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Completed

NCT Number: NCT00656097

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 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.

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Key information

Conditions

Rabies Infections Mononegavirales Infections RNA Virus Infections Rhabdoviridae Infections Virus Diseases

Age range

19 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

MDS Pharma Services , USA

Lincoln, Nebraska, 68502, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CL184

Biological

CL184 20 IU/kg intramuscularly on Day 0; in conjunction with rabies vaccine on Days 0, 3, 7, 14, and 28

HRIG

Biological

HRIG 20 IU/kg intramuscularly on Day0; in conjunction with rabies vaccine on Days 0, 3, 7, 14, and 28

Placebo matching CL184

Biological

Placebo intramuscularly on Day0; in conjunction with rabies vaccine on Days 0, 3, 7, 14, and 28

Primary outcomes

  1. Safety and tolerability

    Time frame: 42 days

Secondary outcomes

  1. Rabies virus neutralizing activity

    Time frame: 42 days

Sponsors and collaborators

Lead sponsor

Crucell Holland BV

Industry

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Apr 10, 2008
Registry last updated
Sep 21, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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