NCT04847050 · OUTCOME
Immunogenicity of Messenger Ribonucleic Acid (mRNA) Titers - 1273 Administered in 2 Doses in the Initial Phase
A Trial of the Safety and Immunogenicity of the COVID-19 Vaccine (mRNA-1273) in Participants With Hematologic Malignancies and Various Regimens of Immunosuppression, and in Participants With Solid Tumors on PD1/PDL1 Inhibitor Therapy · Source last updated 2024-08-27
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- Au/mL
- Interval / dispersion
- Full Range
- Time frame
- Day 1, Day 29, Day 36, Day 57, Day 209, and Day 394
What was measured
Immunogenicity of mRNA 1273 administered in 2 doses was assessed by titer or level of specific binding antibody (bAb), in participants who have a hematological malignancy and are immunosuppressed due to their disease and/or treatment or receiving a programmed death-1 (PD-1)/programmed death-ligand 1 inhibitor for treatment of a solid tumor - Titer or level of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)-specific binding antibody (bAb) measured by enzyme-linked immunosorbent assay (ELISA) on Day 1, Day 29, Day 36, Day 57, Day 209, and Day 394.
Analysis population: Day 394 Groups 1, 2 and 4 respectively; no participants reached this timepoint to be analyzed because, 1) the follow up was too short for participants and/or participants crossed over to the booster cohort.
Groups in this outcome
Hematologic Low Immunosuppression - Initial Phase
100 mcg (0.5 mL) messenger ribonucleic acid (mRNA)-1273 injection, intramuscular (IM) on days 1 and 29; with option for subsequent booster dose, 100 mcg (0.5 mL) mRNA-1273 injection (IM) no less than 4 weeks after day 29.
Hematologic Intermediate Immunosuppression - Initial Phase
100 mcg (0.5 mL) messenger ribonucleic acid (mRNA)-1273 injection, intramuscular (IM) on days 1 and 29; with option for subsequent booster dose, 100 mcg (0.5 mL) mRNA-1273 injection (IM) no less than 4 weeks after day 29.
Hematologic High Immunosuppression - Initial Phase
100 mcg (0.5 mL) messenger ribonucleic acid (mRNA)-1273 injection, intramuscular (IM) on days 1 and 29; with option for subsequent booster dose, 100 mcg (0.5 mL) mRNA-1273 injection (IM) no less than 4 weeks after day 29
Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Initial Phase
100 mcg (0.5 mL) messenger ribonucleic acid (mRNA)-1273 injection, intramuscular (IM) on days 1 and 29; with option for subsequent booster dose, 100 mcg (0.5 mL) mRNA-1273 injection (IM) no less than 4 weeks after day 29.
Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.
Analysis denominator · Participants
| Group | Source count |
|---|
| Hematologic Low Immunosuppression - Initial Phase | 2 |
|---|
| Hematologic Intermediate Immunosuppression - Initial Phase | 3 |
|---|
| Hematologic High Immunosuppression - Initial Phase | 7 |
|---|
| Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Initial Phase | 3 |
|---|
Analysis denominator · Blood samples
| Group | Source count |
|---|
| Hematologic Low Immunosuppression - Initial Phase | 9 |
|---|
| Hematologic Intermediate Immunosuppression - Initial Phase | 14 |
|---|
| Hematologic High Immunosuppression - Initial Phase | 42 |
|---|
| Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Initial Phase | 15 |
|---|
Reported measurements
Day 1
Analysis denominator · Participants
| Group | Source count |
|---|
| Hematologic Low Immunosuppression - Initial Phase | 2 |
|---|
| Hematologic Intermediate Immunosuppression - Initial Phase | 3 |
|---|
| Hematologic High Immunosuppression - Initial Phase | 7 |
|---|
| Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Initial Phase | 3 |
|---|
Analysis denominator · Blood samples
| Group | Source count |
|---|
| Hematologic Low Immunosuppression - Initial Phase | 2 |
|---|
| Hematologic Intermediate Immunosuppression - Initial Phase | 3 |
|---|
| Hematologic High Immunosuppression - Initial Phase | 7 |
|---|
| Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Initial Phase | 3 |
|---|
Values in Au/mL · Interval/dispersion: Full Range| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Hematologic Low Immunosuppression - Initial Phase | 0 | Not reported | 0 | 0 | Not reported |
|---|
| Hematologic Intermediate Immunosuppression - Initial Phase | 0 | Not reported | 0 | 1.4 | Not reported |
|---|
| Hematologic High Immunosuppression - Initial Phase | 2.1 | Not reported | 0 | 815.2 | Not reported |
|---|
| Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Initial Phase | 0 | Not reported | 0 | 0.7 | Not reported |
|---|
Day 29
Analysis denominator · Participants
| Group | Source count |
|---|
| Hematologic Low Immunosuppression - Initial Phase | 2 |
|---|
| Hematologic Intermediate Immunosuppression - Initial Phase | 3 |
|---|
| Hematologic High Immunosuppression - Initial Phase | 7 |
|---|
| Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Initial Phase | 3 |
|---|
Analysis denominator · Blood samples
| Group | Source count |
|---|
| Hematologic Low Immunosuppression - Initial Phase | 2 |
|---|
| Hematologic Intermediate Immunosuppression - Initial Phase | 3 |
|---|
| Hematologic High Immunosuppression - Initial Phase | 7 |
|---|
| Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Initial Phase | 3 |
|---|
Values in Au/mL · Interval/dispersion: Full Range| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Hematologic Low Immunosuppression - Initial Phase | 0.3 | Not reported | 0 | 0.6 | Not reported |
|---|
| Hematologic Intermediate Immunosuppression - Initial Phase | 0 | Not reported | 0 | 8.4 | Not reported |
|---|
| Hematologic High Immunosuppression - Initial Phase | 838.4 | Not reported | 0.8 | 9276.0 | Not reported |
|---|
| Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Initial Phase | 608.3 | Not reported | 297.8 | 1982.4 | Not reported |
|---|
Day 36
Analysis denominator · Participants
| Group | Source count |
|---|
| Hematologic Low Immunosuppression - Initial Phase | 2 |
|---|
| Hematologic Intermediate Immunosuppression - Initial Phase | 3 |
|---|
| Hematologic High Immunosuppression - Initial Phase | 7 |
|---|
| Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Initial Phase | 3 |
|---|
Analysis denominator · Blood samples
| Group | Source count |
|---|
| Hematologic Low Immunosuppression - Initial Phase | 2 |
|---|
| Hematologic Intermediate Immunosuppression - Initial Phase | 3 |
|---|
| Hematologic High Immunosuppression - Initial Phase | 7 |
|---|
| Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Initial Phase | 3 |
|---|
Values in Au/mL · Interval/dispersion: Full Range| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Hematologic Low Immunosuppression - Initial Phase | 0.6 | Not reported | 0.1 | 1.2 | Not reported |
|---|
| Hematologic Intermediate Immunosuppression - Initial Phase | 0 | Not reported | 0 | 6.3 | Not reported |
|---|
| Hematologic High Immunosuppression - Initial Phase | 10830.2 | Not reported | 1.8 | 29849.1 | Not reported |
|---|
| Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Initial Phase | 35863.4 | Not reported | 26558.4 | 40941.6 | Not reported |
|---|
Day 57
Analysis denominator · Participants
| Group | Source count |
|---|
| Hematologic Low Immunosuppression - Initial Phase | 2 |
|---|
| Hematologic Intermediate Immunosuppression - Initial Phase | 3 |
|---|
| Hematologic High Immunosuppression - Initial Phase | 7 |
|---|
| Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Initial Phase | 3 |
|---|
Analysis denominator · Blood samples
| Group | Source count |
|---|
| Hematologic Low Immunosuppression - Initial Phase | 2 |
|---|
| Hematologic Intermediate Immunosuppression - Initial Phase | 3 |
|---|
| Hematologic High Immunosuppression - Initial Phase | 7 |
|---|
| Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Initial Phase | 3 |
|---|
Values in Au/mL · Interval/dispersion: Full Range| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Hematologic Low Immunosuppression - Initial Phase | 40.0 | Not reported | 39.2 | 40.7 | Not reported |
|---|
| Hematologic Intermediate Immunosuppression - Initial Phase | 0.23 | Not reported | 0 | 8.0 | Not reported |
|---|
| Hematologic High Immunosuppression - Initial Phase | 23084.7 | Not reported | 0.6 | 32795.2 | Not reported |
|---|
| Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Initial Phase | 27319.8 | Not reported | 20401 | 38429.7 | Not reported |
|---|
Day 209
Analysis denominator · Participants
| Group | Source count |
|---|
| Hematologic Low Immunosuppression - Initial Phase | 1 |
|---|
| Hematologic Intermediate Immunosuppression - Initial Phase | 3 |
|---|
| Hematologic High Immunosuppression - Initial Phase | 7 |
|---|
| Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Initial Phase | 3 |
|---|
Analysis denominator · Blood samples
| Group | Source count |
|---|
| Hematologic Low Immunosuppression - Initial Phase | 1 |
|---|
