The Immunology and Safety of Maternal RSV Vaccination (ABRYSVO), Infant Nirsevimab (BEYFORTUS) Immunization, or Both Products
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
2 other identifiers
interventional
181
1 country
8
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Sep 2024
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 9, 2024
CompletedFirst Posted
Study publicly available on registry
August 13, 2024
CompletedStudy Start
First participant enrolled
September 19, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 31, 2026
May 1, 2026
January 30, 2026
1.7 years
August 9, 2024
April 30, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Geometric mean titer (GMT) of serum RSV A and B neutralizing antibodies in infants
GMT of RSV A and B neutralizing antibodies in infant serum at Day 1, 43, 91, 181, and 366. Day 1 infant specimen represents infant cord blood or serum (if unable to collect cord blood). Mother-infant pairs will be randomized 1:1 to either Day 43 or Day 91 blood collection.
Through Day 366
Secondary Outcomes (12)
Frequency and relatedness of serious adverse events (SAEs) in each study arm (infants only)
Through Day 181
Frequency and severity of unsolicited Grade 3 or higher related adverse events (AEs)
Through 30 days following each nirsevimab dose
Frequency and severity of medically attended adverse events (MAAEs)
Through 30 days following each nirsevimab dose
Geometric mean titer (GMT) of RSV A and B neutralizing antibodies in cord blood
Day 1
Geometric mean titer (GMT) of RSV pre-F binding IgG antibodies in cord blood
Day 1
- +7 more secondary outcomes
Study Arms (4)
Group 1A
EXPERIMENTALMother 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.
Group 1B
EXPERIMENTALMother 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 birth. N= 50.
Group 1C
EXPERIMENTALMother 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 2
EXPERIMENTALMother 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.
Interventions
Eligibility Criteria
You may qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (8)
Emory University School of Medicine
Atlanta, Georgia, 30322-1014, United States
University of Maryland, School of Medicine, Center for Vaccine Development and Global Health
Baltimore, Maryland, 21201-1509, United States
New York University School of Medicine - Langone Medical Center - Vaccine Center
New York, New York, 10016-6402, United States
University of Rochester Medical Center - Vaccine Research Unit
Rochester, New York, 14611-3201, United States
Cincinnati Children's Hospital Medical Center Vaccine Research Center
Cincinnati, Ohio, 45229-3039, United States
University of Pittsburgh - Medicine - Infectious Diseases
Pittsburgh, Pennsylvania, 15213-3108, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37212, United States
Baylor College of Medicine
Houston, Texas, 77030-3411, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 9, 2024
First Posted
August 13, 2024
Study Start
September 19, 2024
Primary Completion (Estimated)
May 31, 2026
Study Completion (Estimated)
May 31, 2026
Last Updated
May 1, 2026
Record last verified: 2026-01-30