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Dose-Confirmation Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1273 COVID-19 Vaccine in Adults Aged 18 Years and Older

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04405076
Recruitment Status : Active, not recruiting
First Posted : May 28, 2020
Last Update Posted : July 10, 2020
Sponsor:
Collaborator:
Biomedical Advanced Research and Development Authority
Information provided by (Responsible Party):
ModernaTX, Inc.

Brief Summary:
This clinical study will assess the safety, reactogenicity, and immunogenicity of 2 dose levels of mRNA-1273 SARS-COV-2 vaccine in adults 18 years of age or older.

Condition or disease Intervention/treatment Phase
SARS-CoV-2 Biological: Biological: mRNA-1273: 50 mcg Other: Placebo Biological: Biological: mRNA-1273: 100 mcg Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Double (Participant, Investigator)
Masking Description: Observer-blind
Primary Purpose: Prevention
Official Title: A Phase 2a, Randomized, Observer-Blind, Placebo Controlled, Dose-Confirmation Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1273 SARS-COV-2 Vaccine in Adults Aged 18 Years and Older
Actual Study Start Date : May 29, 2020
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : August 2021

Arm Intervention/treatment
Experimental: mRNA-1273: Dose 50 mcg - Adults Aged 18-54
Groups: Adults aged 18-54 years Dose: 50 mcg Intervention: Biological/Vaccine: mRNA-1273 50 mcg
Biological: Biological: mRNA-1273: 50 mcg
Biological: mRNA-1273: 50 mcg
Other Name: 50 mcg

Other: Placebo
Placebo: Saline
Other Name: Saline

Experimental: mRNA-1273: Dose 50 mcg - Adults Aged 55+ years
Groups: Adults aged 55+ years Dose: 50 mcg Intervention: Biological/Vaccine: mRNA-1273 50 mcg
Biological: Biological: mRNA-1273: 50 mcg
Biological: mRNA-1273: 50 mcg
Other Name: 50 mcg

Other: Placebo
Placebo: Saline
Other Name: Saline

Experimental: mRNA-1273: Dose 100 mcg - Adults Aged 18-54
Groups: Adults aged 18-54 years Dose: 100 mcg Intervention: Biological/Vaccine: mRNA-1273 100 mcg
Other: Placebo
Placebo: Saline
Other Name: Saline

Biological: Biological: mRNA-1273: 100 mcg
Biological: mRNA-1273: 100 mcg
Other Name: 100 mcg

Experimental: mRNA-1273: Dose 100 mcg - Adults Aged 55+ years
Groups: Adults aged 55+ years Dose: 100 mcg Intervention: Biological/Vaccine: mRNA-1273 100 mcg
Other: Placebo
Placebo: Saline
Other Name: Saline

Biological: Biological: mRNA-1273: 100 mcg
Biological: mRNA-1273: 100 mcg
Other Name: 100 mcg




Primary Outcome Measures :
  1. Solicited local and systemic adverse reactions (ARs) [ Time Frame: 7 days post-vaccination ]
  2. Unsolicited adverse events (AEs) [ Time Frame: 28 days post-vaccination ]
  3. Medically-attended adverse events (MAAEs) [ Time Frame: Month 0 through Month 13 ]
  4. Serious adverse events (SAEs) [ Time Frame: Month 0 through Month 13 ]
  5. Change in the measure of clinical safety laboratory values in Cohort 2 from baseline [ Time Frame: Through 1 month after last vaccination ]
  6. The number and percentage of participants with abnormalities in blood pressure, temperature, HR or respiratory rate will be assessed. [ Time Frame: Through 1 year after last vaccination ]
  7. The number and percentage of participants with abnormalities in physical examinations will be assessed [ Time Frame: Through 1 year after last vaccination ]
  8. Evaluate immunogenicity of mRNA-1273 by titer of SARS-CoV-2-specific binding antibody (bAb) measured by enzyme-linked immunosorbent assay (ELISA) [ Time Frame: Through 1 year after the final dose ]

