mRNA-1345 Vaccine for Respiratory Syncytial Virus

No longer recruiting at 412 trial locations

Overseen By Moderna Clinical Trials Support Center

Age: 18+

Sex: Any

Trial Phase: Phase 2 & 3

Sponsor: ModernaTX, Inc.

Disqualifiers: Guillain-Barré, Other vaccines, others

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

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

Compensation: Varies

Number of Visits: 2

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new vaccine, mRNA-1345, to determine if it can safely and effectively prevent respiratory syncytial virus (RSV) in adults. The study aims to assess the effectiveness of a single dose in preventing the first episode of RSV-related lung issues and the safety and immune response of a booster dose given two years later. It seeks adults aged 60 and older who manage their own daily care and have stable health conditions, such as heart failure or COPD. Participants should not have received another RSV vaccine or experienced serious reactions to past vaccines. As a Phase 2/Phase 3 trial, this study evaluates the vaccine's effectiveness in a larger group and represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking prevention methods.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, it does mention restrictions on receiving other vaccines around the time of the study injection.

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

Research has shown that the mRNA-1345 vaccine for RSV is generally well-tolerated. Studies have found no major safety concerns among recipients. In one study, the vaccine reduced the rate of RSV-related lung disease without causing significant side effects. Another study found that adults accepted the vaccine well, with no safety issues reported. These findings suggest that the vaccine is likely safe for humans, as it is well-tolerated with no significant adverse events. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about the mRNA-1345 vaccine for Respiratory Syncytial Virus (RSV) because it uses cutting-edge mRNA technology, which is different from traditional vaccines that often use inactivated virus or viral proteins. This mRNA vaccine works by instructing cells to produce a protein that triggers an immune response, potentially providing robust protection against RSV. Additionally, mRNA vaccines are generally quicker to produce and can be easily updated, which is a significant advantage in responding to viral mutations. Unlike the standard options like palivizumab, which is a monoclonal antibody given monthly, mRNA-1345 aims for a more efficient, single-injection approach, simplifying prevention strategies.

What evidence suggests that the mRNA-1345 vaccine could be effective for preventing RSV-associated lower respiratory tract disease?

Research has shown that the mRNA-1345 vaccine effectively prevents respiratory syncytial virus (RSV) in older adults. One study found that a single dose of the vaccine was 83.7% effective in preventing RSV-related illness, significantly reducing the risk of infection. The vaccine also triggered strong immune responses lasting at least six months. Its safety profile is similar to other vaccines, indicating it is generally safe and well-tolerated. These findings suggest that the mRNA-1345 vaccine could be a promising method for RSV protection. Participants in this trial will receive either the mRNA-1345 vaccine or a matching placebo to further assess its effectiveness and safety. ^{3 4 5 6 7}

Are You a Good Fit for This Trial?

This trial is for adults aged 60 and older who are generally healthy, can care for themselves, and may have stable chronic conditions like heart failure or lung disease. They must not have had severe vaccine reactions before, should not be undergoing changes in medical therapy, nor have life-limiting diagnoses that could prevent them from completing the study.

Inclusion Criteria

I have a history of chronic heart failure or COPD.

I am 80 or older, can care for myself, and my chronic conditions are stable.

You do not have any immune system disorders or defects from birth.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single injection of either mRNA-1345 vaccine or placebo

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and efficacy of the vaccine

12 months

Booster Dose

Participants receive a booster dose of mRNA-1345 or placebo 24 months after the primary dose

1 day

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• mRNA-1345 Vaccine

Trial Overview The trial is testing mRNA-1345 vaccine's safety and its ability to prevent serious lung infections caused by RSV compared to a placebo. Participants will receive one dose of either the vaccine or placebo and will be monitored for up to 12 months post-injection.

How Is the Trial Designed?

Group I: mRNA-1345 BD Experimental Treatment 1 Intervention

Single injection of mRNA-1345 on BD Day 1.

Group II: mRNA-1345 Experimental Treatment 1 Intervention

Single injection of mRNA-1345 on Day 1.

