Kathleen Fullerton1, Christine G. Casey
2, Robert Pless
3, Scott R Campbell
1, and Robert Chen
4. (1) Vaccine Safety and Development Activity, Epi and Surv Division, CDC, 1600 Clifton Road, Mailstop E-61, Atlanta, GA, USA, (2) NIP - Vaccine Safety and Development Activities, CDC, 1600 Clifton Rd NE MS-E61, Atlanta, GA, USA, (3) NIP/ESD/VSDA, Centers for Disease Control and, 1600 Clifton Road, MS E-61, Atlanta, GA, USA, (4) NIP/vsda, CDC, 1600 clifton Rd. NE, mail stop e-61, atltanta, USA
KEYWORD1:
vaccine safety, adverse events, smallpox, clinical evaluation network, expertise, VAERS, public confidence, standardization
BACKGROUND:
The Clinical Immunization Safety Assessment (CISA) Network was established in 2001. This Network of seven centers of academic excellence (Johns Hopkins University, The University of Maryland, Northern California Kaiser, Stanford University, Vanderbilt University, Boston University Medical Center, and Columbia-New York Presbyterian Hospital) was developed to improve the scientific understanding of vaccine safety issues at the individual patient level and to serve as a source of clinical expertise in the management of adverse events following immunization. Through this work CISA aims to increase public confidence in vaccines.
OBJECTIVE:
In the first year, the objectives of CISA were to 1) initiate the development of clinical evaluation and management protocols, 2) develop research protocols, and 3) develop its informatics infrastructure to facilitate efficient sharing of data Network-wide.
METHOD:
Hypotheses for research protocols were generated through systematic review of adverse events submitted to the Vaccine Adverse Event Reporting System (VAERS). Development of clinical evaluation and management protocols was determined by the national priority of bioterrorism preparedness.
RESULT:
Protocols developed include clinical guideline protocols and algorithms for the management of adverse events following smallpox (vaccinia) vaccination. In particular, smallpox protocols were developed for neurological, generalized and localized dermatological complications, and a treatment protocol for the use of Vaccinia Immune Globulin (VIG) and Cidofovir (CDV). Other clinical research protocols developed cover a variety of vaccine safety hot topics. The Network is set to begin a DTaP revaccination study to address pathophysiology and immunogenicity in 2003. CISA will provide clinical consultation in the Smallpox Immunization Safety System (SISS).
CONCLUSION:
In its initial year, CISA produced clinical research protocols and algorithms and began development of its informatics infrastructure. The foundation for a successful research future has been laid.
LEARNINGOBJECTIVES:
To provide an update on CISA Network protocols and research topics.
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