Comparison of Silevimig, a Novel Bispecific Anti-Rabies Monoclonal Antibody, with Human Rabies Immunoglobulin for Post-Exposure Prophylaxis: A Phase III, Randomized, Double-Blind, Non-Inferiority Trial
Rattachement africain : cn, tw. Niveau de preuve : code pays fourni par la source.
Le résumé fourni par la source
This phase III randomized, double-blind, non-inferiority trial evaluated Silevimig, a bispecific anti-rabies monoclonal antibody targeting antigenic sites I and III, as a substitute for human rabies immunoglobulin (HRIG) in post-exposure prophylaxis. Adults (>18 years) with suspected WHO category III rabies exposure were randomly assigned (3:1) to receive Silevimig or HRIG. After wound cleansing, the study drug was administered on day 0, together with a rabies vaccine given on days 0, 3, 7, 14, and 28. The co-primary endpoints were the adjusted geometric mean concentration (GMC) of rabies virus-neutralizing antibodies (RVNAs) on day 7, the proportion of participants with an RVNA level of ≥ 0.5 IU/mL (seroresponse) by day 14, and the rabies-free survival rate in 1 year (D365). Safety was assessed through adverse events (AEs) and serious adverse events (SAEs). A total of 1,200 participants were enrolled. On day 7, the adjusted GMC of RVNAs was 0.40 IU/mL in the Silevimig group versus 0.36 IU/mL in the HRIG group, meeting the non-inferiority criterion (ratio 1.11; 95% CI: 1.01-1.21). Seroresponse rates on days 14 and 90 were slightly higher with Silevimig. No rabies cases occurred during the 1-year follow-up, yielding a 100% rabies-free survival rate in both groups. Most AEs were mild to moderate. Silevimig was non-inferior to HRIG in inducing early RVNA responses, was well tolerated, and did not interfere with vaccine-induced immunity. These findings support Silevimig as a safe and effective alternative for passive rabies post-exposure prophylaxis (ClinicalTrials, NCT05846568).
Ce résumé expose les affirmations des auteurs. BNTIC ne l’interprète pas comme une validation indépendante des résultats.
Le contrôle bibliographique ouvert
DOI retrouvé dans Crossref DOI retrouvé ; titre concordant.
- Titre Crossref
- Comparison of Silevimig, a Novel Bispecific Anti-Rabies Monoclonal Antibody, with Human Rabies Immunoglobulin for Post-Exposure Prophylaxis: A Phase III, Randomized, Double-Blind, Non-Inferiority Trial
- Date Crossref
- 21/09/2026
- Éditeur
- Oxford University Press (OUP)
- Type
- journal-article
Ce recoupement confirme des métadonnées liées au DOI. Il ne confirme ni la méthode ni les conclusions de l’étude, et il ne compte pas comme une seconde source scientifique indépendante.
Où se fait cette recherche
-
Yunnan Center for Disease Control And Prevention pays non établi dans la noticeOrganisme public
-
People’s Hospital of Wenshan Prefecture pays non établi dans la noticeÉtablissement de santé
-
Taiwan Centers for Disease Control pays non établi dans la noticeStructure de recherche
-
Vaccine Clinical Research Center pays non établi dans la noticeStructure de recherche
-
Yanshan County Center for Disease Control and Prevention pays non établi dans la noticeInstitution
-
Honghe Hani and Yi Autonomous Prefecture Mile Center for Disease Control and Prevention pays non établi dans la noticeOrganisation à but non lucratif
-
Qiubei County Center for Disease Control and Prevention pays non établi dans la noticeInstitution
-
Tengchong Center for Disease Control and Prevention pays non établi dans la noticeOrganisation à but non lucratif
-
Xiangyun County Center for Disease Control and Prevention pays non établi dans la noticeInstitution
-
Longyang District Center for Disease Control and Prevention pays non établi dans la noticeOrganisation à but non lucratif
-
Yongde County Center for Disease Control and Prevention pays non établi dans la noticeOrganisation à but non lucratif
-
Binchuan County Center for Disease Control and Prevention pays non établi dans la noticeInstitution
Yunnan Center for Disease Control And Prevention, People’s Hospital of Wenshan Prefecture et Taiwan Centers for Disease Control, avec 9 autres affiliations.
Une affiliation ne permet pas de déduire la nationalité d’un auteur.