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Cohort1: mRNA-1273_dose level 1
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| Administration route |
intramuscular injection |
| Dosage |
mRNA-1273, 50 ug, on Day 1 and on Day 29 |
| Pts |
200 |
| Age |
Adult, Older_Adult |
| Outcome |
Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs):Grade 1:95(47.5%); Grade 2:61(30.5%); Grade 3:25(12.5%); Grade 4:0(0.0%)|Number of Participants With Unsolicited AEs:57(28.5%)|Number of Participants With Medically-Attended Adverse Events (MAAEs):74(37.0%)|Number of Participants With SAEs:5(2.5%)|Part A: Level of Severe Acute Respiratory Syndrome Coronavirus (SARS-COV-2)-Specific Binding Antibody (bAb) as Measured by Enzyme-Linked Immunosorbent Assay (ELISA):Day 1 (Baseline):0.70(0.63 to 0.78); Day 29:59.42(52.05 to 67.82); Day 43:720.85(660.30 to 786.96); Day 57:519.48(474.00 to 569.33); Day 209:97.02(87.58 to 107.47) |
| Adverse reactions |
0/200(All-cause mortality); 5/200(Cardiac disorders; Infections and infestations; Musculoskeletal and connective tissue disorders; Nervous system disorders; Pregnancy, puerperium and perinatal conditions) |
| References |
PMID:
35241844
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Cohort2: mRNA-1273_dose level 2
|
| Administration route |
intramuscular injection |
| Dosage |
mRNA-1273, 100 ug, on Day 1 and on Day 29 |
| Pts |
200 |
| Age |
Adult, Older_Adult |
| Outcome |
Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs):Grade 1:69(34.5%); Grade 2:90(45.0%); Grade 3:32(16.0%); Grade 4:0(0.0%)|Number of Participants With Unsolicited AEs:56(28.0%)|Number of Participants With Medically-Attended Adverse Events (MAAEs):38(19.0%)|Number of Participants With SAEs:2(1.0%)|Part A: Level of Severe Acute Respiratory Syndrome Coronavirus (SARS-COV-2)-Specific Binding Antibody (bAb) as Measured by Enzyme-Linked Immunosorbent Assay (ELISA):Day 1 (Baseline):0.67(0.60 to 0.73); Day 29:81.51(70.19 to 94.67); Day 43:834.66(765.28 to 910.33); Day 57:647.22(588.98 to 711.21); Day 209:128.00(114.44 to 143.18) |
| Adverse reactions |
0/200(All-cause mortality); 2/200(Cardiac disorders; Injury, poisoning and procedural complications; Pregnancy, puerperium and perinatal conditions) |
| References |
PMID:
35241844
|
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|
Cohort3: Placebo
|
| Administration route |
intramuscular injection |
| Dosage |
mRNA-1273-matching placebo, on Day 1 and on Day 29 |
| Pts |
200 |
| Age |
Adult, Older_Adult |
| Outcome |
Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs):Grade 1:72(36.0%); Grade 2:21(10.5%); Grade 3:6(3.0%); Grade 4:0(0.0%)|Number of Participants With Unsolicited AEs:51(25.5%)|Number of Participants With Medically-Attended Adverse Events (MAAEs):64(32.0%)|Number of Participants With SAEs:0(0.0%)|Part A: Level of Severe Acute Respiratory Syndrome Coronavirus (SARS-COV-2)-Specific Binding Antibody (bAb) as Measured by Enzyme-Linked Immunosorbent Assay (ELISA):Day 1 (Baseline):0.67(0.61 to 0.73); Day 29:0.68(0.61 to 0.76); Day 43:0.65(0.59 to 0.71); Day 57:0.67(0.60 to 0.75); Day 209:0.91(0.73 to 1.14) |
| Adverse reactions |
No serious clinical adverse events |
| References |
PMID:
35241844
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|
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Cohort4: mRNA-1273_dose level 1_dose level 1
|
| Administration route |
intramuscular injection |
| Dosage |
mRNA-1273, 50 ug, partA; mRNA-1273, 50 ug partB |
| Pts |
173 |
| Age |
Adult, Older_Adult |
| Outcome |
Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs):Grade 1:65(39.6%); Grade 2:59(36.0%); Grade 3:29(17.7%); Grade 4:0(0.0%)|Number of Participants With Unsolicited AEs:17(9.8%)|Number of Participants With Medically-Attended Adverse Events (MAAEs):42(24.3%)|Part B: Level of SARS-CoV-2-Specific bAb as Measured by ELISA:Day 1 (Baseline):86.29(76.89 to 96.83); Day 29:1069.73(992.92 to 1152.49) |
| Adverse reactions |
0/173(All-cause mortality); 2/173(Cardiac disorders; Respiratory, thoracic and mediastinal disorders; Vascular disorders) |
| References |
PMID:
35241844
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|
