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

Trial Profile

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

Status: Active, no longer recruiting
Phase of Trial: Phase I

Latest Information Update: 07 Apr 2021

At a glance

  • Drugs MRNA 1273 (Primary)
  • Indications COVID 2019 infections
  • Focus Adverse reactions; First in man
  • Acronyms NIH-Led
  • Most Recent Events

    • 07 Apr 2021 According to a Moderna Therapeutics media release, publication of antibody persistence data out to 6 months following the second dose of the Moderna COVID-19 Vaccine in The New England Journal of Medicine.
    • 07 Apr 2021 Results (n=33) published in the Moderna Therapeutics Media Release
    • 11 Feb 2021 Number of treatment arms has been increased from 13 to 15, with the addition of experimental arms 14 and 15 for optional sub-study. 9 new primary end-point have been added for evaluating various adverse events in 7, 28 or 366 days' time-frame.

Trial Overview

Purpose

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. 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.

Comments

According to a Moderna Therapeutics media release, the company today announced the initiation of a rolling submission to Health Canada and in Switzerland by Swissmedic for mRNA-1273, the Companys vaccine candidate against COVID-19. This initiation follows positive results from a preclinical viral challenge study of mRNA-1273 and the positive interim analysis of this study published in the New England Journal of Medicine.The rolling submission has been accepted under the Canadian Minister of Healths Interim Order, which permits companies to submit safety and efficacy data and information as they become available.

Primary Endpoints

Frequency of solicited local reactogenicity adverse events (AEs)

[ Time Frame: Through 7 days post-vaccination]

Frequency of any medically-attended adverse events (MAAEs)

[ Time Frame: Day 1 to Day 394]

Frequency of any new-onset chronic medical conditions (NOCMCs)

[ Time Frame: Day 1 to Day 394]

Frequency of any serious adverse events (SAEs)

[ Time Frame: Day 1 to Day 394]

Frequency of any unsolicited adverse events (AEs)

[ Time Frame: Through 28 days post-vaccination]

Frequency of solicited systemic reactogenicity adverse events (AEs)

[ Time Frame: Through 7 days post-vaccination]

Grade of any unsolicited adverse events (AEs)

[ Time Frame: Through 28 days post-vaccination]

Grade of solicited local reactogenicity adverse events (AEs)

[ Time Frame: Through 7 days post-vaccination]

Grade of solicited systemic reactogenicity adverse events (AEs)

[ Time Frame: Through 7 days post-vaccination]

Frequency of any medically-attended adverse events (MAAEs)

Optional third mRNA-1273 vaccination sub-study

[Time Frame: Through Day 366 post third vaccination]

Frequency of any new-onset chronic medical conditions (NOCMCs)

Optional third mRNA-1273 vaccination sub-study

[Time Frame: Through Day 366 post third vaccination]

Frequency of any serious adverse events (SAEs)

Optional third mRNA-1273 vaccination sub-study

[Time Frame: Through Day 366 post third vaccination]

Frequency of any unsolicited adverse events (AEs)

Optional third mRNA-1273 vaccination sub-study

[Time Frame: Through 28 days post third vaccination]

Frequency of solicited local reactogenicity adverse events (AEs)

Optional third mRNA-1273 vaccination sub-study

[Time Frame: Through 7 days post third vaccination]

Frequency of solicited systemic reactogenicity adverse events (AEs)

Optional third mRNA-1273 vaccination sub-study

[Time Frame: Through 7 days post third vaccination]

Grade of any unsolicited adverse events (AEs)

Optional third mRNA-1273 vaccination sub-study

[Time Frame: Through 28 days post third vaccination]

Grade of solicited local reactogenicity adverse events (AEs)

Optional third mRNA-1273 vaccination sub-study

[Time Frame: Through 7 days post third vaccination]

Grade of solicited systemic reactogenicity adverse events (AEs)

Optional third mRNA-1273 vaccination sub-study

[Time Frame: Through 7 days post third vaccination]

Other Endpoints

Geometric mean fold rise (GMFR) in IgG titer from baseline

time_frame: Day 1 to Day 57

Geometric mean fold rise (GMFR) in IgG titer from pre-first dose baseline

description: Optional third mRNA-1273 vaccination sub-study time_frame: Day 1 through Day 366 post third vaccination

Geometric mean fold rise (GMFR) in IgG titer from pre-third dose baseline

description: Optional third mRNA-1273 vaccination sub-study time_frame: Through Day 366 post third vaccination

Geometric mean titer (GMT) of antibody

time_frame: Day 57

Geometric mean titer (GMT) of antibody

description: Optional third mRNA-1273 vaccination sub-study time_frame: Through Day 366 post third vaccination

