A randomized non-inferiority clinical study to assess post-exposure prophylaxis by a new purified vero cell rabies vaccine (Rabivax-S) administered by intramuscular and intradermal routes
| Autor: | B R Harish, B J Mahendra, Radha Madhab Tripathy, Anuradha Bose, Shampur Narayan Madhusudana, Prasad S. Kulkarni, Kuryan George, Rajeev M. Dhere, Tapas Ranjan Behera, Ashwin Belludi Yajaman, Abhilash, Dipti Kumbhar, Venkata Raghava, Debasis Das Adhikari, Ashish Sahai, K Manjunath, Reeta S. Mani, Saket J. Thaker, Bhagwat Gunale, Renuka Munshi, Nithya J Gogtay, Reginald Alex, U M Thatte |
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| Rok vydání: | 2016 |
| Předmět: |
Adult
Male Adolescent Injections Intradermal Rabies medicine.medical_treatment 030231 tropical medicine India Antibodies Viral Injections Intramuscular 03 medical and health sciences Young Adult 0302 clinical medicine Rabies vaccine Chlorocebus aethiops medicine Animals Humans 030212 general & internal medicine Post-exposure prophylaxis Neutralizing antibody Adverse effect Child Vero Cells Aged General Veterinary General Immunology and Microbiology biology business.industry Immunogenicity Public Health Environmental and Occupational Health Middle Aged medicine.disease Antibodies Neutralizing Infectious Diseases Rabies Vaccines Child Preschool Immunology biology.protein Vero cell Molecular Medicine Female Antibody business Post-Exposure Prophylaxis medicine.drug |
| Zdroj: | Vaccine. 34(40) |
| ISSN: | 1873-2518 |
| Popis: | Background Rabies is a 100% fatal disease but preventable with vaccines and immunoglobulins. We have developed a new purified vero cell rabies vaccine (Rabivax-S) and evaluated its safety and immunogenicity in post-exposure prophylaxis by intramuscular (IM) and intradermal (ID) routes. Methods This was a randomized active-controlled non-inferiority study in 180 individuals (age 5 years and above) with suspected rabies exposure (90 each with WHO Category II and Category III exposures). The participants received either Rabivax-S (1 mL IM; five doses), Rabivax-S (0.1 mL ID; eight doses) or purified chick embryo cell vaccine (PCEC, Rabipur®) (1 mL IM; five doses). The IM doses were given on Day 0, 3, 7, 14 and 28 while the ID doses were given on days 0, 3, 7 and 28. Category III patients also received a human rabies immunoglobulin (HRIG) on Day 0. Adverse events (AEs) were recorded with diary cards till day 42. Rabies neutralizing antibody levels were measured on day 0, 7, 14, 28 and 42. Results In both the category II and III patients, the geometric mean concentration (GMC) ratios of Rabivax-S IM and Rabivax-S ID groups to PCEC IM were more than 1, thus proving the non-inferiority. GMCs were similar or higher in Rabivax-S groups at all the time points. Seroresponse against rabies (RFFIT titre ⩾ 0.5 IU/mL) was achieved in all participants. Mostly mild local and systemic adverse events were reported across the three groups and all resolved without sequelae. Conclusions Rabivax-S was well tolerated and showed immunogenicity comparable to a licensed rabies vaccine by both IM and ID routes in post-exposure prophylaxis. Registry No.: CTRI/2012/11/003135 |
| Databáze: | OpenAIRE |
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