A Study to Assess Safety, Pharmacokinetics Anti-Drug Antibody and Anti-RSV Antibody After 2 Doses of Nirsevimab (JUBILUS)

A Phase III Single-Arm Open-Label Study to Evaluate the Safety PK ADA and Anti RSV nAb Following Administration of 2 Doses of Nirsevimab Given 5 to 6 Months Apart in Infants With CHD, CLD, Immunocompromise, Down Syndrome, or Born Pre-Term in Japan

The purpose of this study is to measure the safety, PK, occurrence of ADA to nirsevimab, and anti-RSV neutralizing Ab in Japanese children with certain health conditions or pre-term infants aged ≤12 months.

Study details include

• The study duration is approximately 21 months with a 2-month enrollment period.
• Study intervention is 2 doses administered 5- 6 months apart.
• The study has 5 or 6 site visits and several telephone contacts with a 2 or 4 week interval.

Study Overview

• Status: Completed
• Conditions: Respiratory Syncytial Virus Infections
• Intervention / Treatment: Drug: Nirsevimab

• Study Type: Interventional
• Enrollment (Actual): 33
• Phase: Phase 3

Contacts and Locations

Study Locations

• Japan
  • Bunkyō City, Japan, 113-8519
    • Research Site
  • Fuchu-shi, Japan, 183-8561
    • Research Site
  • Fukuoka, Japan, 813-0017
    • Research Site
  • Kitakyusyu-shi, Japan, 806-8501
    • Research Site
  • Kurume-shi, Japan, 830-0011
    • Research Site
  • Kōtoku, Japan, 135-8577
    • Research Site
  • Nagasaki, Japan, 852-8501
    • Research Site
  • Saitama-shi, Japan, 336-8522
    • Research Site
  • Yokohama, Japan, 232 8555
    • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Written informed consent and any locally required authorization obtained from the participant's parent(s)/legally authorized representative(s) before performing any protocol-related procedures, including screening evaluations

2. Japanese infants of ≤12 months of age eligible to receive palivizumab in accordance with national or local guidelines and those who must meet at least one of the following conditions at the time of informed consent.

   1. Immunodeficiency
   2. Chronic Lung Disease
   3. Congenital Heart Disease
   4. Down syndrome
   5. Born pre-term ≤28 wks Gestation age and aged ≤12 months, or born pre-term >28 wks and ≤35 wks Gestation age and aged ≤6 months
3. The participant's parent(s)/legally authorized representative(s) can understand and comply with the requirements of the protocol including follow-up visits as judged by the investigator.
4. The participant is available to complete the follow-up period for approximately 19 months, which will be approximately 1 year after receipt of 2nd dose of nirsevimab

Exclusion Criteria:

1. Requirement for mechanical ventilation, extracorporeal membrane oxygenation, continuous positive airway pressure (CPAP), or other mechanical respiratory or cardiac support at the time of enrollment
2. A current, active RSV infection at the time of screening and investigational product administration
3. Any fever (≥100.4°F [≥38.0°C], regardless of route) or acute illness at the time of prior to investigational product administration

4. Any serious concurrent medical condition (except those resulting in an immune deficiency condition), including:

   1. Known renal impairment
   2. Known hepatic dysfunction including known or suspected active or chronic hepatitis infection
   3. Any seizure disorder or evolving or unstable neurological condition
5. Anticipated cardiac surgery within 5-6 months after enrollment
6. Prior history of a suspected or actual acute life-threatening event
7. Receipt or intended use of palivizumab in the current enrollment season
8. Any known allergy or history of allergic reaction to any component of nirsevimab
9. Any known allergy or history of allergic reaction to immunoglobulin products, blood products, or other foreign proteins
10. Concurrent enrollment in another interventional study, or prior receipt of any investigational agent
11. Anticipated survival of less than 1 year at the time of informed consent
12. Any condition that, in the opinion of the investigator, would interfere with the evaluation of the investigational product or interpretation of study results
13. Children of employees of the Sponsor, clinical study site, or any other individuals involved with the conduct of the study, or immediate family members of such individuals

