An interventional study of Chengdu Kanghua (one booster shot) and Chengdu Kanghua (two booster shots) in Rabies, sponsored by Jiangsu Province Centers for Disease Control and Prevention. Completed at 1 site in China. Open to participants aged 20 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-12-01.
Sponsored by Jiangsu Province Centers for Disease Control and Prevention · Not applicable, Interventional, and Prevention
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.
118 studies on the registry are indexed under Rabies; 14 are open to participants now.
This study's enrollment of 342 is above the median of 200 across 108 interventional studies indexed under Rabies.
Browse Rabies studies →Jiangsu Province Centers for Disease Control and Prevention is the lead sponsor of 75 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
one dose, A rabies vaccine (human diploid cell) for human use, Freeze-dried produced by Chengdu Kanghua Biological Products Co.,Ltd.
Biological: Chengdu Kanghua (one booster shot)
two doses at 0 and 3 days, on A rabies vaccine (human diploid cell) for human use, Freeze-dried produced by Chengdu Kanghua Biological Products Co.,Ltd.
Biological: Chengdu Kanghua (two booster shots)
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
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 study is completed, as verified in Nov 2020. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Jiangsu Province Centers for Disease Control and Prevention