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Cohort5: mRNA-1273_dose level 2_dose level 1
|
| Administration route |
intramuscular injection |
| Dosage |
mRNA-1273, 100 ug, partA; mRNA-1273, 50 ug partB |
| Pts |
171 |
| Age |
Adult, Older_Adult |
| Outcome |
Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs):Grade 1:73(43.7%); Grade 2:59(35.3%); Grade 3:18(10.8%); Grade 4:0(0.0%)|Number of Participants With Unsolicited AEs:25(14.6%)|Number of Participants With Medically-Attended Adverse Events (MAAEs):47(27.5%)|Number of Participants With SAEs:2(1.2%)|Part B: Level of SARS-CoV-2-Specific bAb as Measured by ELISA:Day 1 (Baseline):109.56(96.79 to 124.02); Day 29:1083.21(1018.75 to 1151.75) |
| Adverse reactions |
0/171(All-cause mortality); 2/171(Injury, poisoning and procedural complications; Pregnancy, puerperium and perinatal conditions) |
| References |
PMID:
35241844
|
|
|
Cohort6: Placebo_mRNA-1273_dose level 2
|
| Administration route |
intramuscular injection |
| Dosage |
mRNA-1273-matching placebo, partA; mRNA-1273, 100 ug partB |
| Pts |
158 |
| Age |
Adult, Older_Adult |
| Outcome |
Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs):Grade 1:50(31.8%); Grade 2:71(45.2%); Grade 3:28(17.8%); Grade 4:0(0.0%)|Number of Participants With Unsolicited AEs:42(26.6%)|Number of Participants With Medically-Attended Adverse Events (MAAEs):59(37.3%)|Number of Participants With SAEs:2(1.3%) |
| Adverse reactions |
0/158(All-cause mortality); 2/158(Cardiac disorders; Gastrointestinal disorders; Infections and infestations) |
| References |
PMID:
35241844
|
|
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Cohort7: mRNA-1273.351_dose level 1
|
| Administration route |
intramuscular injection |
| Dosage |
mRNA-1273.351, 20 ug, on Day 1 |
| Pts |
20 |
| Age |
Adult, Older_Adult |
| Outcome |
Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs):Grade 1:13(68.4%); Grade 2:6(31.6%); Grade 3:0(0%); Grade 4:0(0.0%)|Number of Participants With Unsolicited AEs:3(15.0%)|Number of Participants With Medically-Attended Adverse Events (MAAEs):7(35.0%)|Number of Participants With SAEs:0(0.0%)|Part C: Level of SARS-CoV-2-Specific bAb as Measured by MSD:Day 1 (Baseline):59742.3(43057.8 to 82891.8); Day 8:240180.0(166361.1 to 346754.3); Day 15:297880.2(224089.6 to 395969.4); Day 29:297962.7(227337.5 to 390528.5) |
| Adverse reactions |
No serious clinical adverse events |
| References |
PMID:
35241844
|
|
|
Cohort8: mRNA-1273.351_dose level 2
|
| Administration route |
intramuscular injection |
| Dosage |
mRNA-1273.351, 50 ug, on Day 1 |
| Pts |
20 |
| Age |
Adult, Older_Adult |
| Outcome |
Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs):Grade 1:10(52.6%); Grade 2:2(10.5%); Grade 3:2(10.5%); Grade 4:0(0.0%)|Number of Participants With Unsolicited AEs:3(15.0%)|Number of Participants With Medically-Attended Adverse Events (MAAEs):3(15.0%)|Number of Participants With SAEs:1(5.0%)|Part C: Level of SARS-CoV-2-Specific bAb as Measured by MSD:Day 1 (Baseline):44921.5(28539.6 to 70706.5); Day 8:267002.2(199939.9 to 356558.2); Day 15:418215.3(311988.7 to 560610.2); Day 29:345765.9(251640.5 to 475098.5) |
| Adverse reactions |
0/20(All-cause mortality); 1/20(Infections and infestations) |
| References |
PMID:
35241844
|
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Cohort9: mRNA-1273/mRNA-1273.351 mixture
|
| Administration route |
intramuscular injection |
| Dosage |
mRNA-1273/mRNA-1273.351 mixture, 50 ug, on Day 1 |
| Pts |
20 |
| Age |
Adult, Older_Adult |
| Outcome |
Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs):Grade 1:12(60.0%); Grade 2:3(15.0%); Grade 3:2(10.0%); Grade 4:0(0.0%)|Number of Participants With Unsolicited AEs:4(20.0%)|Number of Participants With Medically-Attended Adverse Events (MAAEs):7(35.0%)|Number of Participants With SAEs:0(0.0%)|Part C: Level of SARS-CoV-2-Specific bAb as Measured by MSD:Day 1 (Baseline):33409.8(25264.8 to 44180.6); Day 8:228572.0(178986.7 to 291894.2); Day 15:384521.1(282461.4 to 523457.3); Day 29:367714.1(268913.2 to 502815.1) |
| Adverse reactions |
No serious clinical adverse events |
| References |
PMID:
35241844
|
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