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NCT04847050 · OUTCOME

Number of Neutralizing Antibody Samples - Booster 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
Day 1, Day 29, Day 57, Day 180, and Day 360

What was measured

Number of samples with a neutralizing response (defined as neutralization assay above 30%) will be reported. Participants would receive one to two vaccine boosters. Analysis of timepoints after booster 1 and booster 2 are reported collectively. Immunogenicity of mRNA-1273 vaccine was assessed for Booster Arm in participants with hematologic malignancy with or without ongoing immune suppression and participants with solid tumor receiving programmed death-1 (PD-1)/programmed death-ligand 1 inhibitor (PD-L1) inhibitors: Day 1, Day 29, Day 57, Day 180, and Day 360.

Analysis population: No participants were enrolled in Groups CLL, CLL/BTK, CAR-T Cell and Other Adult Solid Tumor Booster Phase. Regarding Other Hematologic Malignancy Booster Phase Group 1 participant crossed over from hematologic low immunosuppression-initial phase; 3 participants crossed over from hematologic intermediate immunosuppression-initial phase; 3 participants crossed over from hematologic high immunosuppression-initial phase; \& 3 participants were initially enrolled (did not cross over) into this group.

Groups in this outcome

Chronic Lymphocytic Leukemia (CLL) Not on Active Therapy - Booster Phase

100 mcg (0.5 mL) messenger ribonucleic acid (mRNA)-1273 injection on day (D)1.

Chronic Lymphocytic Leukemia(CLL) Receiving Bruton´s Tyrosine Kinase(BTK) Interruption-Booster Phase

100 mcg (0.5 mL) messenger ribonucleic acid (mRNA)-1273 injection on day (D)1.

Chimeric Antigen Receptor (CAR) T Cell Therapy - Booster Phase

100 mcg (0.5 mL) messenger ribonucleic acid (mRNA)-1273 injection on day (D)1.

Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Booster Phase

100 mcg (0.5 mL) messenger ribonucleic acid (mRNA)-1273 injection on day (D)1.

Post Allogeneic Transplant - Booster Phase

100 mcg (0.5 mL) messenger ribonucleic acid (mRNA)-1273 injection on day (D)1.

Other Hematologic Malignancy - Booster Phase

100 mcg (0.5 mL) messenger ribonucleic acid (mRNA)-1273 injection, intramuscular (IM) on day 1.

Other Adult Solid Tumor - Booster Phase

100 mcg (0.5 mL) messenger ribonucleic acid (mRNA)-1273 injection on day (D)1.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Chronic Lymphocytic Leukemia (CLL) Not on Active Therapy - Booster Phase0
Chronic Lymphocytic Leukemia(CLL) Receiving Bruton´s Tyrosine Kinase(BTK) Interruption-Booster Phase0
Chimeric Antigen Receptor (CAR) T Cell Therapy - Booster Phase0
Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Booster Phase2
Post Allogeneic Transplant - Booster Phase1
Other Hematologic Malignancy - Booster Phase10
Other Adult Solid Tumor - Booster Phase0

Analysis denominator · Blood samples

GroupSource count
Chronic Lymphocytic Leukemia (CLL) Not on Active Therapy - Booster Phase0
Chronic Lymphocytic Leukemia(CLL) Receiving Bruton´s Tyrosine Kinase(BTK) Interruption-Booster Phase0
Chimeric Antigen Receptor (CAR) T Cell Therapy - Booster Phase0
Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Booster Phase12
Post Allogeneic Transplant - Booster Phase7
Other Hematologic Malignancy - Booster Phase63
Other Adult Solid Tumor - Booster Phase0

Reported measurements

Day 1

Analysis denominator · Participants

GroupSource count
Chronic Lymphocytic Leukemia (CLL) Not on Active Therapy - Booster Phase0
Chronic Lymphocytic Leukemia(CLL) Receiving Bruton´s Tyrosine Kinase(BTK) Interruption-Booster Phase0
Chimeric Antigen Receptor (CAR) T Cell Therapy - Booster Phase0
Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Booster Phase2
Post Allogeneic Transplant - Booster Phase1
Other Hematologic Malignancy - Booster Phase10
Other Adult Solid Tumor - Booster Phase0

