Randomized Controlled Trial of the Immunogenicity and Safety of a Serum-Free Purified Vero Rabies Vaccine (PVRV-NG2) Using a Simulated Postexposure Zagreb Regimen With Human Rabies Immunoglobulin in Adults in Thailand.

ABSTRACT:

Background

A serum-free, highly purified Vero rabies vaccine-next generation (PVRV-NG2) is under development. We conducted a phase III trial to describe the safety and immunogenicity profile of PVRV-NG2 compared with those of licensed purified Vero rabies vaccine (PVRV) in a simulated rabies postexposure prophylaxis (PEP) Zagreb regimen in Thailand.

Methods

Healthy adults aged ≥18 years (n = 201) were randomized in a 2:1 ratio to receive PVRV-NG2 or PVRV in a rabies PEP Zagreb (days 0, 7, 21 [2-1-1]) regimen, with concomitant human rabies immunoglobulin (HRIG) at day 0. Immunogenicity end points included the proportion of participants with rabies virus-neutralizing antibody (RVNA) titers ≥0.5 IU/mL at days 0, 14, and 35. Safety outcomes were also assessed.

Results

A t

SUBMITTER: Chansinghakul D 

PROVIDER: S-EPMC11561577 | biostudies-literature | 2024 Nov

REPOSITORIES: biostudies-literature