Clinical trial NCT05375838: A Safety, Reactogenicity, and Immunogenicity Study of mRNA-1073 (COVID-19/Influenza) Vaccine in Adults 18 to 75 Years Old
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: SARS-CoV-2
Influenza
Lead sponsor: ModernaTX, Inc.
Sponsor class: INDUSTRY
First posted: 2022-05-17
Enrollment: 550
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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. 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.

Primary outcomes:
measure: Number of Participants With Solicited Local and Systemic Adverse Reaction (ARs)
timeFrame: Up to Day 8 (7 days post vaccination)
measure: Number of Participants With Unsolicited Adverse Events (AEs)
timeFrame: Up to Day 29 (28 days post vaccination)
measure: Number of Participants With Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs), Medically-Attended AEs (MAAEs) and AEs Leading to Discontinuation
timeFrame: Up to Day 181
Secondary outcomes:
measure: 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
timeFrame: Day 29
measure: 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)
timeFrame: Day 29
measure: 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
timeFrame: Day 29
measure: 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
timeFrame: Day 29
measure: Percentage of Participants With Seroconversion as Measured by HAI Assay For Vaccine-Matched Seasonal Influenza A and B Strains
timeFrame: Day 29
measure: Percentage of Participants With Seroresponse as Measured by PsVNA (or Binding Antibody Assay) For SARS-CoV-2
timeFrame: Day 29
Other outcomes:
Locations:
city: Hollywood
country: United States
facility: Research Centers of America
state: Florida
city: Peoria
country: United States
facility: AES - DRS - Optimal Research Illinois - Peoria
state: Illinois
city: Sioux City
country: United States
facility: Meridian
state: Iowa
city: Metairie
country: United States
facility: Benchmark Research
state: Louisiana
city: Norfolk
country: United States
facility: Meridian
state: Nebraska
city: Binghamton
country: United States
facility: Meridian
state: New York
city: Rochester
country: United States
facility: Rochester Clinical Research Inc
state: New York
city: Cincinnati
country: United States
facility: Meridian
state: Ohio
city: Cincinnati
country: United States
facility: Meridian
state: Ohio
city: Austin
country: United States
facility: Benchmark Research
state: Texas
city: Fort Worth
country: United States
facility: Benchmark Research
state: Texas
city: Houston
country: United States
facility: DM Clinical Research - CyFair
state: Texas
city: Houston
country: United States
facility: DM Clinical Research - TCDD
state: Texas
city: Salt Lake City
country: United States
facility: J Lewis Research
state: Utah
Study officials:
References: