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AzTrials

COVID-19Phase 1NCT04283461

Safety and Immunogenicity Study of 2019-nCoV Vaccine (mRNA-1273) for Prophylaxis of SARS-CoV-2 Infection (COVID-19)

A Phase 1 study testing mRNA-1273 in people with COVID-19 and COVID-19 Immunisation, run by National Institute of Allergy and Infectious Diseases (NIAID) at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This is a phase I, open-label, dose-ranging clinical trial in males and non-pregnant females, starting at 18 years of age, inclusive, who are in good health and meet all eligibility criteria. Read more about this study

Who is it for?
Ages 18 to 99 yearsHealthy volunteers can take part
Conditions the study is for
COVID-19, COVID-19 Immunisation
What is being tested?
mRNA-1273
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
3 sitesUnited States
Study dates
16 Mar 2020to 26 Apr 2022
Phase
Phase 1
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 99 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • A subject must meet all of the following criteria to be eligible to participate in this study:
  • Provides written informed consent prior to initiation of any study procedures.
  • Be able to understand and agrees to comply with planned study procedures and be available for all study visits.
  • Agrees to the collection of venous blood per protocol.
  • Male or non-pregnant female, >/= to 18 years of age at time of enrollment.
  • Body Mass Index (BMI) 18.0-35.0 kg/m^2, inclusive (< 56 years of age), at screening; BMI 18.0-30.0 kg/m^2, inclusive (>/= 56 years of age), at screening.
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  • Women of childbearing potential* must agree to use or have practiced true abstinence or use at least one acceptable primary form of contraception.*, **** Note: These criteria are applicable to females in a heterosexual relationship and child-bearing potential (i.e., the criteria do not apply to subjects in a same sex relationship).
  • Not of childbearing potential - post-menopausal females (defined as having a history of amenorrhea for at least one year) or a documented status as being surgically sterile (hysterectomy, bilateral oophorectomy, tubal ligation/salpingectomy, or Essure(R) placement).
  • True abstinence is 100% of time no sexual intercourse (male's penis enters the female's vagina). (Periodic abstinence [e.g., calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception).
  • Acceptable forms of primary contraception include monogamous relationship with a vasectomized partner who has been vasectomized for 180 days or more prior to the subject's first vaccination, intrauterine devices, birth control pills, and injectable/implantable/insertable hormonal birth control products.
  • Must use at least one acceptable primary form of contraception for at least 30 days prior to the first vaccination and at least one acceptable primary form of contraception for 60 days after the last vaccination.
  • Women of childbearing potential must have a negative urine or serum pregnancy test within 24 hours prior to each vaccination.
  • Male subjects of childbearing potential*: use of condoms to ensure effective contraception with a female partner of childbearing potential from first vaccination until 60 days after the last vaccination.
  • Biological males who are post-pubertal and considered fertile until permanently sterile by bilateral orchiectomy or vasectomy.
  • Male subjects agree to refrain from sperm donation from the time of first vaccination until 60 days after the last vaccination.
  • In good health.* *As determined by medical history and physical examination to evaluate acute or ongoing chronic medical diagnoses/conditions that have been present for at least 90 days, which would affect the assessment of safety of subjects. Chronic medical diagnoses/conditions should be stable for the last 60 days (no hospitalizations, emergency room (ER), or urgent care for condition or need for supplemental oxygen). This includes no change in chronic prescription medication, dose, or frequency as a result of deterioration of the chronic medical diagnosis/condition in the 60 days before enrollment. Any prescription change that is due to change of health care provider, insurance company, etc., or done for financial reasons, and in the same class of medication, will not be considered a deviation of this inclusion criterion. Any change in prescription medication due to improvement of a disease outcome, as determined by the participating site principal investigator (PI) or appropriate sub-investigator, will not be considered a deviation of this inclusion criterion. Subjects may be on chronic or as needed (prn) medications if, in the opinion of the participating site PI or appropriate sub-investigator, they pose no additional risk to subject safety or assessment of reactogenicity and immunogenicity, and do not indicate a worsening of medical diagnosis/condition. Similarly, medication changes subsequent to enrollment and study vaccination are acceptable provided the change was not precipitated by deterioration in the chronic medical condition, and there is no anticipated additional risk to the subject or interference with the evaluation of responses to study vaccination.
  • Oral temperature is less than 100.0 degrees Fahrenheit (37.8 degrees Celsius).
  • Pulse no greater than 100 beats per minute.
  • Systolic blood pressure (BP) is 85 to 150 mm Hg, inclusive.
  • Clinical screening laboratory evaluations (white blood cell (WBC), hemoglobin (Hgb), platelets (PLTs), alanine transaminase (ALT), aspartate transaminase (AST), creatinine (Cr), alkaline phosphatase (ALP), total bilirubin (T. Bili), Lipase, prothrombin time (PT), and partial thromboplastin time (PTT)) are within acceptable normal reference ranges at the clinical laboratory being used.
  • Must agree to have samples stored for secondary research.
  • Agrees to adhere to Lifestyle Considerations throughout study duration.
  • Must agree to refrain from donating blood or plasma during the study (outside of this study).
  • Leukapheresis Inclusion Criteria:
  • A subject must meet all of the following criteria to be eligible for leukapheresis:
  • Written informed consent for leukapheresis is provided.
  • Weight >/= 110 pounds.
  • Screening laboratory evaluations are within acceptable ranges at the site where the leukapheresis procedure will be performed.
  • Negative urine or serum pregnancy test within 48 hours of the leukapheresis procedure for women of childbearing potential.
  • Adequate bilateral antecubital venous access.
  • No use of blood thinners, aspirin or nonsteroidal anti-inflammatory drugs (NSAIDs) at least 5 days before the leukapheresis procedure.
  • Enrolled in cohorts 2, 3, 5, 10, or 11, and possibly cohort 6, if enrolled, and completed the two-dose vaccination series.
  • Optional Substudy Inclusion Criteria:
  • Enrolled in the main study and received both the first and second mRNA-1273 vaccinations.
  • Provides written informed consent for the third mRNA-1273 vaccination.
  • Agrees to the collection of venous blood per substudy.
  • Must agree to have samples stored for secondary research.
  • Women of childbearing potential have had a negative urine pregnancy test within 24 hours before the third mRNA-1273 vaccination.
  • Women of childbearing potential* must agree to use or have practiced true abstinence or use at least one acceptable primary form of contraception.*/****
  • Not of childbearing potential - post-menopausal females (defined as having a history of amenorrhea for at least one year) or a documented status as being surgically sterile (hysterectomy, bilateral oophorectomy, tubal ligation/salpingectomy, or Essure® placement).
  • True abstinence is 100% of time no sexual intercourse (male's penis enters the female's vagina). (Periodic abstinence [e.g., calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception).
  • Acceptable forms of primary contraception include monogamous relationship with a vasectomized partner who has been vasectomized for 180 days or more prior to the subject's first vaccination, intrauterine devices, birth control pills, and injectable/implantable/insertable hormonal birth control products.
  • Must use at least one acceptable primary form of contraception for at least 30 days prior to the third mRNA-1273 vaccination and for at least 30 days after the third mRNA-1273 vaccination.

