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

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05375838
Recruitment Status : Recruiting
First Posted : May 17, 2022
Last Update Posted : May 17, 2022
Sponsor:
Information provided by (Responsible Party):
ModernaTX, Inc.

Brief 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.

Condition or disease Intervention/treatment Phase
SARS-CoV-2 Influenza Biological: mRNA-1073 Biological: mRNA-1010 Biological: mRNA-1273 Biological: Placebo Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1050 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : May 13, 2022
Estimated Primary Completion Date : December 15, 2022
Estimated Study Completion Date : December 15, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot Vaccines

Arm Intervention/treatment
Experimental: Phase 1: mRNA-1273 Plus Placebo
Participants will receive 2 intramuscular (IM) injections, one in each arm, of mRNA-1273 plus placebo at the specified dose level on Day 1.
Biological: mRNA-1273
Sterile liquid for injection

Biological: Placebo
0.9% sodium chloride (normal saline) injection

Experimental: Phase 1: mRNA-1010 Plus Placebo
Participants will receive 2 IM injections, one in each arm, of mRNA-1010 plus placebo at the specified dose level on Day 1.
Biological: mRNA-1010
Sterile liquid for injection

Biological: Placebo
0.9% sodium chloride (normal saline) injection

Experimental: Phase 1: mRNA-1010 Plus mRNA-1273
Participants will receive 2 IM injections, one in each arm, of mRNA-1010 plus mRNA-1273 at the specified dose level on Day 1.
Biological: mRNA-1010
Sterile liquid for injection

Experimental: Phase 1 Dose A: mRNA-1073 Plus Placebo
Participants will receive 2 IM injections, one in each arm, of mRNA-1073 plus placebo at the specified dose level on Day 1.
Biological: mRNA-1073
Sterile liquid for injection

Biological: Placebo
0.9% sodium chloride (normal saline) injection

Experimental: Phase 1 Dose B: mRNA-1073 Plus Placebo
Participants will receive 2 IM injections, one in each arm, of mRNA-1073 plus placebo at the specified dose level on Day 1.
Biological: mRNA-1073
Sterile liquid for injection

Biological: Placebo
0.9% sodium chloride (normal saline) injection

Experimental: Phase 1 Dose C: mRNA-1073 Plus Placebo
Participants will receive 2 IM injections, one in each arm, of mRNA-1073 plus placebo at the specified dose level on Day 1.
Biological: mRNA-1073
Sterile liquid for injection

Biological: Placebo
0.9% sodium chloride (normal saline) injection

Experimental: Phase 2: mRNA-1010 Plus mRNA-1273
Participants will receive 2 IM injections, one in each arm, of mRNA-1010 plus mRNA-1273 at the specified dose level on Day 1.
Biological: mRNA-1010
Sterile liquid for injection

Experimental: Phase 2 Dose A: mRNA-1073 Plus Placebo
Participants will receive 2 IM injections, one in each arm, of mRNA-1073 plus placebo at the specified dose level on Day 1.
Biological: mRNA-1073
Sterile liquid for injection

Biological: Placebo
0.9% sodium chloride (normal saline) injection




Primary Outcome Measures :
  1. Number of Participants with Solicited Local and Systemic Adverse Reactions (ARs) [ Time Frame: Up to Day 8 (7 days post vaccination) ]
  2. Number of Participants with Unsolicited Adverse Events (AEs) [ Time Frame: Up to Day 29 (28 days post vaccination) ]
  3. Number of Participants with Serious Adverse Events (SAEs) [ Time Frame: Up to Day 181 ]
  4. Number of Participants with Adverse Events of Special Interest (AESIs) [ Time Frame: Up to Day 181 ]
  5. Number of Participants with Medically-Attended AEs (MAAEs) [ Time Frame: Up to Day 181 ]
  6. Number of Participants with AEs Leading to Discontinuation [ Time Frame: Up to Day 181 ]

Secondary Outcome Measures :
  1. Change From Baseline in Geometric Mean Titer (GMT) as Measured by Hemagglutination Inhibition (HAI) Assay [ Time Frame: Baseline (Day 1), Days 8, 29, and 181 ]
  2. Change From Baseline in GMT as Measured by Pseudovirus Neutralization Assay (PsVNA) (or Binding Antibody Assay) [ Time Frame: Baseline (Day 1), Days 8, 29, and 181 ]
  3. Change From Baseline in Geometric Mean Fold-Rise (GMFR) as Measured by HAI Assay [ Time Frame: Baseline (Day 1), Days 8, 29, and 181 ]
  4. Change From Baseline in GMFR as Measured by PsVNA (or Binding Antibody Assay) [ Time Frame: Baseline (Day 1), Days 8, 29, and 181 ]
  5. Influenza: Percentage of Participants with Seroconversion as Measured by HAI Assay [ Time Frame: Baseline (Day 1), Days 8, 29, and 181 ]
    Seroconversion is defined as a Day 29 titer ≥1:40 if baseline is <1:10 or a 4-fold or greater rise if baseline is ≥1:10 in anti-HA antibodies measured by HAI assay.

  6. SARS-CoV-2: Percentage of Participants with Seroresponse as Measured by PsVNA (or Binding Antibody Assay) [ Time Frame: Baseline (Day 1), Days 8, 29, and 181 ]
    Seroresponse is defined as a Day 29 titer ≥4-fold if baseline is ≥lower limit of quantification (LLOQ) or ≥4 × LLOQ if baseline titer is <LLOQ in nAb titers measured by PsVNA (or binding antibody assay).



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 to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • 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.
  • 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.
  • 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.

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): NCT05375838


Contacts
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Contact: Moderna Clinical Trials Support Center 1-877-777-7187 clinicaltrials@modernatx.com

Locations
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United States, Florida
Research Centers of America Recruiting
Hollywood, Florida, United States, 33024
United States, Illinois
AES - DRS - Optimal Research Illinois - Peoria Recruiting
Peoria, Illinois, United States, 61614
United States, Iowa
Meridian Recruiting
Sioux City, Iowa, United States, 51106
United States, Louisiana
Benchmark Research Recruiting
Metairie, Louisiana, United States, 70006
United States, Nebraska
Meridian Recruiting
Norfolk, Nebraska, United States, 68701
United States, New York
Meridian Recruiting
Binghamton, New York, United States, 13901
Rochester Clinical Research Inc Recruiting
Rochester, New York, United States, 14609
United States, Ohio
Meridian Recruiting
Cincinnati, Ohio, United States, 45219
Meridian Recruiting
Cincinnati, Ohio, United States, 45246
United States, Texas
Benchmark Research Recruiting
Austin, Texas, United States, 78705
Benchmark Research Recruiting
Fort Worth, Texas, United States, 76135
DM Clinical Research - CyFair Recruiting
Houston, Texas, United States, 77065
DM Clinical Research - TCDD Recruiting
Houston, Texas, United States, 77081
United States, Utah
J Lewis Research Recruiting
Salt Lake City, Utah, United States, 84121
Sponsors and Collaborators
ModernaTX, Inc.
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Responsible Party: ModernaTX, Inc.
ClinicalTrials.gov Identifier: NCT05375838    
Other Study ID Numbers: mRNA-1073-P101
First Posted: May 17, 2022    Key Record Dates
Last Update Posted: May 17, 2022
Last Verified: May 2022

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Influenza, Human
Respiratory Tract Infections
Infections
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Diseases