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NCT04785144

Safety and Immunogenicity Study of a SARS-CoV-2 (COVID-19) Variant Vaccine (mRNA-1273.351) in Naïve and Previously Vaccinated Adults

Completed Phase 1 Results posted Last updated 18 March 2024
What this trial tests

Phase 1 trial testing mRNA-1273 in COVID-19 in 135 participants. Completed in 5 July 2022.

Timeline
31 March 2021
Primary endpoint
5 July 2022
5 July 2022

Quick facts

Lead sponsorNational Institute of Allergy and Infectious Diseases (NIAID)
PhasePhase 1
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposeprevention
Enrollment135
Start date31 March 2021
Primary completion5 July 2022
Estimated completion5 July 2022
Sites4 locations across United States

Drugs / interventions tested

Conditions studied

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Who can join

Adults 18 to 99, any sex, with COVID-19 or COVID-19 Immunisation. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants With Any Medically-attended Adverse Events (MAAEs) Primary · Day 1 to study completion, up to 1 year post last dose

Number of participants that experienced MAAEs during the course of the study.

GroupValue95% CI
Arm 1A: 50 mcg of mRNA-1273.3511
Arm 1B: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.3511
Arm 2A: 100 mcg mRNA-1273/100 mcg mRNA-1273/50 mcg mRNA-1273.3510
Arm 2B: 50 mcg mRNA-1273/50 mcg mRNA-1273/50 mcg mRNA-1273.3510
Arm 2C: 100 mcg mRNA-1273.351/100 mcg mRNA-1273.3510
Arm 2D: 50 mcg mRNA-1273.351/50 mcg mRNA-1273.3510
Arm 2E: 100 mcg mRNA-1273/100 mcg mRNA-1273.3510
Arm 2F: 50 mcg mRNA-1273/50 mcg mRNA-1273.3510
Arm 2G: 50 mcg mRNA-1273 + 50 mcg mRNA-1273.351/50 mcg mRNA-1273 + 50 mcg mRNA-1273.3510
Arm 2H: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351/25 mcg mRNA-1273 + 25 mcg mRNA-1273.3510
Frequency of Any New-onset Chronic Medical Conditions (NOCMCs) Primary · Day 1 to study completion, up to 1 year post last dose

Number of participants that experienced any NOCMCs during the course of the study.

GroupValue95% CI
Arm 1A: 50 mcg of mRNA-1273.3510
Arm 1B: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.3511
Arm 2A: 100 mcg mRNA-1273/100 mcg mRNA-1273/50 mcg mRNA-1273.3511
Arm 2B: 50 mcg mRNA-1273/50 mcg mRNA-1273/50 mcg mRNA-1273.3510
Arm 2C: 100 mcg mRNA-1273.351/100 mcg mRNA-1273.3510
Arm 2D: 50 mcg mRNA-1273.351/50 mcg mRNA-1273.3510
Arm 2E: 100 mcg mRNA-1273/100 mcg mRNA-1273.3510
Arm 2F: 50 mcg mRNA-1273/50 mcg mRNA-1273.3510
Arm 2G: 50 mcg mRNA-1273 + 50 mcg mRNA-1273.351/50 mcg mRNA-1273 + 50 mcg mRNA-1273.3511
Arm 2H: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351/25 mcg mRNA-1273 + 25 mcg mRNA-1273.3510
Frequency of Any Protocol Specified Adverse Events of Special Interest (AESIs) Primary · Day 1 to study completion, up to 1 year post last dose

Number of participants that experienced any AESIs during the course of the study. An adverse event of special interest (serious or non-serious) is one of scientific and medical concern specific to the sponsor's product or program, for which ongoing monitoring and rapid communication by the investigator to the sponsor is required. AESIs include anosmia, ageusia, subacute thyroiditis, acute pancreatitis, appendicitis, rhabdomyolysis, acute respiratory distress syndrome, coagulation disorders, acute cardiovascular injury, acute kidney injury, acute liver injury, dermatologic findings, multisystem

GroupValue95% CI
Arm 1A: 50 mcg of mRNA-1273.3511
Arm 1B: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.3511
Arm 2A: 100 mcg mRNA-1273/100 mcg mRNA-1273/50 mcg mRNA-1273.3511
Arm 2B: 50 mcg mRNA-1273/50 mcg mRNA-1273/50 mcg mRNA-1273.3510
Arm 2C: 100 mcg mRNA-1273.351/100 mcg mRNA-1273.3510
Arm 2D: 50 mcg mRNA-1273.351/50 mcg mRNA-1273.3510
Arm 2E: 100 mcg mRNA-1273/100 mcg mRNA-1273.3510
Arm 2F: 50 mcg mRNA-1273/50 mcg mRNA-1273.3510
Arm 2G: 50 mcg mRNA-1273 + 50 mcg mRNA-1273.351/50 mcg mRNA-1273 + 50 mcg mRNA-1273.3511
Arm 2H: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351/25 mcg mRNA-1273 + 25 mcg mRNA-1273.3510
Frequency of Any Serious Adverse Events (SAEs) Primary · Day 1 to study completion, up to 1 year post last dose

The number of participants that experience any SAEs from Day 1 to study completion. An AE or suspected adverse reaction is considered serious if, in the view of either the participating site PI or appropriate sub-investigator or the sponsor, it results in: death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, or a congenital anomaly/birth defect.

