Safety and immunogenicity of an inactivated vero cell-based rabies vaccine (Rabivax-S) in pre-exposure prophylaxis schedule in Vietnam

• DOI: 10.7774/cevr.2025.14.e9
• Publication Date: 2025-01-31T10:46:26Z
• Authors: Pham Ngoc Hung; Le Thi Huong Giang; Nguyen Thi Anh; Bui Dang The Anh; Dinh Cong Pho; Pham Van Hung
• Keywords: Vero cell; Rabies vaccine; Post-exposure prophylaxis

We evaluated the immunogenicity and safety of Rabivax-S (Pitman-Moore 3218 strain) by intramuscular (IM) intradermal (ID) routes in Vietnam. conducted an open-label, randomized, phase 4, single-center clinical trial healthy individuals aged five to 60 years divided into two groups according age (5-15 old 16-60 old). They were randomized receive 3 doses IM 1 mL) or ID (0.1 1:1 ratio on days 0, 7, 21. Adverse events (AEs) collected for 7 after each dose rabies-neutralizing antibody levels measured RFFIT 21 42. Totally 220 participants 5-15 (117 participants) (103 participants). The seroconversion rates antibodies among (IM doses) all 100.0% D21 D42/42. On D42/42, geometric mean concentration was much higher than immune protection level 0.5 IU/mL. There no AEs serious recorded four visits. Unsolicited reported 3% participants. most common during seven fever, pain, erythema. Mostly mild local systemic across resolved without sequelae. study results conclusively demonstrate that complete regimen both 3-dose series found be clinically safe immunogenic. After this study, is now available Vietnam can used pre- post-exposure prophylaxis. ClinicalTrials.gov Identifier: NCT05937113.