Who cannot join

  • A subject who meets any of the following criteria will be excluded from participation in this study:
  • Positive pregnancy test either at screening or just prior to each vaccine administration.
  • Female subject who is breastfeeding or plans to breastfeed from the time of the first vaccination through 60 days after the last vaccination.
  • Has any medical disease or condition that, in the opinion of the participating site principal investigator (PI) or appropriate sub-investigator, precludes study participation.*
  • Including acute, subacute, intermittent or chronic medical disease or condition that would place the subject at an unacceptable risk of injury, render the subject unable to meet the requirements of the protocol, or may interfere with the evaluation of responses or the subject's successful completion of this trial.
  • Presence of self-reported or medically documented significant medical or psychiatric condition(s).*
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  • Significant medical or psychiatric conditions include but are not limited to: Respiratory disease (e.g., chronic obstructive pulmonary disease [COPD], asthma) requiring daily medications currently or any treatment of respiratory disease exacerbations (e.g., asthma exacerbation) in the last 5 years. Asthma medications: inhaled, oral, or intravenous (IV) corticosteroids, leukotriene modifiers, long and short acting beta agonists, theophylline, ipratropium, biologics.
  • Significant cardiovascular disease (e.g., congestive heart failure, cardiomyopathy, ischemic heart disease), history of myocarditis or pericarditis as an adult, myocardial infarction (MI) within past 6 months, coronary artery bypass surgery or stent placement, or uncontrolled cardiac arrhythmia.
  • Neurological or neurodevelopmental conditions (e.g., history of migraines in the past 5 years, epilepsy, stroke, seizures in the last 3 years, encephalopathy, focal neurologic deficits, Guillain-Barré syndrome, encephalomyelitis, transverse myelitis, stroke or transient ischemic attack, multiple sclerosis, Parkinson's disease, amyotrophic lateral sclerosis, Creutzfeldt-Jakob disease, or Alzheimer's disease).
  • Ongoing malignancy or recent diagnosis of malignancy in the last five years excluding basal cell and squamous cell carcinoma of the skin, which are allowed.
  • An autoimmune disease, including hypothyroidism without a defined non-autoimmune cause, localized or history of psoriasis.
  • An immunodeficiency of any cause. Chronic kidney disease, estimated glomerular filtration rate (eGFR) <60 mL/min/1.73m^2.
  • Has an acute illness*, as determined by the participating site PI or appropriate sub-investigator, with or without fever [oral temperature >/= 38.0 degrees Celsius (100.4 degrees Fahrenheit)] within 72 hours prior to each vaccination.
  • An acute illness which is nearly resolved with only minor residual symptoms remaining is allowable if, in the opinion of the participating site PI or appropriate sub-investigator, the residual symptoms will not interfere with the ability to assess safety parameters as required by the protocol.
  • Has a positive test result for hepatitis B surface antigen, hepatitis C virus antibody, or human immunodeficiency virus (HIV) types 1 or 2 antibodies at screening.
  • Has participated in another investigational study involving any investigational product* within 60 days, or 5 half-lives, whichever is longer, before the first vaccine administration.
  • study drug, biologic or device
  • Currently enrolled in or plans to participate in another clinical trial with an investigational agent* that will be received during the study-reporting period.**
  • Including licensed or unlicensed vaccine, drug, biologic, device, blood product, or medication.
  • 13 months after the first vaccination.
  • Has previously participated in an investigational study involving lipid nanoparticles (LNPs) (a component of the investigational vaccine assessed in this trial).
  • Has a history of hypersensitivity or severe allergic reaction (e.g., anaphylaxis, generalized urticaria, angioedema, other significant reaction) to any previous licensed or unlicensed vaccines.
  • Chronic use (more than 14 continuous days) of any medications that may be associated with impaired immune responsiveness.*