GroupValue95% CI
Arm 1A: 50 mcg of mRNA-1273.3510
Arm 1B: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.3511
Arm 2A: 100 mcg mRNA-1273/100 mcg mRNA-1273/50 mcg mRNA-1273.3510
Arm 2B: 50 mcg mRNA-1273/50 mcg mRNA-1273/50 mcg mRNA-1273.3510
Arm 2C: 100 mcg mRNA-1273.351/100 mcg mRNA-1273.3510
Arm 2D: 50 mcg mRNA-1273.351/50 mcg mRNA-1273.3510
Arm 2E: 100 mcg mRNA-1273/100 mcg mRNA-1273.3510
2F: 50 mcg mRNA-1273/50 mcg mRNA-1273.3510
2G: 50 mcg mRNA-1273 + 50 mcg mRNA-1273.351/50 mcg mRNA-1273 + 50 mcg mRNA-1273.3510
2H: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351/25 mcg mRNA-1273 + 25 mcg mRNA-1273.3510
Frequency of Solicited Reactogenicity Adverse Events (AEs) Primary · Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, Day 57-64 for Arms 2A-2B

The number of participants that experienced at least one solicited (local and systemic) AE through 7 days post vaccination. Systemic events include: fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration.

Local Events
GroupValue95% CI
1A: 50 mcg of mRNA-1273.35124
1B: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.35120
2A: 100 mcg mRNA-1273/100 mcg mRNA-1273/50 mcg mRNA-1273.3515
2B: 50 mcg mRNA-1273/50 mcg mRNA-1273/50 mcg mRNA-1273.3516
2C: 100 mcg mRNA-1273.351/100 mcg mRNA-1273.35110
2D: 50 mcg mRNA-1273.351/50 mcg mRNA-1273.35112
2E: 100 mcg mRNA-1273/100 mcg mRNA-1273.35113
2F: 50 mcg mRNA-1273/50 mcg mRNA-1273.35111
2G: 50 mcg mRNA-1273 + 50 mcg mRNA-1273.351/50 mcg mRNA-1273 + 50 mcg mRNA-1273.35112
2H: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351/25 mcg mRNA-1273 + 25 mcg mRNA-1273.35113
Systemic Events
GroupValue95% CI
1A: 50 mcg of mRNA-1273.35122
1B: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.35120
2A: 100 mcg mRNA-1273/100 mcg mRNA-1273/50 mcg mRNA-1273.3515
2B: 50 mcg mRNA-1273/50 mcg mRNA-1273/50 mcg mRNA-1273.3516
2C: 100 mcg mRNA-1273.351/100 mcg mRNA-1273.35112
2D: 50 mcg mRNA-1273.351/50 mcg mRNA-1273.35111
2E: 100 mcg mRNA-1273/100 mcg mRNA-1273.35112
2F: 50 mcg mRNA-1273/50 mcg mRNA-1273.35111
2G: 50 mcg mRNA-1273 + 50 mcg mRNA-1273.351/50 mcg mRNA-1273 + 50 mcg mRNA-1273.35112
2H: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351/25 mcg mRNA-1273 + 25 mcg mRNA-1273.35112
Grade of Solicited Reactogenicity Adverse Events (AEs) Primary · Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, Day 57-64 for Arms 2A-2B

Number of participants who experienced any solicited (local and systemic) AEs through 7 days post vaccination by grade. Systemic events include: fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration.

