Study of Rabies Vaccine Safety and Immune Response in Special Groups Including Immunocompromised, Chronic Disease Patients, and Elderly After Rabies Exposure

What this Trial Is About

Researchers are evaluating the immune response and safety of a lyophilized Vero cell-derived human rabies vaccine in special populations after exposure to rabies. The study includes groups of immunocompromised individuals, patients with chronic diseases, elderly participants, and a control group of healthy adults. The goal is to compare how well the vaccine triggers antibody production and how long antibodies last between these groups following WHO category II or III rabies exposure. Participants will receive post-exposure rabies vaccination according to either the Zagreb 2-1-1 or Essen five-dose regimen based on national guidelines. The study group includes 150 special population participants divided into immunocompromised, chronic disease, and elderly subgroups, each with 50 individuals. A control group of 30 healthy adults aged 18 to under 60 years will also be studied. Vaccination schedules and subgroup assignment are based on health conditions and age. Participants will have blood samples collected 14 and 90 days after completing their full vaccination schedule to measure rabies virus neutralizing antibody levels and seropositivity rates. Safety monitoring includes recording adverse events occurring within 30 minutes and up to 7 days after each vaccine dose through telephone follow-up. The study assesses both the immune response and safety profile of the rabies vaccine in these special and healthy populations over the course of the vaccination and follow-up period.

Clinical Study on Immunogenicity and Safety of Lyophilized Vero Cell-Derived Human Rabies Vaccine in Special Populations