Study D5290C00008 is a Phase 2, open-label, uncontrolled, single-dose study to evaluate the safety and tolerability, pharmacokinetic(s) (PK), occurrence of antidrug antibody (ADA), and efficacy of nirsevimab in immunocompromised children who are ≤ 24 months of age at the time of dose administration. Approximately 100 subjects will be enrolled. Subjects will be followed for approximately 1 year after dose administration.
Respiratory syncytial virus (RSV) is the most common cause of lower respiratory tract infection (LRTI) among infants and young children, resulting in annual epidemics in Japan. Children with congenital or acquired immunodeficiencies, transplant recipients, and those receiving immunosuppressive therapy are at increased risk for severe RSV-associated LRTI with prolonged viral shedding and higher viral loads, resulting in prolonged hospitalizations, admissions to the intensive care unit (ICU), and the need for mechanical ventilation. Palivizumab (Synagis®) is the only approved agent for RSV prophylaxis, and its half-life (t1/2) is approximately 1 month, infants and young children need to receive monthly intramuscular doses of palivizumab throughout the RSV season to maintain protection. This constitutes a significant burden on healthcare providers as well as the infants/children and their families. Nirsevimab may provide a cost-effective opportunity to protect all infants from RSV disease based on an improvement in potency and the extended t1/2 that is expected to support once-per-RSV-season dosing.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
100
Single fixed IM dose of nirsevimab 50 mg if body weight \< 5 kg or 100 mg if body weight ≥ 5 kg, and subjects entering their second RSV season will receive a single fixed IM dose of nirsevimab 200 mg
Research Site
Los Angeles, California, United States
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Serious AEs (TESAEs), AEs of Special Interest (AESIs), and New Onset Chronic Disease (NOCDs)
An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the treatment. TEAEs were AEs whose onset occurred after receiving nirsevimab and within 360 days post dose. A TESAE was any AE that resulted in death, was life-threatening, required inpatient hospitalization, resulted in persistent or significant disability/incapacity, was a congenital abnormality, or was medically significant. AESIs were defined as AEs of immediate (type I) hypersensitivity (including anaphylaxis), thrombocytopenia, and immune complex disease following the administration of nirsevimab based on investigator assessment and Medical Dictionary for Regulatory Activities (MedDRA) preferred term (PT) codes. An NOCD was a newly diagnosed medical condition of a chronic, ongoing nature post administration of treatment.
Time frame: TEAEs were collected from the first dose administration (Day 1) up to 360 days post dose
Serum Concentrations of Nirsevimab
Serum concentrations of nirsevimab at selected time points were evaluated to confirm that adequate exposures for protection from respiratory syncytial virus (RSV) lower respiratory tract infection (LRTI) are maintained for at least 5 months after dosing.
Time frame: Baseline (Day 1) and on Days 8 (for Japanese participants), 31, 151 and 361
Number of Participants With Anti-Drug Antibody (ADA) Response to Nirsevimab
Blood samples were analyzed for the presence of ADAs for nirsevimab using validated assays.
Time frame: Baseline (Day 1) and on Days 31, 151 and 361
Number of Participants With Medically Attended (MA) RSV LRTI (Inpatient and Outpatient) and Hospitalizations
Number of participants with LRTI and hospitalizations due to reverse transcriptase-polymerase chain reaction (RT-PCR)-confirmed RSV was assessed. MA RSV LRTI consisted of participants with protocol-defined LRTI, positive central RT-PCR RSV test result, Investigator assessed LRTI at an inpatient or outpatient setting. MA RSV LRTI with hospitalization consisted of participants with protocol-defined LRTI, positive central RT-PCR RSV test result, Investigator assessed LRTI at an inpatient setting.
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Research Site
Tampa, Florida, United States
Research Site
Syracuse, New York, United States
Research Site
North Charleston, South Carolina, United States
Research Site
Memphis, Tennessee, United States
Research Site
Fort Worth, Texas, United States
Research Site
Tacoma, Washington, United States
Research Site
Brussels, Belgium
Research Site
Liège, Belgium
Research Site
Bunkyō City, Japan
...and 18 more locations
Time frame: Through 150 days post dose