Analysis denominator · Blood samples

GroupSource count
Chronic Lymphocytic Leukemia (CLL) Not on Active Therapy - Booster Phase0
Chronic Lymphocytic Leukemia(CLL) Receiving Bruton´s Tyrosine Kinase(BTK) Interruption-Booster Phase0
Chimeric Antigen Receptor (CAR) T Cell Therapy - Booster Phase0
Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Booster Phase3
Post Allogeneic Transplant - Booster Phase2
Other Hematologic Malignancy - Booster Phase16
Other Adult Solid Tumor - Booster Phase0
Values in Samples · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Booster Phase3Not reportedNot reportedNot reportedNot reported
Post Allogeneic Transplant - Booster Phase1Not reportedNot reportedNot reportedNot reported
Other Hematologic Malignancy - Booster Phase10Not reportedNot reportedNot reportedNot reported
Day 29

Analysis denominator · Participants

GroupSource count
Chronic Lymphocytic Leukemia (CLL) Not on Active Therapy - Booster Phase0
Chronic Lymphocytic Leukemia(CLL) Receiving Bruton´s Tyrosine Kinase(BTK) Interruption-Booster Phase0
Chimeric Antigen Receptor (CAR) T Cell Therapy - Booster Phase0
Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Booster Phase2
Post Allogeneic Transplant - Booster Phase1
Other Hematologic Malignancy - Booster Phase9
Other Adult Solid Tumor - Booster Phase0

Analysis denominator · Blood samples

GroupSource count
Chronic Lymphocytic Leukemia (CLL) Not on Active Therapy - Booster Phase0
Chronic Lymphocytic Leukemia(CLL) Receiving Bruton´s Tyrosine Kinase(BTK) Interruption-Booster Phase0
Chimeric Antigen Receptor (CAR) T Cell Therapy - Booster Phase0
Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Booster Phase3
Post Allogeneic Transplant - Booster Phase2
Other Hematologic Malignancy - Booster Phase15
Other Adult Solid Tumor - Booster Phase0
Values in Samples · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Booster Phase3Not reportedNot reportedNot reportedNot reported
Post Allogeneic Transplant - Booster Phase2Not reportedNot reportedNot reportedNot reported
Other Hematologic Malignancy - Booster Phase12Not reportedNot reportedNot reportedNot reported
Day 57

Analysis denominator · Participants

GroupSource count
Chronic Lymphocytic Leukemia (CLL) Not on Active Therapy - Booster Phase0
Chronic Lymphocytic Leukemia(CLL) Receiving Bruton´s Tyrosine Kinase(BTK) Interruption-Booster Phase0
Chimeric Antigen Receptor (CAR) T Cell Therapy - Booster Phase0
Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Booster Phase2
Post Allogeneic Transplant - Booster Phase1
Other Hematologic Malignancy - Booster Phase10
Other Adult Solid Tumor - Booster Phase0

Analysis denominator · Blood samples

GroupSource count
Chronic Lymphocytic Leukemia (CLL) Not on Active Therapy - Booster Phase0
Chronic Lymphocytic Leukemia(CLL) Receiving Bruton´s Tyrosine Kinase(BTK) Interruption-Booster Phase0
Chimeric Antigen Receptor (CAR) T Cell Therapy - Booster Phase0
Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Booster Phase3
Post Allogeneic Transplant - Booster Phase1
Other Hematologic Malignancy - Booster Phase13
Other Adult Solid Tumor - Booster Phase0
Values in Samples · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Booster Phase3Not reportedNot reportedNot reportedNot reported
Post Allogeneic Transplant - Booster Phase1Not reportedNot reportedNot reportedNot reported
Other Hematologic Malignancy - Booster Phase10Not reportedNot reportedNot reportedNot reported
Day 180

Analysis denominator · Participants

GroupSource count
Chronic Lymphocytic Leukemia (CLL) Not on Active Therapy - Booster Phase0
Chronic Lymphocytic Leukemia(CLL) Receiving Bruton´s Tyrosine Kinase(BTK) Interruption-Booster Phase0
Chimeric Antigen Receptor (CAR) T Cell Therapy - Booster Phase0
Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Booster Phase2
Post Allogeneic Transplant - Booster Phase1
Other Hematologic Malignancy - Booster Phase10
Other Adult Solid Tumor - Booster Phase0