Secondary Outcome Measures :
  1. Titer of SARS-CoV-2-specific neutralizing antibody (nAb) [ Time Frame: Through 1 year post last vaccination ]
  2. Seroconversion as measured by an increase of SARS-CoV-2-specific neutralizing antibody (nAb) titer [ Time Frame: Through 1 year post last vaccination ]
    Seroconversion as measured by an increase of SARS-CoV-2-specific neutralizing antibody (nAb) titer either from below the limit of detection (LOD) or lower limit of quantification (LLOQ) to equal to or above LOD or LLOQ, or a 4-times higher titer in participants with pre-existing nAb titers.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Each participant must meet all of the following criteria during the screening period and at Day 1, unless noted otherwise, to be enrolled in this study:

  1. Male or female, 18 years of age or older at the time of consent (Screening Visit, Day 0).
  2. Understands and agrees to comply with the study procedures and provides written informed consent.
  3. According to the assessment of the investigator, is in good general health and can comply with study procedures.
  4. Body mass index (BMI) of 18 kg/m2 to 30 kg/m2 (inclusive) at the Screening Visit (Day 0).
  5. Female participants of nonchildbearing potential may be enrolled in the study. Nonchildbearing potential is defined as surgically sterile (history of bilateral tubal ligation, bilateral oophorectomy, hysterectomy) or postmenopausal (defined as amenorrhea for ≥ 12 consecutive months prior to Screening (Day 0) without an alternative medical cause). A follicle-stimulating hormone (FSH) level may be measured at the discretion of the investigator to confirm postmenopausal status.
  6. Female participants of childbearing potential may be enrolled in the study if the participant fulfills all the following criteria:

    • Has a negative pregnancy test at Screening (Day 0) and on the day of the first injection (Day 1).
    • Has practiced adequate contraception or has abstained from all activities that could result in pregnancy for at least 28 days prior to the first injection (Day 1).
    • Has agreed to continue adequate contraception through 3 months following the second injection (Day 29).
    • Is not currently breastfeeding.

    Adequate female contraception is defined as consistent and correct use of a Food and Drug Administration (FDA) approved contraceptive method in accordance with the product label. For example:

    • Barrier method (such as condoms, diaphragm, or cervical cap) used in conjunction with spermicide
    • Intrauterine device
    • Prescription hormonal contraceptive taken or administered via oral (pill), transdermal (patch), subdermal, or IM route
    • Sterilization of a female participant's monogamous male partner prior to entry into the study Note: periodic abstinence (eg, calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception.
  7. Male participants engaging in activity that could result in pregnancy of sexual partners must agree to practice adequate contraception from the time of the first injection and through 3 months after the last injection.

Adequate contraception for male participants is defined as:

  • Monogamous relationship with a female partner using an intrauterine device or hormonal contraception (described above)
  • Use of barrier methods and spermicide
  • History of surgical sterilization
  • Male participants with partners who have become pregnant prior to Screening are eligible to participate in the study.

Exclusion Criteria:

Participants meeting any of the following criteria at the Screening Visit (Day 0) or at Day 1, unless noted otherwise, will be excluded from the study:

