TY - JOUR
T1 - Animal models and antibody assays for evaluating candidate SARS vaccines
T2 - Summary of a technical meeting 25-26 August 2005, London, UK
AU - Roberts, Anjeanette
AU - Wood, John
AU - Subbarao, Kanta
AU - Ferguson, Morag
AU - Wood, David
AU - Cherian, Thomas
N1 - Funding Information:
The authors thank Dr. Marc P. Girard and Dr. Marie-Paule Kieny for their invaluable assistance in preparing the manuscript. The contributions of Anjeanette Roberts and Kanta Subbarao were supported in part by the intramural research program of NIH/NIAID.
PY - 2006/11/30
Y1 - 2006/11/30
N2 - Severe acute respiratory syndrome (SARS) emerged in the Guangdong province of China in late 2002 and spread to 29 countries. By the end of the outbreak in July 2003, the CDC and WHO reported 8437 cases with a 9.6% case fatality rate. The disease was caused by a previously unrecognized coronavirus, SARS-CoV. Drawing on experience with animal coronavirus vaccines, several vaccine candidates have been developed and evaluated in pre-clinical trials. Available data suggest that vaccines should be based on the the 180 kDa viral spike protein, S, the only significant neutralization antigen capable of inducing protective immune responses in animals. In the absence of clinical cases of SARS, candidate vaccines should be evaluated for efficacy in animal models, and although it is uncertain whether the United States Food and Drug Administration's "animal rule" would apply to licensure of a SARS vaccine, it is important to develop standardized animal models and immunological assays in preparation for this eventuality. This report summarizes the recommendations from a WHO Technical Meeting on Animal Models and Antibody Assays for Evaluating Candidate SARS Vaccines held on 25-26 August 2005 in South Mimms, UK, provides guidance on the use of animal models, and outlines the steps to develop standard reagents and assays for immunological evaluation of candidate SARS vaccines.
AB - Severe acute respiratory syndrome (SARS) emerged in the Guangdong province of China in late 2002 and spread to 29 countries. By the end of the outbreak in July 2003, the CDC and WHO reported 8437 cases with a 9.6% case fatality rate. The disease was caused by a previously unrecognized coronavirus, SARS-CoV. Drawing on experience with animal coronavirus vaccines, several vaccine candidates have been developed and evaluated in pre-clinical trials. Available data suggest that vaccines should be based on the the 180 kDa viral spike protein, S, the only significant neutralization antigen capable of inducing protective immune responses in animals. In the absence of clinical cases of SARS, candidate vaccines should be evaluated for efficacy in animal models, and although it is uncertain whether the United States Food and Drug Administration's "animal rule" would apply to licensure of a SARS vaccine, it is important to develop standardized animal models and immunological assays in preparation for this eventuality. This report summarizes the recommendations from a WHO Technical Meeting on Animal Models and Antibody Assays for Evaluating Candidate SARS Vaccines held on 25-26 August 2005 in South Mimms, UK, provides guidance on the use of animal models, and outlines the steps to develop standard reagents and assays for immunological evaluation of candidate SARS vaccines.
KW - Animal models
KW - Guidelines
KW - SARS virus
KW - Vaccines
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U2 - 10.1016/j.vaccine.2006.07.009
DO - 10.1016/j.vaccine.2006.07.009
M3 - Article
C2 - 16930781
AN - SCOPUS:33846242183
SN - 0264-410X
VL - 24
SP - 7056
EP - 7065
JO - Vaccine
JF - Vaccine
IS - 49-50
ER -