| Hematologic Intermediate Immunosuppression - Initial Phase | 2 |
|---|
| Hematologic High Immunosuppression - Initial Phase | 2 |
|---|
| Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Initial Phase | 3 |
|---|
Values in Au/mL · Interval/dispersion: Full Range| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Hematologic Low Immunosuppression - Initial Phase | 53156.4 | Not reported | NA | 53156.4 | One out of two participants provided a sample, which was included for analysis. The other participant was not analyzed and moved to the booster cohort, so this timepoint was censored. |
|---|
| Hematologic Intermediate Immunosuppression - Initial Phase | 53.7 | Not reported | 0 | 107.4 | Not reported |
|---|
| Hematologic High Immunosuppression - Initial Phase | 26153.9 | Not reported | 23639.6 | 28668.2 | Not reported |
|---|
| Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Initial Phase | 3198.9 | Not reported | 2467.1 | 4041.3 | Not reported |
|---|
Day 394
Analysis denominator · Participants
| Group | Source count |
|---|
| Hematologic Low Immunosuppression - Initial Phase | 0 |
|---|
| Hematologic Intermediate Immunosuppression - Initial Phase | 0 |
|---|
| Hematologic High Immunosuppression - Initial Phase | 7 |
|---|
| Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Initial Phase | 0 |
|---|
Analysis denominator · Blood samples
| Group | Source count |
|---|
| Hematologic Low Immunosuppression - Initial Phase | 0 |
|---|
| Hematologic Intermediate Immunosuppression - Initial Phase | 0 |
|---|
| Hematologic High Immunosuppression - Initial Phase | 3 |
|---|
| Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Initial Phase | 0 |
|---|
Values in Au/mL · Interval/dispersion: Full Range| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Hematologic High Immunosuppression - Initial Phase | 24665.2 | Not reported | 20779.1 | 33967.9 | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0
- upper Limit
- 0
- value
- 0
- group Id
- OG001
- lower Limit
- 0
- upper Limit
- 1.4
- value
- 0
- group Id
- OG002
- lower Limit
- 0
- upper Limit
- 815.2
- value
- 2.1
- group Id
- OG003
- lower Limit
- 0
- upper Limit
- 0.7
- value
- 0
- denoms
- counts
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 7
- group Id
- OG003
- value
- 3
- units
- Participants
- counts
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 7
- group Id
- OG003
- value
- 3
- units
- Blood samples
- title
- Day 1
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0
- upper Limit
- 0.6
- value
- 0.3
- group Id
- OG001
- lower Limit
- 0
- upper Limit
- 8.4
- value
- 0
- group Id
- OG002
- lower Limit
- 0.8
- upper Limit
- 9276.0
- value
- 838.4
- group Id
- OG003
- lower Limit
- 297.8
- upper Limit
- 1982.4
- value
- 608.3
- denoms
- counts
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 7
- group Id
- OG003
- value
- 3
- units
- Participants
- counts
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 7
- group Id
- OG003
- value
- 3
- units
- Blood samples
- title
- Day 29
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.1
- upper Limit
- 1.2
- value
- 0.6
- group Id
- OG001
- lower Limit
- 0
- upper Limit
- 6.3
- value
- 0
- group Id
- OG002
- lower Limit
- 1.8
- upper Limit
- 29849.1
- value
- 10830.2
- group Id
- OG003
- lower Limit
- 26558.4
- upper Limit
- 40941.6
- value
- 35863.4
- denoms
- counts
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 7
- group Id
- OG003
- value
- 3
- units
- Participants
- counts
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 7
- group Id
- OG003
- value
- 3
- units
- Blood samples
- title
- Day 36
- categories
- measurements
- group Id
- OG000
- lower Limit
- 39.2
- upper Limit
- 40.7
- value
- 40.0
- group Id
- OG001
- lower Limit
- 0
- upper Limit
- 8.0
- value
- 0.23
- group Id
- OG002
- lower Limit
- 0.6
- upper Limit
- 32795.2
- value
- 23084.7
- group Id
- OG003
- lower Limit
- 20401
- upper Limit
- 38429.7
- value
- 27319.8
- denoms
- counts
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 7
- group Id
- OG003
- value
- 3
- units
- Participants
- counts
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 7
- group Id
- OG003
- value
- 3
- units
- Blood samples
- title
- Day 57
- categories
- measurements
- comment
- One out of two participants provided a sample, which was included for analysis. The other participant was not analyzed and moved to the booster cohort, so this timepoint was censored.
