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SARS-CoV-2Phase 1NCT04813796

A Study to Evaluate Safety, Reactogenicity, and Immunogenicity of mRNA-1283 and mRNA-1273 Vaccines in Healthy Adults Between 18 Years and 55 Years of Age to Prevent COVID-19

A Phase 1 study testing mRNA-1283 and mRNA-1273 in people with SARS-CoV-2, run by ModernaTX, Inc. at 5 sites in United States.

Completed

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

Official record
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Trial summary

The primary goal for this study is to evaluate the safety and reactogenicity of 3 dose levels of mRNA-1283 and 1 dose level of mRNA-1273 vaccine given to healthy adults in 2 doses, 28 days apart, and 1 dose level of mRNA-1283 administered as a single dose to healthy adults. Read more about this study

Who is it for?
Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for
SARS-CoV-2
What is being tested?
mRNA-1283 and mRNA-1273
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
104 participants
Where
5 sitesUnited States
Study dates
11 Mar 2021to 25 Jul 2023
Phase
Phase 1
Are there results?
None posted in the registry

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 55 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Understands and agrees to comply with the study procedures and provides written informed consent.
  • According to the assessment of the investigator, is in good general health and can comply with study procedures.
  • Body mass index (BMI) of 18 kilograms/square meter (kg/m^2) to 35 kg/m^2 (inclusive) at the Screening Visit (Day 0).
  • For female participants of childbearing potential: negative pregnancy test, adequate contraception or has abstained from all activities that could result in pregnancy for at least 28 days prior to the first injection, agreement to continue adequate contraception or abstinence through 3 months following the second injection, and not currently breastfeeding.

Who cannot join

  • Known history of SARS-CoV-2 infection or known exposure to someone with SARS-CoV-2 infection or COVID-19 in the past 30 days.
  • Positive serology results for SARS-CoV-2 at the Screening Visit. A negative serological test for SARS-CoV-2, performed on a blood sample obtained at the Screening Visit, is required before a participant can be dosed.
  • Travel outside of the United States in the 28 days prior to the Screening Visit (Day 0).
  • Prior administration of an investigational, authorized, or licensed CoV (for example, SARS-CoV-2, SARS-CoV, or Middle East Respiratory Syndrome [MERS]-CoV) vaccine, based on medical history interview.
  • Current treatment with investigational agents for prophylaxis against COVID-19.
  • Recent (within the last 12 months) use of a dermal filler.
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  • 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.
  • Has received systemic immunosuppressants or immune-modifying drugs for >14 days in total within 6 months prior to Screening (for corticosteroids, 10 milligrams (mg)/day of prednisone equivalent) or is anticipating the need for immunosuppressive treatment at any time during participation in the study.
  • Has received or plans to receive any 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, with the exception of licensed influenza vaccines, which may be received more than 14 days before the first study injection or more than 14 days after the second study injection.
  • Receipt of systemic immunoglobulins or blood products within 3 months prior to the Screening Visit (Day 0) or plans for receipt during the study.
  • Current use of any inhaled substance (for example, tobacco or cannabis smoke, nicotine vapors).
  • History of chronic smoking (1 cigarette a day) within 1 year of the Screening Visit.
  • Resides in a nursing home.
  • Has donated 450 milliliters (mL) of blood products within 28 days prior to the Screening Visit or plans to donate blood products during the study.
  • Participated in an interventional clinical study within 28 days prior to the Screening Visit based on the medical history interview or plans to do so while participating in this study.

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

United States5 sites

  • Optimal Research Texas, LLC

    Austin, Texas, 78705

  • Synexus Clinical Research US Phoenix Southeast, Inc.

    Chandler, Arizona, 85224

  • Optimal Research Melbourne, LLC

    Melbourne, Florida, 32934

  • Optimal Research Illinois, LLC

    Peoria, Illinois, 61614

  • Optimal Research San Diego, LLC

    San Diego, California, 92108

Other trials in United States

About this study

Official title: A Phase 1, Randomized, Observer-Blind, Dose-Ranging Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1283 and mRNA-1273 SARS-CoV-2 Vaccine in Adults Aged 18-55 Years

The primary goal for this study is to evaluate the safety and reactogenicity of 3 dose levels of mRNA-1283 and 1 dose level of mRNA-1273 vaccine given to healthy adults in 2 doses, 28 days apart, and 1 dose level of mRNA-1283 administered as a single dose to healthy adults.

