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

Description

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.

Conditions

Respiratory Syncytial Virus Infection

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Study Overview

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Study Details

Study overview

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.

A Prospective, Randomized, Open-label Phase 4 Study of the Immunology and Safety of Maternal RSV Vaccination (ABRYSVO (TM)), Infant Nirsevimab (BEYFORTUS (TM)) Immunization, or Both Products During the First Year of Life

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

Condition
Respiratory Syncytial Virus Infection
Intervention / Treatment

-

Contacts and Locations

Atlanta

Emory University School of Medicine, Atlanta, Georgia, United States, 30322-1014

Baltimore

University of Maryland, School of Medicine, Center for Vaccine Development and Global Health, Baltimore, Maryland, United States, 21201-1509

New York

New York University School of Medicine - Langone Medical Center - Vaccine Center, New York, New York, United States, 10016-6402

Rochester

University of Rochester Medical Center - Vaccine Research Unit, Rochester, New York, United States, 14611-3201

Cincinnati

Cincinnati Children's Hospital Medical Center Vaccine Research Center, Cincinnati, Ohio, United States, 45229-3039

Pittsburgh

University of Pittsburgh - Medicine - Infectious Diseases, Pittsburgh, Pennsylvania, United States, 15213-3108

Nashville

Vanderbilt University Medical Center, Nashville, Tennessee, United States, 37212

Houston

Baylor College of Medicine, Houston, Texas, United States, 77030-3411

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. 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
  • 2. Understands and agrees to comply with all study procedures
  • 3. Willing and able to provide consent for study participation for themselves and their infant prior to initiation of any study procedures
  • 4. 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.
  • 5. Intention to deliver at a hospital or birthing facility where study procedures can be performed
  • 6. 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)
  • 1. 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
  • 2. 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
  • 3. Maternal bleeding diathesis, or any condition which may contraindicate intramuscular injection
  • 4. Maternal known or suspected congenital or acquired disease that impairs the immune system, including functional asplenia or immunosuppression due to underlying illness or treatment
  • 5. 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)
  • 6. Maternal conditions known to impair transplacental transfer of maternal antibodies (e.g., placental pathology, hypergammaglobulinemia, HIV)
  • 7. Maternal history of GBS or other potentially immune-mediated medical condition (PIMMC)
  • 8. Maternal history of severe adverse reaction or anaphylaxis to ABRYSVO or its components
  • 9. Maternal history of preterm birth (\<34 weeks GA)
  • 10. Current pregnancy complicated by uncontrolled hypertension, pre-eclampsia, or eclampsia
  • 11. Previous receipt of ABRYSVO or other approved or investigational RSV vaccine

Ages Eligible for Study

18 Years to 45 Years

Sexes Eligible for Study

FEMALE

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

National Institute of Allergy and Infectious Diseases (NIAID),

Study Record Dates

2025-11-15