  • Including, but not limited to, systemic corticosteroids exceeding 10 mg/day of prednisone equivalent, allergy injections, immunoglobulin, interferon, immunomodulators, cytotoxic drugs, or other similar or toxic drugs during the preceding 6-month period prior to vaccine administration (Day 1). The use of low dose topical, ophthalmic, inhaled and intranasal steroid preparations will be permitted.
  • Anticipating the need for immunosuppressive treatment within the next 6 months.
  • Received immunoglobulins and/or any blood or blood products within the 4 months before the first vaccine administration or at any time during the study.
  • Has any blood dyscrasias or significant disorder of coagulation.
  • Has any chronic liver disease, including fatty liver.
  • Has a history of alcohol abuse or other recreational drug (excluding cannabis) use within 6 months before the first vaccine administration.
  • Has a positive test result for drugs of abuse at screening or before the first vaccine administration. If cannabis is the only detected drug, inclusion is permitted.
  • Has any abnormality or permanent body art (e.g., tattoo) that would interfere with the ability to observe local reactions at the injection site (deltoid region).
  • Received or plans to receive a licensed, live vaccine within 4 weeks before or after each vaccination.
  • Received or plans to receive a licensed, inactivated vaccine within 2 weeks before or after each vaccination.
  • Receipt of any other SARS-CoV-2 or other experimental coronavirus vaccine at any time prior to or during the study.
  • Close contact of anyone known to have SARS-CoV-2 infection within 30 days prior to vaccine administration.
  • History of COVID-19 diagnosis.
  • On current treatment with investigational agents for prophylaxis of COVID-19.
  • Current use of any prescription or over-the-counter medications within 7 days prior to vaccination, unless approved by the investigator or necessary to manage a chronic condition.
  • Plan to travel outside the United States (US) (continental US, Hawaii, and Alaska) from enrollment through 28 days after the last vaccination.
  • Reside in a nursing home or other skilled nursing facility or have a requirement for skilled nursing care.
  • Non-ambulatory.
  • For subjects >/= 56 years of age, history of chronic smoking within the prior year.
  • For subjects >/= 56 years of age, current smoking or vaping.
  • For subjects >/= 56 years of age, individuals currently working with high risk of exposure to SARS-CoV-2 (e.g., active health care workers with direct patient contact, emergency response personnel).
  • Optional Substudy Exclusion Criteria:
  • Anaphylaxis or other systemic hypersensitivity reaction following a mRNA-1273 or any other vaccination.
  • Immediate allergic reaction of any severity after mRNA-1273 or any of its components.*
  • Including polyethylene glycol (PEG)
  • Immediate allergic reaction of any severity to polysorbate.*
  • Due to potential cross-reactive hypersensitivity with the vaccine ingredient PEG
  • History of an SAE judged related to mRNA-1273 vaccine.
  • Female subject who is breastfeeding or plans to breastfeed from the time of the third mRNA-1273 vaccination through 30 days after the third mRNA-1273 vaccination.
  • Has an acute illness*, as determined by the participating site PI or appropriate sub-investigator, with or without fever [oral temperature >/=38.0°C (100.4°F)], within 72 hours prior to the third mRNA-1273 vaccination.
  • An acute illness which is nearly resolved with only minor residual symptoms remaining is allowable if, in the opinion of the participating site PI or appropriate sub-investigator, the residual symptoms will not interfere with the ability to assess safety parameters as required by the substudy.
  • Has received any approved, authorized or investigational COVID-19 vaccine outside of this trial.
  • Any clinically significant medical condition that, in the opinion of the investigator, poses an additional risk to the subject from vaccination.
  • History of documented COVID-19 infection.
  • Has any medical disease or condition that, in the opinion of the participating site PI or appropriate sub-investigator, precludes substudy participation.
  • Received or plans to receive a licensed vaccine, other than a COVID-19 vaccine, within 2 weeks before or after the third mRNA-1273 vaccination.

