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Immunogenicity and safety of a new Vero cell rabies vaccine produced using serum-free medium.
Vaccine. 2007 Nov 23; 25(48):8140-5.V

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 > or =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.

Authors+Show Affiliations

aInstituto Pasteur, Secretaria de Estado da Saúde de São Paulo, Av. Paulista 393, 01311-000 São Paulo, Brazil. wagcosta@uol.com.brNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Randomized Controlled Trial

Language

eng

PubMed ID

18029066

Citation

Costa, Wagner A., et al. "Immunogenicity and Safety of a New Vero Cell Rabies Vaccine Produced Using Serum-free Medium." Vaccine, vol. 25, no. 48, 2007, pp. 8140-5.
Costa WA, Cunha RS, Bolzan VL, et al. Immunogenicity and safety of a new Vero cell rabies vaccine produced using serum-free medium. Vaccine. 2007;25(48):8140-5.
Costa, W. A., Cunha, R. S., Bolzan, V. L., Silva, A. d. e. . C., Caporale, G. M., Chaves, L. B., Oselka, G. W., Junqueira, D. A., Panacho, M. R., Dias, R. A., & Takaoka, N. Y. (2007). Immunogenicity and safety of a new Vero cell rabies vaccine produced using serum-free medium. Vaccine, 25(48), 8140-5.
Costa WA, et al. Immunogenicity and Safety of a New Vero Cell Rabies Vaccine Produced Using Serum-free Medium. Vaccine. 2007 Nov 23;25(48):8140-5. PubMed PMID: 18029066.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Immunogenicity and safety of a new Vero cell rabies vaccine produced using serum-free medium. AU - Costa,Wagner A, AU - Cunha,Ricardo S, AU - Bolzan,Vera Lucia, AU - Silva,Andrea de Cássia R, AU - Caporale,Graciane Maria M, AU - Chaves,Luciana B, AU - Oselka,Gabriel W, AU - Junqueira,Dulce A, AU - Panacho,Maria Rosana I, AU - Dias,Ricardo A, AU - Takaoka,Neide Y, PY - 2007/07/06/received PY - 2007/09/12/revised PY - 2007/09/15/accepted PY - 2007/11/22/pubmed PY - 2008/2/26/medline PY - 2007/11/22/entrez SP - 8140 EP - 5 JF - Vaccine JO - Vaccine VL - 25 IS - 48 N2 - 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 > or =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. SN - 0264-410X UR - https://www.unboundmedicine.com/medline/citation/18029066/Immunogenicity_and_safety_of_a_new_Vero_cell_rabies_vaccine_produced_using_serum_free_medium_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0264-410X(07)01071-7 DB - PRIME DP - Unbound Medicine ER -