GroupValue95% CI
1A: 50 mcg of mRNA-1273.3511
1B: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.3511
2A: 100 mcg mRNA-1273/100 mcg mRNA-1273/50 mcg mRNA-1273.3510
2B: 50 mcg mRNA-1273/50 mcg mRNA-1273/50 mcg mRNA-1273.3510
2C: 100 mcg mRNA-1273.351/100 mcg mRNA-1273.3510
2D: 50 mcg mRNA-1273.351/50 mcg mRNA-1273.3511
2E: 100 mcg mRNA-1273/100 mcg mRNA-1273.3510
2F: 50 mcg mRNA-1273/50 mcg mRNA-1273.3511
2G: 50 mcg mRNA-1273 + 50 mcg mRNA-1273.351/50 mcg mRNA-1273 + 50 mcg mRNA-1273.3510
2H: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351/25 mcg mRNA-1273 + 25 mcg mRNA-1273.3510
1A: 50 mcg of mRNA-1273.3514
1B: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.3516
2A: 100 mcg mRNA-1273/100 mcg mRNA-1273/50 mcg mRNA-1273.3510
2B: 50 mcg mRNA-1273/50 mcg mRNA-1273/50 mcg mRNA-1273.3512
2C: 100 mcg mRNA-1273.351/100 mcg mRNA-1273.3512
2D: 50 mcg mRNA-1273.351/50 mcg mRNA-1273.3513
2E: 100 mcg mRNA-1273/100 mcg mRNA-1273.3511
2F: 50 mcg mRNA-1273/50 mcg mRNA-1273.3512
2G: 50 mcg mRNA-1273 + 50 mcg mRNA-1273.351/50 mcg mRNA-1273 + 50 mcg mRNA-1273.3511
2H: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351/25 mcg mRNA-1273 + 25 mcg mRNA-1273.3514
1A: 50 mcg of mRNA-1273.35118
1B: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.35113
2A: 100 mcg mRNA-1273/100 mcg mRNA-1273/50 mcg mRNA-1273.3512
2B: 50 mcg mRNA-1273/50 mcg mRNA-1273/50 mcg mRNA-1273.3514
2C: 100 mcg mRNA-1273.351/100 mcg mRNA-1273.3516
2D: 50 mcg mRNA-1273.351/50 mcg mRNA-1273.3517
2E: 100 mcg mRNA-1273/100 mcg mRNA-1273.3518
2F: 50 mcg mRNA-1273/50 mcg mRNA-1273.3517
2G: 50 mcg mRNA-1273 + 50 mcg mRNA-1273.351/50 mcg mRNA-1273 + 50 mcg mRNA-1273.3519
2H: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351/25 mcg mRNA-1273 + 25 mcg mRNA-1273.3516
1A: 50 mcg of mRNA-1273.3512
1B: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.3513
2A: 100 mcg mRNA-1273/100 mcg mRNA-1273/50 mcg mRNA-1273.3513
2B: 50 mcg mRNA-1273/50 mcg mRNA-1273/50 mcg mRNA-1273.3510
2C: 100 mcg mRNA-1273.351/100 mcg mRNA-1273.3514
2D: 50 mcg mRNA-1273.351/50 mcg mRNA-1273.3512
2E: 100 mcg mRNA-1273/100 mcg mRNA-1273.3514
2F: 50 mcg mRNA-1273/50 mcg mRNA-1273.3512
2G: 50 mcg mRNA-1273 + 50 mcg mRNA-1273.351/50 mcg mRNA-1273 + 50 mcg mRNA-1273.3513
2H: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351/25 mcg mRNA-1273 + 25 mcg mRNA-1273.3513
Frequency of Unsolicited Adverse Events (AEs) by Relationship to Study Product Primary · Day 1 through Day 29 for Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, Day 57 through Day 85 from Arms 2A-2B

Number of events of any unsolicited AE through 28 days post vaccination by relationship to study product and severity, experienced by participants in the Safety Analysis population. Unsolicited AEs were events that were spontaneously reported by the subject, or revealed by observation, physical examination or other diagnostic procedures.

Not Related
GroupValue95% CI
1A: 50 mcg of mRNA-1273.35110
1B: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.35111
2A: 100 mcg mRNA-1273/100 mcg mRNA-1273/50 mcg mRNA-1273.3514
2B: 50 mcg mRNA-1273/50 mcg mRNA-1273/50 mcg mRNA-1273.3515
2C: 100 mcg mRNA-1273.351/100 mcg mRNA-1273.3516
2D: 50 mcg mRNA-1273.351/50 mcg mRNA-1273.3510
2E: 100 mcg mRNA-1273/100 mcg mRNA-1273.3513
2F: 50 mcg mRNA-1273/50 mcg mRNA-1273.3516
2G: 50 mcg mRNA-1273 + 50 mcg mRNA-1273.351/50 mcg mRNA-1273 + 50 mcg mRNA-1273.3517
2F: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351/25 mcg mRNA-1273 + 25 mcg mRNA-1273.3518
Related
GroupValue95% CI
1A: 50 mcg of mRNA-1273.35112
1B: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.3513
2A: 100 mcg mRNA-1273/100 mcg mRNA-1273/50 mcg mRNA-1273.3513
2B: 50 mcg mRNA-1273/50 mcg mRNA-1273/50 mcg mRNA-1273.3511
2C: 100 mcg mRNA-1273.351/100 mcg mRNA-1273.3515
2D: 50 mcg mRNA-1273.351/50 mcg mRNA-1273.35116
2E: 100 mcg mRNA-1273/100 mcg mRNA-1273.3514
2F: 50 mcg mRNA-1273/50 mcg mRNA-1273.3512
2G: 50 mcg mRNA-1273 + 50 mcg mRNA-1273.351/50 mcg mRNA-1273 + 50 mcg mRNA-1273.35113
2F: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351/25 mcg mRNA-1273 + 25 mcg mRNA-1273.35110
Grade of Any Unsolicited Adverse Events (AEs) Primary · Day 1 through Day 29 for Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, Day 57 through Day 85 from Arms 2A-2B

Number of any unsolicited AEs through 28 days post vaccination by severity.