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • National Institutes of Health - Clinical Center - Vaccine Research Center Clinical Trials Program

    Bethesda, Maryland, 20892

  • The Hope Clinic of Emory University

    Decatur, Georgia, 30030-1705

  • Kaiser Permanente Washington Health Research Institute

    Seattle, Washington, 98101-1466

Other trials in United States

About this study

Official title: Phase I, Open-Label, Dose-Ranging Study of the Safety and Immunogenicity of 2019-nCoV Vaccine (mRNA-1273) in Healthy Adults

This is a phase I, open-label, dose-ranging clinical trial in males and non-pregnant females, starting at 18 years of age, inclusive, who are in good health and meet all eligibility criteria. This clinical trial is designed to assess the safety, reactogenicity and immunogenicity of mRNA-1273 manufactured by ModernaTX, Inc. mRNA-1273 is a novel lipid nanoparticle (LNP)-encapsulated mRNA-based vaccine that encodes for a full-length, prefusion stabilized spike (S) protein of SARS-CoV-2. Enrollment will occur at up to 3 domestic clinical research sites. Up to one hundred and fifty-five subjects will be enrolled into one of thirteen cohorts (10 micrograms [mcg], 25 mcg, 50 mcg, 100 mcg, and 250 mcg). Subjects will receive an intramuscular (IM) injection (0.5 milliliters [mL]) of mRNA-1273 on Days 1 and 29 in the deltoid muscle and will be followed through 12 months post second vaccination (Day 394). Follow-up visits will occur 1, 2, and 4 weeks post each vaccination (Days 8, 15, 29, 36, 43, and 57), as well as 3, 6, and 12 months post second vaccination (Days 119, 209, and 394). The primary objective is to evaluate the safety and reactogenicity of a 2-dose vaccination schedule of mRNA-1273, given 28 days apart, across 5 dosages in healthy adults.

