mRNA-1345 Vaccine for RSV

Not currently recruiting at 56 trial locations

Overseen By Moderna Clinical Trials Support Center

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: ModernaTX, Inc.

Must be taking: Immunosuppressive therapy

Must not be taking: Alemtuzumab, Rituximab, Immunosuppressants

Disqualifiers: Myocarditis, Pericarditis, Anaphylaxis, 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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new vaccine, mRNA-1345, to evaluate its safety and effectiveness in boosting the immune response against RSV, a virus that causes lung infections. Part A focuses on adults under 60 with conditions such as heart disease, chronic lung disease, or diabetes. Part B targets adults who have undergone a kidney, liver, or lung transplant and are on medication to prevent organ rejection. Individuals who can care for themselves and have one of these conditions might be suitable for the trial. As a Phase 3 trial, this is the final step before FDA approval, offering participants a chance to contribute to a potentially groundbreaking treatment.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are in Part A, you should not have been on chronic immunosuppressants or immune-modifying drugs for more than 14 days within 180 days before starting the trial. If you are in Part B, you should not have had certain treatments like alemtuzumab or rituximab within 2 years before starting the trial.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that the mRNA-1345 vaccine is generally well-tolerated by adults aged 18-59. In one study, researchers found no major safety issues, and participants did not report any serious side effects.

The most common reactions were mild, such as soreness at the injection site or temporary fatigue. The vaccine was also found to be as effective as other similar vaccines in boosting the immune system.

Notably, the FDA has already approved the mRNA-1345 vaccine for other uses, suggesting its safety. However, as it is still under study for new applications, ongoing research will continue to monitor its safety. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about the mRNA-1345 vaccine for RSV because it uses mRNA technology, a newer approach that has already shown promise in fighting other viruses like COVID-19. Unlike traditional vaccines that often use weakened or inactive parts of the virus, mRNA-1345 instructs cells to produce a protein that triggers an immune response, potentially enhancing effectiveness and safety. Additionally, this vaccine is being tested in both single and dual-dose regimens, offering flexibility that could lead to more tailored protection strategies against RSV.

What evidence suggests that this trial's treatments could be effective for RSV?

Research has shown that the mRNA-1345 vaccine could help protect adults from RSV, a virus affecting the lungs. In this trial, participants will receive different dosing regimens of the mRNA-1345 vaccine. One study found that a single dose of this vaccine reduced RSV-related lung infections in older adults. It also maintained a strong immune response for up to six months after administration, with no major safety concerns. Receiving another dose after a year continued to provide good protection. These results suggest that mRNA-1345 could effectively prevent RSV infections in high-risk adults, including those who have had organ transplants. ^{4 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for adults aged 18-59 with heart disease, chronic lung conditions, or stable diabetes on medication. It's also for those over 18 who've had an organ transplant and are on anti-rejection drugs. People can't join if they're in another study, have unstable health issues that could affect safety or results, severe allergies to the vaccine ingredients, recent use of immune-modifying drugs, a history of certain heart inflammations, or recent organ rejection.

Inclusion Criteria

You have received a lung transplant at least 6 months ago.

You have received a lung transplant at least 6 months ago.

You are currently receiving chronic immunosuppressive therapy.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Part A

Single injection of mRNA-1345 administered intramuscularly (IM) on Day 1 for high-risk adults aged ≥18 to <60 years

1 day

Treatment Part B

Two injections of mRNA-1345 administered IM on Day 1 and Day 57 for adults who received solid organ transplant (SOT)

8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• mRNA-1345

Trial Overview The trial tests mRNA-1345 vaccine's safety and immune response in two groups: high-risk adults (Part A) and adult solid organ transplant recipients (Part B). The goal is to see how well the vaccine works in these different populations who are at higher risk from respiratory syncytial virus.

How Is the Trial Designed?

Group I: Part B: mRNA-1345 Dose 2 Experimental Treatment 1 Intervention

Two injections of mRNA-1345 administered IM on Day 1 and Day 57.

Group II: Part A: mRNA-1345 Dose 2 Experimental Treatment 1 Intervention

Single injection of mRNA-1345 administered IM on Day 1.

Group III: Part A: mRNA-1345 Dose 1 Experimental Treatment 1 Intervention

Single injection of mRNA-1345 administered intramuscularly (IM) on Day 1.

mRNA-1345 is already approved in United States for the following indications:

Approved in United States as mRESVIA for:

• Prevention of lower respiratory tract disease caused by RSV infection in adults aged 60 years and older

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

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]

Vaccination with Arexvy and Abrysvo can significantly reduce the health burden of respiratory syncytial virus (RSV) in older adults, leading to fewer hospitalizations and deaths, making it a valuable intervention for this age group.

