Change |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 IV | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgA) | 365 Days after 1st Vaccine | 1.0 Fold Change |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgA) | 56 Days after 1st Vaccine | 1.9 Fold Change |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgA) | 365 Days after 1st Vaccine | 1.0 Fold Change |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgA) | 14 Days after 1st Vaccine | 1.5 Fold Change |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgA) | 28 Days after 1st Vaccine | 2.6 Fold Change |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgA) | 42 Days after 1st Vaccine | 1.7 Fold Change |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgA) | 168 Days after 1st Vaccine | 1.6 Fold Change |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgA) | 252 Days after 1st Vaccine | 1.3 Fold Change |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgA) | Baseline | 1.0 Fold Change |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgA) | 28 Days after 1st Vaccine | 2.0 Fold Change |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgA) | 14 Days after 1st Vaccine | 1.0 Fold Change |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgA) | 42 Days after 1st Vaccine | 1.6 Fold Change |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgA) | 56 Days after 1st Vaccine | 1.5 Fold Change |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgA) | Baseline | 1.0 Fold Change |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgA) | 168 Days after 1st Vaccine | 0.9 Fold Change |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgA) | 365 Days after 1st Vaccine | 1.0 Fold Change |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgA) | 252 Days after 1st Vaccine | 3.1 Fold Change |
| REGN10933+REGN10987 + Vaccine 12 mg Day 1 IV | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgA) | 365 Days after 1st Vaccine | 1.1 Fold Change |
| REGN10933+REGN10987 + Vaccine 12 mg Day 1 IV | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgA) | 14 Days after 1st Vaccine | 1.8 Fold Change |
| REGN10933+REGN10987 + Vaccine 12 mg Day 1 IV | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgA) | 28 Days after 1st Vaccine | 2.7 Fold Change |
| REGN10933+REGN10987 + Vaccine 12 mg Day 1 IV | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgA) | 252 Days after 1st Vaccine | 3.8 Fold Change |
| REGN10933+REGN10987 + Vaccine 12 mg Day 1 IV | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgA) | 42 Days after 1st Vaccine | 1.5 Fold Change |
| REGN10933+REGN10987 + Vaccine 12 mg Day 1 IV | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgA) | Baseline | 1.0 Fold Change |
| REGN10933+REGN10987 + Vaccine 12 mg Day 1 IV | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgA) | 168 Days after 1st Vaccine | 1.1 Fold Change |
| REGN10933+REGN10987 + Vaccine 12 mg Day 1 IV | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgA) | 56 Days after 1st Vaccine | 2.0 Fold Change |
| REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgA) | 168 Days after 1st Vaccine | 0.2 Fold Change |
| REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgA) | 28 Days after 1st Vaccine | 2.1 Fold Change |
| REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgA) | 6 Days after 1st Vaccine | 0.7 Fold Change |
| REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgA) | 252 Days after 1st Vaccine | 1.2 Fold Change |
| REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgA) | 14 Days after 1st Vaccine | 0.8 Fold Change |
| REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgA) | 56 Days after 1st Vaccine | 2.2 Fold Change |
| REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgA) | 365 Days after 1st Vaccine | 1.3 Fold Change |
| REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgA) | 42 Days after 1st Vaccine | 1.5 Fold Change |
| REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgA) | Baseline | 1.0 Fold Change |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgA) | 42 Days after 1st Vaccine | 1.7 Fold Change |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgA) | Baseline | 1.0 Fold Change |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgA) | 56 Days after 1st Vaccine | 1.7 Fold Change |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgA) | 14 Days after 1st Vaccine | 0.8 Fold Change |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgA) | 365 Days after 1st Vaccine | 0.8 Fold Change |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgA) | 168 Days after 1st Vaccine | 1.6 Fold Change |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgA) | 252 Days after 1st Vaccine | 0.6 Fold Change |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgA) | 28 Days after 1st Vaccine | 1.4 Fold Change |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgA) | 365 Days after 1st Vaccine | 1.0 Fold Change |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgA) | 28 Days after 1st Vaccine | 2.8 Fold Change |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgA) | Baseline | 1.0 Fold Change |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgA) | 14 Days after 1st Vaccine | 1.3 Fold Change |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgA) | 42 Days after 1st Vaccine | 1.9 Fold Change |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgA) | 56 Days after 1st Vaccine | 2.1 Fold Change |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgA) | 168 Days after 1st Vaccine | 2.6 Fold Change |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgA) | 252 Days after 1st Vaccine | 0.9 Fold Change |
Secondary
Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgG)
Anti-S protein Fold Change based on medians = (median value in vaccine only arm / median value in the active arm)
Time frame: Up to 365 Days from 1st dose of vaccination
Population: Per protocol set (PPS) includes all randomized participants who have received both doses of vaccine and who do not meet the exclusion criteria. The PPS is the primary analysis set for assessing vaccine response related endpoints. As was pre-specified in the study protocol, only participants in the Vaccine Only and REGN10933+REGN10987 + Vaccine 1200 mg Day 7 Arm/Group were assessed for measure 6 days after the first vaccine.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Vaccine Only | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgG) | 28 Days after 1st Vaccine | 3.1 Fold Change |
| Vaccine Only | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgG) | 14 Days after 1st Vaccine | 1.6 Fold Change |
| Vaccine Only | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgG) | 365 Days after 1st Vaccine | 0.7 Fold Change |
| Vaccine Only | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgG) | 252 Days after 1st Vaccine | 1.1 Fold Change |
| Vaccine Only | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgG) | 168 Days after 1st Vaccine | 1.7 Fold Change |
| Vaccine Only | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgG) | 56 Days after 1st Vaccine | 1.2 Fold Change |
| Vaccine Only | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgG) | 42 Days after 1st Vaccine | 1.1 Fold Change |
| Vaccine Only | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgG) | Baseline | 0.4 Fold Change |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 IV | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgG) | Baseline | 1.0 Fold Change |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 IV | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgG) | 365 Days after 1st Vaccine | 0.7 Fold Change |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 IV | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgG) | 14 Days after 1st Vaccine | 1.7 Fold Change |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 IV | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgG) | 28 Days after 1st Vaccine | 4.1 Fold Change |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 IV | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgG) | 42 Days after 1st Vaccine | 1.5 Fold Change |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 IV | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgG) | 56 Days after 1st Vaccine | 1.5 Fold Change |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 IV | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgG) | 168 Days after 1st Vaccine | 1.7 Fold Change |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 IV | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgG) | 252 Days after 1st Vaccine | 1.4 Fold Change |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgG) | 168 Days after 1st Vaccine | 1.8 Fold Change |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgG) | 365 Days after 1st Vaccine | 0.9 Fold Change |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgG) | Baseline | 1.0 Fold Change |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgG) | 42 Days after 1st Vaccine | 1.6 Fold Change |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgG) | 56 Days after 1st Vaccine | 1.8 Fold Change |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgG) | 14 Days after 1st Vaccine | 1.8 Fold Change |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgG) | 252 Days after 1st Vaccine | 0.6 Fold Change |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgG) | 28 Days after 1st Vaccine | 3.7 Fold Change |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgG) | 168 Days after 1st Vaccine | 0.4 Fold Change |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgG) | 56 Days after 1st Vaccine | 1.1 Fold Change |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgG) | 28 Days after 1st Vaccine | 2.8 Fold Change |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgG) | 14 Days after 1st Vaccine | 3.5 Fold Change |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgG) | Baseline | 1.0 Fold Change |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgG) | 42 Days after 1st Vaccine | 1.1 Fold Change |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgG) | 252 Days after 1st Vaccine | 1.2 Fold Change |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgG) | 365 Days after 1st Vaccine | 1.6 Fold Change |
| REGN10933+REGN10987 + Vaccine 12 mg Day 1 IV | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgG) | 252 Days after 1st Vaccine | 1.2 Fold Change |
| REGN10933+REGN10987 + Vaccine 12 mg Day 1 IV | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgG) | 28 Days after 1st Vaccine | 3.7 Fold Change |
| REGN10933+REGN10987 + Vaccine 12 mg Day 1 IV | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgG) | 42 Days after 1st Vaccine | 1.4 Fold Change |
| REGN10933+REGN10987 + Vaccine 12 mg Day 1 IV | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgG) | Baseline | 1.0 Fold Change |
| REGN10933+REGN10987 + Vaccine 12 mg Day 1 IV | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgG) | 56 Days after 1st Vaccine | 1.4 Fold Change |
| REGN10933+REGN10987 + Vaccine 12 mg Day 1 IV | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgG) | 365 Days after 1st Vaccine | 1.8 Fold Change |
| REGN10933+REGN10987 + Vaccine 12 mg Day 1 IV | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgG) | 168 Days after 1st Vaccine | 1.1 Fold Change |
| REGN10933+REGN10987 + Vaccine 12 mg Day 1 IV | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgG) | 14 Days after 1st Vaccine | 2.5 Fold Change |
| REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgG) | 42 Days after 1st Vaccine | 1.2 Fold Change |
| REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgG) | 168 Days after 1st Vaccine | 0.4 Fold Change |
| REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgG) | 365 Days after 1st Vaccine | 1.4 Fold Change |
| REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgG) | 28 Days after 1st Vaccine | 2.6 Fold Change |
| REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgG) | 252 Days after 1st Vaccine | 0.5 Fold Change |
| REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgG) | 6 Days after 1st Vaccine | 0.5 Fold Change |
| REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgG) | 56 Days after 1st Vaccine | 1.6 Fold Change |
| REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgG) | Baseline | 1.0 Fold Change |
| REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgG) | 14 Days after 1st Vaccine | 1.0 Fold Change |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgG) | 56 Days after 1st Vaccine | 1.6 Fold Change |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgG) | 14 Days after 1st Vaccine | 2.4 Fold Change |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgG) | 252 Days after 1st Vaccine | 1.0 Fold Change |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgG) | 42 Days after 1st Vaccine | 1.3 Fold Change |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgG) | 168 Days after 1st Vaccine | 1.3 Fold Change |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgG) | Baseline | 1.0 Fold Change |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgG) | 365 Days after 1st Vaccine | 0.5 Fold Change |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgG) | 28 Days after 1st Vaccine | 2.3 Fold Change |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgG) | 365 Days after 1st Vaccine | 0.5 Fold Change |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgG) | Baseline | 1.0 Fold Change |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgG) | 14 Days after 1st Vaccine | 2.1 Fold Change |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgG) | 28 Days after 1st Vaccine | 2.9 Fold Change |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgG) | 42 Days after 1st Vaccine | 1.4 Fold Change |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgG) | 56 Days after 1st Vaccine | 1.6 Fold Change |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgG) | 168 Days after 1st Vaccine | 1.5 Fold Change |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgG) | 252 Days after 1st Vaccine | 1.2 Fold Change |
Secondary
Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgM)
Anti-S protein (Spike protein) Fold Change based on medians = (median value in vaccine only arm / median value in the active arm)
Time frame: Up to 365 Days from 1st dose of vaccination
Population: Per protocol set (PPS) includes all randomized participants who have received both doses of vaccine and who do not meet the exclusion criteria. The PPS is the primary analysis set for assessing vaccine response related endpoints. As was pre-specified in the study protocol, only participants in the Vaccine Only and REGN10933+REGN10987 + Vaccine 1200 mg Day 7 Arm/Group were assessed for measure 6 days after the first vaccine.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Vaccine Only | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgM) | Baseline | 1.0 Fold Change |
