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.

January 19, 2016 updated by: Beijing Chaoyang District Centre for Disease Control and Prevention
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

300

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: rhRIG（20 IU/kg）only
Subjects received rhRIG（20 IU/kg） on day 0
Biological: rhRIG（20 IU/kg）
Experimental: rhRIG（40 IU/kg）only
Subjects received rhRIG（40 IU/kg） on day 0
Biological: rhRIG（40 IU/kg）
Active Comparator: HRIG（20 IU/kg）only
Subjects received HRIG（20 IU/kg）on day 0
Biological: HRIG（20 IU/kg）
Experimental: 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
Biological: rhRIG（20 IU/kg） and vaccine
Experimental: 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
Biological: rhRIG（40 IU/kg） and vaccine
Experimental: 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
Biological: HRIG（20 IU/kg） and vaccine
Placebo Comparator: 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
Biological: placebo and vaccine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Time Frame: 42 days
42 days

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing Chaoyang District Centre for Disease Control and Prevention

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2014

Primary Completion (Actual)

August 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

September 23, 2015

First Submitted That Met QC Criteria

September 24, 2015

First Posted (Estimate)

September 25, 2015

Study Record Updates

Last Update Posted (Estimate)

January 20, 2016

Last Update Submitted That Met QC Criteria

January 19, 2016

Last Verified

September 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • cycdc2015-3

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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