What side effects are associated with this type of intervention?

The most common side effects of mRNA-based vaccines, such as those targeting RSV like mRNA-1345, typically include local reactions at the injection site (pain, redness, swelling), systemic reactions (fever, fatigue, headache, muscle pain), and, less commonly, allergic reactions. These side effects are generally mild to moderate and resolve within a few days. For other RSV treatments, side effects can vary depending on the specific medication but may include gastrointestinal symptoms, respiratory issues, and potential allergic reactions.

What prior FDA approvals exist?

As of now, there are no FDA-approved mRNA-based vaccines specifically for the treatment of Respiratory Syncytial Virus (RSV). Traditional treatments for RSV have included supportive care and the use of antiviral drugs like ribavirin. The development of mRNA vaccines, such as mRNA-1345, represents a novel approach aimed at eliciting an immune response to prevent RSV infections, similar to the successful mRNA vaccines developed for COVID-19. This ongoing research could potentially lead to new, effective preventive measures against RSV in high-risk populations.

What other types of research exist?

A promising novel alternative to mRNA-1345 for RSV patients is the live-attenuated RSV vaccine candidate lacking G protein mucin domains. This candidate has demonstrated significant attenuation and retained immunogenicity in preclinical studies, making it a viable option for consideration in 2024.

← Back to Search

Cancer Vaccine

mRNA-1345 Vaccine for RSV

Verified Trial

Phase 3

Recruiting

Research Sponsored by ModernaTX, Inc.

Eligibility Criteria Checklist

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

Must have

You are 18 years of age or older.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 1 through day 28 (28 days post injection) for part a and day 1 through day 84 (28 days post second injection) for part b

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial tests the safety and immune response of the mRNA-1345 vaccine in high-risk adults and those with organ transplants. The vaccine uses genetic instructions to help the body recognize and fight the virus.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While not specified here, typical side effects of vaccines may include pain at injection site, fatigue, headache, muscle pain, chills fever and nausea. Severe allergic reactions are rare but possible.

Eligibility Criteria

Inclusion Criteria

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 1 through day 28 (28 days post injection) for part a and day 1 through day 84 (28 days post second injection) for part b

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 1 through day 28 (28 days post injection) for part a and day 1 through day 84 (28 days post second injection) for part b

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 through day 28 (28 days post injection) for part a and day 1 through day 84 (28 days post second injection) for part b for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Number of Participants With Medically Attended AEs (MAAEs)

Number of Participants With Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs), and AEs Leading to Discontinuation

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

+3 more

Secondary study objectives

Part A: GMT of Postinjection/Baseline Titers to RSV-A and RSV-B Neutralizing Abs

Part A: GMT of Serum RSV-A and RSV-B Neutralizing Abs at Day 29

Part A: Geometric Mean Fold Rise (GMFR) of Postinjection/Baseline Titers to RSV-A and RSV-B Neutralizing Abs

+6 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

3Treatment groups

Experimental Treatment

Group I: Part B: mRNA-1345 Dose 2Experimental Treatment1 Intervention

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

Group II: Part A: mRNA-1345 Dose 2Experimental Treatment1 Intervention

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

Group III: Part A: mRNA-1345 Dose 1Experimental Treatment1 Intervention

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

mRNA-1345

2023

Completed Phase 3

~2560

0 / 7Eligibility 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 mRNA-1345 vaccine, like other mRNA-based vaccines, works by introducing a small, non-infectious piece of messenger RNA (mRNA) into the body. This mRNA encodes a protein found on the surface of the RSV virus. Once inside the body's cells, the mRNA instructs the cells to produce this viral protein, which is then recognized by the immune system as foreign. This triggers an immune response, including the production of antibodies, which prepares the immune system to recognize and fight the actual virus if the person is exposed in the future. This mechanism is significant for RSV patients as it provides a proactive approach to preventing RSV infections, which can be particularly severe in high-risk populations such as infants, the elderly, and those with compromised immune systems.

New therapies for acute RSV infections: where are we?