Randomized Phase II Trial on Safety and Neutralizing Activity of CL184 and Rabies Vaccine Versus Human Rabies Immune Globulin (HRIG) and Rabies Vaccine in Children and Adolescents

Study Overview
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Brief Summary
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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) in combination with rabies vaccine in healthy children and adolescents.

Official Title
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A Single-blind, Randomized, Monocentric Phase II Trial to Explore the Safety and Rabies-neutralizing Activity of Combined Administration of CL184 and Rabies Vaccine Versus Human Rabies Immune Globulin Plus Rabies Vaccine in Simulated Rabies Post-exposure Prophylaxis in Children and Adolescents

Conditions
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Rabies

Intervention / Treatment
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* Biological: CL184
* Biological: HRIG


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects free of obvious health-problems or with stable conditions Male or female subject aged ≥5 to ≤18 years Subject is living, studying, or working close to the study referral site Parent or legal representative signed written informed consent; in addition for subjects ≥12 years: signed assent form Exclusion Criteria: Prior history of rabies exposure or immunization (rabies vaccine and/or immune globulin) Acute infection or disease within the last 2 weeks History and/or family history of clinically significant immunodeficiency or auto-immune disease Any history of known or suspected anaphylaxis or hypersensitivity reaction Planned immunization with live vaccines during the next 3 months Chronic administration of immunosuppressants or other immune-modifying drugs within 6 months before the first dose of investigational medicinal product

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>CL184 combined with rabies vaccination | Biological: CL184<br>* CL184 20 IU/kg intramuscularly on Day 0; in conjunction with rabies vaccine on Days 0, 3, 7, 14, and 28<br>|
| Active Comparator: B<br>HRIG combined with rabies vaccination | Biological: HRIG<br>* HRIG 20 IU/kg intramuscularly on Day 0; in conjunction with rabies vaccine on Days 0, 3, 7, 14, and 28<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability |  | 42 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rabies virus neutralizing activity |  | 42 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Rabies post-exposure prophylaxis, Monoclonal antibody