What side effects are associated with this type of intervention?

Common side effects of mRNA vaccines for Respiratory Syncytial Virus (RSV), such as mRNA-1365 and mRNA-1345, include local reactions at the injection site (pain, redness, and swelling) and systemic reactions (fever, fatigue, headache, muscle pain, chills, and joint pain). Rarely, severe allergic reactions may occur. These side effects are typically mild to moderate and resolve within a few days.

What prior FDA approvals exist?

As of now, there are no FDA-approved mRNA vaccines specifically for the treatment of Respiratory Syncytial Virus (RSV). Traditional treatments for RSV have included supportive care and the use of antiviral medications like ribavirin. Additionally, monoclonal antibodies such as palivizumab have been used for the prevention of severe RSV infection in high-risk infants. The mRNA vaccines mRNA-1365 and mRNA-1345, which are currently under study, represent a novel approach by instructing cells to produce viral proteins to stimulate an immune response, potentially offering a new method for preventing RSV infections.

What other types of research exist?

Promising alternatives to mRNA-1365 and mRNA-1345 for RSV treatment include: 1) RSV fusion (F) protein-based subunit vaccines, which have shown high immunogenicity in clinical trials. 2) Virus-like particle (VLP) vaccines, which mimic the structure of RSV without containing live virus, thereby eliciting a strong immune response. 3) Monoclonal antibodies, such as nirsevimab, designed to provide passive immunity by directly targeting RSV. These alternatives offer different mechanisms to stimulate the immune system and provide protection against RSV.

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mRNA Vaccine

mRNA Vaccines for RSV

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

The most common treatments for Respiratory Syncytial Virus (RSV) include supportive care, antiviral medications, and preventive measures like vaccines. mRNA vaccines, such as mRNA-1365 and mRNA-1345, work by instructing cells to produce viral proteins that stimulate the immune system to recognize and fight the virus. This mechanism is crucial for RSV patients as it helps the body build immunity without causing the disease, potentially reducing the severity and incidence of RSV infections.

Phase 1

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

In general, do you consider your child to be in good health?

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline up to month 12

Awards & highlights

Summary

This trial tests the safety and effectiveness of two vaccines for RSV and hMPV in babies and toddlers.

Who is the study for?

This trial is for children aged 5 to less than 24 months who are generally healthy and have not had recent RSV or hMPV infections. They must be born full-term with a normal birth weight, without severe allergies to vaccine components, and haven't received RSV/hMPV prophylaxis.Check my eligibility

What is being tested?

The study tests two mRNA vaccines: mRNA-1365 against both RSV and hMPV, and mRNA-1345 against only RSV. Participants will receive the vaccines or placebo over several visits, with their safety and immune response monitored.See study design

What are the potential side effects?

Possible side effects include typical reactions at the injection site like pain or swelling, fever, fatigue, headache, muscle pain, chills. Severe allergic reactions are rare but possible due to vaccine ingredients.

Eligibility Criteria

Inclusion Criteria

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

Select...

Is your child generally healthy?

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline up to month 12

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline up to month 12

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline up to month 12 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of Participants with Adverse Event of Special Interests (AESIs), Serious Adverse Events (SAEs) and Adverse Events Leading to Discontinuation

Number of Participants with Medically-Attended Adverse Events (MAAEs)

Number of Participants with Solicited Local and Systemic Adverse Reactions (ARs)

+1 more

Secondary outcome measures

Geometric Mean Fold-Rise (GMFR) Postbaseline/baseline Neutralizing Antibody Titers

Geometric Mean Titer (GMT) of Serum RSV and hMPV Neutralizing Antibodies

GeometricMean Concentration (GMC) of Serum RSV F- and hMPV F-Binding Antibodies

+1 more

Trial Design

10Treatment groups

Experimental Treatment

Placebo Group

Group I: Part C: mRNA-1345 Dose 1 (Age Group 8 to <12 months not exposed to nirsevimab)Experimental Treatment1 Intervention

Participants who have not been previously exposed to nirsevimab will receive mRNA 1345 by IM on Days 1, 57, and 113.

Group II: Part C: mRNA-1345 Dose 1 (Age Group 8 to <12 months exposed to nirsevimab)Experimental Treatment1 Intervention

Participants who have been previously exposed to nirsevimab will receive mRNA 1345 by IM on Days 1, 57, and 113.

Group III: Part B: mRNA-1365, Dose 2 (Age Group: 5 to <8 months)Experimental Treatment1 Intervention

Participants will receive mRNA-1365 by IM injection on Days 1, 57 and 113.

Group IV: Part B: mRNA-1365 Dose 1 (Age Group: 5 to <8 months)Experimental Treatment1 Intervention

Participants will receive mRNA-1365 by IM injection on Days 1, 57 and 113.

Group V: Part B: mRNA-1345, Dose 2 (Age Group: 5 to <8 months)Experimental Treatment1 Intervention

Participants will receive mRNA-1345 by IM injection on Days 1, 57 and 113.

Group VI: Part B: mRNA-1345 Dose 1 (Age Group: 5 to <8 months)Experimental Treatment1 Intervention

Participants will receive mRNA-1345 by IM injection on Days 1, 57 and 113.

Group VII: Part A: mRNA-1365, Dose 1 (Age Group: 8 to <24 months)Experimental Treatment1 Intervention

Participants will receive mRNA-1365 vaccine by IM injection on Days 1, 57 and 113.

Group VIII: Part A: mRNA-1345, Dose 1 (Age Group: 8 to <24 months)Experimental Treatment1 Intervention

Participants will receive mRNA-1345 vaccine by intramuscular (IM) injection on Days 1, 57 and 113.

Group IX: Part B: Placebo (Age Group: 5 to <8 months)Placebo Group2 Interventions

Participants will receive mRNA-1345/ mRNA-1365 vaccine matching placebo by IM injection on Days 1, 57 and 113. In countries where applicable, participants may receive Nimenrix instead of placebo on Day 113.

Group X: Part A: Placebo (Age Group: 8 to <24 months)Placebo Group2 Interventions

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

mRNA-1345

2023

Completed Phase 3

~1900

0 / 1Eligibility 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, antiviral medications, and preventive measures like vaccines. mRNA vaccines, such as mRNA-1365 and mRNA-1345, work by instructing cells to produce viral proteins that stimulate the immune system to recognize and fight the virus. This mechanism is crucial for RSV patients as it helps the body build immunity without causing the disease, potentially reducing the severity and incidence of RSV infections.