Analysis denominator · Blood samples

GroupSource count
Chronic Lymphocytic Leukemia (CLL) Not on Active Therapy - Booster Phase0
Chronic Lymphocytic Leukemia(CLL) Receiving Bruton´s Tyrosine Kinase(BTK) Interruption-Booster Phase0
Chimeric Antigen Receptor (CAR) T Cell Therapy - Booster Phase0
Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Booster Phase2
Post Allogeneic Transplant - Booster Phase1
Other Hematologic Malignancy - Booster Phase10
Other Adult Solid Tumor - Booster Phase0
Values in Samples · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Booster Phase2Not reportedNot reportedNot reportedNot reported
Post Allogeneic Transplant - Booster Phase1Not reportedNot reportedNot reportedNot reported
Other Hematologic Malignancy - Booster Phase10Not reportedNot reportedNot reportedNot reported
Day 360

Analysis denominator · Participants

GroupSource count
Chronic Lymphocytic Leukemia (CLL) Not on Active Therapy - Booster Phase0
Chronic Lymphocytic Leukemia(CLL) Receiving Bruton´s Tyrosine Kinase(BTK) Interruption-Booster Phase0
Chimeric Antigen Receptor (CAR) T Cell Therapy - Booster Phase0
Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Booster Phase1
Post Allogeneic Transplant - Booster Phase1
Other Hematologic Malignancy - Booster Phase9
Other Adult Solid Tumor - Booster Phase0