Optional Substudy:

This is an optional third mRNA-1273 vaccination substudy, in subjects 18 years of age and older, who received both the first and second mRNA-1273 vaccinations in the main study and meet all other substudy eligibility criteria. This optional third mRNA-1273 vaccination substudy is designed to assess safety, reactogenicity, and immunogenicity through 12 months post third vaccination (Day 731). Subjects who receive the third mRNA-1273 vaccination will exit the Schedule of Activities for the main study and will enter the Schedule of Activities for the optional substudy. Up to one hundred and twenty subject will be enrolled into two cohorts (consisting of participating subjects who received 2 doses of 25 or 50 mcg and participating subjects who received 2 doses of 100 and 250 mcg). Subjects will receive an IM injection (0.5 mL) at a dosage of 100 mcg/0.5 mL. The primary objective is to evaluate the safety and reactogenicity of a third mRNA-1273 vaccination, at a dosage of 100 mcg.

Read the detailed description

This is a phase I, open-label, dose-ranging clinical trial in males and non-pregnant females, starting at 18 years of age, inclusive, who are in good health and meet all eligibility criteria. This clinical trial is designed to assess the safety, reactogenicity and immunogenicity of mRNA-1273 manufactured by ModernaTX, Inc. mRNA-1273 is a novel lipid nanoparticle (LNP)-encapsulated mRNA-based vaccine that encodes for a full-length, prefusion stabilized spike (S) protein of SARS-CoV-2. Enrollment will occur at up to 3 domestic clinical research sites. Up to one hundred and fifty-five subjects will be enrolled into one of thirteen cohorts (10 micrograms [mcg], 25 mcg, 50 mcg, 100 mcg, or 250 mcg). Subjects will receive an intramuscular (IM) injection (0.5 milliliters [mL]) of mRNA-1273 on Days 1 and 29 in the deltoid muscle and will be followed through 12 months post second vaccination (Day 394). Follow-up visits will occur 1, 2, and 4 weeks post each vaccination (Days 8, 15, 29, 36, 43, and 57), as well as 3, 6, and 12 months post second vaccination (Days 119, 209, and 394). The primary objective is to evaluate the safety and reactogenicity of a 2-dose vaccination schedule of mRNA-1273, given 28 days apart, across 5 dosages in healthy adults. The secondary objective is to evaluate the immunogenicity as measured by Immunoglobulin G (IgG) enzyme-linked immunosorbent assay (ELISA) to the SARS-CoV-2 S (spike) protein following a 2-dose vaccination schedule of mRNA-1273 at Day 57.

Optional Substudy:

This is an optional third mRNA-1273 vaccination substudy, in subjects 18 years of age and older, who received both the first and second mRNA-1273 vaccinations in the main study and meet all other substudy eligibility criteria. This optional third mRNA-1273 vaccination substudy is designed to assess safety, reactogenicity, and immunogenicity through 12 months post third vaccination (Day 731). Subjects who receive the third mRNA-1273 vaccination will exit the Schedule of Activities for the main study and will enter the Schedule of Activities for the optional substudy. Up to one hundred and twenty subject will be enrolled into two cohorts (consisting of participating subjects who received 2 doses of 25 or 50 mcg and participating subjects who received 2 doses of 100 and 250 mcg). Subjects will receive an IM injection (0.5 mL) at a dosage of 100 mcg/0.5 mL. The primary objective is to evaluate the safety and reactogenicity of a third mRNA-1273 vaccination, at a dosage of 100 mcg. The secondary objective is to evaluate the immunogenicity as measured by IgG ELISA to the SARS-CoV-2 S protein following a third mRNA-1273 vaccination, at a dosage of 100 mcg, at all timepoints after the third mRNA-1273 vaccination.

