Evaluating a new mRNA influenza vaccine in healthy adults

Phase 2, Open-Label Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1010 and Comparator Seasonal Influenza Vaccines in Healthy Adults

This study is testing a new mRNA flu vaccine in healthy adults to see if it is safe and works better than regular flu vaccines.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 325 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: ModernaTX, Inc. (industry)
• Drugs / interventions: Infliximab, prednisone
• Locations: 1 site (Saint Louis, Missouri)
• Trial ID: NCT05606965 on ClinicalTrials.gov

What this trial studies

This study aims to assess the safety, reactogenicity, and immunogenicity of the mRNA-1010 influenza vaccine compared to traditional influenza vaccines in healthy adults. It is divided into three parts, with Part A conducted during the 2022-23 influenza season, Part B in the 2023-24 season, and Part C planned for the 2024-25 season. Participants will receive either the mRNA-1010 vaccine or various comparator vaccines, and their immune responses will be measured at Day 29 post-vaccination.

Who should consider this trial

Good fit: Ideal candidates for this study are healthy adults aged 18-50 years and older adults aged 65-80 years.

Not a fit: Patients who are acutely ill or have certain medical or psychiatric conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to a more effective and safer influenza vaccine for adults.

How similar studies have performed: Other studies have shown promise with mRNA vaccine technology, suggesting potential for success in this approach.

Eligibility criteria

Inclusion Criteria:

* Adults 18-50 years (Study Parts A, B, and C) and 65-80 years (Study Parts A and B only) of age at the time of consent (Screening Visit).
* Part A only: Body mass index (BMI) of 18 kilograms (kg)/meter (m)\^2 to \< 40 kg/m\^2 at the Screening Visit. There will be no BMI requirement for inclusion in Part B and Part C.
* A person of childbearing potential (POCBP): has a negative highly sensitive pregnancy test at the Screening Visit and before each administration of study intervention; must use a contraceptive method that is highly effective from at least 28 days prior to Day 1 (Baseline) to at least 3 months after the last study intervention; and is not currently pregnant or breastfeeding.

Exclusion Criteria:

* Acutely ill or febrile (temperature ≥ 38.0°Celsius (C)/100.4° Fahrenheit (F) hours before or at the D1 vaccination visit. Participants meeting this criterion may be rescheduled within the 28-day screening window.
* Any medical, psychiatric, or occupational condition, including reported history of substance 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.
* Reported history of congenital or acquired immunodeficiency, immunocompromizing or immunosuppressive condition, asplenia, or history of recurrent severe infections. Certain immune-mediated conditions that are stable and well-controlled (for example, Hashimoto's thyroid disease) or that do not require systemic immunosuppressive therapy may be permitted at the discretion of the Investigator.
* Dermatologic conditions that could affect local solicited AR assessments (tattoos, psoriatic patches or vitiligo affecting skin over the deltoid injection site area).
* Has received systemic immunosuppressants (for glucocorticoids ≥ 10 mg/day of prednisone or equivalent) for \> 14 days in total within 180 days before vaccination visit (D1) or is anticipating the need for systemic immunosuppressive treatment at any time during participation in the study (including intra-articular steroid injections). Inhaled, nasal, and topical steroids are allowed.
* Has received systemic immunoglobulins or long-acting biological therapies that may suppress or alter immune responses (for example, Infliximab®) or blood products within 90 days before the vaccination visit or plans to receive them during the study.
* Has a history of anaphylaxis or severe hypersensitivity reaction after receipt of any mRNA or influenza vaccines or any components of the mRNA or influenza vaccines, including egg protein.

Other protocol-defined inclusion/exclusion criteria apply.

Where this trial is running

Saint Louis, Missouri

• Washington University in St. Louis — Saint Louis, Missouri, United States (RECRUITING)

Study contacts

• Study coordinator: Moderna WeCare Team

Conditions: Influenza, mRNA-1010, Influenza Vaccine, Moderna