What side effects are associated with this type of intervention?

Common treatments for Respiratory Syncytial Virus (RSV) include supportive care, antiviral medications like ribavirin, and monoclonal antibodies such as palivizumab. Known side effects of these treatments can range from mild to severe and include respiratory issues, fever, rash, and gastrointestinal symptoms. For mRNA-based vaccines, which are similar to the mRNA-1345 being studied, common side effects typically include injection site reactions, fatigue, headache, muscle pain, chills, fever, and nausea. These side effects are generally mild to moderate and resolve within a few days.

What prior FDA approvals exist?

Currently, there are no FDA-approved mRNA-based vaccines specifically targeting Respiratory Syncytial Virus (RSV). Traditional treatments for RSV primarily focus on supportive care, such as oxygen therapy and hydration, and in severe cases, antiviral medications like ribavirin. The development of mRNA-1345 represents a novel approach, aiming to leverage mRNA technology to induce an immune response against RSV, similar to the mRNA vaccines developed for COVID-19.

What other types of research exist?

Promising alternatives to mRNA-1345 for RSV treatment include other vaccine candidates such as the RSV F protein nanoparticle vaccine (RSV F) and the live-attenuated RSV vaccine. Additionally, monoclonal antibodies like nirsevimab, which has shown efficacy in preventing RSV in infants, are also noteworthy. These alternatives are in various stages of clinical trials and have demonstrated potential in providing effective protection against RSV.

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Cancer Vaccine

mRNA Vaccine for Respiratory Syncytial Virus

Q: What is the mechanism of action of this treatment?

The most common treatments for Respiratory Syncytial Virus (RSV) include supportive care and, more recently, mRNA-based vaccines like mRNA-1345. mRNA vaccines work by introducing a small piece of messenger RNA (mRNA) that encodes a viral protein, in this case, a protein from RSV. When the mRNA is taken up by cells, it instructs them to produce the viral protein, which then triggers an immune response without causing disease. This immune response helps the body recognize and fight the actual virus if exposed in the future. For RSV patients, this is crucial as it provides a proactive approach to preventing severe infections, reducing the incidence and severity of the disease, and potentially lowering hospitalization rates.

Phase 2

Waitlist Available

Research Sponsored by ModernaTX, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Cohort 1: 2 to <5 years of age, at the time the informed consent is signed.

Be younger than 18 years old

Must not have

Acutely ill or febrile (temperature ≥38.0°Celsius [100.4°Fahrenheit]) within 72 hours prior to or at the Screening Visit or Day 1.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to day 29 and month 6

Summary

This trial is testing a new vaccine called mRNA-1345 to protect young children and high-risk older children from RSV. The vaccine works by teaching the immune system to recognize and fight the virus. mRNA-1345 is among the most promising RSV vaccines, leveraging the success of mRNA technology seen in COVID-19 vaccines.

Who is the study for?

This trial is for children aged 2 to less than 18 years who are at high risk of RSV disease. It includes healthy kids or those with stable chronic conditions that increase RSV risk. Girls able to have babies must test negative for pregnancy, use birth control, and not be breastfeeding.

What is being tested?

The study tests mRNA-1345, an experimental vaccine against Respiratory Syncytial Virus (RSV), compared to a placebo. The goal is to check the vaccine's safety and immune response in young participants to decide on doses for future trials.

What are the potential side effects?

While specific side effects aren't listed here, typically vaccines can cause reactions where the shot was given, fever, fatigue, headaches or muscle pain. Serious side effects are rare but will be monitored closely.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My child is between 2 and under 5 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have not been feverish or severely ill in the last 3 days.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to day 29 and month 6

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to day 29 and month 6

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to day 29 and month 6 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Number of Participants With Seroresponse in RSV Neutralizing Antibody

Trial Design

3Treatment groups

Experimental Treatment

Group I: Cohort 3 (2 to <5 Years of Age)Experimental Treatment2 Interventions

Participants 2 to \<5 years of age will receive either a single IM injection of mRNA-1345 or placebo on Day 1.

Group II: Cohort 2 (5 to <18 Years of Age)Experimental Treatment2 Interventions

Participants 5 to \<18 years of age will receive a single IM injection of mRNA-1345 on Day 1.

Group III: Cohort 1 (2 to <5 Years of Age)Experimental Treatment2 Interventions

Participants 2 to \<5 years of age will receive either a single intramuscular (IM) injection of mRNA-1345 or placebo on Day 1.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Placebo

1995

Completed Phase 3

~2670

mRNA-1345

2023

Completed Phase 3

~2560

0 / 2Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Respiratory Syncytial Virus (RSV) include supportive care and, more recently, mRNA-based vaccines like mRNA-1345. mRNA vaccines work by introducing a small piece of messenger RNA (mRNA) that encodes a viral protein, in this case, a protein from RSV. When the mRNA is taken up by cells, it instructs them to produce the viral protein, which then triggers an immune response without causing disease. This immune response helps the body recognize and fight the actual virus if exposed in the future. For RSV patients, this is crucial as it provides a proactive approach to preventing severe infections, reducing the incidence and severity of the disease, and potentially lowering hospitalization rates.

New therapies for acute RSV infections: where are we?