Being tested
mRNA-1273
Keywords
2019-nCoV (mRNA-1273), COVID-19, Dose-escalation, Immunogenicity, novel coronavirus, Safety, SARS-CoV-2, vaccine
Medical subject headings
COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • mRNA-1273Biological

    Lipid nanoparticle (LNP) dispersion containing an mRNA that encodes for the prefusion stabilized spike protein 2019-nCoV. mRNA-1273 consists of an mRNA Drug Substance that is manufactured into LNPs composed of the proprietary ionizable lipid, SM-102, and 3 commercially available lipids, cholesterol, DSPC, and PEG2000 DMG.

Study groups in NCT04283461
Study groupRoleWhat they receive
Arm 1Experimental25 mcg of mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29 in participants from 18-55 years of age. N=15 (4 sentinel, 11 non-sentinel)
Receives: Biological: mRNA-1273
Arm 10Experimental50 mcg of mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29 in participants from 18-55 years of age. N=15.
Receives: Biological: mRNA-1273
Arm 11Experimental50 mcg of mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29 in participants from 56-70 years of age. N=10.
Receives: Biological: mRNA-1273
Arm 12Experimental50 mcg of mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29 in participants 71 years of age or older. N=10.
Receives: Biological: mRNA-1273
Arm 13Experimental10 mcg of mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29 in participants from 18-55 years of age. N=15.
Receives: Biological: mRNA-1273
Arm 14ExperimentalOptional third mRNA-1273 vaccination sub-study. 100 mcg of mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle after Day 209 in participants from Arm 1,4,7,10, 11, and 12 from 18 years of age or older. N=70.
Receives: Biological: mRNA-1273
Arm 15ExperimentalOptional third mRNA-1273 vaccination sub-study. 100 mcg of mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle no later than Day 394 in participants from Arm 2,3,5 and 8 from 18 years of age or older. N=50.
Receives: Biological: mRNA-1273
Arm 2Experimental100 mcg of mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29 in participants from 18-55 years of age. N=15 (4 sentinel, 11 non-sentinel).
Receives: Biological: mRNA-1273
Arm 3Experimental250 mcg of mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29 in participants from 18-55 years of age. N=15 (4 sentinel, 11 non-sentinel).
Receives: Biological: mRNA-1273
Arm 4Experimental25 mcg of mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29 in participants from 56-70 years of age. N=10.
Receives: Biological: mRNA-1273
Arm 5Experimental100 mcg of mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29 in participants from 56-70 years of age. N=10.
Receives: Biological: mRNA-1273
Arm 6Experimental250 mcg of mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29 in participants from 56-70 years of age. N=10.
Receives: Biological: mRNA-1273
Arm 7Experimental25 mcg of mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29 in participants 71 years of age or older. N=10.
Receives: Biological: mRNA-1273
Arm 8Experimental100 mcg of mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29 in participants 71 years of age or older. N=10.
Receives: Biological: mRNA-1273
Arm 9Experimental250 mcg of mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29 in participants 71 years of age or older. N=10.
Receives: Biological: mRNA-1273

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Frequency of Any Medically-attended Adverse Events (MAAEs)

    Number of participants that experienced any MAAEs from Day 1 to Day 394.

    Measured: Day 1 to Day 394

  2. Frequency of Any New-onset Chronic Medical Conditions (NOCMCs)

    Number of participants that experienced any NOCMCs from Day 1 to Day 394.

    Measured: Day 1 to Day 394

  3. Frequency of Any Serious Adverse Events (SAEs)

    The number of participants that experience any SAEs from Day 1 to Day 394. An AE or suspected adverse reaction is considered serious if, in the view of either the participating site PI or appropriate sub-investigator or the sponsor, it results in: death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, or a congenital anomaly/birth defect.

    Measured: Day 1 to Day 394

  4. Frequency of Solicited Reactogenicity Adverse Events (AEs)

    The number of participants that experienced at least one solicited (local and systemic) AE through 7 days post vaccination. Systemic events include: fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration.

    Measured: Through 7 days post-vaccination

  5. Frequency of Any Unsolicited Adverse Events (AEs) by Relationship to Study Product and Severity

    Number of events of any unsolicited AE through 28 days post vaccination by relationship to study product and severity, experienced by participants in the Safety Analysis population . Unsolicited AEs were events that were spontaneously reported by the subject, or revealed by observation, physical examination or other diagnostic procedures.