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MEDI8897; Anti-RSV monoclonal antibody	Drug: Nirsevimab; Participants in the first year of life will receive the 1st dose of nirsevimab as a single, fixed intramuscular (IM) dose of 50 mg if body weight is <5 kg or 100 mg if body weight is ≥5 kg. A 2nd fixed IM dose of 50 mg if body weight is <5 kg or 100 mg if body weight is ≥5 kg will be administered 5 to 6 months following the 1st dose.; Other Names: MEDI8897

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Treatment-emergent Adverse Events (TEAEs), Treatment-emergent Serious Adverse Events (TESAEs), Adverse Events of Special Interest (AESIs), and New-onset Chronic Diseases (NOCDs)	An AE was development of any untoward medical occurrence in a participant or clinical study participant administered medicinal product and which did not necessarily have causal relationship with this treatment. TEAEs were AEs whose onset occurred after receiving nirsevimab through 360 days post second dose. An SAE was any AE that resulted in death, was immediately life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly or birth defect or was an important medical event that might jeopardize the participant or may require medical treatment to prevent 1 of the outcomes listed above. AESIs were based on assessment by investigators following the administration of nirsevimab. An NOCD was a newly diagnosed medical condition of chronic, ongoing nature post administration of study drug.	From the first dose administration (Day 1) through 360 days post 2nd dose, study Day 511

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serum Concentrations of Nirsevimab	Serum samples were collected at specified timepoints to evaluate concentrations of nirsevimab at selected time points.	Pre-dose Day 1, pre-dose Day 151, Day 181 post first-dose, Day 301 post first-dose, and Day 511 post first-dose
Number of Participants With Anti-drug Antibody (ADA) Response to Nirsevimab	Blood samples were analyzed for the presence of ADAs for nirsevimab using an appropriately validated bioanalytical method.	Pre-dose Day 1, pre-dose Day 151, Day 181 post first-dose, Day 301 post first-dose, and Day 511 post first-dose
Serum Anti-respiratory Syncytial Virus (RSV) Neutralizing Antibody (nAb) Levels	Blood samples were collected for the determination anti-RSV nAb in serum using an appropriately validated bioanalytical method.	Pre-dose Day 1, pre-dose Day 151, Day 181 post first-dose, Day 301 post first-dose, and Day 511 post first-dose

Other Outcome Measures

Outcome Measure	Time Frame
MA-RSV LRTI - Occurrence of MA-LRTI (inpatient and outpatient) due to RT-PCR-confirmed RSV	through 150 and 360 days post 2nd dose
MA-RSV LRTI - Occurrence of hospitalizations due to RT-PCR-confirmed RSV	through 150 and 360 days post 2nd dose
Monitoring for RSV Resistance - Genotypic analysis of the F protein from collected RSV-positive respiratory secretion specimens	through 150 and 360 days post 2nd dose
Monitoring RSV Resistance to Nirsevimab - RSV novel variants will be phenotypically characterized for nirsevimab susceptibility	through 150 and 360 days post 2nd dose

Collaborators and Investigators

• Sponsor: AstraZeneca
• Collaborators: IQVIA Pty Ltd

Publications and helpful links

Helpful Links

• D5290C00009_Redacted_CSP
• D5290C00009_Redacted_SAP.
• D5290C00009_Redacted_CSR_synopsis

Study record dates

Study Major Dates

• Study Start (Actual): July 27, 2023
• Primary Completion (Actual): July 24, 2025
• Study Completion (Actual): July 24, 2025

Study Registration Dates

• First Submitted: July 13, 2023
• First Submitted That Met QC Criteria: September 11, 2023
• First Posted (Actual): September 18, 2023

Study Record Updates

• Last Update Posted (Actual): April 16, 2026
• Last Update Submitted That Met QC Criteria: March 30, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; RNA Virus Infections; Virus Diseases; Pneumovirus Infections; Paramyxoviridae Infections; Mononegavirales Infections; Respiratory Syncytial Virus Infections; nirsevimab
• Other Study ID Numbers: D5290C00009; 2025-000021-13 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal.

All request will be evaluated as per the AZ disclosure commitment:

https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

• IPD Sharing Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
• IPD Sharing Access Criteria: When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No