Healthy Volunteers
Conditions
Keywords
mRNA-1273.712, Vaccine, Cardiac Troponin
Brief summary
The primary objective of this study is to assess cardiac troponin I (cTnI) values in participants who received mRNA-1273.712 or placebo.
Interventions
BIOLOGICALmRNA-1273.712
Intramuscular (IM) injection.
BIOLOGICALPlacebo
Sodium chloride for IM injection.
Sponsors
ModernaTX, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
12 Years to 30 Years
Healthy volunteers
Yes
Inclusion criteria
1. Investigator's assessment that participant understands and is willing and physically able to comply with protocol-mandated follow-up, including all procedures. 2. Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF). 3. Contraceptive use by participants should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
Exclusion criteria
1. History of anaphylaxis or severe hypersensitivity reaction requiring medical intervention after receipt of any mRNA vaccine or therapeutic or any components of an mRNA vaccine or therapeutic. 2. Has known history of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection within 3 months prior to enrollment. 3. Has a documented history of myocarditis or pericarditis. 4. Is acutely ill or febrile (temperature ≥38.0 degrees Celsius \[°C\]/100.4 degrees Fahrenheit \[°F\]) less than 72 hours prior to or at the Screening Visit or Day 1. 5. Has known conditions that may cause elevated cTnI. * Cardiac disease/conditions including rhythm disorders and congenital heart disease * Diabetes * Uncontrolled hypertension (defined as systolic blood pressure \>140 millimeter of mercury (mmHg) or diastolic blood pressure \>90 mmHg) * Alcohol or substance abuse * Kidney disease * Severe obesity, defined as body mass index (BMI) ≥40 kilograms per square meter (kg/m\^2) (\>20 years) or severe obesity defined as BMI for sex and age ≥120% of the 95th percentile \[BMI ≥35 kg/m\^2\] (for 12 to 20 years) 6. Currently has symptomatic acute or unstable chronic disease requiring medical or surgical care, to include significant change in therapy or hospitalization for worsening disease, at the discretion of the Investigator. 7. Has a medical, psychiatric, or occupational condition that may pose additional risk as a result of participation, or that could interfere with safety assessments or interpretation of results according to the Investigator's judgment. 8. Reported history of congenital or acquired immunodeficiency (eg, human immunodeficiency virus \[HIV\]), immunosuppressive condition or immune-mediated disease, asplenia, or recurrent severe infections disease. 9. History of Guillain-Barré syndrome. 10. Receipt of the following: * Coronavirus disease 2019 (COVID-19) vaccine within 3 months prior to the first injection or if planning to receive at any time during the study (except for study intervention). * Any other licensed vaccine within 28 days before the study injection or planned receipt prior to end of study (EOS). * Systemic immunosuppressants or immune-modifying drugs for \>14 days in total within 6 months prior to Screening (for corticosteroids ≥10 milligrams (mg)/day of prednisone equivalent) or is anticipating the need for immunosuppressive treatment at any time during participation in the study. * Systemic immunoglobulins or blood products within 3 months prior to the Screening/Baseline Visit or plans for receipt during the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Elevated Cardiac Troponin I (cTnI) at Day 4 or Day 32 (3 Days After Injection 1 or Injection 2) | Day 4 and Day 32 | Elevated cTnI was defined as \>53.53 picograms per milliliter (pg/mL) in males and \>38.64 pg/mL in females. One participant who was included in the analysis, had an elevation of cTnI pre-injection of study intervention on Day 1 and had a normal value of cTnI pre-injection of study intervention on Day 29. Note that other factors such as physical activity can affect cTnI. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Elevated cTnI Level at Day 1 (Baseline) | Pre-injection 1: Day 1 | Elevated cTnI was defined as \>53.53 pg/mL in males and \>38.64 pg/mL in females. |
| Number of Participants With Elevated cTnI Level at Day 29 or Day 57 (28 Days After Injection 1 or Injection 2) | Day 29 and Day 57 | Elevated cTnI was defined as \>53.53 pg/mL in males and \>38.64 pg/mL in females. |
| Number of Participants With Serious Adverse Events (SAEs), Medically-attended Adverse Events (MAAEs), Adverse Events of Special Interest (AESIs), and Adverse Events Leading to Withdrawal | Day 1 up to Day 57 | An adverse event (AE) was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An SAE was defined as any AE that resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in birth defects or was an important medical event. A MAAE was defined as an AE that led to an unscheduled visit to a healthcare practitioner. Investigators reported AEs as AESIs based on pre-defined criteria. All suspected cases of cardiomyopathy and non-infectious myocarditis, pericarditis, and myopericarditis were reported as AESIs. A summary of all Serious Adverse Events and Other Adverse Events (nonserious) regardless of causality is located in the 'Adverse Events' module. |
Countries
United States
Participant flow
Pre-assignment details
Participants were randomized in a 1:1 ratio (500 participants in each injection sequence) to receive 2 study injections (mRNA-1273.712 and placebo) in a crossover design.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 19.8 years STANDARD_DEVIATION 5.72 |
| Age, Customized 85 years and over | 0 Participants |
| Age, Customized Adolescents (12-17 years) | 235 Participants |
| Age, Customized Adults (18-64 years) | 285 Participants |
| Age, Customized Children (2-11 years) | 0 Participants |
| Age, Customized From 65-84 years | 0 Participants |
| Age, Customized Infants and toddlers (28 days-23 months) | 0 Participants |
| Age, Customized In utero | 0 Participants |
| Age, Customized Newborns (0-27 days) | 0 Participants |
| Age, Customized Preterm newborn infants (gestational age < 37 wks) | 0 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 68 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 840 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 13 Participants |
| Race/Ethnicity, Customized American Indian or Alaska Native | 1 Participants |
| Race/Ethnicity, Customized Asian | 14 Participants |
| Race/Ethnicity, Customized Black or African American | 132 Participants |
| Race/Ethnicity, Customized Multiple | 30 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 2 Participants |
| Race/Ethnicity, Customized Not Reported | 3 Participants |
| Race/Ethnicity, Customized Other | 3 Participants |
| Race/Ethnicity, Customized White | 320 Participants |
| Sex: Female, Male Female | 266 Participants |
| Sex: Female, Male Male | 228 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 500 | 0 / 460 | 0 / 497 | 0 / 454 |
| other Total, other adverse events | 0 / 500 | 0 / 460 | 0 / 497 | 0 / 454 |
| serious Total, serious adverse events | 0 / 500 | 0 / 460 | 0 / 497 | 1 / 454 |
Outcome results
None listed