infection, and malaria. The committee chose human papillomavirus, rotavirus, and pneumococcal infection as the test cases for evaluation; licensed vaccines currently exist for the causative agents of each of these three diseases.
The purpose of including these candidate vaccines in SMART Vaccines was to demonstrate the functionality of the software. Each vaccine candidate offers a scenario that may arise in the process of developing and delivering a new preventive vaccine. These scenarios may include decision points that arise in the development and distribution of a vaccine that is aimed at a particular disease and that has certain intended health and economic benefits.
Because vaccines for human papillomavirus, rotavirus, and pneumococcal infection currently exist, the committee considered their inclusion in the model as providing test examples of the process one goes through in developing improved vaccines by such methods as including adjuvants, increasing effectiveness, or reducing doses. Another reason for the selection of these three particular vaccines is that each targeted disease affects a different population and has different health implications: Human papillomavirus infects sexually active individuals and can lead to anal or cervical cancer over time; rotavirus affects children, and this burden is greater in low-income countries; pneumococcal disease is known to affect young children and the elderly population worldwide.
Disease profiles for these three diseases as well as for the diseases targeted by the vaccine candidates evaluated by the Phase I committee—influenza, tuberculosis, and group B streptococcus—are provided in Appendix B. A snapshot of the data needs for SMART Vaccines is presented in Table 3-1. Due to time constraints in the Phase I study, data for South Africa were collected only for tuberculosis; for the United States, data for influenza, tuberculosis, and group B streptococcus were collected.
In this study, the data for human papillomavirus, pneumococcal infection, and rotavirus were collected for both the United States and South Africa. Thus, a total of six datasets for the United States and four for South Africa are available as downloadable spreadsheets (along with the SMART Vaccines software package) on the Institute of Medicine and the National Academies Press websites. Data sources for the necessary parameters are provided in the spreadsheets along with explanatory notes and references. For ease of use, SMART Vaccines 1.0 contains these datasets pre-populated as defaults.