Trial Outcomes & Findings for High-Dose Moderna mRNA-1273 Booster Study for Lung Transplant Recipients (NCT NCT05280158)
NCT ID: NCT05280158
Last Updated: 2025-03-26
Results Overview
Solicited local and systemic reactogenicity adverse events were documented daily in a dedicated diary, and assigned a grade 1-3 according to the "Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials" (FDA grading scale). Higher grades are assigned to more severe events.
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
19 participants
Primary outcome timeframe
Day 1 - Day 7 after study drug administration
Results posted on
2025-03-26
Participant Flow
High Dose arm was not recorded because no participants enrolled in this group.
Participant milestones
| Measure |
Standard Dose Group
50 ug dose of mRNA-1273
|
Mid Dose Group
100 ug dose of mRNA-1273
|
|---|---|---|
|
Overall Study
STARTED
|
8
|
11
|
|
Overall Study
COMPLETED
|
8
|
11
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
High-Dose Moderna mRNA-1273 Booster Study for Lung Transplant Recipients
Baseline characteristics by cohort
| Measure |
Standard-dose - Initial Group
n=8 Participants
50 ug ) mRNA-1273 booster vaccine
|
Mid-dose - Sentinel Group
n=11 Participants
100 ug ) mRNA-1273 booster vaccine
|
High-dose - Sentinel Group
200 ug ) mRNA-1273 booster vaccine
|
Total
n=19 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Count of Participants
|
8 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Day 1 - Day 7 after study drug administrationSolicited local and systemic reactogenicity adverse events were documented daily in a dedicated diary, and assigned a grade 1-3 according to the "Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials" (FDA grading scale). Higher grades are assigned to more severe events.
Outcome measures
| Measure |
Standard-dose
n=8 Participants
mRNA-1273 (Moderna COVID-19 vaccine) 50 ug
mRNA-1273 (Moderna COVID-19 vaccine): Study Drug administered via intramuscular injection (IM). Only one dose of study drug administered for the study.
|
Mid-Dose
n=11 Participants
mRNA-1273 (Moderna COVID-19 vaccine) 100 ug
mRNA-1273 (Moderna COVID-19 vaccine): Study Drug administered via intramuscular injection (IM). Only one dose of study drug administered for the study.
|
|---|---|---|
|
Participants Experiencing Solicited Local and Systemic Reactogenicity Adverse Reactions (AR)
Any Local AR
|
5 participants
|
9 participants
|
|
Participants Experiencing Solicited Local and Systemic Reactogenicity Adverse Reactions (AR)
Injection site pain -Grade 1
|
4 participants
|
7 participants
|
|
Participants Experiencing Solicited Local and Systemic Reactogenicity Adverse Reactions (AR)
Injection site pain -Grade 2
|
2 participants
|
4 participants
|
|
Participants Experiencing Solicited Local and Systemic Reactogenicity Adverse Reactions (AR)
Injection Site Swelling-Grade 1
|
0 participants
|
1 participants
|
|
Participants Experiencing Solicited Local and Systemic Reactogenicity Adverse Reactions (AR)
Injection site swelling, Grade 2
|
0 participants
|
1 participants
|
|
Participants Experiencing Solicited Local and Systemic Reactogenicity Adverse Reactions (AR)
Any Systemic AR
|
3 participants
|
3 participants
|
|
Participants Experiencing Solicited Local and Systemic Reactogenicity Adverse Reactions (AR)
Fatigue - grade 1
|
1 participants
|
1 participants
|
|
Participants Experiencing Solicited Local and Systemic Reactogenicity Adverse Reactions (AR)
Fatigue - Grade 2
|
2 participants
|
1 participants
|
|
Participants Experiencing Solicited Local and Systemic Reactogenicity Adverse Reactions (AR)
Fatigue - Grade 3
|
1 participants
|
1 participants
|
|
Participants Experiencing Solicited Local and Systemic Reactogenicity Adverse Reactions (AR)
Headache - Grade 1
|
2 participants
|
2 participants
|
|
Participants Experiencing Solicited Local and Systemic Reactogenicity Adverse Reactions (AR)
Headache - Grade 2
|
1 participants
|
1 participants
|
|
Participants Experiencing Solicited Local and Systemic Reactogenicity Adverse Reactions (AR)
Headache - Grade 3
|
1 participants
|
0 participants
|
|
Participants Experiencing Solicited Local and Systemic Reactogenicity Adverse Reactions (AR)
Myalgia - Grade 1
|
1 participants
|
1 participants
|
|
Participants Experiencing Solicited Local and Systemic Reactogenicity Adverse Reactions (AR)
Arthralgia - Grade 1
|
1 participants
|
0 participants
|
|
Participants Experiencing Solicited Local and Systemic Reactogenicity Adverse Reactions (AR)
Chills - Grade 1
|
0 participants
|
1 participants
|
|
Participants Experiencing Solicited Local and Systemic Reactogenicity Adverse Reactions (AR)
Nausea/Vomiting - Grade 1
|
1 participants
|
0 participants
|
|
Participants Experiencing Solicited Local and Systemic Reactogenicity Adverse Reactions (AR)
Nausea/Vomiting - Grade 2
|
1 participants
|
0 participants
|
|
Participants Experiencing Solicited Local and Systemic Reactogenicity Adverse Reactions (AR)
Nausea/Vomiting - Grade 3
|
1 participants
|
0 participants
|
PRIMARY outcome
Timeframe: Day 1 - Day 30 after study drug administrationComprehensive recording of occurrence and severity grade of unsolicited adverse events (AEs) daily. These events were documented in a dedicated diary starting from Day 1 of the study and continued through to Day 30. Data collection encompassed adverse events not specifically solicited, with each event's frequency recorded for analysis.
