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Cancer Vaccine

RSV Vaccination + Immunization for Respiratory Syncytial Virus

Phase 4

Recruiting

Research Sponsored by National Institute of Allergy and Infectious Diseases (NIAID)

Eligibility Criteria Checklist

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

Must have

Eligible to receive either product per recommended guidelines at the recommended gestational age and during the recommended seasonal time period (Maternal RSVpreF from 32 0/7 to 36 6/7 weeks GA from September 1 to January)

Be between 18 and 65 years old

Must not have

Maternal bleeding diathesis, or any condition which may contraindicate intramuscular injection

Maternal known or suspected congenital or acquired disease that impairs the immune system, including functional asplenia or immunosuppression due to underlying illness or treatment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through day 366

Awards & highlights

Drug Has Already Been Approved

No Placebo-Only Group

Pivotal Trial

Summary

This trial is evaluating the effectiveness and longevity of antibodies against Respiratory Syncytial Virus (RSV) in infants up to 12 months old after receiving either a maternal RSV vaccine during pregnancy,

Who is the study for?

This trial is for healthy infants at risk of Respiratory Syncytial Virus (RSV) infection. It includes those whose mothers are vaccinated during pregnancy with ABRYSVO and infants receiving BEYFORTUS at birth or the start of RSV season. Specific eligibility criteria were not provided.

What is being tested?

The study tests the immune response in infants to either maternal vaccination with ABRYSVO, infant immunization with BEYFORTUS, or both. It's a Phase 4 trial aiming to understand how well these interventions protect against RSV over the first year of life.

What are the potential side effects?

While specific side effects are not detailed here, similar vaccines may cause reactions at injection sites, fever, irritability in infants, and mild respiratory symptoms. Side effects from monoclonal antibodies can include allergic reactions.

Eligibility Criteria

Inclusion Criteria

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

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I am eligible for the RSV vaccine between 32 and 36 weeks of pregnancy during September to January.

Exclusion Criteria

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

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I have a condition that makes bleeding more likely or can't have shots in my muscles.

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I have a condition or treatment that weakens my immune system.

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I have received an RSV vaccine before.

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I am pregnant with high blood pressure issues.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through day 366

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through day 366

This trial's timeline: 3 weeks for screening, Varies for treatment, and through day 366 for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Geometric mean titer (GMT) of serum RSV A and B neutralizing antibodies in infants

Secondary study objectives

Frequency and relatedness of serious adverse events (SAEs) in each study arm (infants only)

Frequency and severity of medically attended adverse events (MAAEs)

Frequency and severity of unsolicited Grade 3 or higher related adverse events (AEs)

+9 more

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

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

4Treatment groups

Experimental Treatment

Group I: Group 2Experimental Treatment1 Intervention

Mother does NOT receive maternal RSVpreF and infant receives one dose of nirsevimab (BEYFORTUS) 50mg/0.5mL if body weight \<5kg or 100mg/mL if body weight is \>= 5kg at birth . N= 50.

Group II: Group 1CExperimental Treatment2 Interventions

Mother receives 120 mcg/0.5ml of maternal RSVpreF (ABRYSVO) administered intramuscularly once during 32 0/7 to 36 6/7 weeks GA and infant receives one dose of nirsevimab (BEYFORTUS) 50mg/0.5mL if body weight \<5kg or 100mg/mL if body weight is \>= 5kg at 3-month . N= 50.

Group III: Group 1BExperimental Treatment2 Interventions

Group IV: Group 1AExperimental Treatment1 Intervention

Mother receives 120 mcg/0.5ml of maternal RSVpreF (ABRYSVO) administered intramuscularly once during 32 0/7 to 36 6/7 weeks GA and infant does NOT receive nirsevimab. N= 50.

0 / 5Eligibility criteria met