AzTrials
AzTrials

SARS-CoV-2Phase 1/2NCT05375838

A Safety, Reactogenicity, and Immunogenicity Study of mRNA-1073 (COVID-19/Influenza) Vaccine in Adults 18 to 75 Years Old

A Phase 1/2 study testing mRNA-1073, mRNA-1010 and mRNA-1273 in people with SARS-CoV-2 and Influenza, run by ModernaTX, Inc. at 14 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

The primary goal of this study is to evaluate the safety, reactogenicity, and immunogenicity of mRNA-1073 compared to co-administered mRNA-1010 and mRNA-1273 vaccines and to the individual vaccines alone in healthy participants. Read more about this study

Who is it for?
Ages 18 to 75 yearsHealthy volunteers can take part
Conditions the study is for
SARS-CoV-2, Influenza
What is being tested?
mRNA-1073, mRNA-1010 and mRNA-1273
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
550 participants
Where
14 sitesUnited States
Study dates
13 May 2022to 29 Dec 2022
Phase
Phase 1/2
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 75 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Body mass index (BMI) of 18 kilograms per meter squared (kg/m^2) to 35 kg/m^2 (inclusive) at the Screening Visit.
  • Participants must have been fully vaccinated for COVID-19 primary series according to the locally authorized or approved regimen, and their last COVID-19 vaccine (primary series or booster) was ≥ 120 days prior to the randomization visit (or less per local guidance).

Who cannot join

  • Participant is acutely ill or febrile (temperature ≥ 38.0℃ [100.4°F]) 72 hours prior to or at the Screening Visit or Day 1. Participants meeting this criterion may be rescheduled within the 28-day Screening window and will retain their initially assigned participant number.
  • Participant has a history of a diagnosis or condition that, in the judgment of the investigator, is clinically unstable or may affect participant safety, assessment of safety endpoints, assessment of immune response, or adherence to study procedures. Clinically unstable is defined as a diagnosis or condition requiring significant changes in management or medication ≤ 60 days prior to Screening and includes ongoing workup of an undiagnosed illness that could lead to a new diagnosis or condition. Asymptomatic conditions and conditions with no evidence of end organ involvement (for example, mild hypertension, dyslipidemia) are not exclusionary, provided that they are being appropriately managed and are clinically stable (for example, unlikely to result in symptomatic illness within the time course of this study). Illnesses or conditions may be exclusionary, even if otherwise stable, due to therapies used to treat them (for example, immune-modifying treatments), at the discretion of the investigator.
  • Participant has a reported history of congenital or acquired immunodeficiency, immunosuppressive condition, or immune-mediated disease.
  • Participant has dermatologic conditions that could affect local solicited adverse reaction (AR) assessments (for example, tattoos, psoriasis patches affecting skin over the deltoid areas).
  • Participant has a reported history of anaphylaxis or severe hypersensitivity reaction after receipt of any mRNA vaccine(s) or any components of the mRNA vaccines.
  • Participant has a reported history of bleeding disorder that is considered a contraindication to IM injection or phlebotomy.
Show all 21Show fewer
  • Participant has a diagnosis of malignancy within previous 10 years (excluding nonmelanoma skin cancer).
  • Participant has any medical, psychiatric, or occupational condition, including reported history of drug or alcohol abuse, that, in the opinion of the investigator, might pose additional risk due to participation in the study or could interfere with the interpretation of study results.
  • Participant has received systemic immunosuppressants or immune-modifying drugs for > 14 days in total within 6 months prior to Screening (for corticosteroids ≥ 10 mg/day of prednisone or equivalent) or is anticipating the need for immunosuppressive treatment at any time during participation in the study. Inhaled, nasal, topical steroids are not exclusionary.
  • Participant has received or plans to receive any vaccine authorized or approved by a local health agency ≤ 28 days prior to study injections (Day 1) or plans to receive a vaccine authorized or approved by a local health agency within 28 days before or after the study injections.
  • Participant has received a seasonal influenza vaccine or any other investigational influenza vaccine ≤ 180 days prior to the randomization visit.
  • Participant has tested positive for influenza by local health authority approved testing methods ≤ 180 days prior to the Screening Visit.
  • Participant has had close contact to someone with SARS-CoV-2 infection or COVID-19 as defined by the US CDC in the past 10 days prior to the Screening Visit.
  • Participant has known history of SARS-CoV-2 infection within ≤ 90 days.
  • Participant has received systemic immunoglobulins or blood products ≤ 90 days prior to the Screening Visit or plans to receive systemic immunoglobulins or blood products during the study.
  • Participant has a history of myocarditis, pericarditis, or myopericarditis.
  • Participant 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.
  • Participant is an immediate family member or household member of study personnel, study site staff, or Sponsor personnel.
  • Phase 1 Specific Exclusion Criteria:
  • Participant has clinical screening laboratory values (total white blood cell count, hemoglobin, platelets, alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine, alkaline phosphatase, and total bilirubin) > Grade 1.

Trial locations and contacts

14 sites in 1 country.

14 sites in 1 country

United States14 sites

  • Benchmark Research

    Austin, Texas, 78705

  • Meridian

    Binghamton, New York, 13901

  • Meridian

    Cincinnati, Ohio, 45219

  • Meridian

    Cincinnati, Ohio, 45246

  • Benchmark Research

    Fort Worth, Texas, 76135

  • Research Centers of America

    Hollywood, Florida, 33024

  • DM Clinical Research - CyFair

    Houston, Texas, 77065

  • DM Clinical Research - TCDD

    Houston, Texas, 77081

  • Benchmark Research

    Metairie, Louisiana, 70006

  • Meridian

    Norfolk, Nebraska, 68701

  • AES - DRS - Optimal Research Illinois - Peoria

    Peoria, Illinois, 61614

  • Rochester Clinical Research Inc

    Rochester, New York, 14609

  • J Lewis Research

    Salt Lake City, Utah, 84121

  • Meridian

    Sioux City, Iowa, 51106

Other trials in United States

About this study

Official title: Phase 1/2, Randomized, Stratified, Observer-blind Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1073 (SARS-CoV-2 and Influenza Vaccine) Compared to Co-administered mRNA-1010 (Influenza) and mRNA-1273 (SARS-CoV-2) Vaccines and to mRNA- 1010 Vaccine and mRNA-1273 Vaccine Alone in Healthy Adults 18-75 Years of Age

The primary goal of this study is to evaluate the safety, reactogenicity, and immunogenicity of mRNA-1073 compared to co-administered mRNA-1010 and mRNA-1273 vaccines and to the individual vaccines alone in healthy participants.

Being tested
mRNA-1073, mRNA-1010, mRNA-1273, Placebo
Medical subject headings
Influenza, Human

What participants receive

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

  • mRNA-1073Biological

    Sterile liquid for injection

  • mRNA-1010Biological

    Sterile liquid for injection

  • mRNA-1273Biological

    Sterile liquid for injection

  • PlaceboBiological

    0.9% sodium chloride (normal saline) injection

Study groups in NCT05375838
Study groupRoleWhat they receive
mRNA-1273 Plus PlaceboExperimentalParticipants will receive 2 intramuscular (IM) injections, one in each arm, of mRNA-1273 plus placebo at the specified dose level on Day 1.
Receives: Biological: mRNA-1273; Biological: Placebo
mRNA-1010 Plus PlaceboExperimentalParticipants will receive 2 IM injections, one in each arm, of mRNA-1010 plus placebo at the specified dose level on Day 1.
Receives: Biological: mRNA-1010; Biological: Placebo
mRNA-1010 Plus mRNA-1273ExperimentalParticipants will receive 2 IM injections, one in each arm, of mRNA-1010 plus mRNA-1273 at the specified dose level on Day 1.
Receives: Biological: mRNA-1010
Dose A: mRNA-1073 Plus PlaceboExperimentalParticipants will receive 2 IM injections, one in each arm, of mRNA-1073 plus placebo at the specified dose level on Day 1.
Receives: Biological: mRNA-1073; Biological: Placebo
Dose B: mRNA-1073 Plus PlaceboExperimentalParticipants will receive 2 IM injections, one in each arm, of mRNA-1073 plus placebo at the specified dose level on Day 1.
Receives: Biological: mRNA-1073; Biological: Placebo
Dose C: mRNA-1073 Plus PlaceboExperimentalParticipants will receive 2 IM injections, one in each arm, of mRNA-1073 plus placebo at the specified dose level on Day 1.
Receives: Biological: mRNA-1073; 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 Adverse Reaction (ARs)

    Solicited ARs (local and systemic) were collected in the electronic diary (eDiary). Local ARs included: pain at injection site, erythema (redness) at injection site, swelling/induration (hardness) at injection site, and localized axillary swelling or tenderness ipsilateral to the injection arm. Systemic ARs included: headache, fatigue, myalgia (muscle aches all over the body), arthralgia (aching in several joints), nausea/vomiting, rash, body temperature (potentially fever), and chills. Note, that not all solicited ARs were considered adverse events (AEs). The Investigator reviewed whether the solicited AR was also to be recorded as an AE. A Summary of all serious AEs (SAEs) and all nonserious AEs ("Other"), regardless of causality, is in Reported "Adverse Events" section.

    Measured: Up to Day 8 (7 days post vaccination)

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

    An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. A treatment-emergent AE (TEAE) was defined as any event not present before exposure to vaccine or any event already present that worsens in intensity or frequency after exposure. Any abnormal laboratory test result (hematology, clinical chemistry, or prothrombin time [PT]/partial thromboplastin time [PTT]) or other safety assessment (for example, electrocardiogram, radiological scan, vital sign measurement), including one that worsens from baseline and is considered clinically significant in the medical and scientific judgment of the Investigator. A summary of SAEs and all nonserious AEs ("Other") reported up to the end of the study, regardless of causality, is located in the Reported "Adverse Events" section.

