Safety and immunogenicity of pre-exposure prophylaxis of approved freeze-dried rabies vaccine(Vero cell) for human use in adults ≥18 years of age / 中国生物制品学杂志

ABSTRACT

@#Objective To evaluate the safety and immunogenicity of pre-exposure prophylaxis of the approved freeze-dried rabies vaccine(Vero cell)(rabies vaccine in brief)for human use in adults ≥18 years of age.Methods Participants aged ≥18 years in Guizhou and Shanxi provinces from June 2022 to September 2022 were enrolled,vaccinated with 1 dose of rabies vaccine at 0,7,28 d respectively,and collected for 5. 0 mL of venous blood before the first dose and 14 d after the third dose. Immunofluorescence foci assay was used to detect rabies virus neutralizing antibodies,and adverse events were collected 0～7 d after each dose of vaccine.Results A total of 120 participants were enrolled,120 participants received the first dose of rabies vaccine,119 participants received the second dose and 118 participants received the third dose.Before the first dose of rabies vaccine,the seropositive rate of antibody was 2. 54% and the geometric mean concentration(GMC)was 0. 40 IU/mL. After the third dose of rabies vaccine,the seropositive rate and seroconversion rate were 100%,the GMC was 9. 68 IU/mL,and the geometric mean increase(GMI)was 23. 99. The incidence of adverse events 0～7 d after the first,second and third doses of rabies vaccine were 22. 50%,13. 45% and 4. 24%,respectively. The local adverse events were mainly pain,and the systemic adverse events were mainly fever,fatigue/weakness,dizziness,joint pain,and diarrhea.Conclusion Approved rabies vaccine showed good safety and immunogenicity in pre-exposure prophylaxis of people ≥ 18 years old.