    Measured: Through 28 days post-vaccination

  6. Grade of Any Unsolicited Adverse Events (AEs)

    Number of any unsolicited AEs through 28 days post vaccination by severity

    Measured: Through 28 days post-vaccination

  7. Grade of Solicited Reactogenicity Adverse Events (AEs)

    Number of participants who experienced any solicited (local and systemic) AEs through 7 days post vaccination by grade. Systemic events include: fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration.

    Measured: Through 7 days post vaccination

Secondary outcomes (6)

  1. Geometric Mean Fold Rise (GMFR) in IgG Titer From Baseline Against RBD

    Geometric mean fold rise (GMFR) in IgG ELISA titer from baseline against RBD. Fold-rise is calculated by dividing post-vaccination results by the baseline value.

    Measured: Day 1 to Day 394

  2. Geometric Mean Fold Rise (GMFR) in IgG Titer From Baseline Against S-2

    Geometric mean fold rise (GMFR) in IgG titer from baseline against S-2P (Wa-1). Fold-rise is calculated by dividing post-vaccination results by the baseline value.

    Measured: Day 1 to Day 394

  3. Geometric Mean Titer (GMT) of Antibody Against RBD

    Geometric mean titer (GMT) of antibody against RBD

    Measured: Day 1 to Day 394

  4. Geometric Mean Titer (GMT) of Antibody Against S-2P

    Geometric mean titer (GMT) of antibody against S-2P (Wa-1)

    Measured: Day 1 to Day 394

  5. Percentage of Participants Who Seroconverted Against RBD

    Percentage of participants who seroconverted defined as a 4-fold change in antibody titer from baseline against RBD

    Measured: Day 1 to Day 394

  6. Percentage of Participants Who Seroconverted Against S-2P

    Percentage of participants who seroconverted defined as a 4-fold change in antibody titer from baseline against S-2P (Wa-1)

    Measured: Day 1 to Day 394

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Feb 2020
  2. Study start16 Mar 2020
  3. Primary completion26 Apr 2022
  4. Study completion26 Apr 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Prevention
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
120 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04283461
Sponsor's protocol ID
20-0003
Other IDs
5UM1AI148373-05
Status last verified
26 Aug 2021
First submitted
21 Feb 2020
Last updated
18 Mar 2024
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Bangaru S, Jackson AM, Copps J, Fernandez-Quintero ML, Torres JL, Richey ST, Nogal B, Sewall LM, Torrents de la Pena A, Rehman A, Guebre-Xabier M, Girard B, Das R, Corbett-Helaire KS, Seder RA, Graham BS, Edwards DK, Patel N, Smith G, Ward AB. Structural serology of polyclonal antibody responses to mRNA-1273 and NVX-CoV2373 COVID-19 vaccines. Cell Rep. 2025 Jul 22;44(7):115986. doi: 10.1016/j.celrep.2025.115986. Epub 2025 Jul 8.

    PubMed 40632654

  • Anderson E, Jackson L, Rouphael N, Widge A, Montefiori D, Doria-Rose N, Suthar M, Cohen K, O'Connell S, Makowski M, Makhene M, Buchanan W, Spearman P, Creech CB, O'Dell S, Schmidt S, Leav B, Bennett H, Pajon R, Posavad C, Hural J, Beigel J, Albert J, Abebe K, Eaton A, Rostad C, Rebolledo P, Kamidani S, Graciaa D, Coler R, McDermott A, Ledgerwood J, Mascola J, DeRosa S, Neuzil K, McElrath MJ, Roberts P. Safety and Immunogenicity of a Third Dose of SARS-CoV-2 mRNA Vaccine - An Interim Analysis. Res Sq [Preprint]. 2022 May 3:rs.3.rs-1222037. doi: 10.21203/rs.3.rs-1222037/v1.

    PubMed 35547849

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Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing mRNA-1273 in people with COVID-19 and COVID-19 Immunisation, run by National Institute of Allergy and Infectious Diseases (NIAID) at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 43 inclusion and 59 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 May 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Frequency of Any Medically-attended Adverse Events (MAAEs) (time frame: Day 1 to Day 394). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04283461, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2024.

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