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.

Phase 2

Completed

• Conditions: Rabies
• Interventions: Biological: HRIG（20 IU/kg） and vaccine; Biological: rhRIG（20 IU/kg） and vaccine; Biological: rhRIG（40 IU/kg） and vaccine; Biological: rhRIG（20 IU/kg）; Biological: rhRIG（40 IU/kg）; Biological: HRIG（20 IU/kg）; Biological: placebo and vaccine

• Registration Number: NCT02559921
• Lead Sponsor: Beijing Chaoyang District Centre for Disease Control and Prevention

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-12
• Primary Completion: 2015-08
• Status Verified: 2015-09
• Study First Submitted: 2015-09-23
• Study First Submitted QC: 2015-09-24
• Study First Posted: 2015-09-25
• Study Completion: 2015-12
• Last Update Submitted: 2016-01-19
• Last Update Posted: 2016-01-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

1. Male or female subjects aged at least 18 years but not more than 55 years;
2. According to medical history, physical examination and clinical judgment of investigator at enrollment, subjects should have no significant health problems, or their health status or medication treatment remain stable;
3. Subjects and their spouses should use adequate contraceptive methods from the screening day to Day 90;
4. Male subjects must agree not to donate sperm from the first day of enrollment to Day 90;
5. Subjects should sign a written Informed Consent Form;

Exclusion Criteria

1. Previous exposure or immunization histories of rabies (rabies vaccine and/or immunoglobulin);
2. According to the clinical judgment of investigator, subjects had clinically significant acute disease or infection, including pyrexia (>37.0℃) within 2 weeks before the initial dose;
3. After review of medical history or physical examination results, it is found that subjects have medical histories of abnormalities of heart, liver, kidney, blood, digestive tract, nervous system, spirit and metabolism;
4. Subjects are pregnant or plan to become pregnant or are breast-feeding during the study;
5. According to the judgment of investigator, subjects have clinically significant immunodeficiency or medical history and/or family history of autoimmune disease;
6. According to the judgment of investigator, subjects have known or suspected clinically significant anaphylaxis or hypersensitivity reactions;
7. Immunization has been arranged for the subjects within the next 3 months after the initial dose;
8. Subjects have used immunosuppressive preparations or other immunomodulating agents for more than 14 days within 6 months before the initial dose of study drug;
9. Subjects used hormone agents within 3 days before the initial dose;
10. Subjects donated blood or lost a lot of blood within 56 days before the initial dose;
11. Subjects donated plasma within 7 days before the initial dose;
12. Subjects received transfusion of blood or blood products within 6 months before the initial dose;
13. It is suspected that subjects do not follow study procedures;
14. Intake of alcohol within 12 hours before the initial dose;
15. Subjects smoke more than 20 cigarettes a day;
16. Subjects are obviously allergic to antibiotics;
17. Any other conditions which may affect trial assessment at the discretion of the investigator;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HRIG（20 IU/kg）+ vaccine	HRIG（20 IU/kg） and vaccine	Subjects received HRIG（20 IU/kg）in combination with rabies vaccine for human use on day 0 and received vaccine only on days 3,7,14,28
rhRIG（20 IU/kg）+ vaccine	rhRIG（20 IU/kg） and vaccine	Subjects received rhRIG（20 IU/kg）in combination with rabies vaccine for human use on day 0 and received vaccine only on days 3,7,14,28
rhRIG（40 IU/kg）+ vaccine	rhRIG（40 IU/kg） and vaccine	Subjects received rhRIG（40 IU/kg）in combination with rabies vaccine for human use on day 0 and received vaccine only on days 3,7,14,28
rhRIG（20 IU/kg）only	rhRIG（20 IU/kg）	Subjects received rhRIG（20 IU/kg） on day 0
rhRIG（40 IU/kg）only	rhRIG（40 IU/kg）	Subjects received rhRIG（40 IU/kg） on day 0
HRIG（20 IU/kg）only	HRIG（20 IU/kg）	Subjects received HRIG（20 IU/kg）on day 0
placebo + vaccine	placebo and vaccine	Subjects received placebo in combination with rabies vaccine for human use on day 0 and received vaccine only on days 3,7,14,28

Primary Outcome Measures

Name	Time	Method
Evaluate the detection rate of the rabies virus neutralizing antibody (RVNA) activities of rhRIG vs. HRIG in combination with rabies vaccine for human use (Vero cells) in healthy adult subjects	42 days

Secondary Outcome Measures

Name	Time	Method
Evaluate the rate of adverse reactions of rhRIG or HRIG in combination with rabies vaccine for human use (Vero cells) in healthy subjects	42 days