mRNA-1345 for Respiratory Syncytial Virus

Recruiting at 10 trial locations

Overseen By Moderna WeCare Team

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: ModernaTX, Inc.

Must not be taking: Immunoglobulins, Infliximab

Disqualifiers: Recent vaccines, Investigational RSV, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: 1 day

500 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new vaccine, mRNA-1345, to determine its safety and effectiveness for individuals who received an RSV vaccine, such as Arexvy or Abrysvo, at least a year ago. It targets those who feel generally healthy and have not experienced major changes in medical treatments or serious health events recently. Participants must provide proof of their past RSV vaccination. The trial aims to confirm that the new vaccine works well without causing serious side effects. As a Phase 3 trial, it represents the final step before FDA approval, offering participants the opportunity to contribute to a potentially groundbreaking vaccine.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, you should not have had any changes in your medical therapy due to treatment failure or toxicity within 60 days before the trial starts.

Is there any evidence suggesting that mRNA-1345 is likely to be safe for humans?

Research shows that the mRNA-1345 vaccine for Respiratory Syncytial Virus (RSV) is generally safe. Studies have found no safety concerns for adults aged 18 to 59 and have shown that it effectively increased antibody levels in children aged 12 to 59 months. Another study demonstrated that a single dose of mRNA-1345 did not cause safety issues and helped reduce RSV-related breathing problems.

Since this trial is in Phase 3, the vaccine has already undergone safety testing in earlier stages. For those considering joining this trial, current data suggests that the vaccine is generally safe to use. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for Respiratory Syncytial Virus (RSV), which often involve supportive care like oxygen therapy and hydration, mRNA-1345 uses a novel mRNA-based approach to target the virus directly. This innovative method instructs the body to produce a protein that triggers an immune response against RSV, potentially offering a more direct and effective defense. Researchers are excited about mRNA-1345 because it could not only prevent RSV infections but also reduce the severity of the disease, offering a promising new tool in the fight against a virus that affects millions each year.

What evidence suggests that mRNA-1345 might be an effective treatment for Respiratory Syncytial Virus?

Research shows that the mRNA-1345 vaccine, which participants in this trial will receive, may help prevent RSV (Respiratory Syncytial Virus) in older adults. Studies found that a single dose of this vaccine reduces cases of RSV-related lung infections. Testing has confirmed its safety, with no major safety issues. The vaccine remains effective for about 8.6 months in individuals aged 60 and older. Overall, these findings suggest that mRNA-1345 could be a good option for protecting older adults against RSV. ^{2 4 5 6 7}

Are You a Good Fit for This Trial?

This trial is for adults aged 60 or older who have previously received an RSV vaccine like Arexvy or Abrysvo at least a year ago. Participants should be medically stable with no major health issues that could interfere with the study.

Inclusion Criteria

I haven't had any serious health issues in the last 30 days.

Participants may have one or more chronic medical diagnoses, but should be medically stable as assessed by absence of changes in medical therapy within 60 days of Visit 1 due to treatment failure or toxicity

I don't have any health conditions that could stop me from completing the study.

Exclusion Criteria

Prior participation in research involving receipt of any investigational RSV product (drug/biologic)

I have not had, nor plan to have, any vaccines around the time of the study injection.

I have not received immune therapies or blood products in the last 90 days.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single dose of mRNA-1345 injection administered intramuscularly

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety, tolerability, and immunogenicity after receiving the mRNA-1345 vaccine

12 months

What Are the Treatments Tested in This Trial?

Interventions

• mRNA-1345

Trial Overview The study is testing mRNA-1345, which is a new type of vaccine designed to boost immunity against Respiratory Syncytial Virus (RSV). The focus is on its safety and how well it works in people who've had another RSV vaccine before.

How Is the Trial Designed?

Group I: mRNA-1345 Experimental Treatment 1 Intervention

Participants will receive a single dose of mRNA-1345 injection administered intramuscularly on Day 1.

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

ModernaTX, Inc.

Chief Executive Officer since 2011

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

Citations

1. nejm.org nejm.org/doi/full/10.1056/NEJMoa2307079

Efficacy and Safety of an mRNA-Based RSV PreF Vaccine ... A single dose of the mRNA-1345 vaccine resulted in no evident safety concerns and led to a lower incidence of RSV-associated lower respiratory tract disease.

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40610413/

Immune correlates analysis of mRNA-1345 RSV vaccine ... In the pivotal phase 3 trial, the mRNA-1345 vaccine demonstrated efficacy against RSV in older adults (NCT05127434).

3. academic.oup.com academic.oup.com/cid/advance-article/doi/10.1093/cid/ciaf292/8156665

Safety, Tolerability, and Immunogenicity of mRNA-1345 in ... The mRNA-1345 RSV vaccine was well tolerated, with no safety concerns identified, and demonstrated immunologic noninferiority in adults aged 18–59 years at.

4. nature.com nature.com/articles/s41467-025-61153-x

Immune correlates analysis of mRNA-1345 RSV vaccine ... These results confirmed persistent efficacy of a single dose of mRNA-1345 over a median 8.6 months follow-up in adults aged ≥60 years.

5. clinicaltrials.gov clinicaltrials.gov/study/NCT05127434

A Study to Evaluate the Safety and Efficacy of mRNA-1345 ... The main purpose of Part A of this study is to evaluate the safety and tolerability of mRNA-1345 vaccine and to demonstrate the efficacy of a single dose of ...

6. medicomart.com medicomart.com/images/document/RSV%20SDS%20sheet.pdf

Safety Data Sheet Respiratory Syncytial Virus (RSV) vaccine is an mRNA vaccine against RSV. ... No data available for mRNA-1345. For another chemically ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12439546/

Safety and immunogenicity of an mRNA-based RSV vaccine ... In conclusion, mRNA-1345 was well tolerated and boosted antibody levels in seropositive children aged 12–59 months. KEYWORDS: Respiratory ...