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NCT06551506 · ClinicalTrials.gov registry record · Phase 4
The Immunology and Safety of Maternal RSV Vaccination (ABRYSVO), Infant Nirsevimab (BEYFORTUS) Immunization, or Both Products
A Phase 4 study of Respiratory Syncytial Virus Infection, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Active
- Registry status
- Phase 4
- Development phase
- 181
- Enrollment target
- 8
- Study locations
NCT06551506: Active Phase 4 study of Respiratory Syncytial Virus Infection, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT06551506 is a Phase 4 study of Respiratory Syncytial Virus Infection that is active but no longer recruiting, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 181 participants, below the 963-participant average among 4 other Respiratory Syncytial Virus Infection trials with a reported enrollment target (81% lower). The trial reports 8 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06551506, a Phase 4 study of Respiratory Syncytial Virus Infection, is active but no longer recruiting, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- ACTIVE NOT RECRUITING
- Registry status
- Phase 4
- Development phase
- 181 participants
- Enrollment target
- 8
- Study locations
Study 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.
Primary Outcome
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.
Conditions Studied
Interventions
- BIOLOGICAL Abrysvo
- BIOLOGICAL Beyfortus
Study Locations (8)
New York
- New York University School of Medicine - Langone Medical Center - Vaccine Center - New York
- University of Rochester Medical Center - Vaccine Research Unit - Rochester
Georgia
- Emory University School of Medicine - Atlanta
Maryland
- University of Maryland, School of Medicine, Center for Vaccine Development and Global Health - Baltimore
Ohio
- Cincinnati Children's Hospital Medical Center Vaccine Research Center - Cincinnati
Pennsylvania
- University of Pittsburgh - Medicine - Infectious Diseases - Pittsburgh
Tennessee
- Vanderbilt University Medical Center - Nashville
Texas
- Baylor College of Medicine - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 181 participants |
| Start Date | 2024-09-19 |
| Est. Completion | 2026-05-31 |
| Phase | Phase 4 |
What the registry record for NCT06551506 still lists
NCT06551506 is an interventional study that assigns participants to a tested intervention. The registered 181 participants enrollment target is mid-sized for trials with a published cap, below the 963-participant average among 4 other Respiratory Syncytial Virus Infection trials with a reported enrollment target (81% lower).
The record links to 1 condition, with Respiratory Syncytial Virus Infection appearing as the primary indexed condition, and to 2 interventions - of which Abrysvo is the first listed.
NCT06551506 lists 8 locations in 7 states (New York, Georgia, Maryland).
Frequently Asked Questions
What is clinical trial NCT06551506 about?
NCT06551506 is a clinical study titled "The Immunology and Safety of Maternal RSV Vaccination (ABRYSVO), Infant Nirsevimab (BEYFORTUS) Immunization, or Both Products". 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 t...
What is the current status of trial NCT06551506?
This trial is currently active not recruiting. It is a Phase 4 study. The enrollment target is 181 participants. The study started on 2024-09-19. Estimated completion is 2026-05-31.
What conditions does trial NCT06551506 study?
This clinical trial studies the following conditions: Respiratory Syncytial Virus Infection.
What interventions are being tested in trial NCT06551506?
The interventions under investigation include: Abrysvo (BIOLOGICAL), Beyfortus (BIOLOGICAL).
Who is sponsoring clinical trial NCT06551506?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06551506 being conducted?
This trial has 8 study locations across Georgia, Maryland, New York, Ohio, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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