Outcome measures
| Measure |
Standard-dose
n=8 Participants
mRNA-1273 (Moderna COVID-19 vaccine) 50 ug
mRNA-1273 (Moderna COVID-19 vaccine): Study Drug administered via intramuscular injection (IM). Only one dose of study drug administered for the study.
|
Mid-Dose
n=11 Participants
mRNA-1273 (Moderna COVID-19 vaccine) 100 ug
mRNA-1273 (Moderna COVID-19 vaccine): Study Drug administered via intramuscular injection (IM). Only one dose of study drug administered for the study.
|
|---|---|---|
|
Participants Reporting Unsolicited Adverse Events (AEs) Recorded on a Daily Diary
LE edema, Mild
|
0 Participants
|
1 Participants
|
|
Participants Reporting Unsolicited Adverse Events (AEs) Recorded on a Daily Diary
Fatigue, Mild
|
0 Participants
|
1 Participants
|
|
Participants Reporting Unsolicited Adverse Events (AEs) Recorded on a Daily Diary
Fatigue, Moderate
|
0 Participants
|
1 Participants
|
|
Participants Reporting Unsolicited Adverse Events (AEs) Recorded on a Daily Diary
Hyperkalemia, Moderate
|
0 Participants
|
1 Participants
|
|
Participants Reporting Unsolicited Adverse Events (AEs) Recorded on a Daily Diary
Any unsolicited AE
|
1 Participants
|
7 Participants
|
|
Participants Reporting Unsolicited Adverse Events (AEs) Recorded on a Daily Diary
Pain in extremity - left foot, Moderate
|
0 Participants
|
1 Participants
|
|
Participants Reporting Unsolicited Adverse Events (AEs) Recorded on a Daily Diary
Pain in extremity - bilateral shoulder pain, Mild
|
0 Participants
|
1 Participants
|
|
Participants Reporting Unsolicited Adverse Events (AEs) Recorded on a Daily Diary
Creatinine increased, Mild
|
0 Participants
|
1 Participants
|
|
Participants Reporting Unsolicited Adverse Events (AEs) Recorded on a Daily Diary
COVID-19 infection - Mild
|
1 Participants
|
2 Participants
|
|
Participants Reporting Unsolicited Adverse Events (AEs) Recorded on a Daily Diary
COVID-19 infection - Moderate
|
0 Participants
|
3 Participants
|
|
Participants Reporting Unsolicited Adverse Events (AEs) Recorded on a Daily Diary
Joint irritation of left foot and left hand, Mild
|
0 Participants
|
1 Participants
|
|
Participants Reporting Unsolicited Adverse Events (AEs) Recorded on a Daily Diary
Dyspnea, Mild
|
0 Participants
|
1 Participants
|
|
Participants Reporting Unsolicited Adverse Events (AEs) Recorded on a Daily Diary
Palpitations, Mild
|
0 Participants
|
1 Participants
|
|
Participants Reporting Unsolicited Adverse Events (AEs) Recorded on a Daily Diary
Mitral regurgitation worsening, Severe
|
0 Participants
|
1 Participants
|
|
Participants Reporting Unsolicited Adverse Events (AEs) Recorded on a Daily Diary
Chest heaviness, Mild
|
1 Participants
|
0 Participants
|
|
Participants Reporting Unsolicited Adverse Events (AEs) Recorded on a Daily Diary
Shortness of breath worsening, Mild
|
1 Participants
|
0 Participants
|
|
Participants Reporting Unsolicited Adverse Events (AEs) Recorded on a Daily Diary
Chest discomfort worsening, Mild
|
1 Participants
|
0 Participants
|
|
Participants Reporting Unsolicited Adverse Events (AEs) Recorded on a Daily Diary
Lightheadedness, Mild
|
0 Participants
|
1 Participants
|
|
Participants Reporting Unsolicited Adverse Events (AEs) Recorded on a Daily Diary
Mechanical trip and fall, Moderate
|
0 Participants
|
1 Participants
|
|
Participants Reporting Unsolicited Adverse Events (AEs) Recorded on a Daily Diary
Left flank pain, Moderate
|
0 Participants
|
1 Participants
|
|
Participants Reporting Unsolicited Adverse Events (AEs) Recorded on a Daily Diary
Dry cough, Moderate
|
0 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Day 1 - Day 180 after study drug administrationThis comprehensive data collection is intended to provide insights into the occurrence of significant adverse events and specific adverse events of interest over an extended period
Outcome measures
| Measure |
Standard-dose
n=8 Participants
mRNA-1273 (Moderna COVID-19 vaccine) 50 ug
mRNA-1273 (Moderna COVID-19 vaccine): Study Drug administered via intramuscular injection (IM). Only one dose of study drug administered for the study.
|
Mid-Dose
n=11 Participants
mRNA-1273 (Moderna COVID-19 vaccine) 100 ug
mRNA-1273 (Moderna COVID-19 vaccine): Study Drug administered via intramuscular injection (IM). Only one dose of study drug administered for the study.
|
|---|---|---|
|
Participants Reporting Any Serious Adverse Experiences (SAEs) and Adverse Events of Special Interests (AESIs) Related to the Intervention From Day 1 Until Day 180.
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 30 after study drug administrationPopulation: We did not run the assay described. The humoral immunogenicity was measured as neutralizing antibodies since the COVID immunogenicity field had progressed and binding antibodies were not being reported in the literature (only the neutralizing antibodies for the most part).
This evaluation provides insights into the vaccine's ability to induce an immune response by quantifying specific antibody levels targeting key viral components, contributing to the understanding of vaccine efficacy and immune response dynamics.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 1, Day 30 after study drug administrationProvide a direct measure of the vaccine-induced immune response's ability to neutralize viral infection, offering critical insights into vaccine efficacy and immune response effectiveness
Outcome measures
| Measure |
Standard-dose
n=8 Participants
mRNA-1273 (Moderna COVID-19 vaccine) 50 ug
mRNA-1273 (Moderna COVID-19 vaccine): Study Drug administered via intramuscular injection (IM). Only one dose of study drug administered for the study.
|
Mid-Dose
n=11 Participants
mRNA-1273 (Moderna COVID-19 vaccine) 100 ug
mRNA-1273 (Moderna COVID-19 vaccine): Study Drug administered via intramuscular injection (IM). Only one dose of study drug administered for the study.
|
|---|---|---|
|
Humoral Immunogenicity Measured by Neutralizing Antibody Titers From a Pseudovirus Neutralization Assay at Day 30.
