Int J Infect Dis. 2023 May 19:S1201-9712(23)00569-6. doi: 10.1016/j.ijid.2023.05.017. Online ahead of print.
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 3 trial was designed as a randomized, double-blind, non-inferiority clinical trial in patients aged ≥ 18 years with suspected WHO category Ⅲ rabies exposures. The participants were randomized 1:1 to Ormutivimab and HRIG group. 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 (ARs) and serious adverse events (SAEs).
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 HRIG group (0.41 IU/mL), with ratio of adjusted-GMC of 1.01 (95%CI: 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. The majority of local injection site and systemic ARs reported from both groups were mild to moderate in severity.
CONCLUSIONS: Ormutivimab + vaccine can protect aged ≥ 18 years victims with category Ⅲ suspected rabies exposure as a component of post-exposure prophylaxis. Ormutivimab has a weaker influence on immunity response of rabies vaccines.
CLINICAL TRIALS REGISTRATION: ChiCTR1900021478 (the Chinese Clinical Trial Registry of WHO).
PMID:37211270 | DOI:10.1016/j.ijid.2023.05.017
