To evaluate the immunogenicity and safety of different post-exposure prophylaxis (PEP) schedules of Sinovac rabies vaccine, in comparison with a marked rabies vaccinein china, in subjects aged 10-60 years old.
This clinical trial is designed as a randomized, blinded, homologous vaccine-controlled and non-inferiority trial, which consists of two parts. Part 1 (Pilot Study): First, 20 subjects aged 18-60 years are enrolled to receive the trial vaccine (Sinovac rabies vaccine) according to the 5-dose schedule on Days 0, 3, 7, 14 and 28. A preliminary safety assessment is conducted on Day 7 after the third dose (before the fourth dose). If the incidence of Grade 3 and above AEs does not exceed 15%, and no death or life-threatening SAE related to vaccination occurs, another 20 subjects aged 10-17 years are enrolled. A safety assessment is performed again on Day 7 after full-course vaccination. If the incidence of Grade 3 and above AEs during the entire observation period does not exceed 15%, and no death or life-threatening SAE related to vaccination occurs, the trial proceeds to Part 2. All subjects are observed for safety up to 6 months after full-course vaccination. Part 2: A total of 2,000 subjects are enrolled, and randomized at a 1:1:1:1 ratio, 500 in the 5-dose trial group, 500 in the 5-dose control group, 500 in the 4-dose trial group 1, and 500 in the 4-dose trial group 2. The subjects in the 5-dose trial group and the 5-dose control group receive one dose of the trial vaccine or control vaccine (a marketed rabies vaccine in China) on Days 0, 3, 7, 14 and 28, respectively. The subjects in the 4-dose trial group 1 receive one dose of the trial vaccine on Days 0, 3, 7 and 14; and the subjects in the 4-dose test group 2 receive one dose of the trial vaccine on Days 0, 3, 7 and 28. Blood samples were collected on Day 0, 14, 28, 42, as well as 3 and 6 months after the full-course vaccination, which was for testing serum neutralizing antibodies are detected using the Rapid Fluorescent Focus Inhibition Test (RFFIT). Solicited AEs within 0-7 days after each dose, unsolicited AEs from the first dose to 30 days after full-course vaccination, and all SAEs from the first dose to 6 months after full-course vaccination are collected.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
2,040
Rabies Vaccine (Serum-free Vero Cell), Freeze-dried using three types of PEP schedules
A markted Rabies Vaccine using 5 doses of PEP schedules
Dazhu County Center for Disease Control and Prevention
Dazhou, China
Yuechi County Center for Disease Control and Prevention
Guang’an, China
Seroconversion rate of rabies neutralizing antibodies in pre-vaccination negative subjects of each group
Time frame: Day 14 after the first dose vaccination
Seroconversion rate of serum rabies neutralizing antibody in pre-vaccination negative subjects of each group
Time frame: Day 42 after the first dose vaccination
GMC of rabies neutralizing antibodies in pre-vaccination negative subjects of each group
Time frame: Day 14 after the first dose vaccination
GMC of serum rabies neutralizing antibody in pre-vaccination negative subjects of each group
Time frame: Day 42 after the first dose vaccination
Seroconversion rate of serum rabies neutralizing antibody in pre-vaccination negative subjects of each group
Time frame: Day 28 after the first dose vaccination.
Seropositive rate of serum rabies neutralizing antibody in Months 3 and 6 post-full-course vaccination for each group
Time frame: Months 3 and 6 post-full-course vaccination
Incidence of adverse events.
Time frame: Up to 30 days after the last-dose vaccination for AEs
GMC of serum rabies neutralizing antibody in pre-vaccination negative subjects of each group
Time frame: Day 28 after the first dose vaccination.
GMC of serum rabies neutralizing antibody in Months 3 and 6 post-full-course vaccination for each group
Time frame: Months 3 and 6 post-full-course vaccination
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Incidence of serious adverse events.
Time frame: Up to 6 months after the last-dose vaccination for SAEs;