Analysis denominator · Blood samples

GroupSource count
Chronic Lymphocytic Leukemia (CLL) Not on Active Therapy - Booster Phase0
Chronic Lymphocytic Leukemia(CLL) Receiving Bruton´s Tyrosine Kinase(BTK) Interruption-Booster Phase0
Chimeric Antigen Receptor (CAR) T Cell Therapy - Booster Phase0
Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Booster Phase1
Post Allogeneic Transplant - Booster Phase1
Other Hematologic Malignancy - Booster Phase9
Other Adult Solid Tumor - Booster Phase0
Values in Samples · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Booster Phase1Not reportedNot reportedNot reportedNot reported
Post Allogeneic Transplant - Booster Phase1Not reportedNot reportedNot reportedNot reported
Other Hematologic Malignancy - Booster Phase9Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG003
        value
        3
      2. group Id
        OG004
        value
        1
      3. group Id
        OG005
        value
        10
    denoms
    1. counts
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        2
      5. group Id
        OG004
        value
        1
      6. group Id
        OG005
        value
        10
      7. group Id
        OG006
        value
        0
      units
      Participants
    2. counts
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        3
      5. group Id
        OG004
        value
        2
      6. group Id
        OG005
        value
        16
      7. group Id
        OG006
        value
        0
      units
      Blood samples
    title
    Day 1
  2. categories
    1. measurements
      1. group Id
        OG003
        value
        3
      2. group Id
        OG004
        value
        2
      3. group Id
        OG005
        value
        12
    denoms
    1. counts
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        2
      5. group Id
        OG004
        value
        1
      6. group Id
        OG005
        value
        9
      7. group Id
        OG006
        value
        0
      units
      Participants
    2. counts
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        3
      5. group Id
        OG004
        value
        2
      6. group Id
        OG005
        value
        15
      7. group Id
        OG006
        value
        0
      units
      Blood samples
    title
    Day 29
  3. categories
    1. measurements
      1. group Id
        OG003
        value
        3
      2. group Id
        OG004
        value
        1
      3. group Id
        OG005
        value
        10
    denoms
    1. counts
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        2
      5. group Id
        OG004
        value
        1
      6. group Id
        OG005
        value
        10
      7. group Id
        OG006
        value
        0
      units
      Participants
    2. counts
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        3
      5. group Id
        OG004
        value
        1
      6. group Id
        OG005
        value
        13
      7. group Id
        OG006
        value
        0
      units
      Blood samples
    title
    Day 57
  4. categories
    1. measurements
      1. group Id
        OG003
        value
        2
      2. group Id
        OG004
        value
        1
      3. group Id
        OG005
        value
        10
    denoms
    1. counts
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        2
      5. group Id
        OG004
        value
        1
      6. group Id
        OG005
        value
        10
      7. group Id
        OG006
        value
        0
      units
      Participants
    2. counts
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        2
      5. group Id
        OG004
        value
        1
      6. group Id
        OG005
        value
        10
      7. group Id
        OG006
        value
        0
      units
      Blood samples
    title
    Day 180
  5. categories
    1. measurements
      1. group Id
        OG003
        value
        1
      2. group Id
        OG004
        value
        1
      3. group Id
        OG005
        value
        9
    denoms
    1. counts
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        1
      5. group Id
        OG004
        value
        1
      6. group Id
        OG005
        value
        9
      7. group Id
        OG006
        value
        0
      units
      Participants
    2. counts
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        1
      5. group Id
        OG004
        value
        1
      6. group Id
        OG005
        value
        9
      7. group Id
        OG006
        value
        0
      units
      Blood samples
    title
    Day 360
denom Units Selected
Blood samples
denoms
  1. counts
    1. group Id
      OG000
      value
      0
    2. group Id
      OG001
      value
      0
    3. group Id
      OG002
      value
      0
    4. group Id
      OG003
      value
      2
    5. group Id
      OG004
      value
      1
    6. group Id
      OG005
      value
      10
    7. group Id
      OG006
      value
      0
    units
    Participants
  2. counts
    1. group Id
      OG000
      value
      0
    2. group Id
      OG001
      value
      0
    3. group Id
      OG002
      value
      0
    4. group Id
      OG003
      value
      12
    5. group Id
      OG004
      value
      7
    6. group Id
      OG005
      value
      63
    7. group Id
      OG006
      value
      0
    units
    Blood samples
description
Number of samples with a neutralizing response (defined as neutralization assay above 30%) will be reported. Participants would receive one to two vaccine boosters. Analysis of timepoints after booster 1 and booster 2 are reported collectively. Immunogenicity of mRNA-1273 vaccine was assessed for Booster Arm in participants with hematologic malignancy with or without ongoing immune suppression and participants with solid tumor receiving programmed death-1 (PD-1)/programmed death-ligand 1 inhibitor (PD-L1) inhibitors: Day 1, Day 29, Day 57, Day 180, and Day 360.
groups
  1. description
    100 mcg (0.5 mL) messenger ribonucleic acid (mRNA)-1273 injection on day (D)1.
    id
    OG000
    title
    Chronic Lymphocytic Leukemia (CLL) Not on Active Therapy - Booster Phase
  2. description
    100 mcg (0.5 mL) messenger ribonucleic acid (mRNA)-1273 injection on day (D)1.
    id
    OG001
    title
    Chronic Lymphocytic Leukemia(CLL) Receiving Bruton´s Tyrosine Kinase(BTK) Interruption-Booster Phase
  3. description
    100 mcg (0.5 mL) messenger ribonucleic acid (mRNA)-1273 injection on day (D)1.
    id
    OG002
    title
    Chimeric Antigen Receptor (CAR) T Cell Therapy - Booster Phase
  4. description
    100 mcg (0.5 mL) messenger ribonucleic acid (mRNA)-1273 injection on day (D)1.
    id
    OG003
    title
    Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Booster Phase
  5. description
    100 mcg (0.5 mL) messenger ribonucleic acid (mRNA)-1273 injection on day (D)1.
    id
    OG004
    title
    Post Allogeneic Transplant - Booster Phase
  6. description
    100 mcg (0.5 mL) messenger ribonucleic acid (mRNA)-1273 injection, intramuscular (IM) on day 1.
    id
    OG005
    title
    Other Hematologic Malignancy - Booster Phase
  7. description
    100 mcg (0.5 mL) messenger ribonucleic acid (mRNA)-1273 injection on day (D)1.
    id
    OG006
    title
    Other Adult Solid Tumor - Booster Phase
param Type
NUMBER
population Description
No participants were enrolled in Groups CLL, CLL/BTK, CAR-T Cell and Other Adult Solid Tumor Booster Phase. Regarding Other Hematologic Malignancy Booster Phase Group 1 participant crossed over from hematologic low immunosuppression-initial phase; 3 participants crossed over from hematologic intermediate immunosuppression-initial phase; 3 participants crossed over from hematologic high immunosuppression-initial phase; \& 3 participants were initially enrolled (did not cross over) into this group.
reporting Status
POSTED
time Frame
Day 1, Day 29, Day 57, Day 180, and Day 360
title
Number of Neutralizing Antibody Samples - Booster Phase
type
SECONDARY
type Units Analyzed
Blood samples
unit Of Measure
Samples

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice