Tuesday, March 18, 2008

The Clinical Immunization Safety Assessment (CISA) Network: Conducting Clinical Research in Vaccine Safety

Brigid C. Batten, Immunization Safety Office, CDC, 1600 Clifton Rd, NE, MS D-26, Atlanta, GA, USA, Robert C. Sparks, Pediatric Clinical Research Office, Vanderbilt University Medical Center, 1161 21st Avenue South, CCC 5319 B MCN, Nashville, TN, USA, and Barbara A. Slade, Immunization Safety Office, Office of the Chief Science Officer, Centers for Disease Control and Prevention, 1600 Clifton Road, NE, MS D-26, Atlanta, GA, USA.

Learning Objectives for this Presentation:
By the end of the presentation participants will be able to:
1. Describe structure and function of CISA network
2. Identify priority CISA studies currently in progress

Immunizations are an effective method for improving public health. As vaccine preventable disease incidences fall, vaccine adverse events (VAE) become of higher concern among parents and vaccine providers.

CISA is a national network of six research centers (Boston Medical Center, Columbia University Medical Center, Johns Hopkins University, Northern California Kaiser Permanente, Stanford University and Vanderbilt University) with clinical and research expertise in immunization safety.

Individuals who experience VAEs of interest are identified through the Vaccine Adverse Event Reporting System (VAERS) or physician referral.

Project Description:
The CISA network was established in 2001 to investigate pathophysiologic mechanisms for VAEs, to study risk factors for VAEs (including genetic risk factors), and to provide evidence-based guidelines for evaluating VAEs and for revaccination after a VAE.

Results/Lessons Learned:
Current priority studies include genetic-risk factor studies for: (1) myopericarditis following smallpox immunization, (2) Guillain-Barré syndrome (GBS) after immunization, and (3) genetic associations with influenza vaccine response. CISA is following immunocompromised children who receive live viral vaccines (LVV) to develop guidelines for LVV use in these children. Evidence-based clinical guidelines under development include a guideline for revaccination of those who experience hypersensitivity reactions after immunization and a guideline for causality assessment of VAEs. Published studies include: irritant skin test reactions to common vaccines, role of genetics in the immune response to varicella vaccine, and extensive swelling reactions after the 5th dose of DTaP.