mRNA-1345 Vaccine for Respiratory Syncytial Virus

Recruiting at 374 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

36814 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a new vaccine called mRNA-1345 to see if it can prevent lung infections caused by the RSV virus. The vaccine works by teaching the body to recognize and fight the virus. The study will include people who are at risk of these infections and will compare the effects of the vaccine to a non-treatment group.

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 the mRNA-1345 Vaccine for Respiratory Syncytial Virus safe for humans?

There is no specific safety data available for the mRNA-1345 Vaccine for Respiratory Syncytial Virus, but mRNA vaccines used for COVID-19 have been monitored for safety, showing that most side effects are mild, like soreness at the injection site or mild fever. ^{1 2 3 4 5}

How is the mRNA-1345 vaccine for RSV different from other treatments?

The mRNA-1345 vaccine is unique because it uses mRNA technology to encode a stabilized version of the RSV prefusion F glycoprotein, which is designed to trigger a strong immune response. This approach is different from traditional vaccines and is part of a new wave of mRNA-based vaccines that have shown promise in other diseases, like COVID-19. ^{6 7 8 9 10}

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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

Findings from Research

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]

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]

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]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

[Adverse events following vaccination reported to the Netherlands Pharmacovigilance Center Lareb in 2004-2006]. [2008]

2. Korea (South) pubmed.ncbi.nlm.nih.gov

A Nationwide Survey of mRNA COVID-19 Vaccinee's Experiences on Adverse Events and Its Associated Factors. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Short-term safety of live attenuated Japanese encephalitis vaccine (SA14-14-2): results of a randomized trial with 26,239 subjects. [2019]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Post-marketing surveillance of live-attenuated Japanese encephalitis vaccine safety in China. [2022]

5. United States 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. [2023]

6. United States 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. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Current concepts on active immunization against respiratory syncytial virus for infants and young children. [2019]

8. United States pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of an mRNA-Based RSV PreF Vaccine in Older Adults. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Prevention of Respiratory Syncytial Virus Infection in Healthy Adults by a Single Immunization of Ad26.RSV.preF in a Human Challenge Study. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Parainfluenza Virus 5 Expressing Wild-Type or Prefusion Respiratory Syncytial Virus (RSV) Fusion Protein Protects Mice and Cotton Rats from RSV Challenge. [2022]