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

Respiratory Syncytial Virus Infections Clinical Trial

— JUBILUS  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06042049
• Other study ID #: D5290C00009
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: July 27, 2023
• Est. completion date: April 14, 2025

Study information

• Verified date: November 2023
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 33
• Est. completion date: April 14, 2025
• Est. primary completion date: September 18, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 0 Years to 1 Year

Eligibility

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

Related Conditions & MeSH terms

• Respiratory Syncytial Virus Infections

Intervention

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.

Locations

Country	Name	City	State
Japan	Research Site	Bunkyo-ku
Japan	Research Site	Fuchu-shi
Japan	Research Site	Fukuoka-shi
Japan	Research Site	Kitakyusyu-shi
Japan	Research Site	Koto-ku
Japan	Research Site	Kurume-shi
Japan	Research Site	Nagasaki-shi
Japan	Research Site	Saitama-shi
Japan	Research Site	Yokohama-shi

Sponsors (2)

Lead Sponsor	Collaborator
AstraZeneca	Iqvia Pty Ltd

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	MA-RSV LRTI - Occurrence of MA-LRTI (inpatient and outpatient) due to RT-PCR-confirmed RSV		through 150 and 360 days post 2nd dose
Other	MA-RSV LRTI - Occurrence of hospitalizations due to RT-PCR-confirmed RSV		through 150 and 360 days post 2nd dose
Other	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
Other	Monitoring RSV Resistance to Nirsevimab - RSV novel variants will be phenotypically characterized for nirsevimab susceptibility		through 150 and 360 days post 2nd dose
Primary	Incidence of all TEAEs, TESAEs, AESIs, and NOCDs	The number and percentage of participants with TEAEs, TESAEs, AESIs, and NOCDs will be summarized by SOC and PT overall.	360 days after the 2nd or last dose administered in the study
Primary	Study discontinuations prior to Day 151 post 2nd dose.	The number and percentage of subject discontinuations will be summarized.	360 days after the 2nd or last dose administered in the study
Secondary	Pharmacokinetics (PK) - Nirsevimab serum concentrations		360 days after the 2nd or last dose administered in the study
Secondary	ADA - Occurrence of ADA to nirsevimab in serum		360 days after the 2nd or last dose administered in the study
Secondary	Anti-RSV neutralizing Ab - Anti-RSV neutralizing Ab levels (IU/mL) in serum		360 days after the 2nd or last dose administered in the study