Search > Human Metapneumovirus Infection
375 Participants NeededMy employer runs this trial

mRNA-1365 for Respiratory Infections

Recruiting at 9 trial locations
MW
Overseen ByModerna WeCareTeam
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: ModernaTX, Inc.
Disqualifiers: Immunodeficiency, Autoimmune conditions, RSV vaccine, others
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

The main objective of this trial is to evaluate the safety, reactogenicity, and immunogenicity of study interventions across intervention groups

Are You a Good Fit for This Trial?

This trial is for healthy older adults who do not have serious medical conditions. Participants should not have current infections or immune system problems, and must meet other health requirements set by the study team.

Inclusion Criteria

Body mass index within the range 18.5 to 35 kg/m2 inclusive
In good general health or with stable chronic medical conditions as determined by medical evaluation including medical history and physical examination

Exclusion Criteria

History of anaphylaxis or severe hypersensitivity reaction requiring medical intervention after receipt of any mRNA vaccine or therapeutic or any components of an mRNA vaccine or therapeutic
History of congenital or acquired immunodeficiency, immunosuppressive condition, asplenia, or recurrent severe infectious disease
Participants with immune-mediated (autoimmune) conditions generally excluded
See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 1 injection of mRNA-1365 or mRNA-1345 on Day 1

1 day
1 visit (in-person)

Follow-up

Participants are monitored for safety, reactogenicity, and immunogenicity after receiving the injection

4-8 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • mRNA-1365 (Profile 2)

Trial Overview

The study is testing different versions of mRNA vaccines (mRNA-1345 and mRNA-1365) designed to protect against respiratory viruses like RSV and human metapneumovirus. The main focus is on safety and how well these vaccines trigger an immune response.

How Is the Trial Designed?

5

Treatment groups

Experimental Treatment

Active Control

Group I: mRNA-1365 (Profile 2) Dose Level 3Experimental Treatment1 Intervention
Group II: mRNA-1365 (Profile 2) Dose Level 2Experimental Treatment1 Intervention
Group III: mRNA-1365 (Profile 2) Dose Level 1Experimental Treatment1 Intervention
Group IV: mRNA-1345 (Profile 1)Active Control1 Intervention
Group V: mRNA-1345 (Profile 3)Active Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

ModernaTX, Inc.

Lead Sponsor

Trials
127
Recruited
66,790,000+

Dr. Stephen Hoge

ModernaTX, Inc.

Chief Medical Officer

MD from Harvard Medical School

Stéphane Bancel profile image

Stéphane Bancel

ModernaTX, Inc.

Chief Executive Officer since 2011

MBA from Harvard Business School, MSc in Engineering from École Centrale Paris

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