A rabies vaccine (human diploid cell) for human use, Freeze-dried produced by Chengdu Kanghua Biological Products Co.,Ltd is used to prevent human rabies. The vaccine was completed in the Phase III clinical trial from August 2008 to February 2009 in Lianshui County, Jiangsu Province (Approval of Drug Clinical Trial No. 2008L03156). A total of 1200 subjects aged 10-60 years were randomly assigned trial group (Kanghua vaccine group, 600 participants) and control groups (Pasteur vaccine group, 600 participants). The result showed that this vaccine could provide good immunogenicity and mild adverse reactions. On April 28, 2012, the drug registration approval was obtained (Approval No. 2012S00222). To disclose the effects of booster immunization of human diploid cell rabies vaccine (HDCV) after eight years of primary vaccination. Sixty subjects who had participated the phase Ⅲ clinical trial of freeze-dried HDCV were selected and given booster immunization after eight years of primary vaccination. The result showed that the freeze-dried HDCV has good immune effects with one-dose of booster immunization after eight years of primary vaccination. In order to find a ten years of immunization persistence and booster dose immune effect, the investigators decided to perform this immunization persistence and booster immunity trial among these subjects who had received five doses of rabies vaccine vaccines (around ten years after the fundamental immunity). The investigators do the recruitment among these subjects who had participated in the previous phase Ⅲ trail and the subjects were divided into two layers, such as trial group (Kanghua vaccine group) and the control group (Paste vaccine group). Each layer of the subjects randomly received one booster dose (Day 0) and two booster doses (Day 0, 3) the freeze-dried HDCV in a ratio of 1:1.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
342
A rabies vaccine (human diploid cell) for human use, Freeze-dried produced by Chengdu Kanghua Biological Products Co.,Ltd. 1.0 ml experimental vaccine on day 0
A rabies vaccine (human diploid cell) for human use, Freeze-dried produced by Chengdu Kanghua Biological Products Co.,Ltd. 1.0 ml experimental vaccine on day 0 and 3
Lianshui Xinyi Center for Disease Control and Prevention
Huai'an, Jiangsu, China
Proportion of serum rabies virus neutralizing antibodies to protective levels 10 years after primary vaccination
calculate the proportion of serum rabies virus neutralizing antibodies to protective levels 10 years after primary vaccination
Time frame: 10 years after primary vaccination
Geometric mean concentration (GMC) of serum rabies virus neutralizing antibody 10 years after primary vaccination
calculate the geometric mean concentration (GMC) of serum rabies virus neutralizing antibody 10 years after primary vaccination
Time frame: 10 years after primary vaccination
Proportion of serum rabies virus neutralizing antibodies to protective levels
calculate the proportion of serum rabies virus neutralizing antibodies to protective levels 6 hours, 1 day, 3 days, 7 days or 14 days after booster dose injection within 10 years later
Time frame: 6 hours, 1 day, 3 days, 7 days or 14 days after booster dose injection within 10 years later
Positive seroconversion rate of serum rabies virus neutralizing antibody
calculate the positive seroconversion rate of serum rabies virus neutralizing antibody 6 hours, 1 day, 3 days, 7 days or 14 days after booster dose injection within 10 years later
Time frame: 6 hours, 1 day, 3 days, 7 days or 14 days after booster dose injection within 10 years later
Geometric mean concentration (GMC) of serum rabies virus neutralizing antibody
calculate the geometric mean concentration (GMC) of serum rabies virus neutralizing antibody 6 hours, 1 day, 3 days, 7 days or 14 days after booster dose injection within 10 years later
Time frame: 6 hours, 1 day, 3 days, 7 days or 14 days after booster dose injection within 10 years later
Mean geometric increases (GMIs) of serum rabies virus neutralizing antibody
calculate the mean geometric increases (GMIs) of serum rabies virus neutralizing antibody 6 hours, 1 day, 3 days, 7 days or 14 days after booster dose injection within 10 years later
Time frame: 6 hours, 1 day, 3 days, 7 days or 14 days after booster dose injection within 10 years later
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.