Status:
ACTIVE_NOT_RECRUITING
The Immunology and Safety of Maternal RSV Vaccination (ABRYSVO), Infant Nirsevimab (BEYFORTUS) Immunization, or Both Products
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
Respiratory Syncytial Virus Infection
Eligibility:
FEMALE
18-45 years
Phase:
PHASE4
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...
Detailed 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...
Eligibility Criteria
Inclusion
- 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)
Exclusion
- 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
Key Trial Info
Start Date :
September 19 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 31 2026
Estimated Enrollment :
181 Patients enrolled
Trial Details
Trial ID
NCT06551506
Start Date
September 19 2024
End Date
May 31 2026
Last Update
January 9 2026
Active Locations (8)
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1
Emory University School of Medicine
Atlanta, Georgia, United States, 30322-1014
2
University of Maryland, School of Medicine, Center for Vaccine Development and Global Health
Baltimore, Maryland, United States, 21201-1509
3
New York University School of Medicine - Langone Medical Center - Vaccine Center
New York, New York, United States, 10016-6402
4
University of Rochester Medical Center - Vaccine Research Unit
Rochester, New York, United States, 14611-3201