    Measured: Up to Day 29 (28 days post vaccination)

  3. Number of Participants With Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs), Medically-Attended AEs (MAAEs) and AEs Leading to Discontinuation

    An SAE was defined as any AE that resulted in death, is life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in disability/permanent damage, was a congenital anomaly/birth defect, or was an important medical event. AESIs included thrombocytopenia, new onset of or worsening of the protocol specified neurologic diseases, anaphylaxis, and myocarditis/pericarditis. An MAAE is an AE that leads to an unscheduled visit to a healthcare practitioner. This would include visits to a study site for unscheduled assessments (for example, abnormal laboratory follow-up, and/or COVID-19 and visits to healthcare practitioners external to the study site (for example, urgent care, primary care physician). A summary of SAEs and all nonserious AEs ("Other"), regardless of causality, is located in the Reported "Adverse Events" section.

    Measured: Up to Day 181

Secondary outcomes (6)

  1. Geometric Mean Titer of Anti-Hemagglutinin Antibodies at Day 29, as Measured by Hemagglutination Inhibition Assay (HAI) For Vaccine-Matched Seasonal Influenza A and B Strains

    Seasonal influenza A included H1N1 and H3N2 and seasonal influenza B strains included BV and BY.

    Measured: Day 29

  2. Geometric Mean Titer of VAC62 Neutralizing Antibody at Day 29, as Measured by Pseudovirus Neutralization Assay (or Binding Antibody Assay) For Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)

    Measured: Day 29

  3. Geometric Mean Fold Rise of Anti-Hemagglutinin Antibodies at Day 29, as Measured by Hemagglutination Inhibition Assay (HAI) For Vaccine-Matched Seasonal Influenza A and B Strains

    Seasonal influenza A included H1N1 and H3N2 and seasonal influenza B strains included BV and BY.

    Measured: Day 29

  4. Geometric Mean Fold Rise of VAC62 Neutralizing Antibody at Day 29, as Measured by Pseudovirus Neutralization Assay (or Binding Antibody Assay) For SARS-CoV-2

    The GMFR measures the changes in immunogenicity titers or levels from Baseline within participants. 95% CI was calculated based on the difference in the log-transformed values for GMFR, then back transformed to the original scale for presentation.

    Measured: Day 29

  5. Percentage of Participants With Seroconversion as Measured by HAI Assay For Vaccine-Matched Seasonal Influenza A and B Strains

    Seroconversion at a participant level is defined as a pre-vaccination HAI titer < 1:10 and a post-vaccination HAI titer >= 1:40 or a pre-vaccination HAI titer >= 1:10 and a minimum 4-fold rise in post vaccination HAI antibody titer.

    Measured: Day 29

  6. Percentage of Participants With Seroresponse as Measured by PsVNA (or Binding Antibody Assay) For SARS-CoV-2

    Seroresponse at a participant level is defined as an increase from below the lower limit of quantification (LLOQ) to >= 4 x LLOQ if baseline neutralizing antibody (nAb) level is < LLOQ, or >= 4 fold rise if baseline nAb level is >=LLOQ.

    Measured: Day 29

Timeline

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

  1. First posted17 May 2022
  2. Study start13 May 2022
  3. Primary completion29 Dec 2022
  4. Study completion29 Dec 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 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
550 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05375838
Sponsor's protocol ID
mRNA-1073-P101
Status last verified
Jan 2024
First submitted
13 May 2022
Last updated
28 Feb 2024
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Rudman Spergel AK, Henry C, Nachbagauer R, Kaplonek P, Astley E, Avanesov A, Bertera H, Carmona L, Cizmeci D, Collins A, Embry A, Guo R, Mao X, Pucci A, Shao S, Shih-Lu-Lee J, Yu WH, Brune D, Chu L, Irfan M, Alter G, Ananworanich J, Shaw CA. Phase 1/2 randomized, observer-blind clinical trial of a first-generation, mRNA-based vaccine against seasonal influenza and COVID-19 in healthy adults. Hum Vaccin Immunother. 2026 Dec;22(1):2589644. doi: 10.1080/21645515.2025.2589644. Epub 2026 Feb 2.

    PubMed 41627968

  • Sanchez-Martinez ZV, Alpuche-Lazcano SP, Stuible M, Akache B, Renner TM, Deschatelets L, Dudani R, Harrison BA, McCluskie MJ, Hrapovic S, Blouin J, Wang X, Schuller M, Cui K, Cho JY, Durocher Y. SARS-CoV-2 spike-based virus-like particles incorporate influenza H1/N1 antigens and induce dual immunity in mice. Vaccine. 2024 Dec 2;42(26):126463. doi: 10.1016/j.vaccine.2024.126463. Epub 2024 Oct 30.

    PubMed 39481241

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing mRNA-1073, mRNA-1010 and mRNA-1273 in people with SARS-CoV-2 and Influenza, run by ModernaTX, Inc. at 14 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 2 inclusion and 21 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 28 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 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 combined 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.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 28 Feb 2024). 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?

Number of Participants With Solicited Local and Systemic Adverse Reaction (ARs) (time frame: Up to Day 8 (7 days post vaccination)). 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 NCT05375838, which also lists 2 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 28 Feb 2024.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in