NCT03774628

Immunity Duration of Rabies Vaccine and Booster Dose Effects at 10 Years Post-primary Vaccination

Long-term Immunity of Rabies Vaccine(Human Diploid Cell)for Human Use,Freeze-dried and Booster Dose Effects at 10 Years Post-primary Vaccination

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 342 (actual)
• Sponsor: Jiangsu Province Centers for Disease Control and Prevention · Network
• Sex: All
• Age: 20 Years – 70 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Rabies

Interventions

Type	Name	Description
BIOLOGICAL	Chengdu Kanghua (one booster shot)	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
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 and 3

Timeline

• Start date: 2018-08-01
• Primary completion: 2019-02-19
• Completion: 2019-02-19
• First posted: 2018-12-13
• Last updated: 2020-12-01

Locations

1 site across 1 country: China