Group III: Placebo Experimental Treatment 1 Intervention

Single injection of mRNA-1345 matching-placebo 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

Published Research Related to This Trial

Between 2004 and 2006, the Netherlands Pharmacovigilance Center Lareb received a total of 914 reports of possible adverse events associated with vaccinations, with most reports coming from health professionals who frequently administered vaccines.

Despite an increase in the proportion of vaccine-related adverse event reports from 1.5% to approximately 6% after 2002, the data did not provide evidence to question the safety of vaccines, indicating that adverse events are relatively rare and difficult to directly link to vaccination.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Adverse events following vaccination reported to the Netherlands Pharmacovigilance Center Lareb in 2004-2006]. Labadie, J., van Grootheest, AC.[2008]

In a survey of 2,849 individuals aged 18-49 who completed mRNA COVID-19 vaccinations, about 90% reported adverse events (AEs), with 3.3% after the first dose and 4.3% after the second dose experiencing severe AEs.

Factors associated with a higher incidence of AEs included receiving the mRNA-1273 vaccine, being female, having dermatologic diseases, and a history of serious allergic reactions or anticoagulant medication use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Nationwide Survey of mRNA COVID-19 Vaccinee's Experiences on Adverse Events and Its Associated Factors. Yoon, D., Jeon, HL., Noh, Y., et al.[2023]

The RSVpreF vaccine candidate was found to be safe and well-tolerated in older adults (ages 65-85), eliciting strong and lasting immune responses against the respiratory syncytial virus, regardless of the formulation used.

Adding the adjuvant CpG/Al(OH)3 did not enhance the immune response compared to the standard aluminum hydroxide adjuvant, and most side effects were mild, indicating that the vaccine is a promising option for protecting older adults from RSV.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Phase 1/2 Study of a Respiratory Syncytial Virus Prefusion F Vaccine With and Without Adjuvant in Healthy Older Adults. Baber, J., Arya, M., Moodley, Y., et al.[2023]

The mRNA-1345 vaccine demonstrated high efficacy, with 83.7% effectiveness in preventing RSV-associated lower respiratory tract disease with at least two symptoms, and 68.4% efficacy against RSV-associated acute respiratory disease in a study involving 35,541 older adults.

The vaccine was generally safe, with most adverse reactions being mild to moderate and transient, although there was a higher incidence of local and systemic reactions compared to the placebo group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of an mRNA-Based RSV PreF Vaccine in Older Adults. Wilson, E., Goswami, J., Baqui, AH., et al.[2023]

During the first 6 months of the US COVID-19 vaccination program, over 298 million doses of mRNA vaccines were administered, with the majority of reported adverse events being mild and short-lived, indicating a favorable safety profile.

Out of 340,522 reports to the Vaccine Adverse Event Reporting System (VAERS), 92.1% were classified as non-serious, and less than 1% of participants sought medical care after vaccination, suggesting that while reactogenicity was common, it was generally manageable.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of mRNA vaccines administered during the initial 6 months of the US COVID-19 vaccination programme: an observational study of reports to the Vaccine Adverse Event Reporting System and v-safe. Rosenblum, HG., Gee, J., Liu, R., et al.[2023]

Citations

1. 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).

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

Efficacy and Safety of an mRNA-Based RSV PreF Vaccine ... In this international, phase 2–3 trial involving adults 60 years of age or older, a single dose of the mRNA-1345 vaccine showed 83.7% efficacy ...

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

Safety, Tolerability, and Immunogenicity of mRNA-1345 in ... mRNA-1345 induced persistent immune responses through 6 months and demonstrated a safety profile consistent with the known profile of mRESVIA [11, 12].

4. 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 ...

5. medrxiv.org medrxiv.org/content/10.1101/2025.08.01.25332812v1

Cost-Effectiveness Analysis of the mRNA-1345 RSV ... Vaccination with mRNA-1345 results in 280,000 fewer hospitalizations, over 19,000 fewer deaths, and over $810 million in economic savings from ...

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, immunization with mRNA-1345 in RSV-seropositive children aged 12–59 months was immunogenic and well tolerated. Supplementary ...