Neutralizing antibody titre - Day 1
|
4260 Titer
Interval 57.0 to 30788.0
|
6514 Titer
Interval 40.0 to 14825.0
|
|
Humoral Immunogenicity Measured by Neutralizing Antibody Titers From a Pseudovirus Neutralization Assay at Day 30.
Neutralizing antibody titre - Day 30
|
5436 Titer
Interval 40.0 to 46022.0
|
5293 Titer
Interval 40.0 to 9791.0
|
SECONDARY outcome
Timeframe: Day 1, Day 30 after study drug administrationPercent of total CD8+ T Cells to quantify vaccine-induced cellular immune response, the activation and functionality of specific immune cell populations to contribute to understanding the vaccine's ability to elicit a robust cellular immune response, which is essential for effective protection against viral infections.
Outcome measures
| Measure |
Standard-dose
n=8 Participants
mRNA-1273 (Moderna COVID-19 vaccine) 50 ug
mRNA-1273 (Moderna COVID-19 vaccine): Study Drug administered via intramuscular injection (IM). Only one dose of study drug administered for the study.
|
Mid-Dose
n=11 Participants
mRNA-1273 (Moderna COVID-19 vaccine) 100 ug
mRNA-1273 (Moderna COVID-19 vaccine): Study Drug administered via intramuscular injection (IM). Only one dose of study drug administered for the study.
|
|---|---|---|
|
Cellular Immunogenicity (CD8+ T Cell Responses After Spike Protein Peptide Pool Stimulation) Measured by Cellular Response Assays Including Flow Cytometry With Intracellular Staining.
Day 30-IFNγ
|
0.04 percent of total CD8+ T Cells detectable
Interval 0.01 to 0.16
|
0.01 percent of total CD8+ T Cells detectable
Interval 0.01 to 0.26
|
|
Cellular Immunogenicity (CD8+ T Cell Responses After Spike Protein Peptide Pool Stimulation) Measured by Cellular Response Assays Including Flow Cytometry With Intracellular Staining.
Day 1-IFNγ
|
0.01 percent of total CD8+ T Cells detectable
Interval 0.01 to 0.13
|
0.01 percent of total CD8+ T Cells detectable
Interval 0.01 to 0.82
|
|
Cellular Immunogenicity (CD8+ T Cell Responses After Spike Protein Peptide Pool Stimulation) Measured by Cellular Response Assays Including Flow Cytometry With Intracellular Staining.
Day 1-IL-2
|
0.01 percent of total CD8+ T Cells detectable
Interval 0.01 to 0.1
|
0.01 percent of total CD8+ T Cells detectable
Interval 0.01 to 0.1
|
|
Cellular Immunogenicity (CD8+ T Cell Responses After Spike Protein Peptide Pool Stimulation) Measured by Cellular Response Assays Including Flow Cytometry With Intracellular Staining.
Day 30-IL-2
|
0.01 percent of total CD8+ T Cells detectable
Interval 0.01 to 0.52
|
0.01 percent of total CD8+ T Cells detectable
Interval 0.01 to 0.52
|
|
Cellular Immunogenicity (CD8+ T Cell Responses After Spike Protein Peptide Pool Stimulation) Measured by Cellular Response Assays Including Flow Cytometry With Intracellular Staining.
Day 1-TNFα
|
0.01 percent of total CD8+ T Cells detectable
Interval 0.01 to 0.42
|
0.01 percent of total CD8+ T Cells detectable
Interval 0.01 to 0.02
|
|
Cellular Immunogenicity (CD8+ T Cell Responses After Spike Protein Peptide Pool Stimulation) Measured by Cellular Response Assays Including Flow Cytometry With Intracellular Staining.
Day 30-TNFα
|
0.01 percent of total CD8+ T Cells detectable
Interval 0.01 to 0.29
|
0.01 percent of total CD8+ T Cells detectable
Interval 0.01 to 0.58
|
|
Cellular Immunogenicity (CD8+ T Cell Responses After Spike Protein Peptide Pool Stimulation) Measured by Cellular Response Assays Including Flow Cytometry With Intracellular Staining.
Day 1- IFNγ, IL-2, or TNFα
|
0.01 percent of total CD8+ T Cells detectable
Interval 0.01 to 0.02
|
0.01 percent of total CD8+ T Cells detectable
Interval 0.01 to 0.67
|
|
Cellular Immunogenicity (CD8+ T Cell Responses After Spike Protein Peptide Pool Stimulation) Measured by Cellular Response Assays Including Flow Cytometry With Intracellular Staining.
Day 30-IFNγ, IL-2, or TNFα
|
0.01 percent of total CD8+ T Cells detectable
Interval 0.01 to 0.48
|
0.01 percent of total CD8+ T Cells detectable
Interval 0.01 to 0.51
|
SECONDARY outcome
Timeframe: Day 1, Day 30 after study drug administrationPercent of total CD4+ T Cells to quantify vaccine-induced cellular immune response, the activation and functionality of specific immune cell populations to contribute to understanding the vaccine's ability to elicit a robust cellular immune response, which is essential for effective protection against viral infections.
Outcome measures
| Measure |
Standard-dose
n=8 Participants
mRNA-1273 (Moderna COVID-19 vaccine) 50 ug
mRNA-1273 (Moderna COVID-19 vaccine): Study Drug administered via intramuscular injection (IM). Only one dose of study drug administered for the study.
|
Mid-Dose
n=11 Participants
mRNA-1273 (Moderna COVID-19 vaccine) 100 ug
mRNA-1273 (Moderna COVID-19 vaccine): Study Drug administered via intramuscular injection (IM). Only one dose of study drug administered for the study.
|
|---|---|---|
|
Cellular Immunogenicity (CD4+ T Cell Responses After Spike Protein Peptide Pool Stimulation) Measured by Cellular Response Assays Including Flow Cytometry With Intracellular Staining.
Day 30-IFNγ, IL-2, or TNFα
|
0.23 percent of total CD4+ T Cells detectable
Interval 0.01 to 1.13
|
0.01 percent of total CD4+ T Cells detectable
Interval 0.01 to 0.29
|
|
Cellular Immunogenicity (CD4+ T Cell Responses After Spike Protein Peptide Pool Stimulation) Measured by Cellular Response Assays Including Flow Cytometry With Intracellular Staining.
Day 1-IFNγ
|
0.01 percent of total CD4+ T Cells detectable
Interval 0.01 to 0.59
|
0.01 percent of total CD4+ T Cells detectable
Interval 0.01 to 0.26
|
|
Cellular Immunogenicity (CD4+ T Cell Responses After Spike Protein Peptide Pool Stimulation) Measured by Cellular Response Assays Including Flow Cytometry With Intracellular Staining.
Day 30-IFNγ
|
0.04 percent of total CD4+ T Cells detectable
Interval 0.01 to 0.65
|
0.02 percent of total CD4+ T Cells detectable
Interval 0.01 to 0.2
|
|
Cellular Immunogenicity (CD4+ T Cell Responses After Spike Protein Peptide Pool Stimulation) Measured by Cellular Response Assays Including Flow Cytometry With Intracellular Staining.
Day 1-IL-2
|
0.01 percent of total CD4+ T Cells detectable
Interval 0.01 to 0.53
|
0.07 percent of total CD4+ T Cells detectable
Interval 0.01 to 1.93
|
|
Cellular Immunogenicity (CD4+ T Cell Responses After Spike Protein Peptide Pool Stimulation) Measured by Cellular Response Assays Including Flow Cytometry With Intracellular Staining.
Day 30-IL-2
|
0.05 percent of total CD4+ T Cells detectable
Interval 0.01 to 0.31
|
0.20 percent of total CD4+ T Cells detectable
Interval 0.01 to 0.99
|
|
Cellular Immunogenicity (CD4+ T Cell Responses After Spike Protein Peptide Pool Stimulation) Measured by Cellular Response Assays Including Flow Cytometry With Intracellular Staining.
Day 1-TNFα
|
0.03 percent of total CD4+ T Cells detectable
Interval 0.01 to 0.62
|
0.01 percent of total CD4+ T Cells detectable
Interval 0.01 to 0.37
|
|
Cellular Immunogenicity (CD4+ T Cell Responses After Spike Protein Peptide Pool Stimulation) Measured by Cellular Response Assays Including Flow Cytometry With Intracellular Staining.
Day 30-TNFα
|
0.15 percent of total CD4+ T Cells detectable
Interval 0.01 to 0.95
|
0.01 percent of total CD4+ T Cells detectable
Interval 0.01 to 0.17
|
|
Cellular Immunogenicity (CD4+ T Cell Responses After Spike Protein Peptide Pool Stimulation) Measured by Cellular Response Assays Including Flow Cytometry With Intracellular Staining.
Day 1- IFNγ, IL-2, or TNFα
|
0.01 percent of total CD4+ T Cells detectable
Interval 0.01 to 0.43
|
0.01 percent of total CD4+ T Cells detectable
Interval 0.01 to 0.34
|
Adverse Events
Standard-dose
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
Mid-Dose
Serious events: 2 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Standard-dose
n=8 participants at risk
mRNA-1273 (Moderna COVID-19 vaccine) 50 ug
mRNA-1273 (Moderna COVID-19 vaccine): Study Drug will be administered via intramuscular injection (IM). Only one dose of study drug will be administered for the study.
|
Mid-Dose
n=11 participants at risk
mRNA-1273 (Moderna COVID-19 vaccine) 100 ug
mRNA-1273 (Moderna COVID-19 vaccine): Study Drug will be administered via intramuscular injection (IM). Only one dose of study drug will be administered for the study.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Acute hypoxic respiratory failure
|
0.00%
0/8 • Adverse events were collected throughout the study, Visit 1 (Day 1) through Visit 6 (Day 180)
The High Dose Group did not have any enrolled participants in this study. This decision was influenced by the availability of the vaccine to the public starting in September 2022. Therefore, results for this arm/group are not reported
|
9.1%
1/11 • Number of events 1 • Adverse events were collected throughout the study, Visit 1 (Day 1) through Visit 6 (Day 180)
The High Dose Group did not have any enrolled participants in this study. This decision was influenced by the availability of the vaccine to the public starting in September 2022. Therefore, results for this arm/group are not reported
|
|
Infections and infestations
COVID 19 infection
|
0.00%
0/8 • Adverse events were collected throughout the study, Visit 1 (Day 1) through Visit 6 (Day 180)
The High Dose Group did not have any enrolled participants in this study. This decision was influenced by the availability of the vaccine to the public starting in September 2022. Therefore, results for this arm/group are not reported
|
9.1%
1/11 • Number of events 1 • Adverse events were collected throughout the study, Visit 1 (Day 1) through Visit 6 (Day 180)
The High Dose Group did not have any enrolled participants in this study. This decision was influenced by the availability of the vaccine to the public starting in September 2022. Therefore, results for this arm/group are not reported
|
|
Renal and urinary disorders
Acute kidney injury
|
12.5%
1/8 • Number of events 1 • Adverse events were collected throughout the study, Visit 1 (Day 1) through Visit 6 (Day 180)
The High Dose Group did not have any enrolled participants in this study. This decision was influenced by the availability of the vaccine to the public starting in September 2022. Therefore, results for this arm/group are not reported
|
9.1%
1/11 • Number of events 1 • Adverse events were collected throughout the study, Visit 1 (Day 1) through Visit 6 (Day 180)
The High Dose Group did not have any enrolled participants in this study. This decision was influenced by the availability of the vaccine to the public starting in September 2022. Therefore, results for this arm/group are not reported
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration pneumonia
|
0.00%
0/8 • Adverse events were collected throughout the study, Visit 1 (Day 1) through Visit 6 (Day 180)
The High Dose Group did not have any enrolled participants in this study. This decision was influenced by the availability of the vaccine to the public starting in September 2022. Therefore, results for this arm/group are not reported
|
9.1%
1/11 • Number of events 1 • Adverse events were collected throughout the study, Visit 1 (Day 1) through Visit 6 (Day 180)
The High Dose Group did not have any enrolled participants in this study. This decision was influenced by the availability of the vaccine to the public starting in September 2022. Therefore, results for this arm/group are not reported
