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NCT04847050 · OUTCOME

Immunogenicity of Messenger Ribonucleic Acid (mRNA) -1273 Levels Administered in 2 Doses in the 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
MEDIAN
Unit
AU/mL
Interval / dispersion
Full Range
Time frame
Day 1, Day 29, Day 57, Day 180, and Day 360

What was measured

Immunogenicity of mRNA 1273 administered in 2 doses was assessed by titer or level of specific binding antibody (bAb), in participants with hematologic malignancy with or without ongoing immune suppression and patients with solid tumor receiving programmed death-1 (PD-1)/programmed death-ligand 1 inhibitor (PD-L1) inhibitors. 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 57, Day 180, and Day 360. Participants received one or two vaccine boosters. Analysis of timepoints after booster 1 and booster 2 are reported collectively.

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 AU/mL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Booster Phase4041.3Not reported3198.918374.8Not reported
Post Allogeneic Transplant - Booster Phase23271.4Not reported046542.7Not reported
Other Hematologic Malignancy - Booster Phase4904.71Not reported039676.1Not 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 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 Phase15
Other Adult Solid Tumor - Booster Phase0
Values in AU/mL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Booster Phase30161.9Not reported19237.644659.6Not reported
Post Allogeneic Transplant - Booster Phase43021.6Not reported39500.546542.7Not reported
Other Hematologic Malignancy - Booster Phase22317.0Not reported052133.4Not 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 AU/mL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Booster Phase45003.9Not reported33714.849317.2Not reported
Post Allogeneic Transplant - Booster Phase32364.0Not reportedNot reported32364.0Not reported
Other Hematologic Malignancy - Booster Phase16527.2Not reported033450.0Not 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 AU/mL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Booster Phase18918.0Not reported10902.526933.5Not reported
Post Allogeneic Transplant - Booster Phase10662.5Not reportedNot reported10662.5Not reported
Other Hematologic Malignancy - Booster Phase11842.9Not reported1594.038181.6Not 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 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 Phase1
Post Allogeneic Transplant - Booster Phase1
Other Hematologic Malignancy - Booster Phase9
Other Adult Solid Tumor - Booster Phase0
Values in AU/mL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Booster Phase22329.9Not reportedNA22329.9One out of two participants and one sample analyzed here.
Post Allogeneic Transplant - Booster Phase2331.7Not reportedNA2331.7One sample analyzed here.
Other Hematologic Malignancy - Booster Phase8555.06Not reported1855.4114586.3Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG003
        lower Limit
        3198.9
        upper Limit
        18374.8
        value
        4041.3
      2. group Id
        OG004
        lower Limit
        0
        upper Limit
        46542.7
        value
        23271.4
      3. group Id
        OG005
        lower Limit
        0
        upper Limit
        39676.1
        value
        4904.71
    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
        lower Limit
        19237.6
        upper Limit
        44659.6
        value
        30161.9
      2. group Id
        OG004
        lower Limit
        39500.5
        upper Limit
        46542.7
        value
        43021.6
      3. group Id
        OG005
        lower Limit
        0
        upper Limit
        52133.4
        value
        22317.0
    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
        15
      7. group Id
        OG006
        value
        0
      units
      Blood samples
    title
    Day 29
  3. categories
    1. measurements
      1. group Id
        OG003
        lower Limit
        33714.8
        upper Limit
        49317.2
        value
        45003.9
      2. group Id
        OG004
        upper Limit
        32364.0
        value
        32364.0
      3. group Id
        OG005
        lower Limit
        0
        upper Limit
        33450.0
        value
        16527.2
    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
        lower Limit
        10902.5
        upper Limit
        26933.5
        value
        18918.0
      2. group Id
        OG004
        upper Limit
        10662.5
        value
        10662.5
      3. group Id
        OG005
        lower Limit
        1594.0
        upper Limit
        38181.6
        value
        11842.9
    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
        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. comment
        One out of two participants and one sample analyzed here.
        group Id
        OG003
        lower Limit
        NA
        upper Limit
        22329.9
        value
        22329.9
      2. comment
        One sample analyzed here.
        group Id
        OG004
        lower Limit
        NA
        upper Limit
        2331.7
        value
        2331.7
      3. group Id
        OG005
        lower Limit
        1855.4
        upper Limit
        114586.3
        value
        8555.06
    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
        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
        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
Immunogenicity of mRNA 1273 administered in 2 doses was assessed by titer or level of specific binding antibody (bAb), in participants with hematologic malignancy with or without ongoing immune suppression and patients with solid tumor receiving programmed death-1 (PD-1)/programmed death-ligand 1 inhibitor (PD-L1) inhibitors. 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 57, Day 180, and Day 360. Participants received one or two vaccine boosters. Analysis of timepoints after booster 1 and booster 2 are reported collectively.
dispersion Type
Full Range
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
MEDIAN
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
Immunogenicity of Messenger Ribonucleic Acid (mRNA) -1273 Levels Administered in 2 Doses in the Booster Phase
type
SECONDARY
type Units Analyzed
Blood samples
unit Of Measure
AU/mL

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

Preserved source evidence · Not medical advice