| Vaccine Only | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgM) | 168 Days after 1st Vaccine | 2.7 Fold Change |
| Vaccine Only | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgM) | 28 Days after 1st Vaccine | 3.6 Fold Change |
| Vaccine Only | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgM) | 56 Days after 1st Vaccine | 1.7 Fold Change |
| Vaccine Only | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgM) | 365 Days after 1st Vaccine | 0.9 Fold Change |
| Vaccine Only | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgM) | 42 Days after 1st Vaccine | 2.2 Fold Change |
| Vaccine Only | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgM) | 14 Days after 1st Vaccine | 2.1 Fold Change |
| Vaccine Only | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgM) | 252 Days after 1st Vaccine | 1.0 Fold Change |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 IV | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgM) | 14 Days after 1st Vaccine | 2.4 Fold Change |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 IV | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgM) | 28 Days after 1st Vaccine | 5.2 Fold Change |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 IV | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgM) | 252 Days after 1st Vaccine | 3.2 Fold Change |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 IV | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgM) | Baseline | 1.0 Fold Change |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 IV | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgM) | 365 Days after 1st Vaccine | 1.0 Fold Change |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 IV | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgM) | 168 Days after 1st Vaccine | 2.7 Fold Change |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 IV | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgM) | 56 Days after 1st Vaccine | 2.2 Fold Change |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 IV | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgM) | 42 Days after 1st Vaccine | 2.4 Fold Change |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgM) | 14 Days after 1st Vaccine | 2.8 Fold Change |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgM) | 365 Days after 1st Vaccine | 0.9 Fold Change |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgM) | Baseline | 1.0 Fold Change |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgM) | 28 Days after 1st Vaccine | 4.5 Fold Change |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgM) | 42 Days after 1st Vaccine | 2.6 Fold Change |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgM) | 56 Days after 1st Vaccine | 2.0 Fold Change |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgM) | 168 Days after 1st Vaccine | 1.8 Fold Change |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgM) | 252 Days after 1st Vaccine | 1.4 Fold Change |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgM) | 14 Days after 1st Vaccine | 3.2 Fold Change |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgM) | 56 Days after 1st Vaccine | 1.1 Fold Change |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgM) | Baseline | 1.0 Fold Change |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgM) | 42 Days after 1st Vaccine | 1.4 Fold Change |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgM) | 28 Days after 1st Vaccine | 3.3 Fold Change |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgM) | 252 Days after 1st Vaccine | 3.2 Fold Change |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgM) | 168 Days after 1st Vaccine | 1.3 Fold Change |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgM) | 365 Days after 1st Vaccine | 2.2 Fold Change |
| REGN10933+REGN10987 + Vaccine 12 mg Day 1 IV | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgM) | 365 Days after 1st Vaccine | 2.2 Fold Change |
| REGN10933+REGN10987 + Vaccine 12 mg Day 1 IV | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgM) | 168 Days after 1st Vaccine | 2.7 Fold Change |
| REGN10933+REGN10987 + Vaccine 12 mg Day 1 IV | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgM) | 56 Days after 1st Vaccine | 1.4 Fold Change |
| REGN10933+REGN10987 + Vaccine 12 mg Day 1 IV | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgM) | 14 Days after 1st Vaccine | 2.9 Fold Change |
| REGN10933+REGN10987 + Vaccine 12 mg Day 1 IV | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgM) | 42 Days after 1st Vaccine | 1.9 Fold Change |
| REGN10933+REGN10987 + Vaccine 12 mg Day 1 IV | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgM) | Baseline | 1.0 Fold Change |
| REGN10933+REGN10987 + Vaccine 12 mg Day 1 IV | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgM) | 28 Days after 1st Vaccine | 4.9 Fold Change |
| REGN10933+REGN10987 + Vaccine 12 mg Day 1 IV | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgM) | 252 Days after 1st Vaccine | 1.1 Fold Change |
| REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgM) | Baseline | 1.0 Fold Change |
| REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgM) | 28 Days after 1st Vaccine | 1.9 Fold Change |
| REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgM) | 6 Days after 1st Vaccine | 1.0 Fold Change |
| REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgM) | 42 Days after 1st Vaccine | 1.3 Fold Change |
| REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgM) | 365 Days after 1st Vaccine | 2.2 Fold Change |
| REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgM) | 56 Days after 1st Vaccine | 1.2 Fold Change |
| REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgM) | 168 Days after 1st Vaccine | 0.9 Fold Change |
| REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgM) | 252 Days after 1st Vaccine | 1.0 Fold Change |
| REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgM) | 14 Days after 1st Vaccine | 1.1 Fold Change |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgM) | Baseline | 1.0 Fold Change |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgM) | 168 Days after 1st Vaccine | 2.7 Fold Change |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgM) | 42 Days after 1st Vaccine | 2.9 Fold Change |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgM) | 252 Days after 1st Vaccine | 1.1 Fold Change |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgM) | 28 Days after 1st Vaccine | 3.7 Fold Change |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgM) | 14 Days after 1st Vaccine | 3.0 Fold Change |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgM) | 56 Days after 1st Vaccine | 1.8 Fold Change |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgM) | 365 Days after 1st Vaccine | 1.1 Fold Change |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgM) | 28 Days after 1st Vaccine | 3.7 Fold Change |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgM) | 42 Days after 1st Vaccine | 2.0 Fold Change |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgM) | 14 Days after 1st Vaccine | 2.0 Fold Change |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgM) | 56 Days after 1st Vaccine | 1.3 Fold Change |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgM) | 168 Days after 1st Vaccine | 2.7 Fold Change |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgM) | 365 Days after 1st Vaccine | 0.9 Fold Change |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgM) | 252 Days after 1st Vaccine | 1.1 Fold Change |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgM) | Baseline | 1.0 Fold Change |
Secondary
Immunogenicity, as Measured by Anti-drug Antibodies (ADA) to REGN10933
Time frame: Up to Day 183
Population: The AAS are defined for each study drug separately and include all treated participants who received any amount of study drug (active \[SAF\]) and had at least 1 non-missing ADA result of respective analyte following the first dose of study drug.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Vaccine Only | Immunogenicity, as Measured by Anti-drug Antibodies (ADA) to REGN10933 | Treatment-Boosted Response | 0 Percent of Participants |
| Vaccine Only | Immunogenicity, as Measured by Anti-drug Antibodies (ADA) to REGN10933 | Negative | 66.7 Percent of Participants |
| Vaccine Only | Immunogenicity, as Measured by Anti-drug Antibodies (ADA) to REGN10933 | Pre-Existing Immunoreactivity | 0 Percent of Participants |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 IV | Immunogenicity, as Measured by Anti-drug Antibodies (ADA) to REGN10933 | Treatment-Boosted Response | 0 Percent of Participants |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 IV | Immunogenicity, as Measured by Anti-drug Antibodies (ADA) to REGN10933 | Negative | 59.3 Percent of Participants |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 IV | Immunogenicity, as Measured by Anti-drug Antibodies (ADA) to REGN10933 | Pre-Existing Immunoreactivity | 3.7 Percent of Participants |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Immunogenicity, as Measured by Anti-drug Antibodies (ADA) to REGN10933 | Negative | 44.4 Percent of Participants |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Immunogenicity, as Measured by Anti-drug Antibodies (ADA) to REGN10933 | Pre-Existing Immunoreactivity | 3.7 Percent of Participants |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Immunogenicity, as Measured by Anti-drug Antibodies (ADA) to REGN10933 | Treatment-Boosted Response | 0 Percent of Participants |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Immunogenicity, as Measured by Anti-drug Antibodies (ADA) to REGN10933 | Negative | 30.0 Percent of Participants |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Immunogenicity, as Measured by Anti-drug Antibodies (ADA) to REGN10933 | Treatment-Boosted Response | 0 Percent of Participants |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Immunogenicity, as Measured by Anti-drug Antibodies (ADA) to REGN10933 | Pre-Existing Immunoreactivity | 6.7 Percent of Participants |
| REGN10933+REGN10987 + Vaccine 12 mg Day 1 IV | Immunogenicity, as Measured by Anti-drug Antibodies (ADA) to REGN10933 | Treatment-Boosted Response | 0 Percent of Participants |
| REGN10933+REGN10987 + Vaccine 12 mg Day 1 IV | Immunogenicity, as Measured by Anti-drug Antibodies (ADA) to REGN10933 | Pre-Existing Immunoreactivity | 0 Percent of Participants |
| REGN10933+REGN10987 + Vaccine 12 mg Day 1 IV | Immunogenicity, as Measured by Anti-drug Antibodies (ADA) to REGN10933 | Negative | 36.7 Percent of Participants |
| REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC | Immunogenicity, as Measured by Anti-drug Antibodies (ADA) to REGN10933 | Treatment-Boosted Response | 0 Percent of Participants |
| REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC | Immunogenicity, as Measured by Anti-drug Antibodies (ADA) to REGN10933 | Pre-Existing Immunoreactivity | 0 Percent of Participants |
| REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC | Immunogenicity, as Measured by Anti-drug Antibodies (ADA) to REGN10933 | Negative | 91.3 Percent of Participants |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Immunogenicity, as Measured by Anti-drug Antibodies (ADA) to REGN10933 | Treatment-Boosted Response | 0 Percent of Participants |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Immunogenicity, as Measured by Anti-drug Antibodies (ADA) to REGN10933 | Negative | 70.6 Percent of Participants |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Immunogenicity, as Measured by Anti-drug Antibodies (ADA) to REGN10933 | Pre-Existing Immunoreactivity | 0 Percent of Participants |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Immunogenicity, as Measured by Anti-drug Antibodies (ADA) to REGN10933 | Pre-Existing Immunoreactivity | 0 Percent of Participants |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Immunogenicity, as Measured by Anti-drug Antibodies (ADA) to REGN10933 | Negative | 62.9 Percent of Participants |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Immunogenicity, as Measured by Anti-drug Antibodies (ADA) to REGN10933 | Treatment-Boosted Response | 0 Percent of Participants |
Secondary
Immunogenicity, as Measured by Anti-drug Antibodies (ADA) to REGN10987
Time frame: Up to Day 183
Population: The pharmacokinetics (PK) analysis sets (PKAS) are defined for each study drug separately and includes all subjects who received any study drug and who had at least 1 non-missing result following the first dose of the respective study drug.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Vaccine Only | Immunogenicity, as Measured by Anti-drug Antibodies (ADA) to REGN10987 | Negative | 48.1 Percent of Participants |
| Vaccine Only | Immunogenicity, as Measured by Anti-drug Antibodies (ADA) to REGN10987 | Treatment-Boosted Response | 0 Percent of Participants |
| Vaccine Only | Immunogenicity, as Measured by Anti-drug Antibodies (ADA) to REGN10987 | Pre-Existing Immunoreactivity | 7.4 Percent of Participants |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 IV | Immunogenicity, as Measured by Anti-drug Antibodies (ADA) to REGN10987 | Treatment-Boosted Response | 0 Percent of Participants |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 IV | Immunogenicity, as Measured by Anti-drug Antibodies (ADA) to REGN10987 | Pre-Existing Immunoreactivity | 0 Percent of Participants |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 IV | Immunogenicity, as Measured by Anti-drug Antibodies (ADA) to REGN10987 | Negative | 55.6 Percent of Participants |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Immunogenicity, as Measured by Anti-drug Antibodies (ADA) to REGN10987 | Treatment-Boosted Response | 0 Percent of Participants |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Immunogenicity, as Measured by Anti-drug Antibodies (ADA) to REGN10987 | Negative | 44.4 Percent of Participants |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Immunogenicity, as Measured by Anti-drug Antibodies (ADA) to REGN10987 | Pre-Existing Immunoreactivity | 3.7 Percent of Participants |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Immunogenicity, as Measured by Anti-drug Antibodies (ADA) to REGN10987 | Negative | 46.7 Percent of Participants |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Immunogenicity, as Measured by Anti-drug Antibodies (ADA) to REGN10987 | Pre-Existing Immunoreactivity | 3.3 Percent of Participants |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Immunogenicity, as Measured by Anti-drug Antibodies (ADA) to REGN10987 | Treatment-Boosted Response | 3.3 Percent of Participants |
| REGN10933+REGN10987 + Vaccine 12 mg Day 1 IV | Immunogenicity, as Measured by Anti-drug Antibodies (ADA) to REGN10987 | Pre-Existing Immunoreactivity | 3.3 Percent of Participants |
| REGN10933+REGN10987 + Vaccine 12 mg Day 1 IV | Immunogenicity, as Measured by Anti-drug Antibodies (ADA) to REGN10987 | Negative | 56.7 Percent of Participants |
| REGN10933+REGN10987 + Vaccine 12 mg Day 1 IV | Immunogenicity, as Measured by Anti-drug Antibodies (ADA) to REGN10987 | Treatment-Boosted Response | 0 Percent of Participants |
| REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC | Immunogenicity, as Measured by Anti-drug Antibodies (ADA) to REGN10987 | Pre-Existing Immunoreactivity | 8.7 Percent of Participants |
| REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC | Immunogenicity, as Measured by Anti-drug Antibodies (ADA) to REGN10987 | Negative | 56.5 Percent of Participants |
| REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC | Immunogenicity, as Measured by Anti-drug Antibodies (ADA) to REGN10987 | Treatment-Boosted Response | 0 Percent of Participants |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Immunogenicity, as Measured by Anti-drug Antibodies (ADA) to REGN10987 | Pre-Existing Immunoreactivity | 0 Percent of Participants |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Immunogenicity, as Measured by Anti-drug Antibodies (ADA) to REGN10987 | Negative | 55.9 Percent of Participants |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Immunogenicity, as Measured by Anti-drug Antibodies (ADA) to REGN10987 | Treatment-Boosted Response | 2.9 Percent of Participants |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Immunogenicity, as Measured by Anti-drug Antibodies (ADA) to REGN10987 | Negative | 57.1 Percent of Participants |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Immunogenicity, as Measured by Anti-drug Antibodies (ADA) to REGN10987 | Pre-Existing Immunoreactivity | 5.7 Percent of Participants |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Immunogenicity, as Measured by Anti-drug Antibodies (ADA) to REGN10987 | Treatment-Boosted Response | 0 Percent of Participants |
Secondary
Immunogenicity, as Measured by Neutralizing Antibodies (NAb) to REGN10933
Time frame: Up to Day 183
Population: The NAbS are defined for each study drug separately and comprises all treated participants (active) that were included in the AAS and tested negative at all ADA sampling times or tested positive at 1 or more postdose ADA sampling times and had at least 1 non-missing postdose NAb result (imputed or analysis result).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Vaccine Only | Immunogenicity, as Measured by Neutralizing Antibodies (NAb) to REGN10933 | Nab Positive | 0 Participants |
| Vaccine Only | Immunogenicity, as Measured by Neutralizing Antibodies (NAb) to REGN10933 | NAb Negative | 27 Participants |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 IV | Immunogenicity, as Measured by Neutralizing Antibodies (NAb) to REGN10933 | Nab Positive | 2 Participants |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 IV | Immunogenicity, as Measured by Neutralizing Antibodies (NAb) to REGN10933 | NAb Negative | 25 Participants |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Immunogenicity, as Measured by Neutralizing Antibodies (NAb) to REGN10933 | Nab Positive | 1 Participants |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Immunogenicity, as Measured by Neutralizing Antibodies (NAb) to REGN10933 | NAb Negative | 26 Participants |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Immunogenicity, as Measured by Neutralizing Antibodies (NAb) to REGN10933 | NAb Negative | 22 Participants |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Immunogenicity, as Measured by Neutralizing Antibodies (NAb) to REGN10933 | Nab Positive | 8 Participants |
| REGN10933+REGN10987 + Vaccine 12 mg Day 1 IV | Immunogenicity, as Measured by Neutralizing Antibodies (NAb) to REGN10933 | NAb Negative | 23 Participants |
| REGN10933+REGN10987 + Vaccine 12 mg Day 1 IV | Immunogenicity, as Measured by Neutralizing Antibodies (NAb) to REGN10933 | Nab Positive | 7 Participants |
| REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC | Immunogenicity, as Measured by Neutralizing Antibodies (NAb) to REGN10933 | NAb Negative | 21 Participants |
| REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC | Immunogenicity, as Measured by Neutralizing Antibodies (NAb) to REGN10933 | Nab Positive | 2 Participants |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Immunogenicity, as Measured by Neutralizing Antibodies (NAb) to REGN10933 | NAb Negative | 32 Participants |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Immunogenicity, as Measured by Neutralizing Antibodies (NAb) to REGN10933 | Nab Positive | 2 Participants |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Immunogenicity, as Measured by Neutralizing Antibodies (NAb) to REGN10933 | NAb Negative | 32 Participants |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Immunogenicity, as Measured by Neutralizing Antibodies (NAb) to REGN10933 | Nab Positive | 3 Participants |
Secondary
Immunogenicity, as Measured by Neutralizing Antibodies (NAb) to REGN10987
Time frame: Up to Day 183
Population: The NAbS are defined for each study drug separately and comprises all treated participants (active) that were included in the AAS and tested negative at all ADA sampling times or tested positive at 1 or more postdose ADA sampling times and had at least 1 non-missing postdose NAb result (imputed or analysis result).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Vaccine Only | Immunogenicity, as Measured by Neutralizing Antibodies (NAb) to REGN10987 | NAb Negative | 16 Participants |
| Vaccine Only | Immunogenicity, as Measured by Neutralizing Antibodies (NAb) to REGN10987 | NAb Positive | 11 Participants |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 IV | Immunogenicity, as Measured by Neutralizing Antibodies (NAb) to REGN10987 | NAb Negative | 12 Participants |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 IV | Immunogenicity, as Measured by Neutralizing Antibodies (NAb) to REGN10987 | NAb Positive | 6 Participants |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Immunogenicity, as Measured by Neutralizing Antibodies (NAb) to REGN10987 | NAb Negative | 16 Participants |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Immunogenicity, as Measured by Neutralizing Antibodies (NAb) to REGN10987 | NAb Positive | 11 Participants |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Immunogenicity, as Measured by Neutralizing Antibodies (NAb) to REGN10987 | NAb Negative | 17 Participants |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Immunogenicity, as Measured by Neutralizing Antibodies (NAb) to REGN10987 | NAb Positive | 13 Participants |
| REGN10933+REGN10987 + Vaccine 12 mg Day 1 IV | Immunogenicity, as Measured by Neutralizing Antibodies (NAb) to REGN10987 | NAb Negative | 20 Participants |
| REGN10933+REGN10987 + Vaccine 12 mg Day 1 IV | Immunogenicity, as Measured by Neutralizing Antibodies (NAb) to REGN10987 | NAb Positive | 10 Participants |
| REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC | Immunogenicity, as Measured by Neutralizing Antibodies (NAb) to REGN10987 | NAb Negative | 15 Participants |
| REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC | Immunogenicity, as Measured by Neutralizing Antibodies (NAb) to REGN10987 | NAb Positive | 8 Participants |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Immunogenicity, as Measured by Neutralizing Antibodies (NAb) to REGN10987 | NAb Positive | 10 Participants |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Immunogenicity, as Measured by Neutralizing Antibodies (NAb) to REGN10987 | NAb Negative | 24 Participants |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Immunogenicity, as Measured by Neutralizing Antibodies (NAb) to REGN10987 | NAb Negative | 22 Participants |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Immunogenicity, as Measured by Neutralizing Antibodies (NAb) to REGN10987 | NAb Positive | 13 Participants |
Secondary
Median Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgA)
Anti-S1-RBD protein. Fold Change based on medians = (median value in vaccine only arm / median value in the active arm)
Time frame: Up to 365 Days from 1st dose of Vaccination
Population: Per protocol set (PPS) includes all randomized participants who have received both doses of vaccine and who do not meet the exclusion criteria. The PPS is the primary analysis set for assessing vaccine response related endpoints. As was pre-specified in the study protocol, only participants in the Vaccine Only and REGN10933+REGN10987 + Vaccine 1200 mg Day 7 Arm/Group were assessed for measure 6 days after the first vaccine,
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Vaccine Only | Median Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgA) | 168 Days after 1st Vaccine | 1.8 Fold Change |
| Vaccine Only | Median Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgA) | 56 Days after 1st Vaccine | 1.5 Fold Change |
| Vaccine Only | Median Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgA) | 14 Days after 1st Vaccine | 0.8 Fold Change |
| Vaccine Only | Median Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgA) | 28 Days after 1st Vaccine | 1.7 Fold Change |
| Vaccine Only | Median Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgA) | 252 Days after 1st Vaccine | 1.0 Fold Change |
| Vaccine Only | Median Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgA) | 42 Days after 1st Vaccine | 1.5 Fold Change |
| Vaccine Only | Median Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgA) | 365 Days after 1st Vaccine | 0.4 Fold Change |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 IV | Median Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgA) | 252 Days after 1st Vaccine | 1.4 Fold Change |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 IV | Median Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgA) | 14 Days after 1st Vaccine | 0.6 Fold Change |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 IV | Median Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgA) | 365 Days after 1st Vaccine | 0.9 Fold Change |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 IV | Median Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgA) | 28 Days after 1st Vaccine | 2.0 Fold Change |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 IV | Median Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgA) | 42 Days after 1st Vaccine | 1.6 Fold Change |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 IV | Median Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgA) | 56 Days after 1st Vaccine | 2.0 Fold Change |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 IV | Median Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgA) | 168 Days after 1st Vaccine | 4.3 Fold Change |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Median Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgA) | 365 Days after 1st Vaccine | 0.9 Fold Change |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Median Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgA) | 56 Days after 1st Vaccine | 1.8 Fold Change |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Median Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgA) | 14 Days after 1st Vaccine | 1.6 Fold Change |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Median Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgA) | 252 Days after 1st Vaccine | 1.3 Fold Change |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Median Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgA) | 42 Days after 1st Vaccine | 1.7 Fold Change |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Median Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgA) | 168 Days after 1st Vaccine | 1.8 Fold Change |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Median Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgA) | 28 Days after 1st Vaccine | 2.6 Fold Change |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Median Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgA) | 56 Days after 1st Vaccine | 1.7 Fold Change |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Median Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgA) | 28 Days after 1st Vaccine | 1.9 Fold Change |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Median Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgA) | 14 Days after 1st Vaccine | 1.1 Fold Change |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Median Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgA) | 42 Days after 1st Vaccine | 1.9 Fold Change |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Median Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgA) | 168 Days after 1st Vaccine | 1.0 Fold Change |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Median Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgA) | 252 Days after 1st Vaccine | 4.2 Fold Change |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Median Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgA) | 365 Days after 1st Vaccine | 0.9 Fold Change |
| REGN10933+REGN10987 + Vaccine 12 mg Day 1 IV | Median Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgA) | 28 Days after 1st Vaccine | 2.7 Fold Change |
| REGN10933+REGN10987 + Vaccine 12 mg Day 1 IV | Median Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgA) | 56 Days after 1st Vaccine | 2.4 Fold Change |
| REGN10933+REGN10987 + Vaccine 12 mg Day 1 IV | Median Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgA) | 168 Days after 1st Vaccine | 1.1 Fold Change |
| REGN10933+REGN10987 + Vaccine 12 mg Day 1 IV | Median Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgA) | 14 Days after 1st Vaccine | 1.9 Fold Change |
| REGN10933+REGN10987 + Vaccine 12 mg Day 1 IV | Median Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgA) | 365 Days after 1st Vaccine | 1.2 Fold Change |
| REGN10933+REGN10987 + Vaccine 12 mg Day 1 IV | Median Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgA) | 42 Days after 1st Vaccine | 1.9 Fold Change |
| REGN10933+REGN10987 + Vaccine 12 mg Day 1 IV | Median Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgA) | 252 Days after 1st Vaccine | 3.2 Fold Change |
| REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC | Median Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgA) | 42 Days after 1st Vaccine | 2.3 Fold Change |
| REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC | Median Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgA) | 56 Days after 1st Vaccine | 3.0 Fold Change |
| REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC | Median Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgA) | 365 Days after 1st Vaccine | 1.0 Fold Change |
| REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC | Median Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgA) | 168 Days after 1st Vaccine | 0.2 Fold Change |
| REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC | Median Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgA) | 28 Days after 1st Vaccine | 1.7 Fold Change |
| REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC | Median Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgA) | 6 Days after 1st Vaccine | 3.2 Fold Change |
| REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC | Median Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgA) | 252 Days after 1st Vaccine | 1.3 Fold Change |
| REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC | Median Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgA) | 14 Days after 1st Vaccine | 1.3 Fold Change |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Median Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgA) | 28 Days after 1st Vaccine | 1.4 Fold Change |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Median Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgA) | 365 Days after 1st Vaccine | 0.7 Fold Change |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Median Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgA) | 42 Days after 1st Vaccine | 2.1 Fold Change |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Median Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgA) | 252 Days after 1st Vaccine | 0.7 Fold Change |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Median Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgA) | 14 Days after 1st Vaccine | 1.0 Fold Change |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Median Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgA) | 56 Days after 1st Vaccine | 2.0 Fold Change |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Median Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgA) | 168 Days after 1st Vaccine | 2.9 Fold Change |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Median Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgA) | 168 Days after 1st Vaccine | 3.6 Fold Change |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Median Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgA) | 56 Days after 1st Vaccine | 2.3 Fold Change |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Median Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgA) | 28 Days after 1st Vaccine | 2.4 Fold Change |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Median Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgA) | 365 Days after 1st Vaccine | 0.9 Fold Change |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Median Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgA) | 42 Days after 1st Vaccine | 1.4 Fold Change |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Median Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgA) | 252 Days after 1st Vaccine | 1.0 Fold Change |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Median Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgA) | 14 Days after 1st Vaccine | 1.3 Fold Change |
Secondary
Number of Participants With Hypersensitivity Reactions (Grade ≥2) to REGN10933+REGN10987 or Each Dose of Moderna mRNA-1273 Vaccine
Grade 2 - characterized by an adverse local or general response from exposure and oral intervention indicated Grade 3 - hospitalization indicated and intravenous response required Grade 4 - Life Threatening consequence and urgent intervention indicated Grade 5 - Death
Time frame: Through Day 29 post-infusion or post-injection
Population: The safety analysis set (SAF) includes all randomized subjects who have been vaccinated with at least one dose or received any study drug; it is based on the treatment received (as treated). Groups assessment based on time and route of administration
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Vaccine Only | Number of Participants With Hypersensitivity Reactions (Grade ≥2) to REGN10933+REGN10987 or Each Dose of Moderna mRNA-1273 Vaccine | 0 Participants |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 IV | Number of Participants With Hypersensitivity Reactions (Grade ≥2) to REGN10933+REGN10987 or Each Dose of Moderna mRNA-1273 Vaccine | 0 Participants |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Number of Participants With Hypersensitivity Reactions (Grade ≥2) to REGN10933+REGN10987 or Each Dose of Moderna mRNA-1273 Vaccine | 0 Participants |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Number of Participants With Hypersensitivity Reactions (Grade ≥2) to REGN10933+REGN10987 or Each Dose of Moderna mRNA-1273 Vaccine | 0 Participants |
| REGN10933+REGN10987 + Vaccine 12 mg Day 1 IV | Number of Participants With Hypersensitivity Reactions (Grade ≥2) to REGN10933+REGN10987 or Each Dose of Moderna mRNA-1273 Vaccine | 0 Participants |
| REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC | Number of Participants With Hypersensitivity Reactions (Grade ≥2) to REGN10933+REGN10987 or Each Dose of Moderna mRNA-1273 Vaccine | 0 Participants |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Number of Participants With Hypersensitivity Reactions (Grade ≥2) to REGN10933+REGN10987 or Each Dose of Moderna mRNA-1273 Vaccine | 0 Participants |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Number of Participants With Hypersensitivity Reactions (Grade ≥2) to REGN10933+REGN10987 or Each Dose of Moderna mRNA-1273 Vaccine | 0 Participants |
| REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC | Number of Participants With Hypersensitivity Reactions (Grade ≥2) to REGN10933+REGN10987 or Each Dose of Moderna mRNA-1273 Vaccine | 1 Participants |
Secondary
Number of Participants With Infusion-related Reactions (Grade ≥2) to REGN10933+REGN10987
Time frame: Through Day 4 post-infusion
Population: The safety analysis set (SAF) includes all randomized subjects who have been vaccinated with at least one dose or received any study drug; it is based on the treatment received (as treated).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Vaccine Only | Number of Participants With Infusion-related Reactions (Grade ≥2) to REGN10933+REGN10987 | 0 Participants |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 IV | Number of Participants With Infusion-related Reactions (Grade ≥2) to REGN10933+REGN10987 | 0 Participants |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Number of Participants With Infusion-related Reactions (Grade ≥2) to REGN10933+REGN10987 | 0 Participants |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Number of Participants With Infusion-related Reactions (Grade ≥2) to REGN10933+REGN10987 | 0 Participants |
| REGN10933+REGN10987 + Vaccine 12 mg Day 1 IV | Number of Participants With Infusion-related Reactions (Grade ≥2) to REGN10933+REGN10987 | 0 Participants |
| REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC | Number of Participants With Infusion-related Reactions (Grade ≥2) to REGN10933+REGN10987 | 0 Participants |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Number of Participants With Infusion-related Reactions (Grade ≥2) to REGN10933+REGN10987 | 0 Participants |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Number of Participants With Infusion-related Reactions (Grade ≥2) to REGN10933+REGN10987 | 0 Participants |
| REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC | Number of Participants With Infusion-related Reactions (Grade ≥2) to REGN10933+REGN10987 | 0 Participants |
Secondary
Number of Participants With Injection Site Reactions (Grade ≥3) to Moderna mRNA-1273 Vaccine
Time frame: Through Day 4 post-infusion
Population: The safety analysis set (SAF) includes all randomized subjects who have been vaccinated with at least one dose or received any study drug; it is based on the treatment received (as treated).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Vaccine Only | Number of Participants With Injection Site Reactions (Grade ≥3) to Moderna mRNA-1273 Vaccine | 0 Participants |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 IV | Number of Participants With Injection Site Reactions (Grade ≥3) to Moderna mRNA-1273 Vaccine | 0 Participants |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Number of Participants With Injection Site Reactions (Grade ≥3) to Moderna mRNA-1273 Vaccine | 0 Participants |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Number of Participants With Injection Site Reactions (Grade ≥3) to Moderna mRNA-1273 Vaccine | 0 Participants |
| REGN10933+REGN10987 + Vaccine 12 mg Day 1 IV | Number of Participants With Injection Site Reactions (Grade ≥3) to Moderna mRNA-1273 Vaccine | 0 Participants |
| REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC | Number of Participants With Injection Site Reactions (Grade ≥3) to Moderna mRNA-1273 Vaccine | 0 Participants |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Number of Participants With Injection Site Reactions (Grade ≥3) to Moderna mRNA-1273 Vaccine | 0 Participants |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Number of Participants With Injection Site Reactions (Grade ≥3) to Moderna mRNA-1273 Vaccine | 0 Participants |
| REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC | Number of Participants With Injection Site Reactions (Grade ≥3) to Moderna mRNA-1273 Vaccine | 0 Participants |
Secondary
Number of Participants With Injection Site Reactions (Grade ≥3) to REGN10933+REGN10987
Time frame: Through Day 4 post-infusion
Population: The safety analysis set (SAF) includes all randomized subjects who have been vaccinated with at least one dose or received any study drug; it is based on the treatment received (as treated).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Vaccine Only | Number of Participants With Injection Site Reactions (Grade ≥3) to REGN10933+REGN10987 | 0 Participants |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 IV | Number of Participants With Injection Site Reactions (Grade ≥3) to REGN10933+REGN10987 | 0 Participants |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Number of Participants With Injection Site Reactions (Grade ≥3) to REGN10933+REGN10987 | 0 Participants |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Number of Participants With Injection Site Reactions (Grade ≥3) to REGN10933+REGN10987 | 0 Participants |
| REGN10933+REGN10987 + Vaccine 12 mg Day 1 IV | Number of Participants With Injection Site Reactions (Grade ≥3) to REGN10933+REGN10987 | 0 Participants |
| REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC | Number of Participants With Injection Site Reactions (Grade ≥3) to REGN10933+REGN10987 | 0 Participants |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Number of Participants With Injection Site Reactions (Grade ≥3) to REGN10933+REGN10987 | 0 Participants |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Number of Participants With Injection Site Reactions (Grade ≥3) to REGN10933+REGN10987 | 0 Participants |
| REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC | Number of Participants With Injection Site Reactions (Grade ≥3) to REGN10933+REGN10987 | 0 Participants |
Secondary
Number of Participants With Treatment-emergent Adverse Events (TEAEs) Throughout the Study
Time frame: Up to 401 Days
Population: The safety analysis set (SAF) includes all randomized subjects who have been vaccinated with at least one dose or received any study drug; it is based on the treatment received (as treated).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Vaccine Only | Number of Participants With Treatment-emergent Adverse Events (TEAEs) Throughout the Study | 22 Participants |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 IV | Number of Participants With Treatment-emergent Adverse Events (TEAEs) Throughout the Study | 13 Participants |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Number of Participants With Treatment-emergent Adverse Events (TEAEs) Throughout the Study | 16 Participants |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Number of Participants With Treatment-emergent Adverse Events (TEAEs) Throughout the Study | 17 Participants |
| REGN10933+REGN10987 + Vaccine 12 mg Day 1 IV | Number of Participants With Treatment-emergent Adverse Events (TEAEs) Throughout the Study | 15 Participants |
| REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC | Number of Participants With Treatment-emergent Adverse Events (TEAEs) Throughout the Study | 16 Participants |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Number of Participants With Treatment-emergent Adverse Events (TEAEs) Throughout the Study | 13 Participants |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Number of Participants With Treatment-emergent Adverse Events (TEAEs) Throughout the Study | 16 Participants |
| REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC | Number of Participants With Treatment-emergent Adverse Events (TEAEs) Throughout the Study | 23 Participants |
Secondary
Number of Participants With Treatment-emergent Serious Adverse Events (SAEs) Throughout the Study
Time frame: Up to 401 Days
Population: The safety analysis set (SAF) includes all randomized subjects who have been vaccinated with at least one dose or received any study drug; it is based on the treatment received (as treated).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Vaccine Only | Number of Participants With Treatment-emergent Serious Adverse Events (SAEs) Throughout the Study | 2 Participants |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 IV | Number of Participants With Treatment-emergent Serious Adverse Events (SAEs) Throughout the Study | 0 Participants |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Number of Participants With Treatment-emergent Serious Adverse Events (SAEs) Throughout the Study | 0 Participants |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Number of Participants With Treatment-emergent Serious Adverse Events (SAEs) Throughout the Study | 0 Participants |
