What is the mechanism of action of this treatment?

The most common treatments for Respiratory Syncytial Virus (RSV) include supportive care and, in some cases, antiviral medications. However, vaccines like RSVpreF are being studied for their ability to stimulate the immune system to produce antibodies against RSV. These antibodies can neutralize the virus, preventing it from infecting cells and reducing the severity of the illness. This mechanism is crucial for RSV patients, especially those at high risk of severe disease, as it can potentially prevent complications and reduce the need for hospitalization.

What side effects are associated with this type of intervention?

Common side effects of treatments for Respiratory Syncytial Virus (RSV) that stimulate the immune system, such as vaccines like RSVpreF, include pain at the injection site, fever, and fatigue. Rare but more serious side effects can include allergic reactions and anaphylaxis. Immunotherapies may also cause systemic reactions such as fever, chills, and muscle aches, with severe immune responses being uncommon but possible.

What prior FDA approvals exist?

As of now, there are no FDA-approved vaccines specifically for Respiratory Syncytial Virus (RSV) that function by stimulating the immune system to produce antibodies against RSV, similar to the investigational RSVpreF vaccine. Current treatments for RSV primarily focus on supportive care and symptom management. Palivizumab, a monoclonal antibody, is approved for the prevention of severe RSV infection in high-risk infants and children, but it is not a vaccine and does not induce an active immune response.

What other types of research exist?

Currently, the context does not provide specific information on novel alternatives to RSVpreF for RSV treatment. However, patients should consult with their healthcare providers to explore the latest advancements in RSV vaccines and treatments that may have emerged recently.

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Virus Vaccine

RSV Vaccine for Respiratory Syncytial Virus (MONET Trial)

Phase 3

Waitlist Available

Research Sponsored by Pfizer

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up throughout the study duration (an average of 7 months)

Awards & highlights

Pivotal Trial

Summary

This trial is testing a new vaccine to see if it is safe and effective in adults who are at high risk of severe RSV illness. The study includes adults with chronic conditions and those with weakened immune systems. The vaccine helps the body make antibodies to fight the virus.

Who is the study for?

This trial is for adults at high risk of severe RSV disease, aged 18-60 with chronic health issues like lung or heart conditions, but not those who are immunocompromised. It's also for adults over 18, including those over 60 with weakened immune systems. Participants must be able to consent and commit to the study schedule.

What is being tested?

The trial tests a vaccine called RSVpreF against a placebo in one group and gives two doses of the vaccine to another group with weakened immune systems. The goal is to see how well participants' bodies produce antibodies against Respiratory Syncytial Virus after vaccination.

What are the potential side effects?

While specific side effects aren't listed here, common reactions may include pain at the injection site, fatigue, headache, muscle pain, chills, fever, nausea—typical symptoms seen with other vaccines.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ throughout the study duration (an average of 7 months)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~throughout the study duration (an average of 7 months)

This trial's timeline: 3 weeks for screening, Varies for treatment, and throughout the study duration (an average of 7 months) for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Substudy A: Primary Immunogenicity - Difference in seroresponse rate of RSV A and RSV B serum neutralizing titers at 1 month after vaccination with RSVpreF between participants in Study C3671023 and in Study C3671013

Substudy A: Primary Immunogenicity - GMT ratio, estimated by the ratio of the geometric mean titers for RSV A and RSV B serum NTs with RSVpreF in Study C3671023 participants to that in Study C3671013 adults ≥60 years of age.

Substudy A: Primary Safety - The proportion of participants reporting adverse events

+11 more

Secondary study objectives

Substudy A: Secondary Immunogenicity - Geometric mean fold rise of neutralizing titers for RSV A and RSV B

Substudy A: Secondary Immunogenicity - Geometric mean titers of neutralizing titers for RSV A and RSV B

Awards & Highlights

Pivotal Trial

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

Trial Design

3Treatment groups

Experimental Treatment

Placebo Group

Group I: Substudy B - RSVpreFExperimental Treatment1 Intervention

Participants will receive 120-µg doses of RSVpreF at Visit 1 and Visit 2 (open label, single arm only)

Group II: Substudy A - RSVpreFExperimental Treatment1 Intervention

Participants will receive a single 120-µg dose of RSVpreF at Visit 1

Group III: Substudy A - PlaceboPlacebo Group1 Intervention

Participants will receive placebo at Visit 1

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

RSVpreF

2023

Completed Phase 3

~17130

Do I qualify?Apply below to find out

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, in some cases, antiviral medications. However, vaccines like RSVpreF are being studied for their ability to stimulate the immune system to produce antibodies against RSV. These antibodies can neutralize the virus, preventing it from infecting cells and reducing the severity of the illness. This mechanism is crucial for RSV patients, especially those at high risk of severe disease, as it can potentially prevent complications and reduce the need for hospitalization.

New therapies for acute RSV infections: where are we?