Percentage of subjects who seroconverted

description: Seroconversion is defined as a 4-fold change in antibody titer from baseline time_frame: Day 1 to Day 57

Percentage of subjects who seroconverted from pre-first dose baseline

description: Optional third mRNA-1273 vaccination sub-study. Seroconversion is defined as a 4-fold change in antibody titer time_frame: Day 1 through Day 366 post third vaccination

Percentage of subjects who seroconverted from pre-third dose baseline

description: Optional third mRNA-1273 vaccination sub-study. Seroconversion is defined as a 4-fold change in antibody titer time_frame: Through Day 366 post third vaccination [1]

Diseases Treated

Indication Qualifiers Patient Segments
COVID 2019 infections prevention -

Subjects

  • Subject Type patients
  • Number

    Planned: 155

    Actual: 120

  • Sex male & female
  • Age Group 18-99 years; adult; elderly

Patient Inclusion Criteria

A subject must meet all of the following criteria to be eligible to participate in this study: 1. Provides written informed consent prior to initiation of any study procedures. 2. Be able to understand and agrees to comply with planned study procedures and be available for all study visits. 3. Agrees to the collection of venous blood per protocol. 4. Male or non-pregnant female, >/= to 18 years of age at time of enrollment. 5. 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. 6. 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. 7. Women of childbearing potential must have a negative urine or serum pregnancy test within 24 hours prior to each vaccination. 8. 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. 9. Male subjects agree to refrain from sperm donation from the time of first vaccination until 60 days after the last vaccination. 10. 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. 11. Oral temperature is less than 100.0 degrees Fahrenheit (37.8 degrees Celsius). 12. Pulse no greater than 100 beats per minute. 13. Systolic blood pressure (BP) is 85 to 150 mm Hg, inclusive. 14. 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. 15. Must agree to have samples stored for secondary research. 16. Agrees to adhere to Lifestyle Considerations throughout study duration. 17. Must agree to refrain from donating blood or plasma during the study (outside of this study). Leukapheresis A subject must meet all of the following criteria to be eligible for leukapheresis: 1. Written informed consent for leukapheresis is provided. 2. Weight >/= 110 pounds. 3. Screening laboratory evaluations are within acceptable ranges at the site where the leukapheresis procedure will be performed. 4. Negative urine or serum pregnancy test within 48 hours of the leukapheresis procedure for women of childbearing potential. 5. Adequate bilateral antecubital venous access. 6. No use of blood thinners, aspirin or nonsteroidal anti-inflammatory drugs (NSAIDs) at least 5 days before the leukapheresis procedure. 7. Enrolled in cohorts 2, 3, 5, 10, or 11, and possibly cohort 6, if enrolled, and completed the two-dose vaccination series. Optional Substudy 1. Enrolled in the main study and received both the first and second mRNA-1273 vaccinations. 2. Provides written informed consent for the third mRNA-1273 vaccination. 3. Agrees to the collection of venous blood per substudy. 4. Must agree to have samples stored for secondary research. 5. Women of childbearing potential have had a negative urine pregnancy test within 24 hours before the third mRNA-1273 vaccination. 6. 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.

Patient Exclusion Criteria

A subject who meets any of the following criteria will be excluded from participation in this study: 1. Positive pregnancy test either at screening or just prior to each vaccine administration. 2. Female subject who is breastfeeding or plans to breastfeed from the time of the first vaccination through 60 days after the last vaccination. 3. 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. 4. Presence of self-reported or medically documented significant medical or psychiatric condition(s).* *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. 5. 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. 6. 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. 7. 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 8. 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. 9. Has previously participated in an investigational study involving lipid nanoparticles (LNPs) (a component of the investigational vaccine assessed in this trial). 10. 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. 11. 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. 12. Anticipating the need for immunosuppressive treatment within the next 6 months. 13. 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. 14. Has any blood dyscrasias or significant disorder of coagulation. 15. Has any chronic liver disease, including fatty liver. 16. Has a history of alcohol abuse or other recreational drug (excluding cannabis) use within 6 months before the first vaccine administration. 17. 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. 18. 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). 19. Received or plans to receive a licensed, live vaccine within 4 weeks before or after each vaccination. 20. Received or plans to receive a licensed, inactivated vaccine within 2 weeks before or after each vaccination. 21. Receipt of any other SARS-CoV-2 or other experimental coronavirus vaccine at any time prior to or during the study. 22. Close contact of anyone known to have SARS-CoV-2 infection within 30 days prior to vaccine administration. 23. History of COVID-19 diagnosis. 24. On current treatment with investigational agents for prophylaxis of COVID-19. 25. 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. 26. Plan to travel outside the United States (US) (continental US, Hawaii, and Alaska) from enrollment through 28 days after the last vaccination. 27. Reside in a nursing home or other skilled nursing facility or have a requirement for skilled nursing care. 28. Non-ambulatory. 29. For subjects >/= 56 years of age, history of chronic smoking within the prior year. 30. For subjects >/= 56 years of age, current smoking or vaping. 31. 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 1. Anaphylaxis or other systemic hypersensitivity reaction following a mRNA-1273 or any other vaccination. 2. Immediate allergic reaction of any severity after mRNA-1273 or any of its components.* *Including polyethylene glycol (PEG) 3. Immediate allergic reaction of any severity to polysorbate.* *Due to potential cross-reactive hypersensitivity with the vaccine ingredient PEG 4. History of an SAE judged related to mRNA-1273 vaccine. 5. 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. 6. 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. 7. Has received any approved, authorized or investigational COVID-19 vaccine outside of this trial. 8. Any clinically significant medical condition that, in the opinion of the investigator, poses an additional risk to the subject from vaccination. 9. History of documented COVID-19 infection. 10. Has any medical disease or condition that, in the opinion of the participating site PI or appropriate sub-investigator, precludes substudy participation. 11. 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 Details