| REGN10933+REGN10987 + Vaccine 12 mg Day 1 IV | Number of Participants With Treatment-emergent Serious Adverse Events (SAEs) Throughout the Study | 0 Participants |
| REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC | Number of Participants With Treatment-emergent Serious Adverse Events (SAEs) Throughout the Study | 0 Participants |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Number of Participants With Treatment-emergent Serious Adverse Events (SAEs) Throughout the Study | 2 Participants |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Number of Participants With Treatment-emergent Serious Adverse Events (SAEs) Throughout the Study | 1 Participants |
| REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC | Number of Participants With Treatment-emergent Serious Adverse Events (SAEs) Throughout the Study | 0 Participants |
Secondary
Relative Difference Expressed as a Percent in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgM)
Anti-S protein (Spike protein) Relative difference is calculated as: \[(LS Geometric Mean Active Arm - LS Geometric Mean Vaccine Alone Arm) / LS Geometric Mean Vaccine Alone Arm\] x 100%
Time frame: Up to 365 Days from 1st dose of vaccination
Population: Per protocol set (PPS) includes all randomized participants who have received both doses of vaccine and who do not meet the exclusion criteria. The PPS is the primary analysis set for assessing vaccine response related endpoints.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Vaccine Only | Relative Difference Expressed as a Percent in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgM) | 28 Days after 1st Vaccine | -56.7 Percent |
| Vaccine Only | Relative Difference Expressed as a Percent in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgM) | 14 Days after 1st Vaccine | -42.1 Percent |
| Vaccine Only | Relative Difference Expressed as a Percent in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgM) | 252 Days after 1st Vaccine | -19.7 Percent |
| Vaccine Only | Relative Difference Expressed as a Percent in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgM) | 56 Days after 1st Vaccine | -37.3 Percent |
| Vaccine Only | Relative Difference Expressed as a Percent in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgM) | 168 Days after 1st Vaccine | -29.0 Percent |
| Vaccine Only | Relative Difference Expressed as a Percent in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgM) | 365 Days after 1st Vaccine | 4.0 Percent |
| Vaccine Only | Relative Difference Expressed as a Percent in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgM) | 42 Days after 1st Vaccine | -32.5 Percent |
| Vaccine Only | Relative Difference Expressed as a Percent in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgM) | Baseline | 8.9 Percent |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 IV | Relative Difference Expressed as a Percent in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgM) | 56 Days after 1st Vaccine | -61.7 Percent |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 IV | Relative Difference Expressed as a Percent in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgM) | 252 Days after 1st Vaccine | -31.0 Percent |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 IV | Relative Difference Expressed as a Percent in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgM) | 42 Days after 1st Vaccine | -63.0 Percent |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 IV | Relative Difference Expressed as a Percent in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgM) | 365 Days after 1st Vaccine | -1.3 Percent |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 IV | Relative Difference Expressed as a Percent in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgM) | Baseline | 14.7 Percent |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 IV | Relative Difference Expressed as a Percent in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgM) | 168 Days after 1st Vaccine | -33.0 Percent |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 IV | Relative Difference Expressed as a Percent in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgM) | 14 Days after 1st Vaccine | -58.9 Percent |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 IV | Relative Difference Expressed as a Percent in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgM) | 28 Days after 1st Vaccine | -69.2 Percent |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Relative Difference Expressed as a Percent in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgM) | 28 Days after 1st Vaccine | -64.6 Percent |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Relative Difference Expressed as a Percent in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgM) | 14 Days after 1st Vaccine | -60.1 Percent |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Relative Difference Expressed as a Percent in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgM) | 365 Days after 1st Vaccine | -5.7 Percent |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Relative Difference Expressed as a Percent in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgM) | 168 Days after 1st Vaccine | -19.5 Percent |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Relative Difference Expressed as a Percent in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgM) | 252 Days after 1st Vaccine | -21.1 Percent |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Relative Difference Expressed as a Percent in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgM) | 42 Days after 1st Vaccine | -56.9 Percent |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Relative Difference Expressed as a Percent in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgM) | 56 Days after 1st Vaccine | -62.8 Percent |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Relative Difference Expressed as a Percent in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgM) | Baseline | 6.3 Percent |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Relative Difference Expressed as a Percent in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgM) | 14 Days after 1st Vaccine | -54.7 Percent |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Relative Difference Expressed as a Percent in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgM) | 168 Days after 1st Vaccine | 9.4 Percent |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Relative Difference Expressed as a Percent in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgM) | Baseline | -12.1 Percent |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Relative Difference Expressed as a Percent in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgM) | 252 Days after 1st Vaccine | -22.1 Percent |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Relative Difference Expressed as a Percent in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgM) | 28 Days after 1st Vaccine | -50.2 Percent |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Relative Difference Expressed as a Percent in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgM) | 42 Days after 1st Vaccine | -7.5 Percent |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Relative Difference Expressed as a Percent in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgM) | 365 Days after 1st Vaccine | 1.2 Percent |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Relative Difference Expressed as a Percent in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgM) | 56 Days after 1st Vaccine | -20.3 Percent |
| REGN10933+REGN10987 + Vaccine 12 mg Day 1 IV | Relative Difference Expressed as a Percent in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgM) | 56 Days after 1st Vaccine | -34.4 Percent |
| REGN10933+REGN10987 + Vaccine 12 mg Day 1 IV | Relative Difference Expressed as a Percent in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgM) | 365 Days after 1st Vaccine | -9.5 Percent |
| REGN10933+REGN10987 + Vaccine 12 mg Day 1 IV | Relative Difference Expressed as a Percent in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgM) | 168 Days after 1st Vaccine | -14.8 Percent |
| REGN10933+REGN10987 + Vaccine 12 mg Day 1 IV | Relative Difference Expressed as a Percent in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgM) | 252 Days after 1st Vaccine | -17.5 Percent |
| REGN10933+REGN10987 + Vaccine 12 mg Day 1 IV | Relative Difference Expressed as a Percent in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgM) | 14 Days after 1st Vaccine | -66.8 Percent |
| REGN10933+REGN10987 + Vaccine 12 mg Day 1 IV | Relative Difference Expressed as a Percent in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgM) | 28 Days after 1st Vaccine | -61.6 Percent |
| REGN10933+REGN10987 + Vaccine 12 mg Day 1 IV | Relative Difference Expressed as a Percent in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgM) | Baseline | 3.9 Percent |
| REGN10933+REGN10987 + Vaccine 12 mg Day 1 IV | Relative Difference Expressed as a Percent in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgM) | 42 Days after 1st Vaccine | -19.2 Percent |
| REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC | Relative Difference Expressed as a Percent in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgM) | 56 Days after 1st Vaccine | -14.4 Percent |
| REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC | Relative Difference Expressed as a Percent in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgM) | 28 Days after 1st Vaccine | -31.7 Percent |
| REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC | Relative Difference Expressed as a Percent in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgM) | Baseline | -7.3 Percent |
| REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC | Relative Difference Expressed as a Percent in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgM) | 14 Days after 1st Vaccine | -21.8 Percent |
| REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC | Relative Difference Expressed as a Percent in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgM) | 42 Days after 1st Vaccine | -21.1 Percent |
| REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC | Relative Difference Expressed as a Percent in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgM) | 168 Days after 1st Vaccine | 17.4 Percent |
| REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC | Relative Difference Expressed as a Percent in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgM) | 252 Days after 1st Vaccine | -3.1 Percent |
| REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC | Relative Difference Expressed as a Percent in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgM) | 365 Days after 1st Vaccine | 5.6 Percent |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Relative Difference Expressed as a Percent in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgM) | 42 Days after 1st Vaccine | -46.7 Percent |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Relative Difference Expressed as a Percent in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgM) | 14 Days after 1st Vaccine | -40.2 Percent |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Relative Difference Expressed as a Percent in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgM) | 365 Days after 1st Vaccine | -3.0 Percent |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Relative Difference Expressed as a Percent in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgM) | 252 Days after 1st Vaccine | -4.5 Percent |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Relative Difference Expressed as a Percent in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgM) | Baseline | -13.3 Percent |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Relative Difference Expressed as a Percent in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgM) | 168 Days after 1st Vaccine | -37.2 Percent |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Relative Difference Expressed as a Percent in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgM) | 56 Days after 1st Vaccine | -45.1 Percent |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Relative Difference Expressed as a Percent in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgM) | 28 Days after 1st Vaccine | -52.7 Percent |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Relative Difference Expressed as a Percent in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgM) | 168 Days after 1st Vaccine | -35.9 Percent |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Relative Difference Expressed as a Percent in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgM) | 28 Days after 1st Vaccine | -58.7 Percent |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Relative Difference Expressed as a Percent in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgM) | 14 Days after 1st Vaccine | -44.7 Percent |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Relative Difference Expressed as a Percent in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgM) | 42 Days after 1st Vaccine | -43.7 Percent |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Relative Difference Expressed as a Percent in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgM) | Baseline | -5.8 Percent |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Relative Difference Expressed as a Percent in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgM) | 56 Days after 1st Vaccine | -39.3 Percent |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Relative Difference Expressed as a Percent in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgM) | 365 Days after 1st Vaccine | 27.1 Percent |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Relative Difference Expressed as a Percent in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgM) | 252 Days after 1st Vaccine | -2.6 Percent |
Secondary
Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgA)
Anti-S1-RBD protein. Relative difference is calculated as: \[(LS Geometric Mean Active Arm - LS Geometric Mean Vaccine Alone Arm) / LS Geometric Mean Vaccine Alone Arm\] x 100%
Time frame: Up to 365 Days from 1st dose of Vaccination
Population: Per protocol set (PPS) includes all randomized participants who have received both doses of vaccine and who do not meet the exclusion criteria. The PPS is the primary analysis set for assessing vaccine response related endpoints. As was pre-specified in the study protocol, only participants in the Vaccine Only and REGN10933+REGN10987 + Vaccine 1200 mg Day 7 Arm/Group were assessed for measure 6 days after the first vaccine.
