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Trial record 43 of 76 for:    "Rabies" | "Immunologic Factors"

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.

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ClinicalTrials.gov Identifier: NCT02559921
Recruitment Status : Completed
First Posted : September 25, 2015
Last Update Posted : January 20, 2016
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Rabies 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 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Study Start Date : December 2014
Actual Primary Completion Date : August 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rabies

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



Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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;

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Responsible Party: Beijing Chaoyang District Centre for Disease Control and Prevention
ClinicalTrials.gov Identifier: NCT02559921     History of Changes
Other Study ID Numbers: cycdc2015-3
First Posted: September 25, 2015    Key Record Dates
Last Update Posted: January 20, 2016
Last Verified: September 2015

Keywords provided by Beijing Chaoyang District Centre for Disease Control and Prevention:
Recombinant Human Rabies Immunoglobin (rhRIG)

Additional relevant MeSH terms:
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Rabies
Rhabdoviridae Infections
Mononegavirales Infections
RNA Virus Infections
Virus Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs