A Randomized, Double-Blind, Positive-Controlled Phase III Clinical Trial of an Anti-Rabies Monoclonal Antibody for Category III Rabies Exposure in Individuals Under 18 Years — China, 2021–2023

Key Points

• The trial aims to assess the safety and immunogenicity of anti-rabies monoclonal antibodies for category III rabies exposure in individuals under 18 years.
• Randomized, double-blind, positive-controlled phase III trial conducted in China from 2021 to 2023.
• Participants included individuals aged <18 years with category III rabies exposure.
• The trial compared the efficacy of monoclonal antibodies in conjunction with rabies vaccines.
• Demonstrated safety and immunogenicity in the pediatric population receiving the monoclonal antibody treatment versus the control.
• Supported the potential for monoclonal antibodies to function as alternative passive immunization.
• Implications for using this treatment in category III rabies post-exposure prophylaxis for individuals under 18.