Immunogenicity and safety of a new Vero cell rabies vaccine produced using serum-free medium

Abstract The immunogenicity and safety of a new human rabies vaccine, produced in Vero cells by a process that does not require supplementation with human or animal derived components in production, were assessed. Thus, the objective is to produce a safer vaccine at a lower cost. A total of 296 volu...

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Bibliographic Details
Published in:	Vaccine Vol. 25; no. 48; pp. 8140 - 8145
Main Authors:	Costa, Wagner A, Cunha, Ricardo S, Bolzan, Vera Lucia, Silva, Andrea de Cássia R, Caporale, Graciane Maria M, Chaves, Luciana B, Oselka, Gabriel W, Junqueira, Dulce A, Panachão, Maria Rosana I, Dias, Ricardo A, Takaoka, Neide Y
Format:	Journal Article
Language:	English
Published:	Oxford Elsevier Ltd 23-11-2007 Elsevier Elsevier Limited
Subjects:	Adult Allergy and Immunology Animals Antibodies, Viral - biosynthesis Applied microbiology Biological and medical sciences Cercopithecus aethiops Fundamental and applied biological sciences. Psychology Humans Immunization Immunogenicity Medical research Microbiology Middle Aged Miscellaneous Rabies Rabies - drug therapy Rabies - epidemiology Rabies - prevention & control Rabies vaccine Rabies Vaccines - adverse effects Rabies Vaccines - immunology Rabies Vaccines - standards Rabies virus Rabies virus - immunology Safety Serum-free medium Side effects Treatment Outcome Vaccines Vaccines, antisera, therapeutical immunoglobulins and monoclonal antibodies (general aspects) Vero cell Vero Cells - virology Virology Serum-free medium Vero cell Rabies vaccine Serum free medium Nervous system diseases Toxicity Vaccine Rabies virus Infection Virus Mononegavirales Immunogenicity Rhabdoviridae Viral disease Rabies Lyssavirus
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Summary:	Abstract The immunogenicity and safety of a new human rabies vaccine, produced in Vero cells by a process that does not require supplementation with human or animal derived components in production, were assessed. Thus, the objective is to produce a safer vaccine at a lower cost. A total of 296 volunteers was divided into two groups: Group 1, which received the study vaccine, and Group 2, which received the Vero cells vaccine produced by Sanofi Pasteur. Five doses were given on days 0, 3, 7, 14 and 28. Blood samples for determination of rabies virus neutralizing antibodies were collected on days 0, 14, 38 and 90. The geometric mean titers (GMT) were much higher than 0.5 IU/ml in both groups on days 14, 38 and 90, indicating seroconversion according to the World Health Organization. In Group 1, however, the GMTs were higher than in Group 2, the difference being statistically significant in the two last samples. There was no statistical difference between the groups in the ratio of individuals with titers ≥0.5 IU/ml in each sample. Pain at the injection site was the most common adverse reaction and occurred most often in Group 1 ( p < 0.001). All cases had a favorable evolution. There were no severe adverse reactions. It was concluded that the new vaccine is safe and immunogenic.
Bibliography:	ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-Feature-2 content type line 23 ObjectType-Article-2 ObjectType-News-1 ObjectType-Feature-3
ISSN:	0264-410X 1873-2518
DOI:	10.1016/j.vaccine.2007.09.043