Mild
GroupValue95% CI
1A: 50 mcg of mRNA-1273.35114
1B: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.3517
2A: 100 mcg mRNA-1273/100 mcg mRNA-1273/50 mcg mRNA-1273.3514
2B: 50 mcg mRNA-1273/50 mcg mRNA-1273/50 mcg mRNA-1273.3514
2C: 100 mcg mRNA-1273.351/100 mcg mRNA-1273.3519
2D: 50 mcg mRNA-1273.351/50 mcg mRNA-1273.35111
2E: 100 mcg mRNA-1273/100 mcg mRNA-1273.3514
2F: 50 mcg mRNA-1273/50 mcg mRNA-1273.3514
2G: 50 mcg mRNA-1273 + 50 mcg mRNA-1273.351/50 mcg mRNA-1273 + 50 mcg mRNA-1273.35115
2H: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351/25 mcg mRNA-1273 + 25 mcg mRNA-1273.3515
Moderate
GroupValue95% CI
1A: 50 mcg of mRNA-1273.3516
1B: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.3516
2A: 100 mcg mRNA-1273/100 mcg mRNA-1273/50 mcg mRNA-1273.3513
2B: 50 mcg mRNA-1273/50 mcg mRNA-1273/50 mcg mRNA-1273.3512
2C: 100 mcg mRNA-1273.351/100 mcg mRNA-1273.3511
2D: 50 mcg mRNA-1273.351/50 mcg mRNA-1273.3515
2E: 100 mcg mRNA-1273/100 mcg mRNA-1273.3513
2F: 50 mcg mRNA-1273/50 mcg mRNA-1273.3513
2G: 50 mcg mRNA-1273 + 50 mcg mRNA-1273.351/50 mcg mRNA-1273 + 50 mcg mRNA-1273.3515
2H: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351/25 mcg mRNA-1273 + 25 mcg mRNA-1273.35110
Severe
GroupValue95% CI
1A: 50 mcg of mRNA-1273.3512
1B: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.3511
2A: 100 mcg mRNA-1273/100 mcg mRNA-1273/50 mcg mRNA-1273.3510
2B: 50 mcg mRNA-1273/50 mcg mRNA-1273/50 mcg mRNA-1273.3510
2C: 100 mcg mRNA-1273.351/100 mcg mRNA-1273.3511
2D: 50 mcg mRNA-1273.351/50 mcg mRNA-1273.3510
2E: 100 mcg mRNA-1273/100 mcg mRNA-1273.3510
2F: 50 mcg mRNA-1273/50 mcg mRNA-1273.3511
2G: 50 mcg mRNA-1273 + 50 mcg mRNA-1273.351/50 mcg mRNA-1273 + 50 mcg mRNA-1273.3510
2H: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351/25 mcg mRNA-1273 + 25 mcg mRNA-1273.3513
Geometric Mean Titer (GMT) of Antibody Against WA-1 S2-P for Arms 1A and 1B Secondary · Day 1 Pre-Booster Dose, Day 15, Day 29, Day 91, Day 181, Day 366

Geometric mean titer (GMT) of antibody against WA-1 S2-P using a 4-plex ECLIA Assay.

Day 1, Pre-Booster Dose
GroupValue95% CI
1A: 50 mcg of mRNA-1273.35140555.529458.3 – 55833.2
1B: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.35135988.328423.6 – 45566.3
Day 15
GroupValue95% CI
1A: 50 mcg of mRNA-1273.3511065642.8831651.5 – 1365469.3
1B: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351993561.1808666.6 – 1220730.1
Day 29
GroupValue95% CI
1A: 50 mcg of mRNA-1273.3511276347.8996652.8 – 1634534.8
1B: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.3511169728.7935192.8 – 1463083.6
Day 91
GroupValue95% CI
1A: 50 mcg of mRNA-1273.351660179.8482539.5 – 903216.0
1B: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351623572.3476570.8 – 815917.4
Day 181
GroupValue95% CI
1A: 50 mcg of mRNA-1273.351335476.6225669.7 – 498713.5
1B: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351320314.1236469.5 – 433887.4
Day 366
GroupValue95% CI
1A: 50 mcg of mRNA-1273.351287835.1175517.5 – 472027.2
1B: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351268030.8165874.5 – 433101.5
Geometric Mean Titer (GMT) of Antibody Against WA-1 S2-P for Arms 2A and 2B Secondary · Day 1 Pre-Dose, Day 15, Day 29, Day 43, Day 57, Day 71, Day 85, Day 147, Day 237, Day 422

Geometric mean titer (GMT) of antibody against WA-1 S2-P using a 4-plex ECLIA Assay.