Identifiers

Identifier Owner
NCT04283461 ClinicalTrials.gov: US National Institutes of Health
20-0003 -
5UM1AI148684-02 -

Organisations

  • Affiliations Moderna Therapeutics

Trial Dates

  • Initiation Dates

    Planned : 19 Mar 2020

    Actual : 16 Mar 2020

  • Primary Completion Dates

    Planned : 22 Nov 2022

  • End Dates

    Planned : 22 Nov 2022

Substudies/Extensions

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.

Other Details

  • Design multicentre; open; prospective; sequential
  • Phase of Trial Phase I
  • Location USA
  • Focus Adverse reactions; First in man

Interventions

Drugs Route Formulation
MRNA 1273Primary Drug Intramuscular Injection, Nanoparticles

Arm 1

25 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) Biological: mRNA-1273 (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.)

Arm 10

50 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. Biological: mRNA-1273 (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.)

Arm 11

50 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. Biological: mRNA-1273 (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.)

Arm 12

50 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. Biological: mRNA-1273 (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.)

Arm 13

10 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. Biological: mRNA-1273 (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.)

Arm 14

Optional 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. Biological: mRNA-1273 (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.)

Arm 15

Optional 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. Biological: mRNA-1273 (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.)

Arm 2

100 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). Biological: mRNA-1273 (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.)

Arm 3

250 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). Biological: mRNA-1273 (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.)

Arm 4

25 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. Biological: mRNA-1273 (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.)

Arm 5

100 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. Biological: mRNA-1273 (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.)

Arm 6

250 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. Biological: mRNA-1273 (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.)

Arm 7

25 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. Biological: mRNA-1273 (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.)

Arm 8

100 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. Biological: mRNA-1273 (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.)

Arm 9

250 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. Biological: mRNA-1273 (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.)

Results

Adverse events

Updated interim results from a phase I trial in healthy volunteers showed that treatment with mRNA 1273 was generally safe and well-tolerated, with no serious adverse events reported through day 57. Adverse events (AEs) were generally transient and mild to moderate in severity. The most notable adverse events were seen at the 250µg dose level, with three of those 14 participants (21%) reported one or more severe events. Solicited systemic adverse events were more common after the second vaccination and occurred in seven of 13 (54%) participants in the 25µg group, all 15 participants in the 100µg group and all 14 participants in the 250µg group. The most commonly reported systemic adverse events following second vaccination at the 100 µg dose were fatigue (80%), chills (80%), headache (60%) and myalgia (53%), all of which were transient and mild or moderate in severity. The most common solicited local adverse event at the 100µg dose was pain at the injection site (100%), which was transient and mild or moderate in severity. Earlier, results from a phase I trial established a generally safe and well tolerated profile for mRNA 1273, which was consistent with the company's earlier infectious disease vaccine clinical studies. A solitary grade 3 adverse event of erythema at the injection site was seen in one volunteer, in the 100 µg dose cohort. The 250 µg dose level reflected the most notable adverse events in three volunteers with grade 3 systemic symptoms, only after the second dose. The adverse events were predominantly transient and self-resolving. Grade 4 adverse events or serious adverse events were not reported [2] [3] .

