Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 28 of 75 for:    "Rabies" | "Immunologic Factors"

A Randomized Phase II Trial to Compare the Safety and Neutralizing Activity of CL184 in Combination With Rabies Vaccine vs. HRIG or Placebo in Combination With Rabies Vaccine in Healthy Adult Subjects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00656097
Recruitment Status : Completed
First Posted : April 10, 2008
Last Update Posted : September 21, 2011
Sponsor:
Information provided by (Responsible Party):
Crucell Holland BV

Brief Summary:
The aim of this study is to evaluate the safety of the monoclonal antibody cocktail CL184 in combination with rabies vaccine compared with human rabies immune globulin (HRIG) or placebo in combination with rabies vaccine in healthy adult subjects.

Condition or disease Intervention/treatment Phase
Rabies Biological: CL184 Biological: HRIG Biological: Placebo matching CL184 Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: A Randomized, Single-blind, Controlled, Monocentric Phase II Trial to Compare the Safety and Neutralizing Activity of Simulated Rabies Post-exposure Prophylaxis With CL184 in Combination With Rabies Vaccine vs. HRIG or Placebo in Combination With Rabies Vaccine in Healthy Adult Subjects
Study Start Date : March 2008
Actual Primary Completion Date : July 2008
Actual Study Completion Date : July 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rabies

Arm Intervention/treatment
Experimental: A
CL184 combined with rabies vaccination
Biological: CL184
CL184 20 IU/kg intramuscularly on Day 0; in conjunction with rabies vaccine on Days 0, 3, 7, 14, and 28

Active Comparator: B
HRIG combined with rabies vaccination
Biological: HRIG
HRIG 20 IU/kg intramuscularly on Day0; in conjunction with rabies vaccine on Days 0, 3, 7, 14, and 28

Placebo Comparator: C
Placebo combined with rabies vaccination
Biological: Placebo matching CL184
Placebo intramuscularly on Day0; in conjunction with rabies vaccine on Days 0, 3, 7, 14, and 28




Primary Outcome Measures :
  1. Safety and tolerability [ Time Frame: 42 days ]

Secondary Outcome Measures :
  1. Rabies virus neutralizing activity [ Time Frame: 42 days ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   19 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subjects free of obvious health-problems or with stable condition
  • Male or female subjects aged ≥19 to ≤65 years
  • BMI between ≥18 and ≤30 kg/m2

Exclusion Criteria:

  • Prior history of active or passive rabies immunization
  • Clinically significant acute illness or infection within 2 weeks before first dosing based on the clinical judgment of the investigator
  • History and/or family history of clinically significant immunodeficiency or auto-immune disease
  • Any clinically significant history of known or suspected anaphylaxis or hypersensitivity reaction
  • Chronic administration of immunosuppressants or other immune-modifying drugs within 6 months before the first dose of investigational medicinal product

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00656097


Locations
Layout table for location information
United States, Nebraska
MDS Pharma Services , USA
Lincoln, Nebraska, United States, 68502
Sponsors and Collaborators
Crucell Holland BV
Investigators
Layout table for investigator information
Principal Investigator: C. James Kissling, MD MDS Pharma Services, 621 Rose Street, Lincoln, NE 68502, USA

Layout table for additonal information
Responsible Party: Crucell Holland BV
ClinicalTrials.gov Identifier: NCT00656097     History of Changes
Other Study ID Numbers: RAB-M-A003
First Posted: April 10, 2008    Key Record Dates
Last Update Posted: September 21, 2011
Last Verified: September 2011

Keywords provided by Crucell Holland BV:
Rabies post-exposure prophylaxis

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