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/8 • Adverse events were collected throughout the study, Visit 1 (Day 1) through Visit 6 (Day 180)
The High Dose Group did not have any enrolled participants in this study. This decision was influenced by the availability of the vaccine to the public starting in September 2022. Therefore, results for this arm/group are not reported
|
9.1%
1/11 • Number of events 1 • Adverse events were collected throughout the study, Visit 1 (Day 1) through Visit 6 (Day 180)
The High Dose Group did not have any enrolled participants in this study. This decision was influenced by the availability of the vaccine to the public starting in September 2022. Therefore, results for this arm/group are not reported
|
|
Vascular disorders
Hypotension
|
12.5%
1/8 • Number of events 1 • Adverse events were collected throughout the study, Visit 1 (Day 1) through Visit 6 (Day 180)
The High Dose Group did not have any enrolled participants in this study. This decision was influenced by the availability of the vaccine to the public starting in September 2022. Therefore, results for this arm/group are not reported
|
0.00%
0/11 • Adverse events were collected throughout the study, Visit 1 (Day 1) through Visit 6 (Day 180)
The High Dose Group did not have any enrolled participants in this study. This decision was influenced by the availability of the vaccine to the public starting in September 2022. Therefore, results for this arm/group are not reported
|
|
Respiratory, thoracic and mediastinal disorders
Post-aspiration pneumonia dyspnea
|
0.00%
0/8 • Adverse events were collected throughout the study, Visit 1 (Day 1) through Visit 6 (Day 180)
The High Dose Group did not have any enrolled participants in this study. This decision was influenced by the availability of the vaccine to the public starting in September 2022. Therefore, results for this arm/group are not reported
|
9.1%
1/11 • Number of events 1 • Adverse events were collected throughout the study, Visit 1 (Day 1) through Visit 6 (Day 180)
The High Dose Group did not have any enrolled participants in this study. This decision was influenced by the availability of the vaccine to the public starting in September 2022. Therefore, results for this arm/group are not reported
|
|
General disorders
Post-op chest paqin
|
0.00%
0/8 • Adverse events were collected throughout the study, Visit 1 (Day 1) through Visit 6 (Day 180)
The High Dose Group did not have any enrolled participants in this study. This decision was influenced by the availability of the vaccine to the public starting in September 2022. Therefore, results for this arm/group are not reported
|
9.1%
1/11 • Number of events 1 • Adverse events were collected throughout the study, Visit 1 (Day 1) through Visit 6 (Day 180)
The High Dose Group did not have any enrolled participants in this study. This decision was influenced by the availability of the vaccine to the public starting in September 2022. Therefore, results for this arm/group are not reported
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
12.5%
1/8 • Number of events 1 • Adverse events were collected throughout the study, Visit 1 (Day 1) through Visit 6 (Day 180)
The High Dose Group did not have any enrolled participants in this study. This decision was influenced by the availability of the vaccine to the public starting in September 2022. Therefore, results for this arm/group are not reported
|
9.1%
1/11 • Number of events 1 • Adverse events were collected throughout the study, Visit 1 (Day 1) through Visit 6 (Day 180)
The High Dose Group did not have any enrolled participants in this study. This decision was influenced by the availability of the vaccine to the public starting in September 2022. Therefore, results for this arm/group are not reported
|
|
Blood and lymphatic system disorders
Sepsis
|
0.00%
0/8 • Adverse events were collected throughout the study, Visit 1 (Day 1) through Visit 6 (Day 180)
The High Dose Group did not have any enrolled participants in this study. This decision was influenced by the availability of the vaccine to the public starting in September 2022. Therefore, results for this arm/group are not reported
|
9.1%
1/11 • Number of events 1 • Adverse events were collected throughout the study, Visit 1 (Day 1) through Visit 6 (Day 180)
The High Dose Group did not have any enrolled participants in this study. This decision was influenced by the availability of the vaccine to the public starting in September 2022. Therefore, results for this arm/group are not reported
|
|
Cardiac disorders
Mitral valve regurgitation (MR) and aortic valve regurgitation (AR) post valve replacement surgery
|
0.00%
0/8 • Adverse events were collected throughout the study, Visit 1 (Day 1) through Visit 6 (Day 180)
The High Dose Group did not have any enrolled participants in this study. This decision was influenced by the availability of the vaccine to the public starting in September 2022. Therefore, results for this arm/group are not reported
|
9.1%
1/11 • Number of events 1 • Adverse events were collected throughout the study, Visit 1 (Day 1) through Visit 6 (Day 180)
The High Dose Group did not have any enrolled participants in this study. This decision was influenced by the availability of the vaccine to the public starting in September 2022. Therefore, results for this arm/group are not reported
|
|
General disorders
Syncope
|
12.5%
1/8 • Number of events 1 • Adverse events were collected throughout the study, Visit 1 (Day 1) through Visit 6 (Day 180)
The High Dose Group did not have any enrolled participants in this study. This decision was influenced by the availability of the vaccine to the public starting in September 2022. Therefore, results for this arm/group are not reported
|
0.00%
0/11 • Adverse events were collected throughout the study, Visit 1 (Day 1) through Visit 6 (Day 180)
The High Dose Group did not have any enrolled participants in this study. This decision was influenced by the availability of the vaccine to the public starting in September 2022. Therefore, results for this arm/group are not reported
|
Other adverse events
| Measure |
Standard-dose
n=8 participants at risk
mRNA-1273 (Moderna COVID-19 vaccine) 50 ug
mRNA-1273 (Moderna COVID-19 vaccine): Study Drug will be administered via intramuscular injection (IM). Only one dose of study drug will be administered for the study.