Immunogenicity

Phase I: Interim durability data from participants in the phase I trial of mRNA-1273 showed that, it produced high levels of binding and neutralizing antibodies that declined slightly over time and remained elevated in all participants three months after the booster vaccination. At day 119, 3 months post-second 100 µg dose, binding and neutralizing antibody titers remained high in all participants and results were consistent across all age groups (18-55, 56-70 and 71+) [4] . Interim results from a phase I trial showed that in the 18-55 age group, neutralising antibody titers were observed in 100% of evaluated participants and at the 100 µg dose level selected for phase III, the geometric mean titers were above those seen in convalescent sera. mRNA 1273 induced consistently high levels of pseudovirus neutralisation antibody titers in all participants in the 56-70 and 71+ age groups. Vaccination with mRNA-1273 elicited Th1-biased CD4 T cell responses in all age groups. Earlier data showed dose-dependent increases in binding titers across 25 µg, 100 µg and 250 µg dosage levels, and between prime and boost within the 25 µg and 100 µg dose levels. All volunteers aged 18-55 (n=15 per cohort) across all three dose levels seroconverted by day 15, after administration of a single dose. mRNA 1273 induced binding antibodies to the full-length SARS-CoV-2 Spike protein in all participants after the first vaccination, with all participants seroconverting by day 15. After two vaccinations, at day 57, geometric mean titers exceeded those seen in convalescent sera obtained from 38 individuals with confirmed COVID-19 diagnosis. Of the 38 individuals in the convalescent sera group, 15% were classified as having severe symptoms (hospitalization requiring intensive care and/or ventilation), 22% had moderate symptoms and 63% had mild symptoms. After the second vaccination, PsVNA neutralising antibody titers were detected in all participants in all dose cohorts. The day 57 geometric mean titers at the 100 µg dose were 2.1-fold higher than those seen in convalescent sera (n=38). Strong correlations were observed between the binding and neutralisation assays, and between the live virus and pseudovirus neutralization assays. A clear dose response was seen in geometric mean titers between the 25µg and 100µg dose levels, with minimal additional increases at the 250µg dose. Moreover, following second vaccination, mRNA 1273 elicited Th1-biased CD4 T-cell responses without significant elevation of Th2-biased CD4 T-cell responses. Earlier, results from the trial at day 43, at the 25 µg dose level (n=15), the binding antibody levels matched the levels observed in convalescent sera (blood samples from people who have recovered from COVID-19), tested in the same assay. At day 43, at the 100 µg dose level (n=10), binding antibody levels significantly surpassed the levels in convalescent sera. Samples were unavailable for remaining volunteers. Neutralising antibody data from first four volunteers in each of the 25 µg and 100 µg dose level cohorts, also exhibited an evoking of neutralising antibodies in all eight volunteers, as determined by plaque reduction neutralization (PRNT) assays against live SARS-CoV-2, following administration of mRNA 1273. Antibody persistence data out to 6 months following the second dose 100 µg dose (day 209) of the mRNA 1273 showed that, among 33 healthy adult participants, antibodies elicited by the vaccine persisted through 6 months after the second dose. Antibody decay was estimated using two approaches and was consistent with of convalescent patients with COVID-19 through 8 months after symptom onset [2] [3] .
2021-05-11 10:29:18.557

Publications

  1. Moderna Therapeutics. Moderna Announces Publication in The New England Journal of Medicine of Interim Results From Phase 1 Study of Its mRNA Vaccine Against COVID-19 (mRNA-1273). Media-Rel 2020;.

    Media Release
  2. Moderna Therapeutics. Moderna Announces Positive Interim Phase 1 Data for its mRNA Vaccine (mRNA-1273) Against Novel Coronavirus. Media-Rel 2020;.

    Media Release
  3. Moderna Therapeutics. Moderna Provides Updates on the Clinical Development and Production of Its COVID-19 Vaccine Candidate. Media-Rel 2020;.

    Media Release
  4. Investigational COVID-19 vaccine well-tolerated and generates immune response in older adults. Media-Rel 2020;.

    Media Release
  5. Jackson LA, Anderson EJ, Rouphael NG, Roberts PC, Makhene M, Coler RN, et al. An mRNA Vaccine against SARS-CoV-2 - Preliminary Report. . N-Engl-J-Med 2020;.

    PubMed | CrossRef Fulltext
  6. Moderna Therapeutics. Moderna Announces Publication in The New England Journal of Medicine of Interim Results From Older Adult Age Cohorts in Phase 1 Study of its mRNA Vaccine Against COVID-19 (mRNA-1273). Media-Rel 2020;.

    Media Release
  7. Moderna Therapeutics. Moderna Highlights Publication of Antibody Persistence Data of its COVID-19 Vaccine out to 6 Months in the New England Journal of Medicine. Media-Rel 2021;.

    Media Release
  8. Moderna Therapeutics. Moderna Announces Initiation of Rolling Submission to Health Canada for mRNA Vaccine Against COVID-19 (mRNA-1273). Media-Rel 2020;.

