Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06551506
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-09
Brief Title:
The Immunology and Safety of Maternal RSV Vaccination ABRYSVO Infant Nirsevimab BEYFORTUS Immunization or Both Products
Sponsor:
None
Organization:
None
Study Overview
Official Title:
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
Status:
RECRUITING
Status Verified Date:
2024-07-17
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Detailed Description:
RSV is the leading cause of LRTIs in infants and young children It is also a leading cause of mortality in children 5 years of age worldwide Until recently no FDA-approved vaccines were available to prevent RSV infection in infants Only the monoclonal antibody palivizumab was available to high-risk infants 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 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 BEYFORTUS AstraZeneca administered to infants at birth or at the start of the first RSV season Both products were evaluated in Phase 3 pivotal clinical trials and were found to have high efficacy in the prevention of RSV LRTD in infants However the magnitude and durability of antibody responses following administration of the products have not been directly compared This is important because although there are no well-established correlates of protection against RSV serum antibodies have been associated with protection across multiple studies
Furthermore the added benefit of administering both products to an infant has not been characterized While cost-effectiveness analyses have demonstrated that administration of both products to the same mother-infant dyad is not cost-effective or indicated it is likely that some infants may receive both products inadvertently and still others may benefit from both These include infants born to women who may not have mounted an adequate antibody response to vaccination eg due to immunocompromise prematurity or insufficient time from vaccination to delivery or who may have had impaired antibody transfer across the placenta eg due to placental pathology It also includes high-risk infants eg with prematurity or chronic lung disease who may benefit from an interval dose of nirsevimab for protection in the setting of waning antibodies and off-season RSV circulation Thus understanding the safety and serology of administration of both products vs either product alone is of clinical and public health importance These knowledge gaps underlie the objectives for this study
Furthermore the added benefit of administering both products to an infant has not been characterized While cost-effectiveness analyses have demonstrated that administration of both products to the same mother-infant dyad is not cost-effective or indicated it is likely that some infants may receive both products inadvertently and still others may benefit from both These include infants born to women who may not have mounted an adequate antibody response to vaccination eg due to immunocompromise prematurity or insufficient time from vaccination to delivery or who may have had impaired antibody transfer across the placenta eg due to placental pathology It also includes high-risk infants eg with prematurity or chronic lung disease who may benefit from an interval dose of nirsevimab for protection in the setting of waning antibodies and off-season RSV circulation Thus understanding the safety and serology of administration of both products vs either product alone is of clinical and public health importance These knowledge gaps underlie the objectives for this study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None