Immunogenicity and Safety of Verorab™ in Indian Population

Study Overview
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Brief Summary
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To demonstrate that rabies vaccine administered according to the Thai Red Cross, (TRC)-ID regimen (2-2-2-0-1-1) is not inferior to rabies vaccine administered according to the ESSEN IM regimen in terms of Geometric Mean Titers (GMTs) at D28, in subjects with a WHO category III rabies exposure,or, To demonstrate that Rabies vaccine administered according to the ZAGREB-IM regimen (2-1-1) is not inferior to Rabies vaccine administered according to the ESSEN IM regimen in terms of GMTs at D28, in subjects with a WHO category III rabies exposure. Secondary objectives: To describe the immunogenicity profile of each regimen To assess the safety of the vaccine in each group.

Official Title
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Immunogenicity and Safety of Purified Vero Cell Rabies Vaccine (PVRV, Verorab™) Administered for Rabies Post-exposure Treatment. Comparison of Essen-IM, Zagreb-IM, and Thai Red Cross (TRC)-ID Regimens in the Indian Population.

Conditions
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Rabies

Intervention / Treatment
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* Biological: Purified Verocell Rabies Vaccine
* Biological: Purified Verocell Rabies Vaccine
* Biological: Purified Verocell Rabies Vaccine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject with WHO category III rabies exposure Subject aged at least 2 years old (day of second birthday) Exclusion Criteria: Subject unable to comply with the follow-up schedule of the protocol Delayed post-exposure treatment (>72 hours between incident and treatment Subject bitten by an observable animal at the inclusion visit Subject with immune-compromised or underlying diseases which may lead to inferior immune response Subject with known pregnancy at the time of inclusion Subject enrolled or scheduled to be enrolled in another clinical study. Subject with acute febrile illness/ axillary temperature > 37.5 degree celsius Subject in whom blood sampling will be difficult. Subject receiving chloroquine or other anti-malarial treatment Subject receiving immunosuppressive therapy, other immune-modifying drug or cytotoxic drugs Subject with known chronic illnesses (ie. heart, lung, kidney, liver) including immunosuppressive diseases (cancer, HIV, etc.) Previous rabies immunization Subject having received any vaccine within the previous 30 days, except tetanus toxoid and tetanus immunoglobulin Subject with clinical signs of rabies Subject with known allergy to vaccine components (e.g. neomycin) Subject who received blood and/or plasma transfusion within the past 3 months

Ages Eligible for Study
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Minimum Age: 2 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1<br>Participants on Thai Red Cross, TRC-ID regimen | Biological: Purified Verocell Rabies Vaccine<br>* 0.1 mL, ID (TRC regimen)<br>* Other names: PVRV, VERORAB;|
| Experimental: Group 2<br>Participants on Zagreb-IM regimen | Biological: Purified Verocell Rabies Vaccine<br>* 0.5 mL, IM (ZAGREB regimen)<br>* Other names: PVRV, VERORAB;|
| Experimental: Group 3<br>Participants on Essen-IM regimen. | Biological: Purified Verocell Rabies Vaccine<br>* 0.5 mL, IM (ESSEN regimen)<br>* Other names: PVRV, VERORAB;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immunogenicity: To provide information concerning the immune response of Purified Verocell Rabies Vaccine |  | 6 months post-vaccination | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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rabies;, rabies post-exposure;, category III