    Media Release

Authors

Author Total Publications First Author Last Author
Albert J 1 - -
Anderson EJ 1 - -
Beigel JH 1 - 1
Bennett H 1 - -
Buchanan W 1 - -
Chappell JD 1 - -
Coler RN 1 - -
Corbett KS 1 - -
Cross K 1 - -
Denison MR 1 - -
Doria-Rose NA 1 - -
Flach B 1 - -
Graham BS 1 - -
Jackson LA 1 1 -
Ledgerwood JE 1 - -
Makhene M 1 - -
Makowski M 1 - -
Mascola JR 1 - -
McCullough MP 1 - -
McDermott A 1 - -
Moderna Therapeutics 6 6 6
Morabito KM 1 - -
Neuzil KM 1 - -
O'Dell S 1 - -
Padilla M 1 - -
Peters E 1 - -
Pikaart-Tautges R 1 - -
Pruijssers AJ 1 - -
Roberts PC 1 - -
Rouphael NG 1 - -
Schmidt SD 1 - -
Stevens LJ 1 - -
Sun W 1 - -
Swanson PA 2nd 1 - -

Trial Centres

Investigators

Investigator Centre Name Trial Centre Country
20-0003 Central Contact
12062872061 KPWA.vaccine@kp.org
show details
-

Centres

Centre Name Location Trial Centre Country
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-
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Emory Vaccine Center - The Hope Clinic Decatur, Georgia USA
Kaiser Permanente Washington Health Research Institute - Vaccines and Infectious Diseases Seattle, Washington USA
National Institute of Allergy and Infectious Diseases (NIAID)
-
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National Institutes of Health - Clinical Center - Vaccine Research Center Clinical Trials Program Bethesda, Maryland USA

