Safety/Efficacy Evaluation of Live Influenza Vaccine in Patients Receiving Dupilumab

JRCT ID: jRCTs031240442

Registered date:30/10/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Pediatric patient with atopic dermatitis on Dupilumab treatment
• Date of first enrollment: 30/10/2024
• Target sample size: 50
• Study type: Interventional
• Intervention(s): Intranasal live influenza vaccine is administered to eligible patients.

Outcome(s)

• Primary Outcome: Percentage of fourfold or greater increase in antibodies to all three types of vaccine-containing influenza viruses before and after vaccination

Secondary Outcome

Influenza incidence in the 25 weeks after vaccination
Systemic and local adverse events (including influenza-like symptoms) 4 weeks after vaccination

Key inclusion & exclusion criteria

• Age minimum: >= 2age old
• Age maximum: < 19age old
• Gender: Both

Include criteria

Patients who meet all of the following requirements are eligible
1) 2 years of age and older but less than 19 years of age
2) Atopic dermatitis being treated with dupilumab
3) Patients who wish to receive the live influenza vaccine.

Exclude criteria

Patients with any of the following conditions are not eligible
1) Patients in poor general health
2) Patients with gelatin allergy
3) Pregnant patients
4) Patients who have previously received Flumist
5) Patients on Flumist contraindicated drugs
6) Other than the above, patients deemed by the physician to be inappropriate to participate in the program

Related Information

• Primary Sponsor: Nagasawa Koo
• Secondary Sponsor: Ishiwada Naruhiko
• Source(s) of Monetary Support: Chiba University Hospital