The Immunology and Safety of Maternal RSV Vaccination (ABRYSVO), Infant Nirsevimab (BEYFORTUS) Immunization, or Both Products

Completed · Phase 4

Conditions studied: Respiratory Syncytial Virus Infection

In brief

Respiratory Syncytial Virus (RSV) is the leading cause of lower respiratory tract infections (LRTIs) in infants and young children. It is also a leading cause of mortality in children \<5 years of age worldwide. Until recently, no Food and Drug Administration (FDA)-approved vaccines were available to prevent RSV infection. The only prophylactic product for RSV prevention recommended for infants was the monoclonal antibody palivizumab, but administration was limited to those with extreme prematurity, chronic lung disease, or hemodynamically significant congenital heart disease. However, in 2023, the FDA approved two products designed to prevent RSV lower respiratory tract disease (LRTD) in all infants: an active RSV vaccine based on the prefusion F protein (RSVpreF, ABRYSVO, Pfizer) administered during pregnancy, and a passive, long-acting monoclonal antibody (nirsevimab-alip \[henceforth referred to as nirsevimab\], BEYFORTUS, AstraZeneca) administered to infants at birth or at the start of their first RSV season. Both products were evaluated in Phase 3 pivotal clinical trials and have high efficacy in preventing LRTD caused by RSV in infants. Although there is no established correlate of protection against RSV, antibodies have been associated with protection across multiple studies. The clinical development plan for the products did not include comprehensive evaluations of the magnitude and durability of the immune response, nor were the two products tested in a single trial. This study is a prospective, randomized, open-label Phase 4 study with the primary objective of evaluating the magnitude and durability of RSV-specific neutralizing antibodies in infants through 12 months of life following either maternal RSV vaccination, infant nirsevimab administration, or both products combined.

Key facts

Study ID

NCT06551506

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

181

Starts

2024-09-19

Expected to finish

2026-05-05

Last updated by the study team

2026-05-11

Who can join

Age: 18 and older, up to 45. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 18-45 years of age at time of enrollment with an uncomplicated singleton pregnancy who are at no known increased risk for complications per clinical judgement of the investigator
• Understands and agrees to comply with all study procedures
• Willing and able to provide consent for study participation for themselves and their infant prior to initiation of any study procedures
• In good health, as determined by the medical history and clinical judgment of the investigator Note: Healthy volunteers with pre-existing stable disease, defined as disease not requiring significant change in therapy or hospitalization for worsening disease during the 6 weeks before enrollment, can be included.
• Intention to deliver at a hospital or birthing facility where study procedures can be performed
• Eligible to receive either product per the FDA package inserts. (Maternal RSVpreF from 32 0/7 to 36 6/7 weeks gestational age (GA) from September 1 to March 31)

You may not qualify if…

• Behavioral or cognitive impairment or psychiatric disease that, in the opinion of the investigator, may interfere with the participant's ability to participate in the study
• Any condition which, in the opinion of the investigators, may pose a health risk for the participant or interfere with the evaluation of study objectives
• 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
• Maternal receipt of immunosuppressive drugs or biologic agents within 30 days prior to enrollment (This includes oral or parenteral corticosteroids. The use of inhaled/nebulized, intra-articular, intrabursal, or topical (skin, eye, ears) steroids are permitted. This does not include RhoGAM)
• Maternal conditions known to impair transplacental transfer of maternal antibodies (e.g., placental pathology, hypergammaglobulinemia, HIV)
• Maternal history of GBS or other potentially immune-mediated medical condition (PIMMC)
• Maternal history of severe adverse reaction or anaphylaxis to ABRYSVO or its components
• Maternal history of preterm birth (<34 weeks GA)
• Current pregnancy complicated by uncontrolled hypertension, pre-eclampsia, or eclampsia
• Previous receipt of ABRYSVO or other approved or investigational RSV vaccine

Where it is running

• Emory University School of Medicine — Atlanta, Georgia, United States
• University of Maryland, School of Medicine, Center for Vaccine Development and Global Health — Baltimore, Maryland, United States
• New York University School of Medicine - Langone Medical Center - Vaccine Center — New York, New York, United States
• University of Rochester Medical Center - Vaccine Research Unit — Rochester, New York, United States
• Cincinnati Children's Hospital Medical Center Vaccine Research Center — Cincinnati, Ohio, United States
• University of Pittsburgh - Medicine - Infectious Diseases — Pittsburgh, Pennsylvania, United States
• Vanderbilt University Medical Center — Nashville, Tennessee, United States
• Baylor College of Medicine — Houston, Texas, United States

Full record on ClinicalTrials.gov

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