ABSTRACT
OBJECTIVES: To evaluate the immunogenicity and safety of an anti-rabies monoclonal antibody (mAb), ormutivimab, compared with human rabies immunoglobulin (HRIG). METHODS: This phase III trial was designed as a randomized, double-blind, non-inferiority clinical trial in patients aged ≥18 years with suspected World Health Organization category â ¢ rabies exposure. The participants were randomized 1:1 to ormutivimab and HRIG groups. After thorough wound washing and injection of ormutivimab/HRIG on day 0, the vaccination was administered on days 0, 3, 7, 14, and 28. The primary endpoint was the adjusted geometric mean concentration (GMC) of rabies virus-neutralizing activity (RVNA) on day 7. The endpoint of safety included the occurrence of adverse reactions and serious adverse events. RESULTS: A total of 720 participants were recruited. The adjusted-GMC of RVNA (0.41 IU/ml) on day 7 in ormutivimab group was not inferior to that in the HRIG group (0.41 IU/ml), with ratio of adjusted-GMC of 1.01 (95% confidence interval: 0.91, 1.14). The seroconversion rate of the ormutivimab group was higher than that of the HRIG group on days 7, 14, and 42. Most local injection sites and systemic adverse reactions reported from both groups were mild to moderate in severity. CONCLUSION: ormutivimab + vaccine can protect victims aged ≥18 years with category â ¢ suspected rabies exposure as a component of postexposure prophylaxis. ormutivimab has a weaker influence on the immunity response of rabies vaccines. CLINICAL TRIALS REGISTRATION: ChiCTR1900021478 (the Chinese Clinical Trial Registry of World Health Organization).
Subject(s)
Rabies Vaccines , Rabies virus , Rabies , Adolescent , Adult , Humans , Antibodies, Monoclonal/administration & dosage , Antibodies, Viral , Immunologic Factors , Post-Exposure Prophylaxis , Rabies/prevention & control , Rabies Vaccines/adverse effectsABSTRACT
Post-traumatic tetanus is the main type of non-neonatal tetanus. To reduce the incidence and mortality rateof tetanus and guide the primary medical institutions to prevent and control tetanus after trauma, the National Immunization Planning Technical Working Group of the Chinese Center for Disease Control and Prevention has compiled this document in the reference with Position Paper by World Health Organization, and the latest research progress both at home and abroad. The guidelines focus on the basic procedures for the prevention and treatment of post-traumatic tetanus, the application of tetanus vaccines and immune preparation, and pre-exposure immunization in high-risk populations of trauma.
Subject(s)
Immunization, Passive , Tetanus Toxoid/administration & dosage , Tetanus/prevention & control , China , Humans , Tetanus/immunologyABSTRACT
Post-traumatic tetanus is the main type of non-neonatal tetanus. To reduce the incidence and mortality rate of tetanus and guide the primary medical institutions to prevent and control tetanus after trauma, National Immunization Planning Technical Working Group of the Chinese Center for Disease Control and Prevention has compiled this document in the reference with Position Paper by World Health Organization, the latest research progress from home and abroad. The guidelines focus on the basic procedures for the prevention and disposition of post-traumatic tetanus, the application of tetanus vaccines and immune preparation, and the pre-exposure immunization in high-risk populations of trauma.
Subject(s)
Practice Guidelines as Topic , Tetanus Toxoid/administration & dosage , Tetanus/prevention & control , Humans , Immunization , Immunization Programs , Tetanus/immunology , VaccinationABSTRACT
Post-traumatic tetanus is the main type of non-neonatal tetanus. To reduce the incidence and mortality rate of tetanus and guide the primary medical institutions to prevent and control tetanus after trauma, National Immunization Planning Technical Working Group of the Chinese Center for Disease Control and Prevention has compiled this document in the reference with Position Paper by World Health Organization, the latest research progress from home and abroad. The guidelines focus on the basic procedures for the prevention and disposition of post-traumatic tetanus, the application of tetanus vaccines and immune preparation, and the pre-exposure immunization in high-risk populations of trauma.