Day 1, Pre-Dose
GroupValue95% CI
Arm 2A: 100 mcg mRNA-1273/100 mcg mRNA-1273/50 mcg mRNA-1273.3511687.17.1 – 399625.2
Arm 2B: 50 mcg mRNA-1273/50 mcg mRNA-1273/50 mcg mRNA-1273.351601.535.0 – 10335.2
Day 15
GroupValue95% CI
Arm 2A: 100 mcg mRNA-1273/100 mcg mRNA-1273/50 mcg mRNA-1273.351408309.542298.5 – 3941435.8
Arm 2B: 50 mcg mRNA-1273/50 mcg mRNA-1273/50 mcg mRNA-1273.351103325.515879.5 – 672322.4
Day 29
GroupValue95% CI
Arm 2A: 100 mcg mRNA-1273/100 mcg mRNA-1273/50 mcg mRNA-1273.351348738.558387.7 – 2082947.7
Arm 2B: 50 mcg mRNA-1273/50 mcg mRNA-1273/50 mcg mRNA-1273.35185622.215912.6 – 460715.8
Day 43
GroupValue95% CI
Arm 2A: 100 mcg mRNA-1273/100 mcg mRNA-1273/50 mcg mRNA-1273.3511028488.1427257.0 – 2475764.6
Arm 2B: 50 mcg mRNA-1273/50 mcg mRNA-1273/50 mcg mRNA-1273.351622864.8369077.3 – 1051163.4
Day 57
GroupValue95% CI
Arm 2A: 100 mcg mRNA-1273/100 mcg mRNA-1273/50 mcg mRNA-1273.351689051.1311987.0 – 1521830.7
Arm 2B: 50 mcg mRNA-1273/50 mcg mRNA-1273/50 mcg mRNA-1273.351440293.4252560.9 – 767570.3
Day 71
GroupValue95% CI
Arm 2A: 100 mcg mRNA-1273/100 mcg mRNA-1273/50 mcg mRNA-1273.351687273.1354218.2 – 1333484.0
Arm 2B: 50 mcg mRNA-1273/50 mcg mRNA-1273/50 mcg mRNA-1273.351485649.5319892.3 – 737296.4
Day 85
GroupValue95% CI
Arm 2A: 100 mcg mRNA-1273/100 mcg mRNA-1273/50 mcg mRNA-1273.351565917.9329154.7 – 972986.3
Arm 2B: 50 mcg mRNA-1273/50 mcg mRNA-1273/50 mcg mRNA-1273.351373198.2263014.4 – 529540.9
Day 147
GroupValue95% CI
Arm 2A: 100 mcg mRNA-1273/100 mcg mRNA-1273/50 mcg mRNA-1273.351254433.8141392.1 – 457851.2
Arm 2B: 50 mcg mRNA-1273/50 mcg mRNA-1273/50 mcg mRNA-1273.351144121.2102293.2 – 203052.9
Geometric Mean Titer (GMT) of Antibody Against WA-1 S2-P for Arms 2C-H Secondary · Day 1 Pre-Dose, Day 15, Day 29, Day 43, Day 57, Day 119, Day 209, Day 394

Geometric mean titer (GMT) of antibody against WA-1 S2-P using a 4-plex ECLIA Assay

