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

September 15, 2011 updated by: Crucell Holland BV

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

140

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Nebraska
      • Lincoln, Nebraska, United States, 68502
        • MDS Pharma Services , USA

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

19 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Safety and tolerability
Time Frame: 42 days
42 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Rabies virus neutralizing activity
Time Frame: 42 days
42 days

Collaborators and Investigators

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

Sponsor

Crucell Holland BV

Investigators

  • Principal Investigator: C. James Kissling, MD, MDS Pharma Services, 621 Rose Street, Lincoln, NE 68502, USA

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

March 1, 2008

Primary Completion (Actual)

July 1, 2008

Study Completion (Actual)

July 1, 2008

Study Registration Dates

First Submitted

April 4, 2008

First Submitted That Met QC Criteria

April 9, 2008

First Posted (Estimate)

April 10, 2008

Study Record Updates

Last Update Posted (Estimate)

September 21, 2011

Last Update Submitted That Met QC Criteria

September 15, 2011

Last Verified

September 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RAB-M-A003

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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