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.

NCT ID: NCT02559921

Last Updated: 2016-01-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-12-31
• Study Completion Date: 2015-12-31

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.

Conditions

Rabies

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

rhRIG（20 IU/kg）only

Subjects received rhRIG（20 IU/kg） on day 0

Group Type: EXPERIMENTAL

rhRIG（20 IU/kg）

Intervention Type: BIOLOGICAL

rhRIG（40 IU/kg）only

Subjects received rhRIG（40 IU/kg） on day 0

Group Type: EXPERIMENTAL

rhRIG（40 IU/kg）

Intervention Type: BIOLOGICAL

HRIG（20 IU/kg）only

Subjects received HRIG（20 IU/kg）on day 0

Group Type: ACTIVE_COMPARATOR

HRIG（20 IU/kg）

Intervention Type: BIOLOGICAL

rhRIG（20 IU/kg）+ 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

Group Type: EXPERIMENTAL

rhRIG（20 IU/kg） and vaccine

Intervention Type: BIOLOGICAL

rhRIG（40 IU/kg）+ 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

Group Type: EXPERIMENTAL

rhRIG（40 IU/kg） and vaccine

Intervention Type: BIOLOGICAL

HRIG（20 IU/kg）+ 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

Group Type: EXPERIMENTAL

HRIG（20 IU/kg） and vaccine

Intervention Type: BIOLOGICAL

placebo + 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

Group Type: PLACEBO_COMPARATOR

placebo and vaccine

Intervention Type: BIOLOGICAL

Interventions

rhRIG（20 IU/kg）

Intervention Type: BIOLOGICAL

rhRIG（40 IU/kg）

Intervention Type: BIOLOGICAL

HRIG（20 IU/kg）

Intervention Type: BIOLOGICAL

rhRIG（20 IU/kg） and vaccine

Intervention Type: BIOLOGICAL

rhRIG（40 IU/kg） and vaccine

Intervention Type: BIOLOGICAL

HRIG（20 IU/kg） and vaccine

Intervention Type: BIOLOGICAL

placebo and vaccine

Intervention Type: BIOLOGICAL

Eligibility Criteria

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;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Beijing Chaoyang District Centre for Disease Control and Prevention

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

References

Li L, Li Y, Bai Y, Li G, Zhang J, Yang L, Zhao W, Zhao W, Luo F, Zhao Q, Zhang Z, Liu Y, Li S, Lu Q, Wang H, Zhang J, Zhang Y, Gao J, Shi N. Neutralizing antibody activity, safety and immunogenicity of human anti-rabies virus monoclonal antibody (Ormutivimab) in Chinese healthy adults: A phase Ⅱb randomized, double-blind, parallel-controlled study. Vaccine. 2022 Oct 6;40(42):6153-6162. doi: 10.1016/j.vaccine.2022.09.022. Epub 2022 Sep 16.

Reference Type: DERIVED

PMID: 36123259 (View on PubMed)

Zhang J, Shi N, Li G, Li L, Bai Y, Yang L, Zhao W, Gao J, Wei J, Zhao W, Zhai L, Huo P, Ren L, Yu L, Li Y. Population Pharmacodynamic Analyses of Human Anti-Rabies Virus Monoclonal Antibody (Ormutivimab) in Healthy Adult Subjects. Vaccines (Basel). 2022 Jul 29;10(8):1218. doi: 10.3390/vaccines10081218.

Reference Type: DERIVED

PMID: 36016106 (View on PubMed)

Other Identifiers

cycdc2015-3

Identifier Type: -

Identifier Source: org_study_id