What side effects are associated with this type of intervention?

Common treatments for Respiratory Syncytial Virus (RSV) include supportive care, antiviral medications, and vaccines. For mRNA-based vaccines like mRNA-1345, which instruct cells to produce a protein to trigger an immune response, side effects are generally similar to those observed with other mRNA vaccines. These can include injection site reactions (pain, redness, swelling), systemic reactions (fever, fatigue, headache, muscle pain), and, in rare cases, more severe allergic reactions. Other treatments, such as the antiviral medication ribavirin, can cause side effects like hemolytic anemia and respiratory issues. Supportive care, including oxygen therapy and hydration, typically has minimal side effects but is essential for managing severe cases.

What prior FDA approvals exist?

As of now, there are no FDA-approved mRNA-based vaccines specifically for Respiratory Syncytial Virus (RSV). The mRNA-1345 vaccine, which is currently under investigation, represents a novel approach by using mRNA technology to instruct cells to produce a protein that triggers an immune response against RSV. Traditional treatments for RSV have included supportive care and antiviral medications like ribavirin, but these do not utilize mRNA technology. The development of mRNA vaccines for RSV is a promising area of research, building on the success of mRNA vaccines for other viruses such as COVID-19.

What other types of research exist?

Promising alternatives to mRNA-1345 for RSV in 2024 include protein subunit vaccines, vector-based vaccines, and monoclonal antibody therapies. Protein subunit vaccines use purified pieces of the virus to stimulate an immune response. Vector-based vaccines use a different virus to deliver RSV genes into cells to produce an immune response. Monoclonal antibody therapies provide passive immunity by directly supplying antibodies against RSV.

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Cancer Vaccine

mRNA-1345 Vaccine for Respiratory Syncytial Virus

Phase 2

Recruiting

Research Sponsored by ModernaTX, Inc.

Eligibility Criteria Checklist

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

Must have

Maternal participants have received local standard of antenatal care prior to enrollment and expect to continue to do so through the remainder of their pregnancy

Maternal participants will be 28 to 36 weeks pregnant at the time of vaccination (confirmed by an obstetric ultrasound report)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 1 to month 12 (12 months postdelivery)

Summary

This trial is testing a new vaccine called mRNA-1345 that aims to protect against a lung infection virus known as RSV. The study focuses on pregnant women and their newborns. The vaccine works by teaching the body to recognize and fight the virus using a small piece of genetic material. mRNA-1345 is among the most promising RSV vaccines currently being tested.

Who is the study for?

This trial is for pregnant women aged 18 to less than 40, who are between 28-36 weeks into their pregnancy. They must be able to attend all study visits and have had standard antenatal care. Infants born to these mothers can also participate with parental consent.

What is being tested?

The trial is testing mRNA-1345, a new vaccine aimed at preventing respiratory syncytial virus (RSV). Pregnant women will receive either the vaccine or a placebo to assess safety and immune response in them and their newborns.

What are the potential side effects?

Possible side effects of the mRNA-1345 vaccine may include typical reactions seen with other vaccines such as soreness at injection site, fatigue, headache, muscle pain, chills, fever, nausea.

Eligibility Criteria

Inclusion Criteria

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

Select...

I have been and plan to continue receiving standard pregnancy care.

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I am between 28 to 36 weeks pregnant, confirmed by an ultrasound.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 1 to month 12 (12 months postdelivery)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 1 to month 12 (12 months postdelivery)

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 to month 12 (12 months postdelivery) 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 Infant Participants With Birth Outcomes

Number of Maternal Participants With Pregnancy Outcomes

Trial Design

4Treatment groups

Experimental Treatment

Placebo Group

Group I: mRNA-1345 Dose CExperimental Treatment1 Intervention

Participants will be vaccinated in the period from 28 weeks to 36 weeks of gestation with a single IM injection of mRNA-1345 Dose C.

Group II: mRNA-1345 Dose BExperimental Treatment1 Intervention

Participants will be vaccinated in the period from 28 weeks to 36 weeks of gestation with a single IM injection of mRNA-1345 Dose B.

Group III: mRNA-1345 Dose AExperimental Treatment1 Intervention

Participants will be vaccinated in the period from 28 weeks to 36 weeks of gestation with a single intramuscular (IM) injection of mRNA-1345 Dose A.

Group IV: PlaceboPlacebo Group1 Intervention

Participants will receive single IM injection of mRNA-1345 vaccine matching placebo in the period from 28 weeks to 36 weeks of gestation.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

mRNA-1345

2022

Completed Phase 3

~6360

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, antiviral medications, and vaccines. mRNA-based vaccines, such as the investigational mRNA-1345, work by instructing cells to produce a protein that triggers an immune response against RSV. This mechanism is crucial because it helps the immune system recognize and fight the virus more effectively, potentially reducing the severity and duration of the infection. For RSV patients, especially vulnerable populations like infants and the elderly, this can significantly lower the risk of severe respiratory complications and improve overall outcomes.