Day 1, Pre-Dose
GroupValue95% CI
Arm 2C: 100 mcg mRNA-1273.351/100 mcg mRNA-1273.351271.456.6 – 1301.5
Arm 2D: 50 mcg mRNA-1273.351/50 mcg mRNA-1273.35192.344.2 – 193.1
Arm 2E: 100 mcg mRNA-1273/100 mcg mRNA-1273.351346.7106.4 – 1129.4
Arm 2F: 50 mcg mRNA-1273/50 mcg mRNA-1273.351645.6131.8 – 3162.9
Arm 2G: 50 mcg mRNA-1273 + 50 mcg mRNA-1273.351/50 mcg mRNA-1273 + 50 mcg mRNA-1273.351159.866.1 – 386.6
Arm 2H: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351/25 mcg mRNA-1273 + 25 mcg mRNA-1273.351192.785.3 – 435.2
Day 15
GroupValue95% CI
Arm 2C: 100 mcg mRNA-1273.351/100 mcg mRNA-1273.35130368.112103.4 – 76194.9
Arm 2D: 50 mcg mRNA-1273.351/50 mcg mRNA-1273.35121710.78990.4 – 52429.1
Arm 2E: 100 mcg mRNA-1273/100 mcg mRNA-1273.351156640.949419.1 – 496495.6
Arm 2F: 50 mcg mRNA-1273/50 mcg mRNA-1273.35191564.423858.3 – 351410.3
Arm 2G: 50 mcg mRNA-1273 + 50 mcg mRNA-1273.351/50 mcg mRNA-1273 + 50 mcg mRNA-1273.35167811.133999.0 – 135249.3
Arm 2H: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351/25 mcg mRNA-1273 + 25 mcg mRNA-1273.35162111.121508.0 – 179365.2
Day 29
GroupValue95% CI
Arm 2C: 100 mcg mRNA-1273.351/100 mcg mRNA-1273.35128662.212663.2 – 64874.5
Arm 2D: 50 mcg mRNA-1273.351/50 mcg mRNA-1273.35125301.511770.7 – 54386.3
Arm 2E: 100 mcg mRNA-1273/100 mcg mRNA-1273.351125557.343644.1 – 361209.1
Arm 2F: 50 mcg mRNA-1273/50 mcg mRNA-1273.351118461.442867.4 – 327360.8
Arm 2G: 50 mcg mRNA-1273 + 50 mcg mRNA-1273.351/50 mcg mRNA-1273 + 50 mcg mRNA-1273.35163247.330848.1 – 129674.8
Arm 2H: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351/25 mcg mRNA-1273 + 25 mcg mRNA-1273.35173048.131225.8 – 170885.1
Day 43
GroupValue95% CI
Arm 2C: 100 mcg mRNA-1273.351/100 mcg mRNA-1273.351225186.6179455.3 – 282571.7
Arm 2D: 50 mcg mRNA-1273.351/50 mcg mRNA-1273.351258723.7177985.0 – 376087.6
Arm 2E: 100 mcg mRNA-1273/100 mcg mRNA-1273.351550894.5307970.4 – 985435.0
Arm 2F: 50 mcg mRNA-1273/50 mcg mRNA-1273.351427940.0296902.0 – 616811.9
Arm 2G: 50 mcg mRNA-1273 + 50 mcg mRNA-1273.351/50 mcg mRNA-1273 + 50 mcg mRNA-1273.351433732.7321427.9 – 585275.9
Arm 2H: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351/25 mcg mRNA-1273 + 25 mcg mRNA-1273.351313325.4142344.2 – 689686.0
Day 57
GroupValue95% CI
Arm 2C: 100 mcg mRNA-1273.351/100 mcg mRNA-1273.351171256.0129663.6 – 226190.2
Arm 2D: 50 mcg mRNA-1273.351/50 mcg mRNA-1273.351184762.6131348.8 – 259897.5
Arm 2E: 100 mcg mRNA-1273/100 mcg mRNA-1273.351380485.7199113.7 – 727069.0
Arm 2F: 50 mcg mRNA-1273/50 mcg mRNA-1273.351320340.2213401.9 – 480866.6
Arm 2G: 50 mcg mRNA-1273 + 50 mcg mRNA-1273.351/50 mcg mRNA-1273 + 50 mcg mRNA-1273.351301884.2214565.4 – 424738.1
Arm 2H: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351/25 mcg mRNA-1273 + 25 mcg mRNA-1273.351321259.8233943.1 – 441166.4
Day 119
GroupValue95% CI
Arm 2C: 100 mcg mRNA-1273.351/100 mcg mRNA-1273.35178575.357452.9 – 107463.4
Arm 2D: 50 mcg mRNA-1273.351/50 mcg mRNA-1273.35186821.062315.8 – 120962.7
Arm 2E: 100 mcg mRNA-1273/100 mcg mRNA-1273.351176619.991660.5 – 340327.6
Arm 2F: 50 mcg mRNA-1273/50 mcg mRNA-1273.351142765.379953.4 – 254922.7
Arm 2G: 50 mcg mRNA-1273 + 50 mcg mRNA-1273.351/50 mcg mRNA-1273 + 50 mcg mRNA-1273.351142664.086638.7 – 234918.3
Arm 2H: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351/25 mcg mRNA-1273 + 25 mcg mRNA-1273.351134238.499246.4 – 181567.8
Day 209
GroupValue95% CI
Arm 2C: 100 mcg mRNA-1273.351/100 mcg mRNA-1273.35133582.420553.9 – 54869.3
Arm 2D: 50 mcg mRNA-1273.351/50 mcg mRNA-1273.35132839.324068.6 – 44806.1
Arm 2E: 100 mcg mRNA-1273/100 mcg mRNA-1273.35171377.938729.6 – 131548.1
Arm 2F: 50 mcg mRNA-1273/50 mcg mRNA-1273.35143724.826058.5 – 73367.7
Arm 2G: 50 mcg mRNA-1273 + 50 mcg mRNA-1273.351/50 mcg mRNA-1273 + 50 mcg mRNA-1273.35144229.822017.3 – 88851.7
Arm 2H: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351/25 mcg mRNA-1273 + 25 mcg mRNA-1273.35140884.326065.6 – 64127.4
Day 394
GroupValue95% CI
Arm 2C: 100 mcg mRNA-1273.351/100 mcg mRNA-1273.351234021.1118055.7 – 463898.6
Arm 2D: 50 mcg mRNA-1273.351/50 mcg mRNA-1273.35177061.119964.5 – 297449.5
Arm 2E: 100 mcg mRNA-1273/100 mcg mRNA-1273.351399456.3136582.2 – 1168273.1
Arm 2F: 50 mcg mRNA-1273/50 mcg mRNA-1273.351218022.7129671.7 – 366571.2
Arm 2G: 50 mcg mRNA-1273 + 50 mcg mRNA-1273.351/50 mcg mRNA-1273 + 50 mcg mRNA-1273.351347444.1124288.7 – 971266.2
Arm 2H: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351/25 mcg mRNA-1273 + 25 mcg mRNA-1273.351499494.9217234.3 – 1148507.2
Geometric Mean Titer (GMT) of Antibody Against B.1.351 S2-P for Arms 1A and 1B Secondary · Day 1 Pre-Booster Dose, Day 15, Day 29, Day 91, Day 181, Day 366

Geometric Mean Titer (GMT) of Antibody Against B.1.351 S2-P using a 4-plex ECLIA Assay.

Day 1, Pre-Booster Dose
GroupValue95% CI
1A: 50 mcg of mRNA-1273.35116714.512487.0 – 22373.1
1B: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.35114513.911417.0 – 18451.0
Day 15
GroupValue95% CI
1A: 50 mcg of mRNA-1273.351598971.7463182.5 – 774569.7
1B: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351465312.9377354.5 – 573773.7
Day 29
GroupValue95% CI
1A: 50 mcg of mRNA-1273.351633384.7495342.5 – 809896.5
1B: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351495722.6399293.1 – 615439.9
Day 91
GroupValue95% CI
1A: 50 mcg of mRNA-1273.351334468.3248187.1 – 450744.8
1B: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351279134.2214470.3 – 363294.7
Day 181
GroupValue95% CI
1A: 50 mcg of mRNA-1273.351158501.6109437.9 – 229561.9
1B: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351136205.1100841.4 – 183970.2
Day 366
GroupValue95% CI
1A: 50 mcg of mRNA-1273.351131964.982509.5 – 211063.5
1B: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351119198.673758.3 – 192633.4

Adverse events — posted to ClinicalTrials.gov

Time frame: Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Arm 1A: 50 mcg of mRNA-1273.351
Serious: 0/25 (0%)
Deaths: 0/25
Arm 1B: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351
Serious: 1/23 (4%)
Deaths: 0/23
Arm 2A: 100 mcg mRNA-1273/100 mcg mRNA-1273/50 mcg mRNA-1273.351
Serious: 0/5 (0%)
Deaths: 0/5
Arm 2B: 50 mcg mRNA-1273/50 mcg mRNA-1273/50 mcg mRNA-1273.351
Serious: 0/6 (0%)
Deaths: 0/6
Arm 2C: 100 mcg mRNA-1273.351/100 mcg mRNA-1273.351
Serious: 0/12 (0%)
Deaths: 0/12
Arm 2D: 50 mcg mRNA-1273.351/50 mcg mRNA-1273.351
Serious: 0/13 (0%)
Deaths: 0/13
Arm 2E: 100 mcg mRNA-1273/100 mcg mRNA-1273.351
Serious: 0/13 (0%)
Deaths: 0/13
Arm 2F: 50 mcg mRNA-1273/50 mcg mRNA-1273.351
Serious: 0/12 (0%)
Deaths: 0/12
Arm 2G: 50 mcg mRNA-1273 + 50 mcg mRNA-1273.351/50 mcg mRNA-1273 + 50 mcg mRNA-1273.351
Serious: 0/13 (0%)
Deaths: 0/13
Arm 2H: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351/25 mcg mRNA-1273 + 25 mcg mRNA-1273.351
Serious: 0/13 (0%)
Deaths: 0/13

Serious adverse events (1 terms)

ReactionSystemArm 1A: 50 mcg of mRNA-127…Arm 1B: 25 mcg mRNA-1273 +…Arm 2A: 100 mcg mRNA-1273/…Arm 2B: 50 mcg mRNA-1273/5…Arm 2C: 100 mcg mRNA-1273.…Arm 2D: 50 mcg mRNA-1273.3…Arm 2E: 100 mcg mRNA-1273/…Arm 2F: 50 mcg mRNA-1273/5…Arm 2G: 50 mcg mRNA-1273 +…Arm 2H: 25 mcg mRNA-1273 +…
Paresthesia of upper extremityNervous system disorders——————————
Other adverse events (69 terms — click to expand)

ReactionSystemArm 1A: 50 mcg of mRNA-127…Arm 1B: 25 mcg mRNA-1273 +…Arm 2A: 100 mcg mRNA-1273/…Arm 2B: 50 mcg mRNA-1273/5…Arm 2C: 100 mcg mRNA-1273.…Arm 2D: 50 mcg mRNA-1273.3…Arm 2E: 100 mcg mRNA-1273/…Arm 2F: 50 mcg mRNA-1273/5…Arm 2G: 50 mcg mRNA-1273 +…Arm 2H: 25 mcg mRNA-1273 +…
Vaccination site painGeneral disorders——————————
FatigueGeneral disorders——————————
MyalgiaMusculoskeletal and connective tissue disorders——————————
HeadacheNervous system disorders——————————
ChillsGeneral disorders——————————
ArthralgiaMusculoskeletal and connective tissue disorders——————————
NauseaGastrointestinal disorders——————————
PyrexiaGeneral disorders——————————
Vaccination site indurationGeneral disorders——————————
COVID-19Infections and infestations——————————
Vaccination site erythemaGeneral disorders——————————
LymphadenopathyBlood and lymphatic system disorders——————————
Athletic heart syndromeCardiac disorders——————————
Injection site bruisingGeneral disorders——————————
ArthralgiaMusculoskeletal and connective tissue disorders——————————
BradycardiaCardiac disorders——————————
PalpitationsCardiac disorders——————————
Ear congestionEar and labyrinth disorders——————————
TinnitusEar and labyrinth disorders——————————
Abdominal discomfortGastrointestinal disorders——————————
ConstipationGastrointestinal disorders——————————
DiarrhoeaGastrointestinal disorders——————————
Dry mouthGastrointestinal disorders——————————
Frequent bowel movementsGastrointestinal disorders——————————
NauseaGastrointestinal disorders——————————
Chest discomfortGeneral disorders——————————
FatigueGeneral disorders——————————
Injection site erythemaGeneral disorders——————————
Injection site haemorrhageGeneral disorders——————————
Peripheral swellingGeneral disorders——————————
Supraclavicular fossa painGeneral disorders——————————
SwellingGeneral disorders——————————
Vaccination site painGeneral disorders——————————
GastroenteritisInfections and infestations——————————
Kidney infectionInfections and infestations——————————
Upper respiratory tract infectionInfections and infestations——————————
Urinary tract infectionInfections and infestations——————————
ContusionInjury, poisoning and procedural complications——————————
Procedural dizzinessInjury, poisoning and procedural complications——————————
Skin abrasionInjury, poisoning and procedural complications——————————

Most-reported serious reactions: Paresthesia of upper extremity.

