Noninferiority Study of Purified Vero Rabies Vaccine-Serum Free in 3-dose and 2-dose Preexposure Prophylaxis Regimens in Comparison With Licensed Rabies Vaccines.

ABSTRACT:

Background

A next-generation, serum-free, highly purified Vero cell rabies vaccine, PVRV-NG2, is in development.

Methods

This multicenter, observer-blind, phase 3 study evaluated the immunogenicity and safety of PVRV-NG2, compared with 2 licensed rabies vaccines (purified Vero cell rabies vaccine [PVRV] and human diploid cell vaccine [HDCV]), as a preexposure prophylaxis (PrEP) regimen. Participants were randomized 3:1:1 to PVRV-NG2, PVRV, or HDCV, as a 3-dose (cohort 1; children and adults; day [D] 0, D7, and D28) or 2-dose (cohort 2; adults; D0 and D7) PrEP regimen. The primary objective was noninferiority of PVRV-NG2 to PVRV and HDCV as 3-dose PrEP, based on the proportion of participants with rabies virus-neutralizing antibody titer ≥0.5 IU/mL at D42. Noninferiority of i

SUBMITTER: Chokephaibulkit K 

PROVIDER: S-EPMC12497947 | biostudies-literature | 2025 Oct

REPOSITORIES: biostudies-literature