|
Mid-Dose
n=11 participants at risk
mRNA-1273 (Moderna COVID-19 vaccine) 100 ug
mRNA-1273 (Moderna COVID-19 vaccine): Study Drug will be administered via intramuscular injection (IM). Only one dose of study drug will be administered for the study.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
12.5%
1/8 • Number of events 1 • Adverse events were collected throughout the study, Visit 1 (Day 1) through Visit 6 (Day 180)
The High Dose Group did not have any enrolled participants in this study. This decision was influenced by the availability of the vaccine to the public starting in September 2022. Therefore, results for this arm/group are not reported
|
0.00%
0/11 • Adverse events were collected throughout the study, Visit 1 (Day 1) through Visit 6 (Day 180)
The High Dose Group did not have any enrolled participants in this study. This decision was influenced by the availability of the vaccine to the public starting in September 2022. Therefore, results for this arm/group are not reported
|
|
Respiratory, thoracic and mediastinal disorders
Chest heaviness
|
12.5%
1/8 • Number of events 1 • Adverse events were collected throughout the study, Visit 1 (Day 1) through Visit 6 (Day 180)
The High Dose Group did not have any enrolled participants in this study. This decision was influenced by the availability of the vaccine to the public starting in September 2022. Therefore, results for this arm/group are not reported
|
0.00%
0/11 • Adverse events were collected throughout the study, Visit 1 (Day 1) through Visit 6 (Day 180)
The High Dose Group did not have any enrolled participants in this study. This decision was influenced by the availability of the vaccine to the public starting in September 2022. Therefore, results for this arm/group are not reported
|
|
General disorders
Chills
|
0.00%
0/8 • Adverse events were collected throughout the study, Visit 1 (Day 1) through Visit 6 (Day 180)
The High Dose Group did not have any enrolled participants in this study. This decision was influenced by the availability of the vaccine to the public starting in September 2022. Therefore, results for this arm/group are not reported
|
9.1%
1/11 • Number of events 1 • Adverse events were collected throughout the study, Visit 1 (Day 1) through Visit 6 (Day 180)
The High Dose Group did not have any enrolled participants in this study. This decision was influenced by the availability of the vaccine to the public starting in September 2022. Therefore, results for this arm/group are not reported
|
|
Infections and infestations
COVID 19 infection
|
12.5%
1/8 • Number of events 1 • Adverse events were collected throughout the study, Visit 1 (Day 1) through Visit 6 (Day 180)
The High Dose Group did not have any enrolled participants in this study. This decision was influenced by the availability of the vaccine to the public starting in September 2022. Therefore, results for this arm/group are not reported
|
36.4%
4/11 • Number of events 5 • Adverse events were collected throughout the study, Visit 1 (Day 1) through Visit 6 (Day 180)
The High Dose Group did not have any enrolled participants in this study. This decision was influenced by the availability of the vaccine to the public starting in September 2022. Therefore, results for this arm/group are not reported
|
|
General disorders
Increased Creatinine
|
0.00%
0/8 • Adverse events were collected throughout the study, Visit 1 (Day 1) through Visit 6 (Day 180)
The High Dose Group did not have any enrolled participants in this study. This decision was influenced by the availability of the vaccine to the public starting in September 2022. Therefore, results for this arm/group are not reported
|
9.1%
1/11 • Number of events 1 • Adverse events were collected throughout the study, Visit 1 (Day 1) through Visit 6 (Day 180)
The High Dose Group did not have any enrolled participants in this study. This decision was influenced by the availability of the vaccine to the public starting in September 2022. Therefore, results for this arm/group are not reported
|
|
Respiratory, thoracic and mediastinal disorders
Dry cough
|
0.00%
0/8 • Adverse events were collected throughout the study, Visit 1 (Day 1) through Visit 6 (Day 180)
The High Dose Group did not have any enrolled participants in this study. This decision was influenced by the availability of the vaccine to the public starting in September 2022. Therefore, results for this arm/group are not reported
|
9.1%
1/11 • Number of events 1 • Adverse events were collected throughout the study, Visit 1 (Day 1) through Visit 6 (Day 180)
The High Dose Group did not have any enrolled participants in this study. This decision was influenced by the availability of the vaccine to the public starting in September 2022. Therefore, results for this arm/group are not reported
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/8 • Adverse events were collected throughout the study, Visit 1 (Day 1) through Visit 6 (Day 180)
The High Dose Group did not have any enrolled participants in this study. This decision was influenced by the availability of the vaccine to the public starting in September 2022. Therefore, results for this arm/group are not reported
|
9.1%
1/11 • Number of events 1 • Adverse events were collected throughout the study, Visit 1 (Day 1) through Visit 6 (Day 180)
The High Dose Group did not have any enrolled participants in this study. This decision was influenced by the availability of the vaccine to the public starting in September 2022. Therefore, results for this arm/group are not reported
|
|
General disorders
Fatigue
|
25.0%
2/8 • Number of events 4 • Adverse events were collected throughout the study, Visit 1 (Day 1) through Visit 6 (Day 180)
The High Dose Group did not have any enrolled participants in this study. This decision was influenced by the availability of the vaccine to the public starting in September 2022. Therefore, results for this arm/group are not reported
|
36.4%
4/11 • Number of events 5 • Adverse events were collected throughout the study, Visit 1 (Day 1) through Visit 6 (Day 180)
The High Dose Group did not have any enrolled participants in this study. This decision was influenced by the availability of the vaccine to the public starting in September 2022. Therefore, results for this arm/group are not reported
|
|
General disorders
Headache
|
37.5%
3/8 • Number of events 5 • Adverse events were collected throughout the study, Visit 1 (Day 1) through Visit 6 (Day 180)