Data from ClinicalTrials.gov NCT04785144 adverse events section.

Sponsor's own description

This is a phase 1, open-label, randomized clinical trial in males and non-pregnant females, 18 years of age and older, who are in good health, have no known history of COVID-19 or SARS-CoV-2 infection, and meet all other eligibility criteria. This clinical trial is designed to assess the safety, reactogenicity and immunogenicity of mRNA-1273.351 manufactured by ModernaTX, Inc, given in vaccination schedules alone, sequentially, or coadministered with mRNA-1273. mRNA-1273.351 is a novel lipid nanoparticle (LNP)-encapsulated mRNA-based vaccine that encodes for a full-length, prefusion stabilized S protein of the SARS-CoV-2 B.1.351 variant. Enrollment will occur at approximately five domestic clinical research sites. This study includes two cohorts. Cohort 1 will provide rapid information about the immunogenicity of mRNA-1273.351 in a previously vaccinated group. This cohort can inform near term public health decisions if the variant virus becomes more widespread. Cohort 2 will evaluate different strategies for generation of cross protective immune responses in a naïve population. This cohort will take longer to provide information on the immunogenicity of mRNA-1273.351, but is important to inform future public health strategies. Cohort 1 will include approximately 60 subjects 18 years of age and older who received two vaccinations of mRNA-1273 at dosages of 50 mcg, 100 mcg, or 250 mcg in the Phase 1 clinical trial (DMID 20-0003). Subjects in Cohort 1 will receive a single intramuscular (IM) injection of the designated vaccine and will be followed through 12 months after vaccination. Follow-up visits will occur on Days 8, 15, and 29, as well as 3, 6, and 12 months after the vaccination. Cohort 2 will include approximately 150 participants 18 through 55 years of age who have not received a COVID-19 vaccine, have no known history of COVID-19 or SARS-CoV-2 infection, and do not have underlying conditions that are associated with an increased risk of severe illness from SARS-CoV-2 infection. Enrollment may close before the full 150 participants based on estimates on the timing of immunogenicity results and the need to inform public health decisions. They will be randomly assigned to one of 8 treatment arms and will receive 2 or 3 IM injections of the vaccine and followed through 12 months after the last vaccination. Follow-up visits will occur 7, 14, and 28 days after each vaccination, as well as 3, 6 and 12 months post the last vaccination. The primary objective is to evaluate the safety and reactogenicity of mRNA-1273 and mRNA-1273.351 vaccines, in naïve and previously vaccinated individuals.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. mRNA vaccines for infectious diseases: principles, delivery and clinical translation.
    Chaudhary N, Weissman D, Whitehead KA. · · 2021 · cited 1014× · PMID 34433919 · DOI 10.1038/s41573-021-00283-5
  2. Progress of the COVID-19 vaccine effort: viruses, vaccines and variants versus efficacy, effectiveness and escape.
    Tregoning JS, Flight KE, Higham SL, Wang Z, et al · · 2021 · cited 827× · PMID 34373623 · DOI 10.1038/s41577-021-00592-1
  3. Advances in COVID-19 mRNA vaccine development.
    Fang E, Liu X, Li M, Zhang Z, et al · · 2022 · cited 368× · PMID 35322018 · DOI 10.1038/s41392-022-00950-y
  4. Challenges of Storage and Stability of mRNA-Based COVID-19 Vaccines.
    Uddin MN, Roni MA. · · 2021 · cited 230× · PMID 34579270 · DOI 10.3390/vaccines9091033
  5. Efficacy and safety of COVID-19 vaccines.
    Graña C, Ghosn L, Evrenoglou T, Jarde A, et al · · 2022 · cited 227× · PMID 36473651 · DOI 10.1002/14651858.cd015477
  6. Nanotechnology's frontier in combatting infectious and inflammatory diseases: prevention and treatment.
    Huang Y, Guo X, Wu Y, Chen X, et al · · 2024 · cited 188× · PMID 38378653 · DOI 10.1038/s41392-024-01745-z
  7. Current approaches of nanomedicines in the market and various stage of clinical translation.
    Shan X, Gong X, Li J, Wen J, et al · · 2022 · cited 187× · PMID 35865096 · DOI 10.1016/j.apsb.2022.02.025
  8. Recent Advancement in mRNA Vaccine Development and Applications.
    Al Fayez N, Nassar MS, Alshehri AA, Alnefaie MK, et al · · 2023 · cited 95× · PMID 37514158 · DOI 10.3390/pharmaceutics15071972

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Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04785144.

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