Trial History

Event Date Event Type Comment
07 Apr 2021 Results According to a Moderna Therapeutics media release, publication of antibody persistence data out to 6 months following the second dose of the Moderna COVID-19 Vaccine in The New England Journal of Medicine. Updated 21 Apr 2021
07 Apr 2021 Results Results (n=33) published in the Moderna Therapeutics Media Release Updated 21 Apr 2021
09 Mar 2021 Other trial event Last checked against ClinicalTrials.gov record. Updated 09 Mar 2021
11 Feb 2021 Protocol amendment Number of treatment arms has been increased from 13 to 15, with the addition of experimental arms 14 and 15 for optional sub-study. 9 new primary end-point have been added for evaluating various adverse events in 7, 28 or 366 days' time-frame. Updated 19 Feb 2021
11 Feb 2021 Completion date Planned End Date changed from 22 Nov 2021 to 22 Nov 2022. Updated 19 Feb 2021
11 Feb 2021 Other trial event Planned primary completion date changed from 22 Nov 2021 to 22 Nov 2022. Updated 19 Feb 2021
03 Dec 2020 Interim results Interim data presented in a Moderna Therapeutics Media Release. Updated 11 Dec 2020
03 Dec 2020 Interim results According to a Moderna Therapeutics media release, interim data published in the New England Journal of Medicine. Updated 11 Dec 2020
13 Nov 2020 Other trial event According to a Moderna Therapeutics media release, the company has initiated the rolling submission to in Switzerland by Swissmedic for mRNA-1273. This initiation follows positive results from a preclinical viral challenge study of mRNA-1273 and the positive interim analysis of this study published in the New England Journal of Medicine. Updated 30 Nov 2020
02 Nov 2020 Other trial event According to an Emmes media release, the company announced that it provided the data and statistical analysis support for this Phase 1 clinical trial. Three Emmes employees Jim Albert, Dr. Mat Makowski and Kaitlyn Cross were among the co-authors of the recent report published in the New England Journal of Medicine (NEJM). Updated 05 Nov 2020
29 Oct 2020 Other trial event According to a Moderna Therapeutics media release, company expected first review of interim efficacy data, which is expected in November. Updated 02 Nov 2020
13 Oct 2020 Interim results Interim results presented in a Moderna Therapeutics media release. Updated 20 Oct 2020
13 Oct 2020 Other trial event According to a Moderna Therapeutics media release, the rolling submission has been accepted under the Canadian Minister of Healths Interim Order, which permits companies to submit safety and efficacy data and information as they become available. Updated 20 Oct 2020
13 Oct 2020 Other trial event According to a Moderna Therapeutics media release, the company today announced the initiation of a rolling submission to Health Canada for mRNA-1273, the Companys vaccine candidate against COVID-19. This initiation follows positive results from a preclinical viral challenge study of mRNA-1273 and the positive interim analysis of this study published in the New England Journal of Medicine. Updated 20 Oct 2020
29 Sep 2020 Other trial event Phase 1 trial results further support testing of the investigational vaccine in older adults in an ongoing large Phase 3 trial. Updated 05 Oct 2020
29 Sep 2020 Other trial event The trial enrolled 40 healthy volunteers: 20 adults ages 56 to 70 years, and 20 adults ages 71 years and older. Updated 05 Oct 2020
29 Sep 2020 Other trial event Julie Ledgerwood, D.O., deputy director and chief medical officer at the VRC, oversaw the study at the NIH site and this trial is supported by the Infectious Diseases Clinical Research Consortium (IDCRC) through NIAID. Updated 05 Oct 2020
29 Sep 2020 Results Results presented in the Media Release. Updated 05 Oct 2020
29 Sep 2020 Interim results Data from second interim analysis from this trial presented in a Moderna Therapeutics Media Release. Updated 01 Oct 2020
29 Sep 2020 Interim results According to a Moderna Therapeutics media release, data from second interim analysis of this trial presented in The New England Journal of Medicine. Updated 01 Oct 2020
26 Aug 2020 Other trial event According to a Moderna Therapeutics media release, the company is presenting new interim safety and immunogenicity data from the cohorts of older adults from this NIH-led Phase 1 study, at the Centers for Disease Control and Preventions Advisory Committee on Immunization Practices (ACIP) August Meeting today. Updated 31 Aug 2020
12 Aug 2020 Other trial event According to an Emmes media release, the company has provided the data and statistical analysis support for this trial and three Emmes employees were co-authors on the Preliminary Report published in the New England Journal of Medicine on July 14. Updated 19 Aug 2020
05 Aug 2020 Other trial event According to an Moderna Therapeutics media release, Leveraging its mRNA platform and manufacturing facility with the AWS-powered research engine, Moderna delivered the first clinical batch of its vaccine candidate (mRNA-1273) against COVID-19 to the NIH for the Phase 1 trial 42 days after the initial sequencing of the virus. Updated 08 Aug 2020
16 Jul 2020 Status change - active, no longer recruiting Status changed from recruiting to active, no longer recruiting. Updated 20 Jul 2020
14 Jul 2020 Interim results Interim results (n=45) for 25-mcg and 100-mcg dose groups, published in the New England Journal of Medicine. Updated 23 Jul 2020
14 Jul 2020 Other trial event According to an Moderna Therapeutics media release, the company has completed the enrollment of the additional seven cohorts from this study : a 50 µg cohort in adults 18-55 (n=15), three cohorts of older adults and three cohorts of elderly adults. Updated 17 Jul 2020
14 Jul 2020 Interim results Results (n=45, Day 57) of the two-dose vaccination schedule are presented in a Moderna Therapeutics media release. Updated 17 Jul 2020
