NCT04847050 · OUTCOME
Number of Neutralizing Antibody Samples - 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
- NUMBER
- Unit
- Samples
- Interval / dispersion
- Not reported
- Time frame
- For Vaccine Naive Arm: Day 1, Day 29, Day 36, Day 57, Day 209, and Day 394
What was measured
Number of samples with a neutralizing response (defined as neutralization assay above 30%) will be reported. Immunogenicity of mRNA-1273 vaccine was assessed for Vaccine Naive Arm 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. Assessment was performed 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 | 33 |
|---|
| 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 Samples · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Hematologic Low Immunosuppression - Initial Phase | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Hematologic Intermediate Immunosuppression - Initial Phase | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Hematologic High Immunosuppression - Initial Phase | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
| Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Initial Phase | 0 | Not reported | Not reported | Not reported | 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 Samples · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Hematologic Low Immunosuppression - Initial Phase | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Hematologic Intermediate Immunosuppression - Initial Phase | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Hematologic High Immunosuppression - Initial Phase | 5 | Not reported | Not reported | Not reported | Not reported |
|---|
| Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Initial Phase | 3 | Not reported | Not reported | Not reported | 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 Samples · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Hematologic Low Immunosuppression - Initial Phase | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Hematologic Intermediate Immunosuppression - Initial Phase | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Hematologic High Immunosuppression - Initial Phase | 6 | Not reported | Not reported | Not reported | Not reported |
|---|
| Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Initial Phase | 3 | Not reported | Not reported | Not reported | 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 Samples · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Hematologic Low Immunosuppression - Initial Phase | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Hematologic Intermediate Immunosuppression - Initial Phase | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Hematologic High Immunosuppression - Initial Phase | 6 | Not reported | Not reported | Not reported | Not reported |
|---|
| Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Initial Phase | 3 | Not reported | Not reported | Not reported | Not reported |
|---|
Day 209
Analysis denominator · Participants
| 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 |
|---|
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 Samples · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Hematologic Low Immunosuppression - Initial Phase | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| Hematologic Intermediate Immunosuppression - Initial Phase | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| Hematologic High Immunosuppression - Initial Phase | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
| Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Initial Phase | 3 | Not reported | Not reported | Not reported | 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 | 3 |
|---|
| 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 Samples · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Hematologic High Immunosuppression - Initial Phase | 3 | Not reported | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 2
- group Id
- OG003
- 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
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 5
- group Id
- OG003
- value
- 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
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 6
- group Id
- OG003
- value
- 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 36
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 6
- group Id
- OG003
- value
- 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 57
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 2
- group Id
- OG003
- value
- 3
- denoms
- counts
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 2
- group Id
- OG002
- value
- 2
- 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
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 3
- 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
- 33
- group Id
- OG003
- value
- 15
- units
- Blood samples
- description
- Number of samples with a neutralizing response (defined as neutralization assay above 30%) will be reported. Immunogenicity of mRNA-1273 vaccine was assessed for Vaccine Naive Arm 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. Assessment was performed on Day 1, Day 29, Day 36, Day 57, Day 209, and Day 394
- 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
- NUMBER
- 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
- For Vaccine Naive Arm: Day 1, Day 29, Day 36, Day 57, Day 209, and Day 394
- title
- Number of Neutralizing Antibody Samples - Initial Phase
- type
- SECONDARY
- type Units Analyzed
- Blood samples
- unit Of Measure
- Samples
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
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