  1. Known history of SARS-CoV-2 infection or known exposure to someone with SARS CoV 2 infection or COVID-19.
  2. Travel outside of the US in the 28 days prior to the Screening Visit (Day 0).
  3. Pregnant or breastfeeding.
  4. Is acutely ill or febrile 24 hours prior to or at the Screening Visit (Day 0). Fever is defined as a body temperature ≥ 38.0°C/100.4°F. Participants meeting this criterion may be rescheduled within the relevant window periods. Afebrile participants with minor illnesses can be enrolled at the discretion of the investigator.
  5. Prior administration of an investigational CoV (eg, SARS-CoV-2, SARS-CoV, MERS-CoV) vaccine.
  6. Current treatment with investigational agents for prophylaxis against COVID-19.
  7. Has a medical, psychiatric, or occupational condition that may pose additional risk as a result of participation, or that could interfere with safety assessments or interpretation of results according to the investigator's judgment.
  8. Is a healthcare worker or a member of an emergency response team.
  9. Current use of any inhaled substance (eg, tobacco or cannabis smoke, nicotine vapors).
  10. History of chronic smoking (≥ 1 cigarette a day) within 1 year of the Screening Visit (Day 0).
  11. History of illegal substance use or alcohol abuse within the past 2 years. This exclusion does not apply to historical cannabis use that was formerly illegal in the participant's state but is legal at the time of Screening.
  12. Known history of hypertension, or systolic blood pressure > 150 mm Hg in participants in Cohort 1 (≥ 18 to < 55 years old) or systolic blood pressure > 160 mm Hg in participants in Cohort 2 (≥ 55 years old) at the Screening Visit (Day 0)..
  13. Known history of hypotension or systolic blood pressure < 85 mm Hg at the Screening Visit (Day 0).
  14. Diabetes mellitus
  15. Diagnosis of chronic pulmonary disease (eg, chronic obstructive pulmonary disease, asthma)
  16. Chronic cardiovascular disease
  17. Resides in a nursing home
  18. Grade 1 or higher toxicity on clinical safety laboratory testing at the Screening Visit (Day 0)
  19. Current or previous diagnosis of immunocompromising condition, immune-mediated disease, or other immunosuppressive condition.
  20. Received systemic immunosuppressants or immune-modifying drugs for >14 days in total within 6 months prior to the Screening Visit (Day 0) (for corticosteroids ≥ 20 mg/day of prednisone equivalent). Topical tacrolimus is allowed if not used within 14 days prior to the Screening Visit (Day 0).
  21. Anticipating the need for immunosuppressive treatment at any time during participation in the study.
  22. Positive serology for hepatitis B virus surface antigen, hepatitis C virus antibody, or human immunodeficiency virus (HIV) type 1 or 2 antibodies identified at the Screening Visit (Day 0).
  23. History of anaphylaxis, urticaria, or other significant AR requiring medical intervention after receipt of a vaccine.
  24. Bleeding disorder considered a contraindication to IM injection or phlebotomy.
  25. Diagnosis of malignancy within previous 10 years (excluding non-melanoma skin cancer).
  26. Has received or plans to receive a licensed vaccine ≤ 28 days prior to the first injection (Day 1) or plans to receive a licensed vaccine within 28 days before or after any study injection. Licensed influenza vaccines may be received more than 14 days before or after any study injection.
  27. Receipt of systemic immunoglobulins or blood products within 3 months prior to the Screening Visit (Day 0) or plans for receipt during the study.
  28. Has donated ≥ 450 mL of blood products within 28 days prior to the Screening Visit (Day 0) or plans to donate blood products during the study.
  29. Participated in an interventional clinical study within 28 days prior to the Screening Visit (Day 0) or plans to do so while participating in this study.
  30. Is an immediate family member or household member of study personnel

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04405076


Locations
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United States, Georgia
Meridian Clinical Research
Savannah, Georgia, United States, 31406
United States, Kansas
Heartland Research Associates
Newton, Kansas, United States, 67114
United States, Missouri
Heartland Research Associates
Kansas City, Missouri, United States, 64114
United States, Nebraska
Meridian Clinical Research
Norfolk, Nebraska, United States, 68701
Meridian Clinical Research
Omaha, Nebraska, United States, 68134
United States, North Carolina
Trial Management Associates
Wilmington, North Carolina, United States, 28403
United States, South Dakota
Meridian Clinical Research
Dakota Dunes, South Dakota, United States, 57049
United States, Texas
Benchmark Research
Austin, Texas, United States, 78705
Benchmark Research
San Angelo, Texas, United States, 76904
United States, Utah
Advanced Clinical Research/Velocity
West Jordan, Utah, United States, 84088
Sponsors and Collaborators
ModernaTX, Inc.
Biomedical Advanced Research and Development Authority
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Responsible Party: ModernaTX, Inc.
ClinicalTrials.gov Identifier: NCT04405076    
Other Study ID Numbers: mRNA-1273-P201
75A50120C00034 ( Other Grant/Funding Number: BARDA )
First Posted: May 28, 2020    Key Record Dates
Last Update Posted: July 10, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by ModernaTX, Inc.:
mRNA-1273
mRNA-1273 vaccine
SARS-CoV-2
SARS-CoV-2 Vaccine
Coronavirus
Virus Diseases
Messenger RNA
COVID 19
COVID 19 Vaccine
Moderna