14 Jul 2020 Interim results According to an Moderna Therapeutics media release, data from this study were published in the journal of The New England Journal of Medicine. Updated 17 Jul 2020
08 Jul 2020 Other trial event According to an Moderna Therapeutics media release, the cohorts of older adults (ages 56-70, n=30) and elderly adults (ages 71 and above, n=30) from this study has completed enrolment. Results from this study will be published once available. Updated 13 Jul 2020
11 Jun 2020 Other trial event According to an Moderna Therapeutics media release,enrollment in 9 of 12 cohorts complete. The NIH will be submitting the data to a peer-reviewed clinical publication. Updated 17 Jun 2020
28 May 2020 Protocol amendment Number of arms changed from 9 to 13, Experimental Arm 10, 11, 12 and 13 added. Planned number of patients increased. Updated 01 Jun 2020
28 May 2020 Other trial event Planned number of patients changed from 105 to 155. Updated 01 Jun 2020
28 May 2020 Completion date Planned End Date changed from 20 Sep 2021 to 22 Nov 2021. Updated 01 Jun 2020
28 May 2020 Other trial event Planned primary completion date changed from 20 Sep 2021 to 22 Nov 2021. Updated 01 Jun 2020
18 May 2020 Protocol amendment According to an Moderna Therapeutics media release, the trial is amended to include a 50 µg dose level cohort across each of the three age groups. Updated 22 May 2020
18 May 2020 Interim results Positive interim data presented in the Moderna Therapeutics Media Release. Updated 22 May 2020
12 May 2020 Other trial event According to an Moderna Therapeutics media release, the company is awaiting full set of clinical data from this study. Updated 15 May 2020
30 Apr 2020 Protocol amendment Number of arms changed from 3 to 9. Arm 4 - Arm 9 added. Number of patients changed from 45 to 105. Patient eligibility criteria amended. Updated 05 May 2020
30 Apr 2020 Completion date Planned End Date changed from 1 Jun 2021 to 20 Sep 2021. Updated 05 May 2020
30 Apr 2020 Other trial event Planned primary completion date changed from 1 Jun 2021 to 20 Sep 2021. Updated 05 May 2020
27 Apr 2020 Other trial event According to a Moderna Therapeutics, Funding from the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response within the U.S. Department of Health and Human Services, supported the planning for these studies and also will support the late-stage clinical development programs, as well as the scale-up of mRNA-1273 manufacturing. Updated 04 May 2020
27 Apr 2020 Other trial event According to a Moderna Therapeutics media release, Data from the original cohort of healthy adult volunteers ages 18 to 55 years will be reported once available. Updated 04 May 2020
17 Apr 2020 Other trial event Planned number of patients changed from 45 to 105, according to according to a Moderna Therapeutics media release. Updated 21 Apr 2020
17 Apr 2020 Other trial event According to a Moderna Therapeutics media release, enrollment of the first 45 participants in the trial is now complete. The investigators have expanded the trial and will enroll an additional 60 participants: 30 adults ages 56 to 70 years and 30 adults ages 71 years and older in the Atlanta, Bethesda or Seattle areas. Updated 21 Apr 2020
16 Apr 2020 Protocol amendment According to a Moderna Therapeutics media release, the NIH recently amended the Phase 1 protocol to include an additional six cohorts: three cohorts of older adults (ages 51-70) and three cohorts of elderly adults (age 71 and above). Enrollment for these cohorts is ongoing. Updated 20 Apr 2020
16 Apr 2020 Other trial event According to a Moderna Therapeutics media release, it has completed enrollment of 3 dose cohorts (25 µg, 100 µg and 250 µg); expanding to an additional 6 cohorts of older adults and elderly adults. Updated 20 Apr 2020
14 Apr 2020 Other trial event According to a Moderna Therapeutics media release, this trial continues on track with enrollment of participants at the highest dose Updated 15 Apr 2020
16 Mar 2020 Other trial event According to a Moderna Therapeutics media release, this trial is led by Lisa A. Jackson, M.D., (senior investigator at Kaiser Permanente Washington Health Research Institute (KPWHRI) in Seattle). Updated 20 Mar 2020
16 Mar 2020 Other trial event According to a Moderna Therapeutics media release, the company announced that the first participant has been dosed in this study. Updated 18 Mar 2020
05 Mar 2020 Status change - recruiting Status changed from not yet recruiting to recruiting. Updated 11 Mar 2020
02 Mar 2020 Other trial event New source identified and integrated (ClinicalTrials.gov: US National Institutes of Health: NCT04283461) Updated 02 Mar 2020
27 Feb 2020 Other trial event Planned initiation date changed from 6 Mar 2020 to 19 Mar 2020. Updated 03 Mar 2020
24 Feb 2020 Other trial event According to an Moderna Therapeutics media release, the company announced that it has shipped the first batch of mRNA-1273 to the National Institute of Allergy and Infectious Diseases (NIAID), a part of the National Institutes of Health (NIH) to be used in the planned Phase 1 study.Manufacture of this batch was funded by the Coalition for Epidemic Preparedness Innovations (CEPI). Updated 26 Feb 2020
21 Feb 2020 Status change - not yet recruiting Status changed from planning to not yet recruiting. Updated 02 Mar 2020
14 Feb 2020 New trial record New trial record Updated 14 Feb 2020
10 Feb 2020 Other trial event According to a Moderna Therapeutics media release, the company will conduct this study in collaboration with National Institutes of Health. Updated 14 Feb 2020
10 Feb 2020 Other trial event According to a Moderna Therapeutics media release, The first clinical batch, including fill and finishing of vials, was completed on February 7. This mRNA vaccine was designed and manufactured in 25 days and is undergoing analytical testing prior to release to the NIH. Updated 14 Feb 2020