| Arm | Measure | Group | Value (GEOMETRIC_LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Vaccine Only | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgA) | 14 Days after 1st Vaccine | -15.3 Percent |
| Vaccine Only | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgA) | 42 Days after 1st Vaccine | -28.3 Percent |
| Vaccine Only | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgA) | Baseline | -9.8 Percent |
| Vaccine Only | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgA) | 56 Days after 1st Vaccine | -31.6 Percent |
| Vaccine Only | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgA) | 252 Days after 1st Vaccine | -23.2 Percent |
| Vaccine Only | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgA) | 28 Days after 1st Vaccine | -37.3 Percent |
| Vaccine Only | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgA) | 365 Days after 1st Vaccine | 78.4 Percent |
| Vaccine Only | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgA) | 168 Days after 1st Vaccine | -49.8 Percent |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 IV | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgA) | 42 Days after 1st Vaccine | -28.3 Percent |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 IV | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgA) | 365 Days after 1st Vaccine | 0.6 Percent |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 IV | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgA) | 168 Days after 1st Vaccine | -71.8 Percent |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 IV | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgA) | 14 Days after 1st Vaccine | -6.2 Percent |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 IV | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgA) | 56 Days after 1st Vaccine | -44.7 Percent |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 IV | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgA) | 252 Days after 1st Vaccine | -49.4 Percent |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 IV | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgA) | 28 Days after 1st Vaccine | -48.6 Percent |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 IV | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgA) | Baseline | -2.3 Percent |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgA) | 56 Days after 1st Vaccine | -41.8 Percent |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgA) | 168 Days after 1st Vaccine | -47.8 Percent |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgA) | Baseline | -10.1 Percent |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgA) | 365 Days after 1st Vaccine | 39.0 Percent |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgA) | 42 Days after 1st Vaccine | -29.8 Percent |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgA) | 14 Days after 1st Vaccine | -43.6 Percent |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgA) | 28 Days after 1st Vaccine | -52.3 Percent |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgA) | 252 Days after 1st Vaccine | -16.9 Percent |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgA) | 56 Days after 1st Vaccine | -28.9 Percent |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgA) | 42 Days after 1st Vaccine | -22.3 Percent |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgA) | Baseline | 5.0 Percent |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgA) | 28 Days after 1st Vaccine | -43.6 Percent |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgA) | 168 Days after 1st Vaccine | 7.1 Percent |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgA) | 365 Days after 1st Vaccine | 3.0 Percent |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgA) | 14 Days after 1st Vaccine | -31.6 Percent |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgA) | 252 Days after 1st Vaccine | -59.9 Percent |
| REGN10933+REGN10987 + Vaccine 12 mg Day 1 IV | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgA) | 14 Days after 1st Vaccine | -33.9 Percent |
| REGN10933+REGN10987 + Vaccine 12 mg Day 1 IV | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgA) | Baseline | 13.7 Percent |
| REGN10933+REGN10987 + Vaccine 12 mg Day 1 IV | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgA) | 252 Days after 1st Vaccine | -58.1 Percent |
| REGN10933+REGN10987 + Vaccine 12 mg Day 1 IV | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgA) | 168 Days after 1st Vaccine | -41.2 Percent |
| REGN10933+REGN10987 + Vaccine 12 mg Day 1 IV | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgA) | 56 Days after 1st Vaccine | -59.9 Percent |
| REGN10933+REGN10987 + Vaccine 12 mg Day 1 IV | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgA) | 42 Days after 1st Vaccine | -53.3 Percent |
| REGN10933+REGN10987 + Vaccine 12 mg Day 1 IV | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgA) | 365 Days after 1st Vaccine | -19.7 Percent |
| REGN10933+REGN10987 + Vaccine 12 mg Day 1 IV | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgA) | 28 Days after 1st Vaccine | -51.6 Percent |
| REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgA) | 14 Days after 1st Vaccine | -35.0 Percent |
| REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgA) | 28 Days after 1st Vaccine | -32.5 Percent |
| REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgA) | 56 Days after 1st Vaccine | -55.1 Percent |
| REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgA) | Baseline | 13.3 Percent |
| REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgA) | 6 Days after 1st Vaccine | -28.7 Percent |
| REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgA) | 42 Days after 1st Vaccine | -54.6 Percent |
| REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgA) | 168 Days after 1st Vaccine | 66.1 Percent |
| REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgA) | 252 Days after 1st Vaccine | -23.4 Percent |
| REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgA) | 365 Days after 1st Vaccine | 19.5 Percent |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgA) | 14 Days after 1st Vaccine | 5.2 Percent |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgA) | 365 Days after 1st Vaccine | 30.4 Percent |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgA) | Baseline | 6.0 Percent |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgA) | 56 Days after 1st Vaccine | -41.9 Percent |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgA) | 42 Days after 1st Vaccine | -39.4 Percent |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgA) | 252 Days after 1st Vaccine | 6.9 Percent |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgA) | 168 Days after 1st Vaccine | -59.3 Percent |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgA) | 28 Days after 1st Vaccine | -24.0 Percent |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgA) | 168 Days after 1st Vaccine | -72.7 Percent |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgA) | 42 Days after 1st Vaccine | -32.6 Percent |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgA) | 28 Days after 1st Vaccine | -50.9 Percent |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgA) | 14 Days after 1st Vaccine | -3.2 Percent |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgA) | 252 Days after 1st Vaccine | -26.2 Percent |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgA) | Baseline | -4.7 Percent |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgA) | 365 Days after 1st Vaccine | 31.6 Percent |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgA) | 56 Days after 1st Vaccine | -40.9 Percent |
Secondary
Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgG)
Anti-S1-RBD protein Relative difference is calculated as: \[(LS Geometric Mean Active Arm - LS Geometric Mean Vaccine Alone Arm) / LS Geometric Mean Vaccine Alone Arm\] x 100%
Time frame: Up to 365 Days from 1st dose of vaccination
Population: Per protocol set (PPS) includes all randomized participants who have received both doses of vaccine and who do not meet the exclusion criteria. The PPS is the primary analysis set for assessing vaccine response related endpoints. As was pre-specified in the study protocol, only participants in the Vaccine Only and REGN10933+REGN10987 + Vaccine 1200 mg Day 7 Arm/Group were assessed for measure 6 days after the first vaccine.
