Immunogenicity and Safety of Verorab™ in Indian Population

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.

• 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:

1. To describe the immunogenicity profile of each regimen
2. To assess the safety of the vaccine in each group.

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