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Safety and Pharmacokinetics of Nirsevimab in Japanese Infants: Primary Analysis of the Open-Label JUBILUS Trial

Masaaki Mori1,2, Susannah Leach3, Maria Learoyd4

  • 1Department of Lifelong Immunotherapy, Institute of Science Tokyo, Tokyo, Japan.

Journal of the Pediatric Infectious Diseases Society
|March 24, 2026
PubMed

Insights

Nirsevimab is safe for Japanese infants at risk of severe RSV lower respiratory tract infections. Two doses showed no safety concerns and maintained effective serum concentrations for protection.

Area of Science:

  • Pediatrics
  • Immunology
  • Infectious Diseases

Background:

  • Respiratory Syncytial Virus (RSV) poses a significant threat to infants, particularly those at high risk for severe lower respiratory tract infections (LRTIs).
  • Nirsevimab is a monoclonal antibody developed for RSV prevention.

Purpose of the Study:

  • To evaluate the safety and immunogenicity of a two-dose nirsevimab regimen in Japanese infants at risk for severe RSV-associated LRTIs.
  • To assess serum concentrations of nirsevimab following the two-dose regimen.

Main Methods:

  • A study involving Japanese infants aged ≤12 months at risk for severe RSV-associated LRTIs.
  • Administration of two doses of nirsevimab, 5-6 months apart.
  • Monitoring for safety concerns, including the development of anti-drug antibodies.
  • Measurement of nirsevimab serum concentrations.

Main Results:

  • No safety concerns were observed in infants receiving two doses of nirsevimab.
  • No anti-drug antibodies were detected.
  • Nirsevimab serum concentrations were consistent with levels previously shown to be efficacious in healthy infants.

Conclusions:

  • A two-dose nirsevimab regimen is safe and well-tolerated in Japanese infants at risk for severe RSV-associated LRTIs.
  • The observed serum concentrations support the potential efficacy of this regimen for RSV prevention in this vulnerable population.

Keywords:
infantmonoclonal antibodynirsevimabrespiratory syncytial virus infectionsrespiratory tract infection

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