| Arm | Measure | Group | Value (GEOMETRIC_LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Vaccine Only | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgG) | Baseline | 58.3 Percent |
| Vaccine Only | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgG) | 365 Days after 1st Vaccine | 102.8 Percent |
| Vaccine Only | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgG) | 252 Days after 1st Vaccine | -3.9 Percent |
| Vaccine Only | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgG) | 56 Days after 1st Vaccine | 14.8 Percent |
| Vaccine Only | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgG) | 42 Days after 1st Vaccine | -11.8 Percent |
| Vaccine Only | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgG) | 14 Days after 1st Vaccine | -35.5 Percent |
| Vaccine Only | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgG) | 28 Days after 1st Vaccine | -50.8 Percent |
| Vaccine Only | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgG) | 168 Days after 1st Vaccine | -26.0 Percent |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 IV | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgG) | Baseline | 7.3 Percent |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 IV | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgG) | 168 Days after 1st Vaccine | -50.5 Percent |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 IV | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgG) | 42 Days after 1st Vaccine | -41.2 Percent |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 IV | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgG) | 365 Days after 1st Vaccine | 63.5 Percent |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 IV | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgG) | 56 Days after 1st Vaccine | -29.3 Percent |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 IV | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgG) | 252 Days after 1st Vaccine | -48.3 Percent |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 IV | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgG) | 14 Days after 1st Vaccine | -53.3 Percent |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 IV | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgG) | 28 Days after 1st Vaccine | -66.0 Percent |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgG) | 252 Days after 1st Vaccine | 10.5 Percent |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgG) | 42 Days after 1st Vaccine | -40.7 Percent |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgG) | 56 Days after 1st Vaccine | -34.5 Percent |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgG) | 365 Days after 1st Vaccine | 45.5 Percent |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgG) | 168 Days after 1st Vaccine | -20.4 Percent |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgG) | Baseline | -13.0 Percent |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgG) | 28 Days after 1st Vaccine | -71.3 Percent |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgG) | 14 Days after 1st Vaccine | -59.9 Percent |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgG) | 14 Days after 1st Vaccine | -38.5 Percent |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgG) | Baseline | 27.5 Percent |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgG) | 252 Days after 1st Vaccine | -6.6 Percent |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgG) | 42 Days after 1st Vaccine | -0.0 Percent |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgG) | 168 Days after 1st Vaccine | 60.7 Percent |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgG) | 28 Days after 1st Vaccine | -43.2 Percent |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgG) | 365 Days after 1st Vaccine | 2.7 Percent |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgG) | 56 Days after 1st Vaccine | -0.3 Percent |
| REGN10933+REGN10987 + Vaccine 12 mg Day 1 IV | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgG) | Baseline | 25.8 Percent |
| REGN10933+REGN10987 + Vaccine 12 mg Day 1 IV | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgG) | 14 Days after 1st Vaccine | -56.2 Percent |
| REGN10933+REGN10987 + Vaccine 12 mg Day 1 IV | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgG) | 28 Days after 1st Vaccine | -60.6 Percent |
| REGN10933+REGN10987 + Vaccine 12 mg Day 1 IV | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgG) | 42 Days after 1st Vaccine | -44.0 Percent |
| REGN10933+REGN10987 + Vaccine 12 mg Day 1 IV | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgG) | 56 Days after 1st Vaccine | -10.8 Percent |
| REGN10933+REGN10987 + Vaccine 12 mg Day 1 IV | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgG) | 168 Days after 1st Vaccine | -3.1 Percent |
| REGN10933+REGN10987 + Vaccine 12 mg Day 1 IV | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgG) | 252 Days after 1st Vaccine | -1.4 Percent |
| REGN10933+REGN10987 + Vaccine 12 mg Day 1 IV | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgG) | 365 Days after 1st Vaccine | -14.9 Percent |
| REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgG) | 28 Days after 1st Vaccine | -40.7 Percent |
| REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgG) | 252 Days after 1st Vaccine | 48.4 Percent |
| REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgG) | 14 Days after 1st Vaccine | -16.4 Percent |
| REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgG) | 6 Days after 1st Vaccine | 43.3 Percent |
| REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgG) | 365 Days after 1st Vaccine | -27.8 Percent |
| REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgG) | Baseline | 18.2 Percent |
| REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgG) | 56 Days after 1st Vaccine | -19.1 Percent |
| REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgG) | 42 Days after 1st Vaccine | -46.4 Percent |
| REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgG) | 168 Days after 1st Vaccine | 135.3 Percent |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgG) | 28 Days after 1st Vaccine | -46.4 Percent |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgG) | 56 Days after 1st Vaccine | -28.3 Percent |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgG) | 14 Days after 1st Vaccine | -44.1 Percent |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgG) | 365 Days after 1st Vaccine | 82.8 Percent |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgG) | 168 Days after 1st Vaccine | -45.2 Percent |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgG) | Baseline | -14.3 Percent |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgG) | 252 Days after 1st Vaccine | 19.1 Percent |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgG) | 42 Days after 1st Vaccine | -30.3 Percent |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgG) | 365 Days after 1st Vaccine | 145.7 Percent |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgG) | 252 Days after 1st Vaccine | 1.8 Percent |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgG) | 14 Days after 1st Vaccine | -39.1 Percent |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgG) | 56 Days after 1st Vaccine | -14.2 Percent |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgG) | 42 Days after 1st Vaccine | -27.5 Percent |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgG) | 28 Days after 1st Vaccine | -52.0 Percent |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgG) | Baseline | -9.0 Percent |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgG) | 168 Days after 1st Vaccine | -45.2 Percent |
Secondary
Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgM)
Anti-S1-RBD protein Relative difference is calculated as: \[(LS Geometric Mean Active Arm - LS Geometric Mean Vaccine Alone Arm) / LS Geometric Mean Vaccine Alone Arm\] x 100%
Time frame: Up to 365 Days from 1st dose of vaccination
Population: Per protocol set (PPS) includes all randomized participants who have received both doses of vaccine and who do not meet the exclusion criteria. The PPS is the primary analysis set for assessing vaccine response related endpoints.
| Arm | Measure | Group | Value (GEOMETRIC_LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Vaccine Only | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgM) | 28 Days after 1st Vaccine | -46.6 Percent |
| Vaccine Only | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgM) | 14 Days after 1st Vaccine | -43.7 Percent |
| Vaccine Only | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgM) | Baseline | 5.9 Percent |
| Vaccine Only | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgM) | 42 Days after 1st Vaccine | -22.7 Percent |
| Vaccine Only | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgM) | 56 Days after 1st Vaccine | -33.6 Percent |
| Vaccine Only | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgM) | 168 Days after 1st Vaccine | -18.5 Percent |
| Vaccine Only | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgM) | 252 Days after 1st Vaccine | -15.2 Percent |
| Vaccine Only | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgM) | 365 Days after 1st Vaccine | -4.0 Percent |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 IV | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgM) | 56 Days after 1st Vaccine | -58.2 Percent |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 IV | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgM) | 28 Days after 1st Vaccine | -53.6 Percent |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 IV | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgM) | 168 Days after 1st Vaccine | -30.5 Percent |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 IV | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgM) | 252 Days after 1st Vaccine | -20.0 Percent |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 IV | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgM) | Baseline | 3.5 Percent |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 IV | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgM) | 42 Days after 1st Vaccine | -55.9 Percent |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 IV | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgM) | 14 Days after 1st Vaccine | -50.9 Percent |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 IV | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgM) | 365 Days after 1st Vaccine | -12.4 Percent |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgM) | 252 Days after 1st Vaccine | -19.3 Percent |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgM) | 56 Days after 1st Vaccine | -56.6 Percent |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgM) | 365 Days after 1st Vaccine | -6.6 Percent |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgM) | 28 Days after 1st Vaccine | -53.3 Percent |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgM) | 168 Days after 1st Vaccine | -17.8 Percent |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgM) | 42 Days after 1st Vaccine | -51.5 Percent |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgM) | Baseline | -1.5 Percent |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgM) | 14 Days after 1st Vaccine | -54.7 Percent |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgM) | 365 Days after 1st Vaccine | 8.3 Percent |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgM) | 14 Days after 1st Vaccine | -36.7 Percent |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgM) | Baseline | -4.7 Percent |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgM) | 42 Days after 1st Vaccine | 8.0 Percent |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgM) | 28 Days after 1st Vaccine | -26.5 Percent |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgM) | 56 Days after 1st Vaccine | -16.8 Percent |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgM) | 168 Days after 1st Vaccine | 6.8 Percent |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgM) | 252 Days after 1st Vaccine | -17.2 Percent |
| REGN10933+REGN10987 + Vaccine 12 mg Day 1 IV | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgM) | 42 Days after 1st Vaccine | -18.2 Percent |
| REGN10933+REGN10987 + Vaccine 12 mg Day 1 IV | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgM) | 252 Days after 1st Vaccine | -22.3 Percent |
| REGN10933+REGN10987 + Vaccine 12 mg Day 1 IV | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgM) | 28 Days after 1st Vaccine | -52.0 Percent |
| REGN10933+REGN10987 + Vaccine 12 mg Day 1 IV | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgM) | Baseline | 6.0 Percent |
| REGN10933+REGN10987 + Vaccine 12 mg Day 1 IV | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgM) | 365 Days after 1st Vaccine | -19.1 Percent |
| REGN10933+REGN10987 + Vaccine 12 mg Day 1 IV | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgM) | 56 Days after 1st Vaccine | -32.9 Percent |
| REGN10933+REGN10987 + Vaccine 12 mg Day 1 IV | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgM) | 168 Days after 1st Vaccine | -23.8 Percent |
| REGN10933+REGN10987 + Vaccine 12 mg Day 1 IV | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgM) | 14 Days after 1st Vaccine | -62.8 Percent |
| REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgM) | 365 Days after 1st Vaccine | 13.5 Percent |
| REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgM) | 14 Days after 1st Vaccine | -10.9 Percent |
| REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgM) | 28 Days after 1st Vaccine | -15.5 Percent |
| REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgM) | Baseline | 3.6 Percent |
| REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgM) | 252 Days after 1st Vaccine | -13.0 Percent |
| REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgM) | 168 Days after 1st Vaccine | 3.2 Percent |
| REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgM) | 56 Days after 1st Vaccine | -14.0 Percent |
| REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgM) | 42 Days after 1st Vaccine | -20.2 Percent |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgM) | 28 Days after 1st Vaccine | -27.7 Percent |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgM) | 14 Days after 1st Vaccine | -34.9 Percent |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgM) | 42 Days after 1st Vaccine | -36.3 Percent |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgM) | 56 Days after 1st Vaccine | -37.7 Percent |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgM) | 168 Days after 1st Vaccine | -27.3 Percent |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgM) | 365 Days after 1st Vaccine | -8.7 Percent |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgM) | 252 Days after 1st Vaccine | 20.6 Percent |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgM) | Baseline | -1.7 Percent |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgM) | 365 Days after 1st Vaccine | 8.1 Percent |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgM) | 168 Days after 1st Vaccine | -35.4 Percent |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgM) | 56 Days after 1st Vaccine | -42.3 Percent |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgM) | 42 Days after 1st Vaccine | -43.0 Percent |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgM) | 28 Days after 1st Vaccine | -51.3 Percent |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgM) | 14 Days after 1st Vaccine | -41.0 Percent |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgM) | Baseline | -4.9 Percent |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgM) | 252 Days after 1st Vaccine | 6.4 Percent |
Secondary
Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgA)
Anti-S protein Relative difference is calculated as: \[(LS Geometric Mean Active Arm - LS Geometric Mean Vaccine Alone Arm) / LS Geometric Mean Vaccine Alone Arm\] x 100%
Time frame: Up to 365 Days from 1st dose of Vaccination
Population: Per protocol set (PPS) includes all randomized participants who have received both doses of vaccine and who do not meet the exclusion criteria. The PPS is the primary analysis set for assessing vaccine response related endpoints. As was pre-specified in the study protocol, only participants in the Vaccine Only and REGN10933+REGN10987 + Vaccine 1200 mg Day 7 Arm/Group were assessed for measure 6 days after the first vaccine.