Conditions
SARS-CoV-2
Being tested
mRNA-1283, mRNA-1273, Placebo
Keywords
mRNA-1283 vaccine, mRNA-1273, mRNA-1273 vaccine, SARS-CoV-2, SARS-CoV-2 Vaccine, Coronavirus, Virus Diseases, Messenger RNA, COVID-19, COVID-19 Vaccine, Moderna
Medical subject headings
Coronavirus Infections, Virus Diseases, COVID-19

What participants receive

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

  • mRNA-1283Biological

    Sterile liquid for injection

  • mRNA-1273Biological

    Sterile liquid for injection

  • PlaceboBiological

    0.9% sodium chloride (normal saline) injection

Study groups in NCT04813796
Study groupRoleWhat they receive
mRNA-1283 Dose Level 1ExperimentalParticipants will receive 2 intramuscular (IM) injections of mRNA-1283 at Dose Level 1 on Day 1 and Day 29.
Receives: Biological: mRNA-1283
mRNA-1283 Dose Level 2ExperimentalParticipants will receive 2 IM injections of mRNA-1283 at Dose Level 2 on Day 1 and Day 29.
Receives: Biological: mRNA-1283
mRNA-1283 Dose Level 3ExperimentalParticipants will receive 2 IM injections of mRNA-1283 at Dose Level 3 on Day 1 and Day 29.
Receives: Biological: mRNA-1283
mRNA-1273ExperimentalParticipants will receive 2 IM injections of mRNA-1273 at a pre-specified dose for this study on Day 1 and Day 29.
Receives: Biological: mRNA-1273
Placebo / mRNA-1283ExperimentalParticipants will receive 1 IM injection of study drug-matching placebo on Day 1 and 1 IM injection of mRNA-1283 at a pre-specified dose on Day 29. Participants may be offered an opportunity to receive an additional injection of mRNA-1273 at the pre-specified dose on Open-Label Day 1.
Receives: Biological: mRNA-1283; Biological: Placebo

What is being measured

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

  1. Number of Participants with Solicited Local and Systemic Reactogenicity Adverse Reactions (ARs)

    Measured: Up to Day 36 (7 days after second dose)

  2. Number of Participants with Unsolicited Adverse Events (AEs)

    Measured: Up to Day 57 (28 days after second dose)

  3. Number of Participants with Medically-Attended AEs (MAAEs), AE of Special Interest (AESIs), and Serious Adverse Events (SAEs)

    Measured: Up to Day 394 (1 year after second dose)

Secondary outcomes (3)

  1. Geometric Mean (GM) of SARS-CoV-2 Specific Neutralizing Antibody (nAb)

    Measured: Day 1, Day 29, Day 36, Day 57, Day 209, and Day 394

  2. GM of SARS-CoV-2-Specific Binding Antibody (bAb)

    Measured: Day 1, Day 29, Day 36, Day 57, Day 209, and Day 394

  3. Seroconversion as Measured by an Increase of SARS-CoV-2-Specific nAb Titer or bAb Titer

    Seroconversion measured as defined for the study.

    Measured: Day 1, Day 29, Day 36, Day 57, Day 209, and 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 posted24 Mar 2021
  2. Study start11 Mar 2021
  3. Primary completion25 Jul 2023
  4. Study completion25 Jul 2023

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
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
104 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04813796
Sponsor's protocol ID
mRNA-1283-P101
Status last verified
Jul 2023
First submitted
22 Mar 2021
Last updated
1 Aug 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Yassini P, Hutchens M, Paila YD, Schoch L, Aunins A, Siangphoe U, Paris R. Interim analysis of a phase 1 randomized clinical trial on the safety and immunogenicity of the mRNA-1283 SARS-CoV-2 vaccine in adults. Hum Vaccin Immunother. 2023 Dec 31;19(1):2190690. doi: 10.1080/21645515.2023.2190690. Epub 2023 Apr 19.

    PubMed 37074202

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing mRNA-1283 and mRNA-1273 in people with SARS-CoV-2, run by ModernaTX, Inc. at 5 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 4 inclusion and 15 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 1 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Number of Participants with Solicited Local and Systemic Reactogenicity Adverse Reactions (ARs) (time frame: Up to Day 36 (7 days after second dose)). The study lists 3 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 NCT04813796, which also lists 1 linked publication.

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 1 Aug 2023.

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