- group Id
- OG000
- lower Limit
- NA
- upper Limit
- 53156.4
- value
- 53156.4
- group Id
- OG001
- lower Limit
- 0
- upper Limit
- 107.4
- value
- 53.7
- group Id
- OG002
- lower Limit
- 23639.6
- upper Limit
- 28668.2
- value
- 26153.9
- group Id
- OG003
- lower Limit
- 2467.1
- upper Limit
- 4041.3
- value
- 3198.9
- denoms
- counts
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 7
- group Id
- OG003
- value
- 3
- units
- Participants
- counts
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 2
- group Id
- OG002
- value
- 2
- group Id
- OG003
- value
- 3
- units
- Blood samples
- title
- Day 209
- categories
- measurements
- group Id
- OG002
- lower Limit
- 20779.1
- upper Limit
- 33967.9
- value
- 24665.2
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 7
- group Id
- OG003
- value
- 0
- units
- Participants
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 0
- units
- Blood samples
- title
- Day 394
- denom Units Selected
- Blood samples
- denoms
- counts
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 7
- group Id
- OG003
- value
- 3
- units
- Participants
- counts
- group Id
- OG000
- value
- 9
- group Id
- OG001
- value
- 14
- group Id
- OG002
- value
- 42
- group Id
- OG003
- value
- 15
- units
- Blood samples
- description
- Immunogenicity of mRNA 1273 administered in 2 doses was assessed by titer or level of specific binding antibody (bAb), in participants who have a hematological malignancy and are immunosuppressed due to their disease and/or treatment or receiving a programmed death-1 (PD-1)/programmed death-ligand 1 inhibitor for treatment of a solid tumor - Titer or level of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)-specific binding antibody (bAb) measured by enzyme-linked immunosorbent assay (ELISA) on Day 1, Day 29, Day 36, Day 57, Day 209, and Day 394.
- dispersion Type
- Full Range
- groups
- description
- 100 mcg (0.5 mL) messenger ribonucleic acid (mRNA)-1273 injection, intramuscular (IM) on days 1 and 29; with option for subsequent booster dose, 100 mcg (0.5 mL) mRNA-1273 injection (IM) no less than 4 weeks after day 29.
- id
- OG000
- title
- Hematologic Low Immunosuppression - Initial Phase
- description
- 100 mcg (0.5 mL) messenger ribonucleic acid (mRNA)-1273 injection, intramuscular (IM) on days 1 and 29; with option for subsequent booster dose, 100 mcg (0.5 mL) mRNA-1273 injection (IM) no less than 4 weeks after day 29.
- id
- OG001
- title
- Hematologic Intermediate Immunosuppression - Initial Phase
- description
- 100 mcg (0.5 mL) messenger ribonucleic acid (mRNA)-1273 injection, intramuscular (IM) on days 1 and 29; with option for subsequent booster dose, 100 mcg (0.5 mL) mRNA-1273 injection (IM) no less than 4 weeks after day 29
- id
- OG002
- title
- Hematologic High Immunosuppression - Initial Phase
- description
- 100 mcg (0.5 mL) messenger ribonucleic acid (mRNA)-1273 injection, intramuscular (IM) on days 1 and 29; with option for subsequent booster dose, 100 mcg (0.5 mL) mRNA-1273 injection (IM) no less than 4 weeks after day 29.
- id
- OG003
- title
- Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Initial Phase
- param Type
- MEDIAN
- population Description
- Day 394 Groups 1, 2 and 4 respectively; no participants reached this timepoint to be analyzed because, 1) the follow up was too short for participants and/or participants crossed over to the booster cohort.
- reporting Status
- POSTED
- time Frame
- Day 1, Day 29, Day 36, Day 57, Day 209, and Day 394
- title
- Immunogenicity of Messenger Ribonucleic Acid (mRNA) Titers - 1273 Administered in 2 Doses in the Initial Phase
- type
- PRIMARY
- type Units Analyzed
- Blood samples
- unit Of Measure
- Au/mL
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