| Arm | Measure | Group | Value (GEOMETRIC_LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Vaccine Only | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgA) | 28 Days after 1st Vaccine | -36.8 Percent |
| Vaccine Only | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgA) | 14 Days after 1st Vaccine | -3.7 Percent |
| Vaccine Only | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgA) | 365 Days after 1st Vaccine | 44.4 Percent |
| Vaccine Only | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgA) | 252 Days after 1st Vaccine | -23.9 Percent |
| Vaccine Only | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgA) | 168 Days after 1st Vaccine | -41.5 Percent |
| Vaccine Only | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgA) | 56 Days after 1st Vaccine | -21.5 Percent |
| Vaccine Only | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgA) | 42 Days after 1st Vaccine | -18.5 Percent |
| Vaccine Only | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgA) | Baseline | 0.8 Percent |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 IV | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgA) | Baseline | -20.2 Percent |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 IV | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgA) | 365 Days after 1st Vaccine | 4.4 Percent |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 IV | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgA) | 14 Days after 1st Vaccine | 1.8 Percent |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 IV | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgA) | 28 Days after 1st Vaccine | -50.5 Percent |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 IV | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgA) | 42 Days after 1st Vaccine | -24.0 Percent |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 IV | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgA) | 56 Days after 1st Vaccine | -35.0 Percent |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 IV | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgA) | 168 Days after 1st Vaccine | -66.8 Percent |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 IV | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgA) | 252 Days after 1st Vaccine | -47.5 Percent |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgA) | 168 Days after 1st Vaccine | -46.7 Percent |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgA) | 365 Days after 1st Vaccine | 11.3 Percent |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgA) | Baseline | -8.8 Percent |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgA) | 42 Days after 1st Vaccine | -25.3 Percent |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgA) | 56 Days after 1st Vaccine | -42.7 Percent |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgA) | 14 Days after 1st Vaccine | -34.7 Percent |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgA) | 252 Days after 1st Vaccine | -23.6 Percent |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgA) | 28 Days after 1st Vaccine | -53.6 Percent |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgA) | 168 Days after 1st Vaccine | 11.4 Percent |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgA) | 56 Days after 1st Vaccine | -22.8 Percent |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgA) | 28 Days after 1st Vaccine | -44.2 Percent |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgA) | 14 Days after 1st Vaccine | -22.9 Percent |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgA) | Baseline | 3.0 Percent |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgA) | 42 Days after 1st Vaccine | -16.5 Percent |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgA) | 252 Days after 1st Vaccine | -63.8 Percent |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgA) | 365 Days after 1st Vaccine | -7.6 Percent |
| REGN10933+REGN10987 + Vaccine 12 mg Day 1 IV | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgA) | 252 Days after 1st Vaccine | -58.4 Percent |
| REGN10933+REGN10987 + Vaccine 12 mg Day 1 IV | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgA) | 28 Days after 1st Vaccine | -51.8 Percent |
| REGN10933+REGN10987 + Vaccine 12 mg Day 1 IV | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgA) | 42 Days after 1st Vaccine | -39.4 Percent |
| REGN10933+REGN10987 + Vaccine 12 mg Day 1 IV | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgA) | Baseline | -3.2 Percent |
| REGN10933+REGN10987 + Vaccine 12 mg Day 1 IV | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgA) | 56 Days after 1st Vaccine | -54.5 Percent |
| REGN10933+REGN10987 + Vaccine 12 mg Day 1 IV | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgA) | 365 Days after 1st Vaccine | -17.6 Percent |
| REGN10933+REGN10987 + Vaccine 12 mg Day 1 IV | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgA) | 168 Days after 1st Vaccine | -36.9 Percent |
| REGN10933+REGN10987 + Vaccine 12 mg Day 1 IV | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgA) | 14 Days after 1st Vaccine | -27.4 Percent |
| REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgA) | 42 Days after 1st Vaccine | -39.8 Percent |
| REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgA) | 168 Days after 1st Vaccine | 63.2 Percent |
| REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgA) | 365 Days after 1st Vaccine | -0.0 Percent |
| REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgA) | 28 Days after 1st Vaccine | -40.4 Percent |
| REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgA) | 252 Days after 1st Vaccine | -29.9 Percent |
| REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgA) | 6 Days after 1st Vaccine | -2.3 Percent |
| REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgA) | 56 Days after 1st Vaccine | -47.5 Percent |
| REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgA) | Baseline | 2.2 Percent |
| REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgA) | 14 Days after 1st Vaccine | -21.6 Percent |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgA) | 56 Days after 1st Vaccine | -33.5 Percent |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgA) | 14 Days after 1st Vaccine | 10.4 Percent |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgA) | 252 Days after 1st Vaccine | 18.1 Percent |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgA) | 42 Days after 1st Vaccine | -29.9 Percent |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgA) | 168 Days after 1st Vaccine | -56.8 Percent |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgA) | Baseline | -23.1 Percent |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgA) | 365 Days after 1st Vaccine | 13.2 Percent |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgA) | 28 Days after 1st Vaccine | -23.9 Percent |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgA) | 365 Days after 1st Vaccine | 26.0 Percent |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgA) | Baseline | -5.6 Percent |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgA) | 14 Days after 1st Vaccine | 8.8 Percent |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgA) | 28 Days after 1st Vaccine | -48.7 Percent |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgA) | 42 Days after 1st Vaccine | -36.7 Percent |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgA) | 56 Days after 1st Vaccine | -39.9 Percent |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgA) | 168 Days after 1st Vaccine | -70.1 Percent |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgA) | 252 Days after 1st Vaccine | -23.9 Percent |
Secondary
Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgG)
Anti-S protein (Spike) Relative difference is calculated as: \[(LS Geometric Mean Active Arm - LS Geometric Mean Vaccine Alone Arm) / LS Geometric Mean Vaccine Alone Arm\] x 100%
Time frame: Up to 365 Days from 1st dose of vaccination
Population: Per protocol set (PPS) includes all randomized participants who have received both doses of vaccine and who do not meet the exclusion criteria. The PPS is the primary analysis set for assessing vaccine response related endpoints. As was pre-specified in the study protocol, only participants in the Vaccine Only and REGN10933+REGN10987 + Vaccine 1200 mg Day 7 Arm/Group were assessed for measure 6 days after the first vaccine.
| Arm | Measure | Group | Value (GEOMETRIC_LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Vaccine Only | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgG) | 252 Days after 1st Vaccine | -13.4 Percent |
| Vaccine Only | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgG) | 365 Days after 1st Vaccine | 65.6 Percent |
| Vaccine Only | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgG) | 28 Days after 1st Vaccine | -45.5 Percent |
| Vaccine Only | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgG) | 168 Days after 1st Vaccine | -29.1 Percent |
| Vaccine Only | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgG) | 14 Days after 1st Vaccine | -25.1 Percent |
| Vaccine Only | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgG) | Baseline | 58.9 Percent |
| Vaccine Only | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgG) | 42 Days after 1st Vaccine | -25.5 Percent |
| Vaccine Only | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgG) | 56 Days after 1st Vaccine | 6.2 Percent |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 IV | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgG) | 365 Days after 1st Vaccine | 44.0 Percent |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 IV | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgG) | 252 Days after 1st Vaccine | -47.4 Percent |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 IV | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgG) | 42 Days after 1st Vaccine | -50.1 Percent |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 IV | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgG) | 28 Days after 1st Vaccine | -64.1 Percent |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 IV | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgG) | 168 Days after 1st Vaccine | -54.2 Percent |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 IV | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgG) | Baseline | 3.0 Percent |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 IV | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgG) | 56 Days after 1st Vaccine | -34.8 Percent |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 IV | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgG) | 14 Days after 1st Vaccine | -48.5 Percent |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgG) | 56 Days after 1st Vaccine | -36.6 Percent |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgG) | 168 Days after 1st Vaccine | -29.5 Percent |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgG) | 42 Days after 1st Vaccine | -45.9 Percent |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgG) | 252 Days after 1st Vaccine | 4.4 Percent |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgG) | 14 Days after 1st Vaccine | -44.5 Percent |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgG) | Baseline | -18.7 Percent |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgG) | 28 Days after 1st Vaccine | -63.4 Percent |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgG) | 365 Days after 1st Vaccine | 38.1 Percent |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgG) | 42 Days after 1st Vaccine | -15.3 Percent |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgG) | Baseline | 18.3 Percent |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgG) | 252 Days after 1st Vaccine | -2.6 Percent |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgG) | 14 Days after 1st Vaccine | -29.9 Percent |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgG) | 56 Days after 1st Vaccine | -6.9 Percent |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgG) | 168 Days after 1st Vaccine | 48.6 Percent |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgG) | 28 Days after 1st Vaccine | -33.8 Percent |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgG) | 365 Days after 1st Vaccine | -3.1 Percent |
| REGN10933+REGN10987 + Vaccine 12 mg Day 1 IV | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgG) | 14 Days after 1st Vaccine | -47.8 Percent |
| REGN10933+REGN10987 + Vaccine 12 mg Day 1 IV | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgG) | Baseline | 29.4 Percent |
| REGN10933+REGN10987 + Vaccine 12 mg Day 1 IV | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgG) | 28 Days after 1st Vaccine | -57.0 Percent |
| REGN10933+REGN10987 + Vaccine 12 mg Day 1 IV | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgG) | 42 Days after 1st Vaccine | -46.7 Percent |
| REGN10933+REGN10987 + Vaccine 12 mg Day 1 IV | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgG) | 56 Days after 1st Vaccine | -23.6 Percent |
| REGN10933+REGN10987 + Vaccine 12 mg Day 1 IV | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgG) | 168 Days after 1st Vaccine | -9.3 Percent |
| REGN10933+REGN10987 + Vaccine 12 mg Day 1 IV | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgG) | 252 Days after 1st Vaccine | -5.2 Percent |
| REGN10933+REGN10987 + Vaccine 12 mg Day 1 IV | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgG) | 365 Days after 1st Vaccine | -20.2 Percent |
| REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgG) | 56 Days after 1st Vaccine | -18.9 Percent |
| REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgG) | 28 Days after 1st Vaccine | -28.4 Percent |
| REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgG) | 365 Days after 1st Vaccine | -23.9 Percent |
| REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgG) | 168 Days after 1st Vaccine | 98.9 Percent |
| REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgG) | 14 Days after 1st Vaccine | 8.2 Percent |
| REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgG) | 6 Days after 1st Vaccine | 88.0 Percent |
| REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgG) | 252 Days after 1st Vaccine | 49.1 Percent |
| REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgG) | Baseline | 5.4 Percent |
| REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgG) | 42 Days after 1st Vaccine | -46.4 Percent |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgG) | Baseline | -22.9 Percent |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgG) | 14 Days after 1st Vaccine | -34.0 Percent |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgG) | 365 Days after 1st Vaccine | 78.7 Percent |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgG) | 42 Days after 1st Vaccine | -35.4 Percent |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgG) | 56 Days after 1st Vaccine | -29.1 Percent |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgG) | 28 Days after 1st Vaccine | -38.6 Percent |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgG) | 252 Days after 1st Vaccine | 28.2 Percent |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgG) | 168 Days after 1st Vaccine | -40.6 Percent |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgG) | 252 Days after 1st Vaccine | -12.2 Percent |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgG) | 168 Days after 1st Vaccine | -48.0 Percent |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgG) | 56 Days after 1st Vaccine | -20.9 Percent |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgG) | 365 Days after 1st Vaccine | 116.6 Percent |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgG) | 42 Days after 1st Vaccine | -34.7 Percent |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgG) | Baseline | -10.3 Percent |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgG) | 28 Days after 1st Vaccine | -45.7 Percent |
| REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC | Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgG) | 14 Days after 1st Vaccine | -28.3 Percent |