What side effects are associated with this type of intervention?

Common treatments for Respiratory Syncytial Virus (RSV) that aim to induce an immune response, such as vaccines, generally have side effects that include mild to moderate reactions at the injection site, fever, and irritability. In the study of the RSVpreF vaccine, participants are monitored for safety and immune activity, with blood samples collected for testing. Severe side effects are rare but can include allergic reactions. Other treatments, like aerosolized immunoglobulin, have shown some severe side effects in intubated infants, such as increased oxygen requirements and pneumothorax. Overall, while most side effects are manageable, close monitoring is essential.

What prior FDA approvals exist?

The FDA has approved several treatments for Respiratory Syncytial Virus (RSV), primarily focusing on immunoprophylaxis. Palivizumab, a monoclonal antibody, is one such treatment that has been approved to prevent severe RSV infection in high-risk infants and young children. Unlike vaccines, which induce an immune response, palivizumab provides passive immunity by directly supplying antibodies against RSV. Currently, there are no FDA-approved vaccines for RSV, but ongoing research, including the RSVpreF vaccine trial, aims to develop effective vaccines to induce active immunity against the virus.

What other types of research exist?

Promising alternatives to RSVpreF for RSV treatment in 2024 include: 1) Nirsevimab, a monoclonal antibody designed to provide passive immunity against RSV, particularly in infants. 2) mRNA-based RSV vaccines, which are being developed by several pharmaceutical companies and have shown potential in early clinical trials. 3) Antiviral drugs like RSV fusion inhibitors, which are in various stages of clinical development and aim to prevent the virus from entering host cells.

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Virus Therapy

RSV Vaccine for Respiratory Syncytial Virus (PICASSO Trial)

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

Vaccines like RSVpreF work by exposing the immune system to a form of the Respiratory Syncytial Virus (RSV) or its components, which helps the body recognize and remember the virus. This enables the immune system to respond more quickly and effectively if exposed to the actual virus, preventing severe respiratory illness, reducing hospitalizations, and limiting the spread of RSV. This approach is particularly important for protecting vulnerable populations such as young children.

Phase 1

Waitlist Available

Research Sponsored by Pfizer

Eligibility Criteria Checklist

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

Must have

Participants 2 to <18 years of age at enrollment

Be younger than 18 years old

Must not have

Individuals with a history of epilepsy or other seizure disorders, or a history of seizures and/or other neurological complications following vaccination

Receipt of investigational or approved monoclonal antibodies against RSV within 6 months before study intervention administration, or planned receipt throughout the study

Timeline

Screening 3 weeks

Treatment Varies

Follow Up throughout the study duration (approximately 6 months)

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new vaccine called RSVpreF in children aged 2 to under 18 years. The goal is to find a safe and effective dose that helps their immune system fight off the RSV virus. Participants will receive one injection and have several follow-up visits over a period of time.

Who is the study for?

Children aged 2 to <18 years at high risk of RSV disease can join this trial. They may have conditions like cystic fibrosis, asthma, lung issues, Down syndrome, neuromuscular diseases, cerebral palsy or congenital heart disease. For Phase 1 only: kids 2 to <5 must show prior RSV exposure. Parents/guardians must consent and help with study procedures.

What is being tested?

The trial is testing a vaccine called RSVpreF for safety and immune response in two phases. Phase 1 determines the dose for later stages; all get one shot of the vaccine. In Phases 2/3, participants are randomly given either the vaccine or a placebo without knowing which they received.

What are the potential side effects?

Specific side effects aren't listed but generally could include reactions at the injection site, fever, fatigue or allergic responses. Blood tests will monitor health changes post-vaccination.

Eligibility Criteria

Inclusion Criteria

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

Select...

I am between 2 and 17 years old.

Exclusion Criteria

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

Select...

I have a history of epilepsy, seizures, or neurological issues after vaccination.

Select...

I haven't received any RSV monoclonal antibodies in the last 6 months.

Select...

I haven't received any blood products or immunoglobulins in the last 28 days and don't plan to during the study.

Select...

I haven't taken strong immune system suppressing drugs or had radiation in the last 60 days.

Select...

I have not been in any drug studies in the last 28 days.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ throughout the study duration (approximately 6 months)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~throughout the study duration (approximately 6 months)

This trial's timeline: 3 weeks for screening, Varies for treatment, and throughout the study duration (approximately 6 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

Primary Safety - The proportion of participants reporting Adverse Events (AEs)

Primary Safety - The proportion of participants reporting Newly Diagnosed Chronic Medical Conditions (NDCMCs)

Primary Safety - The proportion of participants reporting Serious Adverse Events (SAEs)

+2 more

Secondary study objectives

Secondary Immunogenicity - GMFR of NTs for RSV A and RSV B

Secondary Immunogenicity - GMT of NTs for RSV A and RSV B

Secondary Immunogenicity - Median frequencies of RSV F antigen-specific CD4+ T cells expressing IFN gamma

+1 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

6Treatment groups

Experimental Treatment

Group I: standard dose in 5 to <18 years olds, healthyExperimental Treatment1 Intervention

standard dose (120 µg)

Group II: standard dose in 5 to < 18 years olds, with chronic high risk conditionsExperimental Treatment1 Intervention

standard dose (120 µg)

Group III: standard dose in 2 to < 5 years oldsExperimental Treatment1 Intervention

standard dose (120 µg)

Group IV: low dose in 5 to <18 years olds, with chronic high risk conditionsExperimental Treatment1 Intervention

low dose (60 µg)

Group V: low dose in 5 to <18 years olds, healthyExperimental Treatment1 Intervention

low dose (60 µg)

Group VI: low dose in 2 to < 5 years oldsExperimental Treatment1 Intervention

low dose (60 µg)

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

RSVpreF 120 µg

2023

Completed Phase 1

~130

RSVpreF 60 µg

2023

Completed Phase 1

~130

0 / 6Eligibility 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

Vaccines like RSVpreF work by exposing the immune system to a form of the Respiratory Syncytial Virus (RSV) or its components, which helps the body recognize and remember the virus. This enables the immune system to respond more quickly and effectively if exposed to the actual virus, preventing severe respiratory illness, reducing hospitalizations, and limiting the spread of RSV. This approach is particularly important for protecting vulnerable populations such as young children.