Respiratory syncytial virus (RSV) infection is the major cause of severe respiratory illness in infants and young children, as well as in immune compromised individuals and the elderly. RSV infection of the lungs and respiratory tract leads to a range of illnesses varying from mild infection to life-threatening bronchiolitis and respiratory failure.

Recent epidemiological data indicates that over 3 million children under the age of 5 are hospitalized due to RSV- related infections each year, with over 200,000 deaths annually. There is also a growing body of evidence suggesting that RSV is responsible for significant morbidity among the elderly and in adults with underlying chronic illness. Limited treatment options are driving therapeutic research programs worldwide, including 51 RSV vaccine candidates currently under development.

Despite over 50 years of research, there remains no licensed vaccine product and disease due to RSV infection remains an unmet medical need.

In vitro & in vivo models for RSV vaccine development

providing a critical component in development of anti- RSV antibodies, small molecules and vaccines. The cotton rat (Sigmodon hispidus) has become a standard model for evaluation of RSV-specific vaccines, antivirals, and neutralizing antibodies (e.g., palivizumab) and has facilitated preclinical testing for anti-hRSV therapeutic modalities. Cotton rats are more permissive for hRSV replication than standard mouse models. The model has shown to be highly predictive. Synagis® advanced to clinical trials based on cotton rat efficacy and safety studies, obviating the need for testing in primates. The cotton rat model has also be utilized extensively to study the enhanced respiratory disease elicited by FI-RSV (Formalin inactivated-RSV) vaccination. Despite these benefits, the cotton rat model has several limitations. Compared to mice there are fewer available immunological reagents. Inbred strains of cotton rats are commercially available, but no transgenic or gene-deleted strains have been constructed. Cotton rats are far more difficult to handle than standard mouse strains and have special husbandry requirements.

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