NCT02559921

Safety and Immunogenicity Study of Recombinant Human Rabies Immunoglobin (rhRIG) in Combination With Rabies Vaccine for Human Use With Human Rabies Immune Globulin (HRIG) in Combination With Rabies Vaccine for Human Use in Healthy Adult Subjects.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 300 (actual)
• Sponsor: Beijing Chaoyang District Centre for Disease Control and Prevention · Academic / Other
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This study evaluates the rabies virus neutralizing antibody (RVNA) activities ,safety and tolerability of rhRIG vs. HRIG in combination with rabies vaccine for human use (Vero cells) in healthy adult subjects.The study has 7 groups.Subjects will receive rhRIG（20 IU/kg）only, rhRIG（40 IU/kg）only,HRIG（20 IU/kg）only, rhRIG（20 IU/kg）in combination with rabies vaccine for human use, rhRIG（40 IU/kg）in combination with rabies vaccine for human use,HRIG（20 IU/kg）in combination with rabies vaccine for human use,and placebo in combination with rabies vaccine for human use,respectively.

Conditions

• Rabies

Interventions

Type	Name	Description
BIOLOGICAL	rhRIG（20 IU/kg）
BIOLOGICAL	rhRIG（40 IU/kg）
BIOLOGICAL	HRIG（20 IU/kg）
BIOLOGICAL	rhRIG（20 IU/kg） and vaccine
BIOLOGICAL	rhRIG（40 IU/kg） and vaccine
BIOLOGICAL	HRIG（20 IU/kg） and vaccine
BIOLOGICAL	placebo and vaccine

Timeline

• Start date: 2014-12-01
• Primary completion: 2015-08-01
• Completion: 2015-12-01
• First posted: 2015-09-25
• Last updated: 2016-01-20