References

  1. ClinicalTrials.gov: US National Institutes of Health. Trial-Reg 2021;.

    Available from: URL: http://clinicaltrials.gov
  2. Moderna Therapeutics. Moderna Announces Publication in The New England Journal of Medicine of Interim Results From Phase 1 Study of Its mRNA Vaccine Against COVID-19 (mRNA-1273). Media-Rel 2020;.

    Media Release
  3. Moderna Therapeutics. Moderna Announces Positive Interim Phase 1 Data for its mRNA Vaccine (mRNA-1273) Against Novel Coronavirus. Media-Rel 2020;.

    Media Release
  4. Moderna Therapeutics. Moderna Provides Updates on the Clinical Development and Production of Its COVID-19 Vaccine Candidate. Media-Rel 2020;.

    Media Release
  5. Moderna Therapeutics. AWS Powers Modernas Digital Biotechnology Platform to Develop New Class of Vaccines and Therapeutics. Media-Rel 2020;.

    Media Release
  6. Moderna Therapeutics. Moderna Announces First Participant Dosed in NIH-led Phase 1 Study of mRNA Vaccine (mRNA-1273) Against Novel Coronavirus. Media-Rel 2020;.

    Media Release
  7. Investigational COVID-19 vaccine well-tolerated and generates immune response in older adults. Media-Rel 2020;.

    Media Release
  8. Moderna Therapeutics. Swissmedic Begins Rolling Review of Modernas mRNA Vaccine Against COVID-19 (mRNA-1273). Media-Rel 2020;.

    Media Release
  9. Moderna Therapeutics. Moderna to Present New Interim Clinical Data About mRNA Vaccine Against COVID-19 (mRNA-1273) at Advisory Committee on Immunization Practices (ACIP) Meeting. Media-Rel 2020;.

    Media Release
  10. Emmes. Emmes Announces its Role in Phase 1 COVID-19 Vaccine Trial. Media-Rel 2020;.

    Media Release
  11. Jackson LA, Anderson EJ, Rouphael NG, Roberts PC, Makhene M, Coler RN, et al. An mRNA Vaccine against SARS-CoV-2 - Preliminary Report. . N-Engl-J-Med 2020;.

    PubMed | CrossRef Fulltext
  12. Moderna Therapeutics. Moderna Announces IND Submitted to U.S. FDA for Phase 2 Study of mRNA Vaccine (mRNA-1273) Against Novel Coronavirus. Media-Rel 2020;.

    Media Release
  13. Moderna Therapeutics. Moderna Announces Publication in The New England Journal of Medicine of Interim Results From Older Adult Age Cohorts in Phase 1 Study of its mRNA Vaccine Against COVID-19 (mRNA-1273). Media-Rel 2020;.

    Media Release
  14. Moderna Therapeutics. Moderna Receives FDA Fast Track Designation for mRNA Vaccine (mRNA-1273) Against Novel Coronavirus. Media-Rel 2020;.

    Media Release
  15. National Institutes of Health. NIH clinical trial of investigational vaccine for COVID-19 begins. Media-Rel 2020;.

    Media Release
  16. Moderna Therapeutics. Moderna Completes Enrollment of Phase 2 Study of its mRNA Vaccine Against COVID-19 (mRNA-1273). Media-Rel 2020;.

    Media Release
  17. Moderna Therapeutics. Moderna Highlights Opportunity of mRNA Vaccines at its First Vaccines Day. Media-Rel 2020;.

    Media Release
  18. Moderna Therapeutics. Moderna Partners with Takeda and the Government of Japan to Supply 50 Million Doses of mRNA Vaccine Against COVID-19 (mRNA-1273) to Japan. Media-Rel 2020;.

    Media Release
  19. Moderna Therapeutics. Moderna Announces Progress in Prophylactic Vaccines Modality with CMV Vaccine Phase 2 Study Data Now Expected in Third Quarter 2020 and Expands Investment in This Core Modality with Three New Development Candidates. Media-Rel 2020;.

    Media Release
  20. Moderna Therapeutics. Moderna Highlights Publication of Antibody Persistence Data of its COVID-19 Vaccine out to 6 Months in the New England Journal of Medicine. Media-Rel 2021;.

    Media Release
  21. National Institute of Allergy and Infectious Diseases. NIH Clinical Trial of a Vaccine for COVID-19 Now Enrolling Older Adults. Media-Rel 2020;.

    Media Release
  22. Moderna Therapeutics. Moderna Submits Authorization Application for its COVID-19 Vaccine in Adolescents in Switzerland. Media-Rel 2021;.

    Media Release
  23. National Institutes of Health. NIH clinical trial evaluating Moderna COVID-19 variant vaccine begins. Media-Rel 2021;.

    Media Release
  24. Moderna Therapeutics. Moderna Announces Award from U.S. Government Agency BARDA for up to $483 Million to Accelerate Development of mRNA Vaccine (mRNA-1273) Against Novel Coronavirus. Media-Rel 2020;.

    Media Release
  25. Moderna Therapeutics. Moderna Advances Late-Stage Development of its Vaccine (mRNA-1273) Against COVID-19. Media-Rel 2020;.

    Media Release
  26. Moderna Therapeutics. Moderna Announces Initiation of Rolling Submission to Health Canada for mRNA Vaccine Against COVID-19 (mRNA-1273). Media-Rel 2020;.

    Media Release
  27. Emmes Employees Co-Author COVID-19 Vaccine Report for the New England Journal of Medicine. Media-Rel 2020;.

    Media Release
  28. Moderna Therapeutics. Moderna Ships mRNA Vaccine Against Novel Coronavirus (mRNA-1273) for Phase 1 Study. Media-Rel 2020;.

    Media Release
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