The High Dose Group did not have any enrolled participants in this study. This decision was influenced by the availability of the vaccine to the public starting in September 2022. Therefore, results for this arm/group are not reported
|
27.3%
3/11 • Number of events 3 • Adverse events were collected throughout the study, Visit 1 (Day 1) through Visit 6 (Day 180)
The High Dose Group did not have any enrolled participants in this study. This decision was influenced by the availability of the vaccine to the public starting in September 2022. Therefore, results for this arm/group are not reported
|
|
Blood and lymphatic system disorders
Hyperkalemia
|
0.00%
0/8 • Adverse events were collected throughout the study, Visit 1 (Day 1) through Visit 6 (Day 180)
The High Dose Group did not have any enrolled participants in this study. This decision was influenced by the availability of the vaccine to the public starting in September 2022. Therefore, results for this arm/group are not reported
|
9.1%
1/11 • Number of events 1 • Adverse events were collected throughout the study, Visit 1 (Day 1) through Visit 6 (Day 180)
The High Dose Group did not have any enrolled participants in this study. This decision was influenced by the availability of the vaccine to the public starting in September 2022. Therefore, results for this arm/group are not reported
|
|
General disorders
Injection site pain
|
62.5%
5/8 • Number of events 6 • Adverse events were collected throughout the study, Visit 1 (Day 1) through Visit 6 (Day 180)
The High Dose Group did not have any enrolled participants in this study. This decision was influenced by the availability of the vaccine to the public starting in September 2022. Therefore, results for this arm/group are not reported
|
90.9%
10/11 • Number of events 12 • Adverse events were collected throughout the study, Visit 1 (Day 1) through Visit 6 (Day 180)
The High Dose Group did not have any enrolled participants in this study. This decision was influenced by the availability of the vaccine to the public starting in September 2022. Therefore, results for this arm/group are not reported
|
|
Injury, poisoning and procedural complications
Injection site swelling
|
0.00%
0/8 • Adverse events were collected throughout the study, Visit 1 (Day 1) through Visit 6 (Day 180)
The High Dose Group did not have any enrolled participants in this study. This decision was influenced by the availability of the vaccine to the public starting in September 2022. Therefore, results for this arm/group are not reported
|
9.1%
1/11 • Number of events 2 • Adverse events were collected throughout the study, Visit 1 (Day 1) through Visit 6 (Day 180)
The High Dose Group did not have any enrolled participants in this study. This decision was influenced by the availability of the vaccine to the public starting in September 2022. Therefore, results for this arm/group are not reported
|
|
Musculoskeletal and connective tissue disorders
Joint irritation, foot and hand
|
0.00%
0/8 • Adverse events were collected throughout the study, Visit 1 (Day 1) through Visit 6 (Day 180)
The High Dose Group did not have any enrolled participants in this study. This decision was influenced by the availability of the vaccine to the public starting in September 2022. Therefore, results for this arm/group are not reported
|
9.1%
1/11 • Number of events 1 • Adverse events were collected throughout the study, Visit 1 (Day 1) through Visit 6 (Day 180)
The High Dose Group did not have any enrolled participants in this study. This decision was influenced by the availability of the vaccine to the public starting in September 2022. Therefore, results for this arm/group are not reported
|
|
Vascular disorders
Edema of lower extremity
|
0.00%
0/8 • Adverse events were collected throughout the study, Visit 1 (Day 1) through Visit 6 (Day 180)
The High Dose Group did not have any enrolled participants in this study. This decision was influenced by the availability of the vaccine to the public starting in September 2022. Therefore, results for this arm/group are not reported
|
9.1%
1/11 • Number of events 1 • Adverse events were collected throughout the study, Visit 1 (Day 1) through Visit 6 (Day 180)
The High Dose Group did not have any enrolled participants in this study. This decision was influenced by the availability of the vaccine to the public starting in September 2022. Therefore, results for this arm/group are not reported
|
|
General disorders
Flank pain, left
|
0.00%
0/8 • Adverse events were collected throughout the study, Visit 1 (Day 1) through Visit 6 (Day 180)
The High Dose Group did not have any enrolled participants in this study. This decision was influenced by the availability of the vaccine to the public starting in September 2022. Therefore, results for this arm/group are not reported
|
9.1%
1/11 • Number of events 1 • Adverse events were collected throughout the study, Visit 1 (Day 1) through Visit 6 (Day 180)
The High Dose Group did not have any enrolled participants in this study. This decision was influenced by the availability of the vaccine to the public starting in September 2022. Therefore, results for this arm/group are not reported
|
|
General disorders
Lightheadedness
|
0.00%
0/8 • Adverse events were collected throughout the study, Visit 1 (Day 1) through Visit 6 (Day 180)
The High Dose Group did not have any enrolled participants in this study. This decision was influenced by the availability of the vaccine to the public starting in September 2022. Therefore, results for this arm/group are not reported
|
9.1%
1/11 • Number of events 1 • Adverse events were collected throughout the study, Visit 1 (Day 1) through Visit 6 (Day 180)
The High Dose Group did not have any enrolled participants in this study. This decision was influenced by the availability of the vaccine to the public starting in September 2022. Therefore, results for this arm/group are not reported
|
|
General disorders
Mechanical trip and fall
|
0.00%
0/8 • Adverse events were collected throughout the study, Visit 1 (Day 1) through Visit 6 (Day 180)
The High Dose Group did not have any enrolled participants in this study. This decision was influenced by the availability of the vaccine to the public starting in September 2022. Therefore, results for this arm/group are not reported
|
9.1%
1/11 • Number of events 1 • Adverse events were collected throughout the study, Visit 1 (Day 1) through Visit 6 (Day 180)
The High Dose Group did not have any enrolled participants in this study. This decision was influenced by the availability of the vaccine to the public starting in September 2022. Therefore, results for this arm/group are not reported
|
|
General disorders
Myalgia
|
12.5%
1/8 • Number of events 1 • Adverse events were collected throughout the study, Visit 1 (Day 1) through Visit 6 (Day 180)
The High Dose Group did not have any enrolled participants in this study. This decision was influenced by the availability of the vaccine to the public starting in September 2022. Therefore, results for this arm/group are not reported
|
9.1%
1/11 • Number of events 1 • Adverse events were collected throughout the study, Visit 1 (Day 1) through Visit 6 (Day 180)
The High Dose Group did not have any enrolled participants in this study. This decision was influenced by the availability of the vaccine to the public starting in September 2022. Therefore, results for this arm/group are not reported
|
|
General disorders
Nausea/Vomiting
|
12.5%
1/8 • Number of events 3 • Adverse events were collected throughout the study, Visit 1 (Day 1) through Visit 6 (Day 180)
The High Dose Group did not have any enrolled participants in this study. This decision was influenced by the availability of the vaccine to the public starting in September 2022. Therefore, results for this arm/group are not reported
|
0.00%
0/11 • Adverse events were collected throughout the study, Visit 1 (Day 1) through Visit 6 (Day 180)
The High Dose Group did not have any enrolled participants in this study. This decision was influenced by the availability of the vaccine to the public starting in September 2022. Therefore, results for this arm/group are not reported
|
|
General disorders
Pain in extremity - bilateral shoulder
|
0.00%
0/8 • Adverse events were collected throughout the study, Visit 1 (Day 1) through Visit 6 (Day 180)
The High Dose Group did not have any enrolled participants in this study. This decision was influenced by the availability of the vaccine to the public starting in September 2022. Therefore, results for this arm/group are not reported
|
9.1%
1/11 • Number of events 1 • Adverse events were collected throughout the study, Visit 1 (Day 1) through Visit 6 (Day 180)
The High Dose Group did not have any enrolled participants in this study. This decision was influenced by the availability of the vaccine to the public starting in September 2022. Therefore, results for this arm/group are not reported
|
|
General disorders
Pain in extremity - left foot
|
0.00%
0/8 • Adverse events were collected throughout the study, Visit 1 (Day 1) through Visit 6 (Day 180)
The High Dose Group did not have any enrolled participants in this study. This decision was influenced by the availability of the vaccine to the public starting in September 2022. Therefore, results for this arm/group are not reported
|
9.1%
1/11 • Number of events 1 • Adverse events were collected throughout the study, Visit 1 (Day 1) through Visit 6 (Day 180)
The High Dose Group did not have any enrolled participants in this study. This decision was influenced by the availability of the vaccine to the public starting in September 2022. Therefore, results for this arm/group are not reported
|
|
Cardiac disorders
Palpitations
|
0.00%
0/8 • Adverse events were collected throughout the study, Visit 1 (Day 1) through Visit 6 (Day 180)
The High Dose Group did not have any enrolled participants in this study. This decision was influenced by the availability of the vaccine to the public starting in September 2022. Therefore, results for this arm/group are not reported
|
9.1%
1/11 • Number of events 1 • Adverse events were collected throughout the study, Visit 1 (Day 1) through Visit 6 (Day 180)
The High Dose Group did not have any enrolled participants in this study. This decision was influenced by the availability of the vaccine to the public starting in September 2022. Therefore, results for this arm/group are not reported
|
|
Respiratory, thoracic and mediastinal disorders
Chest discomfort worsening
|
12.5%
1/8 • Number of events 1 • Adverse events were collected throughout the study, Visit 1 (Day 1) through Visit 6 (Day 180)
The High Dose Group did not have any enrolled participants in this study. This decision was influenced by the availability of the vaccine to the public starting in September 2022. Therefore, results for this arm/group are not reported
|
0.00%
0/11 • Adverse events were collected throughout the study, Visit 1 (Day 1) through Visit 6 (Day 180)
The High Dose Group did not have any enrolled participants in this study. This decision was influenced by the availability of the vaccine to the public starting in September 2022. Therefore, results for this arm/group are not reported
|
|
Respiratory, thoracic and mediastinal disorders
Shortness of breath worsening
|
12.5%
1/8 • Number of events 1 • Adverse events were collected throughout the study, Visit 1 (Day 1) through Visit 6 (Day 180)
The High Dose Group did not have any enrolled participants in this study. This decision was influenced by the availability of the vaccine to the public starting in September 2022. Therefore, results for this arm/group are not reported
|
0.00%
0/11 • Adverse events were collected throughout the study, Visit 1 (Day 1) through Visit 6 (Day 180)
The High Dose Group did not have any enrolled participants in this study. This decision was influenced by the availability of the vaccine to the public starting in September 2022. Therefore, results for this arm/group are not reported
|
|
Cardiac disorders
Mitral regurgitation worsening
|
0.00%
0/8 • Adverse events were collected throughout the study, Visit 1 (Day 1) through Visit 6 (Day 180)
The High Dose Group did not have any enrolled participants in this study. This decision was influenced by the availability of the vaccine to the public starting in September 2022. Therefore, results for this arm/group are not reported
|
9.1%
1/11 • Number of events 1 • Adverse events were collected throughout the study, Visit 1 (Day 1) through Visit 6 (Day 180)
The High Dose Group did not have any enrolled participants in this study. This decision was influenced by the availability of the vaccine to the public starting in September 2022. Therefore, results for this arm/group are not reported
|
Additional Information
Yusaku Michael Shino, MD
University of California, Los Angeles
Phone: (310) 866-6327
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place