The cost-effectiveness analysis suggests that these vaccines could be economically viable, with a maximum price-per-dose of $127 for Arexvy and $118 for Abrysvo, potentially rising to $235 and $245 respectively if benefits extend into a second RSV season.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cost-effectiveness of Prefusion F Protein-based Vaccines Against Respiratory Syncytial Virus Disease for Older Adults in the United States. Moghadas, SM., Shoukat, A., Bawden, CE., et al.[2023]

The mRNA-based vaccine V172, designed to target the pre-fusion form of the RSV F glycoprotein, was found to be safe and well-tolerated in a Phase 1 clinical trial involving 112 older adults and 48 younger adults, with common side effects being mild and manageable.

V172 induced higher neutralizing antibody levels compared to a previous vaccine candidate (V171.2) and demonstrated protective effects in an animal model, suggesting it could be an effective option for preventing RSV infections in humans.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of a stabilized RSV pre-fusion F mRNA vaccine: Preclinical studies and Phase 1 clinical testing in healthy adults. Nussbaum, J., Cao, X., Railkar, RA., et al.[2023]

The investigational mRNA vaccine (mRNA-1777) targeting Respiratory Syncytial Virus (RSV) was found to be safe and well-tolerated in both younger (72 participants) and older adults (107 participants), with no serious adverse events reported.

The vaccine successfully triggered a strong immune response, indicated by increased levels of RSV neutralizing antibodies and other immune markers, suggesting its potential effectiveness in protecting against RSV infections.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A phase 1, randomized, placebo-controlled study to evaluate the safety and immunogenicity of an mRNA-based RSV prefusion F protein vaccine in healthy younger and older adults. Aliprantis, AO., Shaw, CA., Griffin, P., et al.[2021]

The Ad26.RSV.preF vaccine, tested in a phase 1/2a study with 352 adults aged 60 and older, was found to be well tolerated, showing similar side effects across different regimens.

Combining Ad26.RSV.preF with RSV preF protein significantly enhanced humoral immune responses while maintaining cellular responses, suggesting this combination could be more effective in generating immunity against RSV.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety, Immunogenicity, and Regimen Selection of Ad26.RSV.preF-based Vaccine Combinations: A Randomized, Double-blind, Placebo-Controlled, Phase 1/2a Study. Comeaux, CA., Bart, S., Bastian, AR., et al.[2023]

Advancements in understanding the RSV surface fusion glycoprotein have led to the development of various vaccine approaches, including mRNA vaccines, which are currently showing promising results in clinical trials for preventing RSV in infants and the elderly.

The mRNA-1345 vaccine has received FDA fast-track designation for adults over 60, highlighting its potential as a safe and effective preventative measure against RSV, especially following the success of mRNA technology in COVID-19 vaccines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of mRNA vaccines against respiratory syncytial virus (RSV). Qiu, X., Xu, S., Lu, Y., 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). Here, we evaluate ...

2. 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.

3. vaccineadvisor.com vaccineadvisor.com/news/revaccination-with-mrna-1345-for-rsv-maintains-robust-immunogenicity-and-safety/

Revaccination With mRNA-1345 for RSV Maintains Robust ... Revaccination with mRNA-1345 against RSV at 12 months was noninferior to primary vaccination among adults aged 50 years and older.

4. cdc.gov cdc.gov/rsv/hcp/vaccine-clinical-guidance/adults.html

RSV Vaccine Guidance for Adults Real-world effectiveness of Arexvy cannot yet be estimated during the second year following vaccination. However, clinical trial data showed durable protection ...

5. 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].

6. products.modernatx.com products.modernatx.com/mresviapro/safety

Safety Profile for mRESVIA® (Respiratory Syncytial Virus ... Evaluate the safety profile of the mRESVIA RSV vaccine, including reported local and systemic adverse reactions between mRESVIA and a placebo.

7. cdc.gov cdc.gov/vaccine-safety/vaccines/rsv.html

Respiratory Syncytial Virus (RSV) Vaccine Safety FDA licensed the Moderna RSV vaccine (mResvia) in May 2024. Because of its recent introduction, post-licensure safety data are not yet available ...

8. fda.gov fda.gov/files/vaccines%2C%20blood%20%26%20biologics/published/Package-Insert-MRESVIA_1.pdf

Package Insert - MRESVIA The safety of MRESVIA was evaluated in Study 2 (NCT06067230) in which 502 participants aged 18 through 59 years at increased risk for LRTD caused by RSV ...

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12392792/

Post-marketing safety monitoring of RSV vaccines: A real ... Owing to inadequate TTO data for mRNA-1345, this analysis focused on RSVPreF3 and RSVpreF. ... Safety surveillance of respiratory syncytial virus ...